Clinical trial NCT02061280
Conditions: Asthma
Keywords: Asthma Clinical Trial Design Electronic Data Entry Mobile Devices Home Spirometry
Sponsor: Nemours Children's Clinic
Start date: 2013-10-01; Completion date: 2017-02-17
Enrollment: 108 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
Asthma is an inflammatory disease that imposes a significant burden affecting an estimated 300 million persons and 20% of all children worldwide. It is one of the most common chronic diseases of childhood and is a leading cause of school absenteeism. There continues to be a great need for clinical trials in asthma but traditional clinical trials are expensive and reasons cited by patients for non-participation are extra inconvenience and logistical barriers. Study designs which are patient centered and reduce trial costs are needed. The long-range goal of this application is to transform the paradigm of clinical research into a more efficient and cost-effective enterprise by capitalizing upon current widely used mobile electronic means of communication and information transfer.

This innovative project is a streamlined clinical trial that will run concurrently with a nearly identical traditional clinical trial, "Long-acting Beta Agonist Step Down Study" (LASST) which will allow for direct comparison of processes and outcomes between the streamlined and traditional approach. Children 12 to 17 years old with asthma will be randomized to participate in this project (streamlined trial) or LASST (traditional trial). In this proposal we will: measure comprehension of study information using an original questionnaire, Research Participant Assessment (developed at Nemours), following a parental permission/assent process delivered over the internet in a dynamic interactive multi-media format (Specific Aim 1); measure the efficiency of participant driven data entry from home into a Research Electronic Data Capture (REDCap) online database using the iPad, and quality of spirometry with the EasyOne Plus handheld meter with remote coaching using the iPad (Specific Aim 2); test whether the streamlined approach has a "trial effect" by comparing the differences in Asthma Control Test (ACT) scores following 12 weeks of study drug treatment in children randomized to this project compared to LASST. We will collect effort reporting data to compare personnel costs between the trials. If this streamlined project lacks a "trial effect" and reduces costs compared to LASST, the methodologies would be generalizable to studies which include adults and other diseases.

Detailed description:
Introduction Phase III / IV clinical trials are expensive and time consuming and often suffer from poor enrollment and retention rates. Pediatric trials are particularly difficult because scheduling around the parent, participant and potentially other sibling schedules can be burdensome. We are evaluating using the internet and mobile devices to conduct the consent process and study visits in a streamlined pediatric asthma trial. Our hypothesis is that these study processes will be noninferior and will be less expensive compared to a traditional pediatric asthma trial.

Materials/Methods Parents and participants, aged 12 through 17 years, complete the informed consent process by viewing a multi-media website containing a consent video and study material in the streamlined trial. Participants are provided an iPad with WiFi (wireless internet) and EasyOne spirometer for use during FaceTime visits and online twice daily symptom reporting during an 8-week run-in followed by 12-week study period. Outcomes are compared with participants completing a similarly designed traditional trial comparing the same treatments within the same pediatric health-system. After 8 weeks of open-label Advair 250/50 twice daily, participants in both trial types are randomized to Advair 250/50, Flovent 250, or Advair 100/50 given 1 inhalation twice daily. Study staff track time spent to determine study costs.

Results Participants have been enrolled in the streamlined and traditional trials and recruitment is ongoing.

Conclusions This project will provide important information on both clinical and economic outcomes for a novel method of conducting clinical trials. The results will be broadly applicable to trials of other diseases.

Arms: arm 1: Participants randomized to MICT will complete study procedures using an iPad for data entry and FaceTime visits rather than coming into the study site for onsite visits. Participants will perform spirometry at home using a handheld spirometer, EasyOne Plus.

Randomized to one of 3 study treatments:

fluticasone/salmeterol 250/50 Dry Powder Inhaler one inhalation twice daily, or fluticasone/salmeterol 100/50 Dry Powder Inhaler one inhalation twice daily, or fluticasone 100mcg Dry Powder Inhaler one inhalation twice daily arm 2: Participants randomized to LASST will complete study procedures in the traditional format in which all study visits are conducted at the study site, all questionnaires are completed by pen/paper, and all spirometry is performed at the clinic site.

Randomized to one of 3 study treatments:

fluticasone/salmeterol 250/50 Dry Powder Inhaler one inhalation twice daily, or fluticasone/salmeterol 100/50 Dry Powder Inhaler one inhalation twice daily, or fluticasone 100mcg Dry Powder Inhaler one inhalation twice daily.
Interventions: intervention 1: fluticasone/salmeterol 250/50 Dry Powder Inhaler intervention 2: fluticasone/salmeterol 100/50 Dry Powder Inhaler intervention 3: fluticasone 100mcg Dry Powder Inhaler
Intervention descriptions: intervention 1: Participants will receive Advair Diskus 250/50 Dry Powder Inhaler, administered twice daily for 12 weeks after randomization intervention 2: Participants will receive Advair Diskus 100/50 Dry Powder Inhaler administered twice daily for 12 weeks after randomization intervention 3: Participants will receive Flovent Diskus 100mcg Dry Powder Inhaler administered twice daily for 12 weeks after randomization

Protocol documents:
ICF_005.pdf: 
Approved by the Nemours IRB: 
Valid from: 
04/04/2014 
through 
04/03/2015 
IRB# JAX: 
332965 
 
 
 
 
 
 
Abbreviated Study Title: 
LASST RPA Ancillary 
 
Template Version Date: 06-13 
Version Date: 04/19/2013 
Page 1 of 7 
NEMOURS  
Jacksonville, FL 
PARENTAL PERMISSION AND INFORMED CONSENT FOR PARTICIPATION IN A RESEARCH STUDY 
 
You have been asked to be in a research study with your child. This form explains the research, your rights 
and your child’s rights as research participants, and any responsibilities that you may have as a result of 
you and your child’s participation.  You should understand the research study before you agree to be in it 
and to permit your child to be in it. Read this form carefully. You may also talk with your family or 
friends about it.  A research team member will answer any questions you have before you make a 
decision. 
 
1. WHAT IS THE TITLE OF THE STUDY? 
Long-Acting Beta Agonist Step Down Study (LASST) – Ancillary Study “Assessment of the Research 
Consent Process” 
 
2. WHO IS IN CHARGE OF THE STUDY AT NEMOURS? 
If you have a question, complaint, or problem related to the study, you can call the investigator anytime at 
the numbers listed below. 
 
 
Nemours - 
Jacksonville 
Nemours - Delaware 
Nemours – Orlando 
Nemours – Pensacola 
Principal 
Investigator 
Kathryn Blake, PharmD 
Co-Investigators 
John Lima, PharmD 
 
David Schaeffer, MD 
Division of Pulmonology 
 
Tim Wysocki, PhD 
 
Holly Antal, PhD 
Behavioral Pediatrics 
 
Paul Garfinkel, MSH 
Aaron Chidekel, MD 
Division of Pulmonology 
 
Christopher Chang, MD 
Division of 
Allergy/Immunology 
 
Jason Lang, MD 
Division of Pulmonology 
 
To be named   
Division of Pulmonology 
Address 
Nemours Children’s 
Clinic 
807 Children’s Way 
Jacksonville, FL  32207 
Alfred I. duPont Hospital 
for Children 
1600 Rockland Rd. 
Wilmington, DE 19803 
 
Nemours Children’s 
Clinic 
1717 S. Orange Ave., 
Suite 100 
Orlando, FL  32806 
 
13535 Nemours 
Parkway, Orlando, 
Florida 32827 
Nemours Children's Clinic-
Pensacola 5153 N. 9th 
Ave Pensacola, FL 32504 
Daytime Phone 
 
 
 
 
 
 
 
 
 
 
Day: (904) 697-3788 
(Division of 
Pulmonology) 
 
Day: (904) 697-3529 
(Research) 
 
Day: (904) 697-3785 
(Behavioral Pediatrics) 
 
 
Day: (302) 651- 6400 
(Division of 
Pulmonology) 
 
Day: (302) 651-4200 
(Division of 
Allergy/Immunology) 
 
Day: (302) 651-6536 
(Research) 
 
Day: (407) 650-7270 
(Division of 
Pulmonology) 
 
Day: (407) 650-7175 
(Research) 
 
 
 
 
 
(850) 473-4553 
 
 
 
 
 
 
 
 
 
 


Approved by the Nemours IRB: 
Valid from: 
04/04/2014 
through 
04/03/2015 
IRB# JAX: 
332965 
 
 
 
 
 
 
Abbreviated Study Title: 
LASST RPA Ancillary 
 
Template Version Date: 06-13 
Version Date: 04/19/2013 
Page 2 of 7 
After Hours Phone 
(Nemours operator) 
 Night: (904) 697-3600 
 
 
 
 
Night: 302-651-4000 
(Nemours operator) 
 
Night: (407) 650-7000 
(Nemours Operator) 
(850) 505-4700 
Long Distance  
1-(800) SOS-KIDS (1-800-767-5437) 
 
 
3. WHO SHOULD RESEARCH PARTICIPANTS CONTACT ABOUT THEIR RIGHTS? 
If you have questions about your or your child’s rights as a research subject, what to do if you or your child 
is injured, if you would like to offer input or obtain information, or if you cannot reach the investigator or want 
to talk to someone else who is not involved with this research, you may contact the persons listed below. 
Carlos Rose, M.D., Co-chair, Nemours Institutional Review Board 2 at (302) 651-5970.  
Paul Garfinkel, MSH, Director, Nemours Office for Human Subjects Protection, at (904) 697-4023. 
Email address: NOHSP@nemours.org. 
 
4. WHAT IS THE PURPOSE OF THE STUDY? 
We know that a lot of parents and their children do not always fully understand medical information given to 
them about being in a study.  We are trying to find ways to improve how well a parent who is considering 
having their child participate in a research study understands the medical information given to them.   
 
But first, we have to find out how well the study staff and the parent communicate on important medical 
information a parent needs to know before their child enters the study.  The purpose of this study is to 
evaluate how well study information is communicated between the parent and study staff and also between 
your child and the study staff. 
 
5. WHO IS SPONSORING OR PAYING FOR THE STUDY? 
The National Institutes of Health is the Sponsor of this study.  The National Institutes of Health will pay 
Nemours its costs in conducting this study.  
 
6. WHO CAN BE IN THE STUDY? 
Any parent and their child who is 12 to 17 years old and who is being screened for the main study “Long-
Acting Beta Agonist Step Down Study” can be in this study.     
 
7. HOW MANY OTHER PEOPLE WILL BE IN THE STUDY? 
Overall about 150 parents (mother, father, or legal guardian) and their child who is screening for the main 
study “Long-Acting Beta Agonist Step Down Study” will be enrolled in this study.  Participants will be 
enrolled from Nemours Children’s Clinic in Jacksonville, Orlando, and Pensacola, Florida, and Wilmington, 
Delaware. 
 
8. HOW LONG WILL PARTICIPATION IN THE STUDY LAST? 
Participation will last for about a little over 1 hour at the screening visit for the main study.  At Visit 6 (20 
weeks from now), we will need about 30 minutes to complete the study procedures.  
 
9. WHAT ARE THE RESEARCH PROCEDURES? 
After you and your child agree to be in this study, you will be given the parental permission form for your 
child that explains the main study “Long-Acting Beta Agonist Step Down Study”.  Your child will be given a 


Approved by the Nemours IRB: 
Valid from: 
04/04/2014 
through 
04/03/2015 
IRB# JAX: 
332965 
 
 
 
 
 
 
Abbreviated Study Title: 
LASST RPA Ancillary 
 
Template Version Date: 06-13 
Version Date: 04/19/2013 
Page 3 of 7 
form explaining the study also.  After you and your child have had a chance to review the forms, the 
coordinator will sit down with both of you and review each section of the form in detail and ask you/your 
child what questions you/your child may have as you go along.  The conversation between you/your child 
and the study staff will be audio recorded on the computer and later analyzed at Nemours.  After you/your 
child and the study staff review the form, the study staff will ask you/your child some questions about the 
study.  The audio recording will continue for this part too.  There will be plenty of time for the study staff to 
answer all your questions. 
 
After the study staff has finished with the questions and you and your child have signed the forms, there is 
one last short part we need for this study.  To help us learn how well patients and in this case, you as a 
parent, understand general medical information, we will give you and your child some health information to 
look at and then ask you a few questions about that information.  Your answers will help doctors learn how 
to provide medical information in ways that parents and their children will understand.  This part will take 
about 3 to 5 minutes. 
 
At Visit 6 of the main study, the study staff will repeat the audio recording and have you and your child 
complete the same questionnaire that asks about the study information.  It is necessary that the same 
parent come with their child at the screening visit and again at Visit 6.  This is to help us understand how 
well the study staff communicates the study information to you and your child throughout the study. 
 
10. WHAT ARE POSSIBLE RISKS OF BEING IN THIS STUDY? 
Any research has some risks (things that could make you or your child sick, feel uncomfortable, or hurt).  
However, there are no known risks with being in this study. 
 
11. WHAT ARE POSSIBLE BENEFITS OF BEING IN THIS STUDY? 
There may be no direct benefit to you from taking part in the study.  You may feel better knowing that by 
being in this study, you may help others.  The information from this study may be helpful in the future to 
other people with asthma.  
 
12. WHAT HAPPENS IF A PROBLEM OR INJURY RESULTS FROM THE RESEARCH PROCEDURES? 
There are no health problems or injury that could result from the procedures in this study. 
 
13. IS BEING IN THE STUDY VOLUNTARY? 
Being in this study is totally voluntary.  Anyone who takes part in the study can stop being in it at any time. 
There will be no change to your child’s usual medical care if you and/or your child decide not to be in the 
study or decide to stop being in the study.  No one will be angry with you or your child, or treat your child 
any differently than before your child was asked to be in the study. 
 
If you stop your/your child’s participation in this study, your child may continue treatment with his/her doctor, 
or you may seek treatment for your child from another doctor of your choice.  You may ask the researcher 
to destroy your/your child’s information.  Your request must be in writing.  The researcher will tell you if this 
is possible.  There may be legal reasons for keeping your child’s information. 
 
14. WHAT OPTIONS ARE AVAILABLE OTHER THAN BEING IN THIS STUDY? 
You can refuse to participate in this study.   
 
15. CAN THE RESEARCHERS REMOVE SOMEONE FROM THE STUDY?  
There is no reason for the researchers to remove anyone from this study. 


Approved by the Nemours IRB: 
Valid from: 
04/04/2014 
through 
04/03/2015 
IRB# JAX: 
332965 
 
 
 
 
 
 
Abbreviated Study Title: 
LASST RPA Ancillary 
 
Template Version Date: 06-13 
Version Date: 04/19/2013 
Page 4 of 7 
 
16. WHAT ARE THE COSTS OF BEING IN THIS STUDY? 
There will be no cost for your participation in this study.   
 
17. WILL PEOPLE BE PAID FOR BEING IN THIS STUDY? 
Your child will receive a $10 Walmart gift card at this visit and Visit 6 for participating in this audio-recording 
of the communication between you, your child, and the study staff. There is additional payment if your child 
participates in the main study, “Long-Acting Beta Agonist Step Down Study” which is described in the 
documents for that study. 
 
18. WILL I BE TOLD OF ANY NEW INFORMATION THAT MIGHT AFFECT MY WILLINGNESS TO STAY 
IN THE STUDY? 
There will not be any new information to give you after you finish this study. 
 
A description of this clinical trial will be available on http://www.ClinicalTrials.gov, as required by U.S. Law if 
it is funded by the National Institutes of Health. This web site will not include information that can identify 
you or your child. At most, the web site will include a summary of the results. You can search this web site 
at any time. 
 
19. WHAT INFORMATION ABOUT ME WILL BE USED OR DISCLOSED?   
Identifiable health information about you or your child will be used by Nemours researchers and may be 
given to people outside of Nemours for this research. This is done to conduct the research study, to monitor 
the safety of research participants and for auditing. Federal law requires us to tell you about, and get your 
approval for research use and disclosure of health information that includes “identifiers” that can connect 
the health information to you or your child. (Names, initials, date of birth, addresses, phone numbers, and 
social security numbers are examples of identifiers.) This Identifiable health information is called Protected 
Health Information (PHI). 
 
Use of Health Information by Nemours Staff 
The health information that will be used within Nemours includes all data collected for this study, as 
described in Section 9 of this form. 
 
Your identity and your child’s identity will be protected as much as possible.  Nemours protects your and 
your child’s health information by storing records in files or computers that can only be used by authorized 
Nemours staff.  Study staff will assign you a unique number and special code that will be used in place of 
your name.  All of your data will also be given this code.     
 
The people within Nemours that may use this health information include: 
• 
The investigators listed on the first page of this permission form and their staff,  
• 
The Nemours Institutional Review Board (IRB) (The IRB is a group of people that reviews research 
activities.  The IRB is responsible for the safety and rights of research participants), and; 
• 
Nemours internal audit staff. 
 
Disclosure of Identifiable Health Information to Others  
Information from this research study will also be contained in your child’s Nemours’ medical record if they 
are seen at Nemours, along with the information about your child’s regular office visits. This will help other 
doctors to know about the research study your child is in and give them extra information from the research 


 
Approved by the Nemours IRB: 
Valid from: 
04/04/2014 
through 
04/03/2015 
IRB# JAX: 
332965 
 
 
 
 
 
 
Abbreviated Study Title: 
LASST RPA Ancillary 
 
Template Version Date: 06-13
Version Date: 04/19/2013 
Page 5 of 7 
that might help them take better care of your child. The same information might also be seen by anyone 
who can look at your child’s medical records, such as your insurance company.  
 
The PHI that will be given (disclosed) to people or groups outside of Nemours for research purposes are 
checked in the table below: 
Type of Identifiable Health Information: 
Disclosed  
History and Physical 
 
Results of Procedures 
 
Demographics (information about race, ethnicity, gender, age, DOB) 
 
Questionnaires
Routine lab results 
 
Alpha-numeric code (using participants initials) 
 
 
Limits on Protection of Privacy and Confidentiality 
Only health care organizations have to follow laws and rules about protecting the privacy of health 
information. If health information containing peoples' identities is given to other kinds of companies or 
organizations, they are not required by law to safeguard the privacy and confidentiality of that information. 
Nemours expects these companies and organization to protect the privacy and confidentiality of research 
participants, but it is not possible for Nemours researchers to assure that this happens. 
 
Government agencies that may look at records for this research study, including the above health 
information, include: 
• The U.S. Food and Drug Administration  
• The U.S. Department of Health and Human Services  
• Other agencies of State and local government as required by law 
 
The research results may be presented at scientific meetings or in print.  Participants' identities will not be 
disclosed in those presentations. 


Approved by the Nemours IRB: 
Valid from: 
04/04/2014 
through 
04/03/2015 
IRB# JAX: 
332965 
 
 
 
 
 
 
Abbreviated Study Title: 
LASST RPA Ancillary 
 
Template Version Date: 06-13 
Version Date: 04/19/2013 
Page 6 of 7 
 
20. SIGNATURES: 
I am making a decision whether or not to consent to participate and to permit my child to participate in this 
study. I understand that my child may also have to agree to participate in the study before he/she will be 
allowed to be in this study.  I have read, or had read to me in a language that I understand, all of the above. 
I have been given enough time to make this decision. I have asked questions and received answers about 
things I did not understand.  I willingly consent to participate and give permission for my child to participate 
in this study.  By signing this form, I am not giving up any rights to which I am entitled under law. 
 
I understand that: 
• 
I can withdraw permission for participation in this study and for the use and/or disclosure of PHI by 
contacting the person in charge of the study listed on the first page of this form.   
• 
The use and/or disclosure of my / my child’s PHI will stop after Nemours receives the withdrawal notice.  
Information that is used or disclosed before the withdrawal may still be used. 
• 
Unless I withdraw permission, the use and/or disclosure of PHI described in this form will not have an 
expiration date.   
• 
My / my child’s PHI may be disclosed again by the person or organization (other than Nemours) that 
receives it.  If this happens, Federal or state law may not protect the information. 
• 
I have the right to refuse to sign this permission form. 
• 
If I refuse to sign this permission form, I / my child will not be allowed to be in this research study. 
• 
I have the right to ask Nemours to tell me who has received my / my child’s protected health information.  
• 
I have the right to revoke my permission for the use and disclosure of my / child’s health information at 
any time, which would end my / my child’s participation in this study. 
• 
I will receive a signed and dated copy of this form. 
 
My signatures indicate that: 
• 
I give the researchers and Nemours permission to use and/or disclose my / my child’s individually 
identifiable health information, for this research study, as described in Section 19.  
• 
As his or her parent or guardian, I give my permission for the minor child named below to participate and 
give consent for my participation in the research study described in this form. 
 
 
Name of Adult Participant (Print) 
 
Signature of Adult Participant 
 
 
 
 
Name of Minor Participant (Print) 
 
Minor Participant Date of Birth: 
 
 
 
 
 
 
 
Signature of  
 
Printed Name of  
 
Date 
Parent /  Guardian 
 
Parent / Guardian 
 
 
 
 
 
 
 
Check Relation to Minor Participant:    __ Parent   __  Guardian: (Guardians must have documented 
authority to give permission for participation in a research study according to the laws of the State in which 
the treatment occurs.)  
 
 


Approved by the Nemours IRB: 
Valid from: 
04/04/2014 
through 
04/03/2015 
IRB# JAX: 
332965 
 
 
 
 
 
 
Abbreviated Study Title: 
LASST RPA Ancillary 
 
Template Version Date: 06-13 
Version Date: 04/19/2013 
Page 7 of 7 
I the undersigned, certify that to the best of my knowledge the parent/legal representative signing this 
consent/permission form had the study fully and carefully explained and that he/she understands the nature, 
risks and benefits of participation in this research study. 
 
 
 
 
Name of Person Obtaining 
permission (Investigator or Designee) 
 
Signature of Person Obtaining 
permission 
 
Date 
 
Copy of the signed form was provided to Parent/ Guardian on [Date] ___________ 

ICF_002.pdf: 
Approved by the Nemours IRB: 
Valid from: 
09/04/2015 
through 
09/03/2016 
IRB# JAX: 
288148 
 
Abbreviated Study Title: 
LASST 
 
Version November 2014 
 
 
 
 
Page 1 of 3 
Continuing Review 2015 
ADOLESCENT ASSENT FORM FOR YOUTH AGES 12-17 
Version November 2014 
 
Your parent has given permission for you to be in a project called a research study. But first, we want to tell 
you all about it so you can decide if you want to be in it. If you don’t understand, please ask questions. You can 
choose to be in the study, not be in the study or take more time to decide. 
 
What is the name of the study? 
Long-Acting Beta Agonist Step Down Study (LASST) 
 
Who is in charge of the study? 
The doctor in charge of the study is Dr. Kathryn Blake.  
 
What is the study about? 
We would like to find out what is the best way to decrease the amount of asthma medicine that people with 
asthma take and still be well controlled. 
 
Why are you asking me to be in this study? 
You are being asked to be in the study because you are between the ages of 12 and 17, have asthma that is 
well controlled and you are on a combination of medications called inhaled corticosteroids (ICS) and long-
acting beta agonists (LABA).   
 
What will happen to me in the study? 
If you decide to be in the study, here is what will happen:  
• 
You will be in the study for up to 56 weeks (13 months) and come to the clinic for 11 scheduled visits.   
• 
You will take study medication two times each day and write down that you took it.  The study 
medication will either be Advair or Flovent.  Neither you, your parents, the nurses, nor the study 
doctors will know which medication you are taking.   
• 
You will blow in to a tube called a Peak Flow Meter every morning and write down the number. 
• 
You will write down some additional information about how you are feeling and any other medicines 
you are taking for asthma each day.   
• 
You will come in for visits about once every 4 to 6 weeks.  The nurse will ask you lots of questions 
about your health and asthma.  You will be asked if you smoke, about your menstrual periods (girls 
only), and if you are on birth control (girls only), but you will be asked this privately.   
• 
You will have some tests done to check how you breathe. You will take deep breaths in and blow out 
hard and fast through a tube. You will be given albuterol. 
• 
A doctor will listen to your heart, your lungs, and check your stomach, eyes, and throat.  This will be 
done at the start and end of the study and at 2 follow up visits.   
• 
You will complete forms that ask you lots of questions about your asthma and how you feel.   
• 
You will pee in a cup two times (for girls only).   
• 
You will also have some blood taken for tests using a needle one time. If requested, a numbing cream 
can be used to help ease the pain associated with the blood draw. 
• 
You have to come see the study doctor when told to. You need to tell the study doctor or nurse if you 
do not feel well or if anything is wrong. You also need to tell them about any other medicines you are 
taking. 
• 
Your information and leftover samples of blood will be saved and might be used in future research 
about other diseases related to asthma and allergy. 


Approved by the Nemours IRB: 
Valid from: 
09/04/2015 
through 
09/03/2016 
IRB# JAX: 
288148 
 
Abbreviated Study Title: 
LASST 
 
Version November 2014 
 
 
 
 
Page 2 of 3 
Continuing Review 2015 
There are often some risks to people who take part in research studies. The main risks that you would face by 
taking part in this study are:  
• 
There might be side effects of the study medication that we don't know yet. If you feel different during 
the study please let your parent and the study staff know. You could have a rare allergic reaction.
• 
Drawing blood may hurt when the needle is first put in your skin. Sometimes you may feel dizzy or you may 
get a bruise.   
• 
Some of the breathing tests may leave you light-headed or tired.   Albuterol could also make you feel 
shaky.   
• 
You might feel embarrassed and bored by some of the questions and procedures.   
 
Taking part in this research may also cause some good things to happen to you. The medicine may help you 
have less asthma symptoms and you may feel better knowing that this study may help others. You will also get 
a peak flow meter to use during the study.  This device will help you keep closer track of your asthma.  You 
can keep it after the study is over.  
 
Information for girls who have started having periods or might begin having periods during the study.   
We do not know if the research procedures (such as drugs or tests) could hurt an unborn baby.  For this 
reason, you should not become pregnant while you are in this study.  If you are having sex, you should use 
effective birth control to prevent pregnancy.  The study doctor may talk to you about effective methods of birth 
control.  
 
Girls can sometimes become pregnant even when using birth control.  For this reason, we will be doing 
pregnancy tests.  We will tell you the results of any pregnancy test that is done during the study.  By law, you 
have a right to confidentiality when talking about pregnancy and birth control with a doctor.  This information 
will be shared with your parents only if you agree.  
 
You should tell the study doctors immediately if you think that you might be pregnant during the study. Anyone 
who is pregnant may be taken out of the study. If this happens, other people may realize that you are pregnant.  
We encourage open honest communication between children and their parents about sexual activity and 
possible pregnancy.  
 
Will I be paid to be in this study? 
You will be paid for being in this study. You will be paid up to $825 for completing all the study visits.  You will 
receive payments for each visit except for the phone visit.  If you decide that you should leave the study before 
finishing all visits, you will be paid for the parts you have completed. We also offer the opportunity for students 
to earn community service hours for participating in this study; our staff will be pleased to complete the 
required paperwork. 
 


Approved by the Nemours IRB: 
Valid from: 
09/04/2015 
through 
09/03/2016 
IRB# JAX: 
288148 
 
Abbreviated Study Title: 
LASST 
 
Version November 2014 
 
 
 
 
Page 3 of 3 
 
Do I have to be in the study?   
You don’t have to do the study if you don’t want to. If you are in the study, you can stop being in it at any time. 
Nobody will be upset with you if you don’t want to be in the study or if you want to stop being in the study. The 
doctors and nurses will take care of you as they have in the past. If you have any questions or don’t like what is 
happening, please tell the doctor or nurse. 
 
You have had the study explained to you. You have been given a chance to ask questions. By writing your 
name below, you are saying that you want to be in the study. 
 
 
 
Name of Adolescent (Print) 
 
Date 
 
 
Signature of Adolescent 
 
 
Name of Person Obtaining Assent (Print) 
 
Date 
 
 
Signature of Person Obtaining Assent 
 

ICF_007.pdf: 
Approved by the Nemours IRB: 
Valid from: 
02/05/2016 
through 
02/04/2017 
IRB# JAX: 
332965 
 
 
 
 
 
 
Abbreviated Study Title: 
MICT 
 
Revised 10/08/2013  
Page 1 of 3 
 
NEMOURS 
Parental Permission and Informed Consent for Participation in the Asthma Research Study 
(revision date 10/08/2013) 
 
Title of Study: 
Use of Mobile Devices and the Internet to Streamline an Asthma Clinical Trial  
 
I am making a decision whether or not to consent to participate and to permit my child to participate in this 
study.  I understand that my child may also have to agree to participate in the study before he / she will be 
allowed to be in this study.  I have watched the Asthma Research Study video and reviewed the other 
information on the website. I have been given enough time to make this decision.  I have asked questions 
and received answers about things I did not understand.  I willingly consent to participate and give 
permission for my child to participate in this study.  By electronically signing this form, I am not giving up 
any rights to which I am entitled under law. 
 
I understand that: 
• 
I can withdraw permission for participation in this study and for the use and/or disclosure of 
(Protected Health Information) PHI by contacting the persons in charge of the study.   
• 
The use and/or disclosure of my / my child’s PHI will stop after Nemours receives the withdrawal 
notice.  Information that is used or disclosed before the withdrawal may still be used. 
• 
Unless I withdraw permission, the use and/or disclosure of PHI, that is described in the section of 
the Video called “Protecting your Privacy” and the sidebar material, will not have an expiration date.   
• 
My / my child’s PHI may be disclosed again by the person or organization (other than Nemours) 
that receives it.  If this happens, Federal or state law may not protect the information. 
• 
I have the right to refuse to sign this permission form. 
• 
If I refuse to sign this permission form, I / my child will not be allowed to be in this research study. 
• 
I have the right to ask Nemours to tell me who has received my / my child’s protected health 
information.  
• 
I have the right to revoke my permission for the use and disclosure of my / my child’s health 
information at any time, which would end my / my child’s participation in this study. 
• 
I can download or print an electronically signed and dated copy of this form for my records from my 
child’s MyNemours account. 
 
My electronic signature indicates that: 
• 
I give the researchers and Nemours permission to use and/or disclose my / my child’s individually 
identifiable health information, for this research study, as described in the section of the Video 
called “Protecting your Privacy” and the sidebar material.  
• 
As his or her parent or guardian, I give my permission for the minor child named below to 
participate and give consent for my participation in the research study described in the Asthma 
Research Study video and the other information on the website. 
 
 
 


Approved by the Nemours IRB: 
Valid from: 
02/05/2016 
through 
02/04/2017 
IRB# JAX: 
332965 
 
 
 
 
 
 
Abbreviated Study Title: 
MICT 
 
Revised 10/08/2013  
Page 2 of 3 
 
What is the first name of the minor child (the participant) who will be in this study? 
 
Please type your child’s first name in the box: 
 
 
 
What is the last name of the minor child (the participant) who will be in this study? 
 
Please type your child’s last name in the box: 
 
 
 
 
Please enter your child’s birth date  
for example, for May 3, 2000, please type 5/3/2000: 
 
 
 
What is your relationship to the participant?  
Guardians must have documented authority to give permission for participation in a research study according to the laws of the State in 
which the treatment occurs. 
 
q 
I am the parent of the participant. 
 
q 
I am the legal guardian of the participant.  
 
What is your decision about participating in this study and having your child participate in this study 
called “Use of Mobile Devices and the Internet to Streamline an Asthma Clinical Trial”? 
Hold your cursor over the answer to read the entire sentence. 
 
q 
Yes, I agree to participate and I give permission for my child to participate in this study. 
 
q 
No, I do NOT agree to participate and I do NOT give permission for my child to participate in this 
study. I understand by checking this box, my child will NOT be able to participate in this study. 
 
 
What is your decision about having your and your child’s conversation with the study staff audio 
recorded and downloaded and stored for later analysis at Visit 1 and Visit 6? 
Hold your cursor over the answer to read the entire sentence. 
 
q 
Yes, I agree to have my and my child’s conversations with the study staff audio recorded at Visit 1 
and Visit 6. 
 
q 
No, I do NOT agree to have my and my child’s conversations with the study staff audio recorded at 
Visit 1 and Visit 6.  By checking this box, my child will NOT be able to participate in this study. 
 


Approved by the Nemours IRB: 
Valid from: 
02/05/2016 
through 
02/04/2017 
IRB# JAX: 
332965 
 
 
 
 
 
 
Abbreviated Study Title: 
MICT 
 
Revised 10/08/2013  
Page 3 of 3 
 
 
 
What is your decision about sharing your child’s lung function test (spirometry) results with your 
child’s primary asthma care doctor? 
 
q 
Yes, please send my child’s results to the doctor. 
 
q 
No, do NOT send my child’s results to the doctor. 
 
 
What is your decision about collection and storage of your child’s blood for DNA and possible future 
genetic analysis? 
Hold your cursor over the answer to read the entire sentence. 
 
q       Yes, I agree to allow my child to provide blood for DNA for use in this study and to be stored for 
possible future genetic analysis. 
 
q 
No, I do NOT agree to allow my child to provide blood for DNA for use in this study and to be stored 
for possible future genetic analysis. 
 
 
Please type your first name in this box:  
This is your electronic signature. 
 
 
 
Please type your last name in this box:  
 
 
 
You may print a copy of this document with your choices after submitting it by going to your Sent 
Messages in MyNemours.  Once it is submitted a copy will be entered into your child’s Nemours 
medical record.  A copy of this document can be found in your MyNemours Sent Messages unless it is 
deleted.  A copy can also be obtained from your child’s medical record at Nemours. 

ICF_003.pdf: 
Approved by the Nemours IRB: 
Valid from: 
09/04/2015 
through 
09/03/2016 
IRB# JAX: 
288148 
 
Abbreviated Study Title: 
LASST 
 
IRB Template Version February 2014 
 
 
Page 1 of 15 
Continuing Review 2015 
Continuing Review 2015 
Nemours 
Parental Permission for  
Participation in a Research Study 
Template Version February 2014 
 
You have been asked to permit your child to be in a research study. This form explains the research, your 
child’s rights as a research participant, and any responsibilities that you may have as a result of your child’s 
participation.  You should understand the research study before you agree to permit your child to be in it. Read 
this permission form carefully. You may also talk with your family or friends about it.  A research team member 
will answer any questions you have before you make a decision.  
 
1. WHAT IS THE TITLE OF THE STUDY? 
Long-Acting Beta Agonist Step Down Study (LASST) 
 
2. WHO IS IN CHARGE OF THE STUDY AT NEMOURS? 
If you have a question, complaint, or problem related to the study, you can call the investigator anytime at the 
numbers listed below. 
 
 
Nemours – Jacksonville 
Nemours - Orlando 
Nemours - Delaware 
Principal 
Investigator 
Kathryn Blake, Pharm.D. 
 
 
Co-
Investigators 
John J. Lima, Pharm.D. 
 
Jason E. Lang, M.D.  
Floyd Livingston, M.D. 
Aaron Chidekel, M.D.. 
Address 
Nemours Children’s Clinic 
807 Children’s Way 
Jacksonville, FL 32207 
 
Nemours Children’s Clinic 
1717 South Orange Ave.  
Suite 100 
Orlando, FL 32806-2946 
 
Nemours Children’s Hospital 
Department of Pulmonology 
13535 Nemours Parkway 
Orlando, FL 32827 
Alfred I. duPont Hospital for 
Children 
1600 Rockland Rd. 
Wilmington, DE 19803 
 
Daytime Phone 
 
After Hours 
Phone 
(904) 697-3529 
 
 
(904) 697-3600 
(407) 650-7175 
(407) 650-7634 
 
(407) 650-7000 
(302) 651- 6400 
 
 
(302) 651-4000 
  
Long Distance  
1-800-SOS-KIDS  1-800-767-4357 
 
3. WHO SHOULD RESEARCH PARTICIPANTS CONTACT ABOUT THEIR RIGHTS? 
If you have questions about your child’s rights as a research subject, what to do if your child is injured, if you 
would like to offer input or obtain information, or if you cannot reach the investigator or want to talk to someone 
else who is not involved with this research, you may contact the persons listed below. 
Tim Wysocki, PhD, Chairperson, Nemours IRB 2 at (904) 697-3415.  
Paul Garfinkel, MSH, Director, Nemours Office for Human Subjects Protection, at (904) 697-4023. 
Email address: NOHSP@nemours.org 


Approved by the Nemours IRB: 
Valid from: 
09/04/2015 
through 
09/03/2016 
IRB# JAX: 
288148 
 
Abbreviated Study Title: 
LASST 
 
IRB Template Version February 2014 
 
 
Page 2 of 15 
Continuing Review 2015 
Continuing Review 2015 
 
4. WHAT IS THE PURPOSE OF THE STUDY? 
Current asthma guidelines recommend decreasing medication once asthma is controlled for at least 3 months, 
but there is no agreement on the best way to decrease the medication(s).This research is being done to test 
what is the best approach to decreasing asthma medications for patients whose asthma is well controlled on a 
combination of medications that include an inhaled corticosteroid (ICS) and a long-acting beta agonist (LABA),  
 
Examples of combination medications include Advair®, Symbicort®, and Dulera®. 
 
Inhaled corticosteroids include fluticasone (Flovent®), mometasone (Asmanex®), ciclesonide (Alvesco®) and 
budesonide (Pulmicort®). 
Long-acting beta agonists include salmeterol (Serevent®) and formoterol (Foradil® or Perforomist®). 
 
This study will test two ways of decreasing medication: 
(1) reducing the dose of (ICS) while keeping the LABA dose the same 
or 
(2) completely stopping the (LABA) while keeping the (ICS) dose the same. 
 
In addition, one group of participants will not decrease their medications. All of the drugs that will be tested in 
this study are approved by the U.S. Food and Drug Administration (FDA) for treatment of asthma. 
 
5. WHO IS SPONSORING OR PAYING FOR THE STUDY? 
American Lung Association is the sponsor of this study.  GlaxoSmithKline will provide the study drug and 
funding to conduct this study. 
 
6. WHO CAN BE IN THE STUDY? 
Children ages 12 to 17 years will be recruited for this study.  Your child is being asked to participate in the 
study because he/she has physician diagnosed asthma that is well controlled on a combination of inhaled 
corticosteroids (ICS) and long-acting beta agonists (LABA).  The study doctor will tell you if there are any 
reasons why your child could not be in the study.  
 
7. HOW MANY OTHER PEOPLE WILL BE IN THE STUDY? 
Overall about four hundred and fifty (450) people will be enrolled in this study.  Participants will be enrolled at 
18 clinical centers in the United States.  We will enroll up to 90 participants at Nemours. 
 
8. HOW LONG WILL PARTICIPATION IN THE STUDY LAST? 
Participation will last 56 weeks (about 13 months) with a total of 11 study visits and 1 telephone visit.  Study 
visits range from 2 to 4 hours; most will last approximately 2 hours. 
 
9. WHAT ARE THE RESEARCH PROCEDURES? 
Your child will be asked to take a study treatment for asthma every day for the entire study (56 weeks).  
Participation in this study is not meant to replace usual care for your child’s asthma.  You should inform your 
child’s primary asthma care doctor of their participation in the study. We will send your child’s primary asthma 
care doctor a letter to notify them of your child’s participation in the study.   If at any time during the study 
he/she has poor asthma control and needs additional care, your child’s primary asthma care doctor will be 
notified. Your child cannot be in this study unless he/she has a source for asthma care other than this research 


Approved by the Nemours IRB: 
Valid from: 
09/04/2015 
through 
09/03/2016 
IRB# JAX: 
288148 
 
Abbreviated Study Title: 
LASST 
 
IRB Template Version February 2014 
 
 
Page 3 of 15 
Continuing Review 2015 
Continuing Review 2015 
study. If your child does not have a place to get asthma care and you or your child ask us, we will refer your 
child to a place where asthma care is provided. 
 
At the first three visits your child will undergo a number of procedures to see if they are eligible for the study 
and to record how their asthma is doing. During that time all study participants will take the same treatment for 
asthma. The treatment is Advair 250/50, a combination of an inhaled corticosteroid and a long-acting beta 
agonist (fluticasone/salmeterol 250/50 mcg). Your child will be asked to take 1 inhalation of the combination 
medication from a diskus inhaler twice a day.  
At the third visit, if your child’s asthma is well controlled, they will be randomly assigned (by chance like 
drawing a number out of a hat) to receive one of the three study treatments for the rest of the study. The three 
study treatments are: 
 
1) Advair 250/50, 1 inhalation twice a day (same as during the first part of the study) 
2) Advair 100/50, 1 inhalation twice a day (lower dose of inhaled corticosteroid) 
3) Flovent (Fluticasone) 250 1 inhalation twice a day (no long-acting beta agonist) 
 
They will have an equal chance of receiving one of the three treatments. Neither you nor the study doctor or 
study staff will know to which treatment your child is assigned, but this information can be obtained if medically 
necessary. After your child completes the study, you will be told which treatment they received.  
 
Your child will be asked to come in for 11 clinic visits, and participate in one telephone visit over a 56 week 
period. Each visit to the clinic will take between 2 and 4 hours to complete. The telephone visit should take 
fewer than 15 minutes. 
 
The schedule of visits is shown below: 
Schedule 
 
Visit Number 
Visit Type 
Weeks after previous visit 
 
Visit 1 
Screening 
 
------- 
 
Visit 2 
Stable Phase 
4 weeks after Visit 1 
 
Visit 3 
Random Assignment 
4 weeks after Visit 2 
 
Phone Visit 4 
Telephone Contact 
3 weeks after Visit 3 
 
Visit 5 
Follow-up 
3 weeks after Phone Visit 4  
 
Visit 6 
Follow-up 
6 weeks after Visit 5 
 
Visit 7 
Follow-up 
6 weeks after Visit 6 
 
Visit 8 
Follow-up 
6 weeks after Visit 7 
 
Visit 9 
Follow-up 
6 weeks after Visit 8 
 
Visit 10 
Follow-up 
6 weeks after Visit 9 
 
Visit 11 
Follow-up 
6 weeks after Visit 10 
 
Visit 12 
Final Follow-up 
6 weeks after Visit 11 
 
Study Procedures: 
Your child will have several tests at each visit.  Some of them will be done more than once.  A description of 
each test follows. 
 
• 
Spirometry is a test that measures how well your child is able to breathe.  He/she will wear a nose clip 
and breathe out forcefully into a machine that measures how much air he/she can blow out and how 
fast it comes out.  He/she will do this before and after inhaling a bronchodilator medication to see if the 


Approved by the Nemours IRB: 
Valid from: 
09/04/2015 
through 
09/03/2016 
IRB# JAX: 
288148 
 
Abbreviated Study Title: 
LASST 
 
IRB Template Version February 2014 
 
 
Page 4 of 15 
Continuing Review 2015 
Continuing Review 2015 
medication improves his/her test results.  The bronchodilator is Albuterol.  Albuterol can help open up 
the breathing tubes in the lungs of people with asthma.  This test will be done at each of the 11 clinic 
visits. 
 
• 
Peak Flow Meter:  We will give your child a peak flow meter, which is used to test the lungs.  To use it, 
your child will take a deep breath and blow hard and fast into the tube.  At the Screening visit (V1) we 
will show you and your child how to use the peak flow meter and how to read and record the results.  If 
your child cannot use the peak flow meter, your child cannot join the study.  Your child will be able to 
keep the peak flow meter after the study is over. 
 
• 
Asthma Diary:  We will ask you and your child to complete an asthma diary card form daily. On the 
diary card he/she will record his/her peak flow every morning, his/her asthma symptoms or other 
symptoms he/she might experience, and whether he/she took the study medication or other asthma 
medication each day.  We will ask you to bring in the completed asthma diaries when you and your 
child come for each visit.  The purpose of this diary is to see how well your child’s asthma symptoms 
are being controlled.  Your child will be asked to start keeping a daily asthma diary after the first visit, 
the Screening visit (V1), until the study is completed, the entire 56 weeks that he/she will be in the 
study. 
 
• 
Physical Exam:  A brief physical exam, including vital signs will be performed at the first visit, at the 
Randomization visit (V3), and at 2 follow-up visits.  Your child’s height and weight will be measured at 
all clinic visits. 
 
• 
Medical History:  You and your child will be asked a series of questions and will be given several 
questionnaires about the history of his/her health and asthma at the first study visit, the Screening visit 
(V1) and questions about the state of his/her health between visits at all other visits.  Some 
questionnaires will ask you and your child about his/her asthma symptoms, cigarette smoke exposure, 
and females will be asked about menstrual periods. 
 
• 
Asthma Control Test:  Your child will be asked to complete a series of multiple-choice questions about 
his/her asthma symptoms and daily activities.  This will be used to measure his/her asthma control.  
Your child will complete these questionnaires at all clinic visits. 
 
• 
Quality of Life Questionnaires:  Your child will be asked to complete a series of multiple-choice 
questions about his/her daily activities and health.  This will be used to measure the quality of your 
child’s life as it relates to his/her asthma.  Your child will complete these questionnaires at 10 of the 11 
clinic visits. 
 
• 
Exhaled Nitric Oxide:  Your child will be asked to take a deep breath in and then blow out all the air 
slowly into a machine that records the amount of nitric oxide that is in his/her lungs.  Nitric oxide is a 
measure of inflammation in the lungs and gives information about your child’s asthma.  This test takes 
about 5 minutes.  Your child will be asked to do this at all 11 clinic visits. 
 
Blood draws:  10 mL (about 2 teaspoons) of blood will be obtained from a vein in your child’s arm at 
visit 3. We will use the blood to test to see if your child has allergies. If requested, a numbing cream 


Approved by the Nemours IRB: 
Valid from: 
09/04/2015 
through 
09/03/2016 
IRB# JAX: 
288148 
 
Abbreviated Study Title: 
LASST 
 
IRB Template Version February 2014 
 
 
Page 5 of 15 
Continuing Review 2015 
Continuing Review 2015 
can be used to help ease the pain associated with the blood draw. Some of the blood will be saved for 
possible future tests related to asthma.  
 
• 
In addition, if you give your permission, an additional 10 mL (about 2 teaspoons) of blood will be drawn 
and saved for possible future tests related to asthma, including the genes (material that contains 
information about our ancestors) that may play a role in determining whether someone gets asthma, 
how severe the asthma may be, and the response to asthma treatments.  Donating your child’s 
blood for DNA genetic testing is optional and not required for participation.  At the end of the 
form there is a section that provides more information on future genetic testing. 
 
• 
Future Research Use of Samples:  Any remaining portion of your child's sample will be permanently 
stored for future research use. These samples and health information about your child might be used 
by other investigators for research about other diseases related to asthma and allergy.  By participating 
in this study, you are also agreeing to this use of your child's samples 
 
• 
Pregnancy Testing: Girls who are capable of having children will have a urine pregnancy test at the 
Screening visit (V1) and the Randomization visit (V3). 
 
What are The Expectations of You and Your Child in the Study? 
If you agree to allow your child to participate in this study, you and your child will be expected to do the 
following: 
1. Attend all eleven (11) clinic visits during business hours. 
2. Your child must take the study medication twice a day, every day for the entire study. You are 
expected to help your child remember to take his/her study drug. 
3. Keep the study medication out of the reach of anyone who is not participating in the study. 
4. At each visit, return your child’s empty study medication containers and all unused study 
medications. 
5. Your child should record whether they took study medication or other asthma medication, 
asthma symptoms, and peak flow readings daily on the diary card provided. You must bring 
your child’s diary cards to every visit. 
 
When should I call the study staff?  Call the study staff for any reason if you feel you need to speak with 
someone about the study.  Possible reasons include the following: 
1. If you have any questions or concerns about the study (see front page, Section 2);  
2. If your child has had worsening asthma and had to go to a doctor’s office or the emergency room or 
had to be started on prednisone; 
3. If your child is experiencing any unusual signs or symptoms, illnesses or injuries, regardless of the 
cause. 
4. If your child has any new medication including over-the-counter medications or medications prescribed 
by another doctor. 
 
10. WHAT ARE POSSIBLE RISKS OF BEING IN THIS STUDY? 
Any research has some risks (things that could make your child sick, make your child feel uncomfortable, or 
hurt your child).  The risks with the most chance of happening to someone in this study are listed below.  Also, 
there is a chance of other risks that almost never happen, or unknown risks. 
 


Approved by the Nemours IRB: 
Valid from: 
09/04/2015 
through 
09/03/2016 
IRB# JAX: 
288148 
 
Abbreviated Study Title: 
LASST 
 
IRB Template Version February 2014 
 
 
Page 6 of 15 
Continuing Review 2015 
Continuing Review 2015 
It is also possible that your child’s asthma may not improve or may worsen while being in this study.  
Uncontrolled asthma may be life-threatening. Increased use of your child’s rescue medications is a sign that 
their asthma may be getting worse. If you feel that their asthma is getting worse, have him/her use their rescue 
medicine as prescribed by their regular asthma care doctor. Then call their regular asthma care doctor 
immediately.  
 
Get emergency medical care if:  
• 
Your child’s breathing problems worsen quickly and  
• 
if your child uses their rescue inhaler medicine, but it does not relieve their breathing problems.  
 
During this study, you and your child will not have access to certain medical information and test results 
collected for study purposes. If an emergency occurs while your child is in the study, medical information 
needed for their treatment can be made available to their study doctor and other doctors who treat them.  
 
Study Treatments  
Advair (fluticasone/salmeterol): The most common symptoms reported by patients taking 
fluticasone/salmeterol treatment were: upper respiratory infections (21% to 27% of participants in earlier 
studies); inflammation of throat, nose or sinuses (5% to 13%); hoarseness or difficulty speaking (2% to 5%); 
headache (12% to 13%); oral candidiasis (thrush, a yeast infection in the mouth) (1% to 4%); nausea and 
vomiting (4% to 6%); other gastrointestinal symptoms (2% to 4%); and muscle or bone pain (2% to 4%). For 
children, infections in the ear, nose, and throat are common.  Less common side effects include serious 
allergic reactions, sudden breathing problems after inhaling, heart and nervous system effects, reduced 
adrenal function, changes in blood, weakened immunity, lower bone mineral density, eye problems and slowed 
growth in children.  
 
Long-acting beta agonists: People with asthma who take long-acting beta2-adrenergic agonist (LABA) 
medicines such as salmeterol (one of the medicines in Advair Diskus), have an increased risk of death from 
asthma problems. A study done in the US showed an increase risk of asthma-related death in participants 
receiving salmeterol alone as compared to participants on placebo (no medicine), 10 in 10,000 participants 
(0.10%) in the group receiving salmeterol compared to 0.02% (2 in 10,000) in the group receiving a placebo. It 
is not known whether fluticasone propionate, the other medicine in Advair Diskus, reduces the risk of death 
from asthma problems seen with salmeterol. For this study participants will not receive salmeterol alone.  
 
Flovent (fluticasone): The most common symptoms reported by patients taking fluticasone treatment were: 
upper respiratory infections (25% to 29% of participants in earlier studies); lower respiratory infections (4% to 
8%); inflammation of throat, nose or sinuses (1% to 12%); hoarseness or difficulty speaking (1% to 4%); 
headache (8% to 14%); oral candidiasis (thrush, a yeast infection in the mouth) (2%); nausea and vomiting 
(1%); other gastrointestinal symptoms (1% to 2%); and muscle or bone pain (3%). Fluticasone has not been 
associated with an increased risk of death from asthma. 
 
Ventolin (albuterol): The most common side effects associated with albuterol are upper respiratory infection 
(21%), sore throat (14%), Nausea (10%), rhinitis (16%), increased heart rate, tremors (shakes) (7%), chest 
tightness, dizziness, nervousness (7%), cough (5%), headaches (7%), and sleeplessness. Serious allergic 
reactions that can be life-threatening are very rare. 
 


Approved by the Nemours IRB: 
Valid from: 
09/04/2015 
through 
09/03/2016 
IRB# JAX: 
288148 
 
Abbreviated Study Title: 
LASST 
 
IRB Template Version February 2014 
 
 
Page 7 of 15 
Continuing Review 2015 
Continuing Review 2015 
• 
Spirometry:  There is little risk from spirometry.  Some people occasionally have chest soreness or 
light-headedness from the hard blowing.  The chest soreness usually goes away by itself, but can be 
relieved with non-prescription pain-relievers.   
 
• 
Peak Flow Measurement with Peak Flow Meter:  Asthma patients commonly use peak flow meter 
readings to see how their lungs are doing.  There is little risk from use of a peak flow meter.  Some 
people may have chest soreness from the hard blowing or light-headedness if they use it standing up.  
The chest soreness usually goes away by itself, but can be relieved with non-prescription pain-
relievers.  If your child’s gets lightheaded, he/she should perform the peak flow measurements while 
sitting down.  
 
• 
Exhaled Nitric Oxide:  Measurement of nitric oxide in breath is a simple procedure with little or no risk.  
It is possible to feel lightheaded if they blow too hard, if your child feels dizzy he/she may take a break.  
These procedures can be done in a seated position.   
 
• 
Blood Draw:  Taking blood may cause discomfort, bleeding or bruising where the needle enters the 
body. In rare cases, it may result in fainting. There is a small risk of infection.    
 
• 
Numbing Cream:  A local anesthetic may be used to numb the site of the blood test if requested. If a 
numbing cream is used, the following side effects may occur: redness, swelling, itching, rash, change in 
sensation to temperature, and rarely, an allergic reaction. 
 
• 
DNA testing: Donating blood for additional DNA testing is optional. Every effort will be made to keep the 
results of the DNA testing on your child’s sample confidential. However, there is a very small risk that 
an unauthorized person may review your child’s information. Additional information about measures 
taken to minimize these risks can be found on the last page of this consent.  
 
• 
Privacy:  There is a risk of loss of privacy and confidentiality when participating in this study.  
Information for this study will be taken from your child’s clinic chart.  The measures taken to prevent 
and minimize these risks are found in Section 19: What information about my child will be used or 
disclosed? 
 
• 
Pregnancy: Girls deciding whether or not to be in this study may already have started having periods or 
may begin having periods while they are in this study.  Therefore, we need to tell you some important 
facts.  
 
We often do not know the effects of research procedures (such as drugs or tests) on unborn babies.  
The drugs being evaluated in the study have been shown to increase the risk of miscarriage and birth 
defects in animals. This research may hurt an embryo or fetus in ways we do not currently know. Your 
child should not plan to become pregnant while participating in this study.  If sexually active, your child 
should use effective birth control to prevent pregnancy while participating in this study.  As appropriate, 
the study doctor will discuss issues of possible sexual activity and use of effective birth control privately 
with your child. Only girls who are not pregnant will be randomized to study treatment. Girls who are 
breastfeeding will not be enrolled in this study; the safety of these drugs during breastfeeding is 
unknown. 
 


Approved by the Nemours IRB: 
Valid from: 
09/04/2015 
through 
09/03/2016 
IRB# JAX: 
288148 
 
Abbreviated Study Title: 
LASST 
 
IRB Template Version February 2014 
 
 
Page 8 of 15 
Continuing Review 2015 
Continuing Review 2015 
Because girls can become pregnant even when using birth control, we will be doing pregnancy tests at 
the first study visit, and again at visit 3.  The results of any pregnancy test done during the study will be 
made available only to your child.  By law, all minors have a right to confidentiality when discussing 
issues of pregnancy and birth control with a doctor.  This information will be discussed with you only if 
your child agrees. If there is any chance that pregnancy could have occurred during the study, the 
study doctors must be told immediately.  Anyone who is pregnant may be taken out of the study right 
away. You and your daughter should be aware that, if this happens, others are likely to realize that she 
is pregnant. We encourage open honest communication between parents and their children regarding 
issues of sexual activity and possible pregnancy. It is also important for you to let the study doctor know 
if a young girl starts having periods during this study so that appropriate precautions can be taken from 
that point onward. 
 
11. WHAT ARE POSSIBLE BENEFITS OF BEING IN THIS STUDY? 
There may be no direct benefit to your child from taking part in the study.  Your child may experience an 
improvement in asthma control.  Your child will receive an assessment of his/her general health and asthma. 
Your child will also receive a peak flow meter. 
 
You and your child may feel better knowing that by being in this study, you may help others with asthma.  The 
information from this study may be helpful in the future to other people with asthma.  
 
12. WHAT HAPPENS IF A PROBLEM OR INJURY RESULTS FROM THE RESEARCH PROCEDURES? 
Nemours will assure that your child receives treatment, if needed, for study related injuries. Neither Nemours, 
the American Lung Association, GlaxoSmithKline, nor the study doctor have a program to pay for medical care 
provided to treat the injury and are not responsible. If you have health insurance, it may, or may not pay for the 
cost of treatment resulting from a study-related injury. If your insurance does not pay, you understand that you 
will be responsible for paying for the cost of treatment.  If your insurance does not pay for study-related injury, 
or if you do not have insurance, you will be responsible for paying for the cost of treatment.  
 
If you think that your child has been injured while in this study or has a problem related to the study, you should 
tell one of the study doctors as soon as possible.  The study doctor or research staff will tell you what you 
should do.  The study doctor’s names and phone numbers are on the first page of this form. 
 
If you or your child has a question or problem related to the study, you can call the principal investigator, Dr. 
Kathryn Blake, the study coordinator, or the study staff anytime. The study staff is available Monday-Friday 
from 8:00am to 5:00pm. During these hours, you should call (904)-697-3529 for medical advice. 
 
During evenings, weekends, and holidays, you should call (904)-697-3600 or (800) SOS-KIDS (Nemours-Long 
Distance Operator).  You will reach the Nemours operator.  Ask to page/call the nurse/coordinators.  
 
13. IS BEING IN THE STUDY VOLUNTARY? 
Being in this study is totally voluntary. Anyone who takes part in the study can stop being in it at any time. 
There will be no change to your child’s usual medical care if you or your child decide not to be in the study or 
decide to stop being in the study. No one will be angry with you or your child, or treat your child any differently 
than before your child was asked to be in the study.  
 
If you withdraw your child from this study, your child may continue treatment with his/her doctor, or you may 
seek treatment for your child from another doctor of your choice.  In the event that you withdraw your child from 


Approved by the Nemours IRB: 
Valid from: 
09/04/2015 
through 
09/03/2016 
IRB# JAX: 
288148 
 
Abbreviated Study Title: 
LASST 
 
IRB Template Version February 2014 
 
 
Page 9 of 15 
Continuing Review 2015 
Continuing Review 2015 
the study, Nemours may use or give out your health information that it already has, and all clinical data related 
to the study may continue to be collected from your child’s medical records, if the information is needed for this 
study or any follow-up activities. 
 
14. WHAT OPTIONS ARE AVAILABLE OTHER THAN BEING IN THIS STUDY? 
You can refuse to permit your child to participate in this study.  There may be other research or treatment 
choices that could be considered for your child.  
 
The study doctor can provide detailed information about the benefits and risks of the various treatment options 
available to your child.  You should feel free to discuss these alternatives with the study doctor. In addition, 
your child’s doctor can prescribe any of the study medications for you even if you do not join the study. 
 
15. CAN THE RESEARCHERS REMOVE SOMEONE FROM THE STUDY?  
Your child may be taken out of the study if: 
• 
Staying in the study would be harmful. 
• 
Your child needs treatment not allowed in the study. 
• 
You or your child fails to follow instructions. 
• 
Your daughter becomes pregnant. 
• 
The study is cancelled. 
• 
There may be other reasons to take your child out of the study that we do not  
know at this time. 
We will continue to ask your child to come in for study visits even if he/she stops taking the study medication, 
however, your child may stop participating at any time.  
 
16. WHAT ARE THE COSTS OF BEING IN THIS STUDY? 
There will be no cost for your child’s participation in this study.   
 
17. WILL PEOPLE BE PAID FOR BEING IN THIS STUDY? 
No arrangement exists that would allow participants to share in any profit generated from this study or future 
research.  Your child will be paid up to $825 for taking part in this study.  Your child will receive payment for 
each visit except for the phone visit. If you or your child decide that he/she should leave the study before 
finishing all visits, your child will be paid for the visits he/she has completed. We also offer the opportunity for 
students to earn community service hours for participating in this study; our staff will be pleased to complete 
the required paperwork. 
 
Visit   
 
 
 
Payment 
Visit 1  
 
 
 
$50.00 
Visit 2  
 
 
 
$25.00 
Visit 3  
 
 
 
$75.00 
Phone Visit 4  
 
 
$0.00 
Visit 5  
 
 
 
$75.00 
Visit 6  
 
 
 
$75.00 
Visit 7  
 
 
 
$75.00 
Visit 8  
 
 
 
$75.00 
Visit 9  
 
 
 
$75.00 
Visit 10 
 
 
 
$75.00 


Approved by the Nemours IRB: 
Valid from: 
09/04/2015 
through 
09/03/2016 
IRB# JAX: 
288148 
 
Abbreviated Study Title: 
LASST 
 
IRB Template Version February 2014 
 
 
Page 10 of 15 
Continuing Review 2015 
Visit 11 
 
 
 
$75.00 
Visit 12 
 
 
 
$150.00 
Total  
 
 
 
$825 
 
18. WILL I BE TOLD OF ANY NEW INFORMATION THAT MIGHT AFFECT MY WILLINGNESS TO PERMIT 
MY CHILD TO STAY IN THE STUDY? 
Any new information that may change your mind about allowing your child to be in this study will be given to 
you.  A committee called the Institutional Review Board (IRB) will review this study at least once per year. If the 
IRB finds that there is new information that you should know about while your child is taking part in this study, it 
will ask the study doctor to tell you about it. You may be asked to sign a new version of this form after 
discussing the new information with a member of the research team. 
 
A description of this clinical trial will be available on http://www.ClinicalTrials.gov, as required by U.S. Law. This 
web site will not include information that can identify you or your child. At most, the web site will include a 
summary of the results. You can search this web site at any time. 
 
19. WHAT INFORMATION ABOUT MY CHILD WILL BE USED OR DISCLOSED?   
Identifiable health information about your child will be used by Nemours researchers and may be given to 
people outside of Nemours for this research. This is done to conduct the research study, to monitor the safety 
of research participants and for auditing. Federal law requires us to tell you about, and get your approval for 
research use and disclosure of health information that includes “identifiers” that can connect the health 
information to your child. (Names, initials, date of birth, addresses, phone numbers, and social security 
numbers are examples of identifiers.) This Identifiable health information is called Protected Health Information 
(PHI).  Your child cannot participate in the study if you choose not to share his/her PHI. You may refuse to 
permit or cancel permission regarding the disclosure of your child’s PHI, however, his/her part in the study will 
then end.   
 
Use of Health Information by Nemours Staff 
The health information that will be used within Nemours includes all data collected for this study, as described 
in Section 9 of this form. In addition, researchers may ask your permission to request your child’s health care 
records from their other health care providers. 
 
Your child’s identity will be protected as much as possible.  Nemours protects you and your child’s health 
information by storing records in files or computers that can only be used by authorized Nemours staff.  Study 
staff will assign your child a unique number and special code that will be used in place of their name.  All of 
your child’s data will also be given this code.  When the study is complete the link to your child’s identification 
and his/her ID code will be removed.   
 
After this study is over, we will remove all information from the samples that could be used to identify your 
child.  This is done to keep your child’s health information private. After this happens, we will not know which 
samples belonged to your child.  This means that if you decided you wanted to have your child’s samples 
destroyed, we would not able to do so because we would not know which ones belonged to your child.   
 
The people within Nemours that may use this health information include: 
• 
The investigators listed on the first page of this permission form and their staff,  
• 
The Nemours Institutional Review Board (IRB) (The IRB is a group of people that reviews research 
activities.  The IRB is responsible for the safety and rights of research participants), and; 


 
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IRB Template Version February 2014 
 
 
Page 11 of 15 
Continuing Review 2015 
• 
Nemours internal audit staff. 
 
Disclosure of Health Information to Others  
Information from this research study will also be contained in your child’s Nemours’ medical record if they are 
seen at Nemours, along with the information about your child’s regular office visits. This will help other doctors 
to know about the research study your child is in and give them extra information from the research that might 
help them take better care of your child. The same information might also be seen by anyone who can look at 
your child’s medical records, such as your insurance company.  
 
Identifiable health information will be given (disclosed) to the following individuals or groups:  
• 
SPONSORS:  American Lung Association Asthma Clinical Research Center (ALA-ACRC), and 
GlaxoSmithKline. 
 
The PHI that will be given (disclosed) to people or groups outside of Nemours for research purposes are 
checked in the table below: 
Type of Identifiable Health Information: 
Disclosed  
 
History and Physical
Results of Procedures 
 
Demographics (information about race, ethnicity, gender, age, DOB) 
 
Questionnaires 
 
Routine lab results 
 
Alpha-numeric code (using participants initials) 
 
Limits on Protection of Privacy and Confidentiality 
Only health care organizations have to follow laws and rules about protecting the privacy of health information. 
If health information containing peoples' identities is given to other kinds of companies or organizations, they 
are not required by law to safeguard the privacy and confidentiality of that information. Nemours expects these 
companies and organization to protect the privacy and confidentiality of research participants, but it is not 
possible for Nemours researchers to assure that this happens. 
 
Government agencies that may look at records for this research study, including the above health information, 
include: 
• The U.S. Food and Drug Administration  
• The U.S. Department of Health and Human Services  
• Other agencies of State and local government as required by law 
 
The research results may be presented at scientific meetings or in print.  Participants' identities will not be 
disclosed in those presentations. 
 
20. WHO CONTROLS AND OWNS THE SAMPLES?  
Scientists at Nemours work to find the causes and cures of disease. The data, blood, and specimens collected 
from your child during this study are important to both this study and to future research. Should you decide to 
donate your child’s DNA for genetic testing their DNA sample will remain in possession of the American Lung 
Association and will be stored at Nemours Children’s Clinic in Jacksonville, FL.  The results of the research on 
these samples might be valuable for commercial and/or intellectual property (for example, patent) purposes.  If 


Approved by the Nemours IRB: 
Valid from: 
09/04/2015 
through 
09/03/2016 
IRB# JAX: 
288148 
 
Abbreviated Study Title: 
LASST 
 
IRB Template Version February 2014 
 
 
Page 12 of 15 
Continuing Review 2015 
you decide to allow your child to participate in this genetic research, you are giving your child’s sample to the 
American Lung Association.  The American Lung Association retains sole ownership of the research results, 
and of any use or development of the research records (including your child’s sample) consistent with this 
consent.  You will not receive any financial benefit that might come from the research results.  
 


Approved by the Nemours IRB: 
Valid from: 
09/04/2015 
through 
09/03/2016 
IRB# JAX: 
288148 
 
Abbreviated Study Title: 
LASST 
 
IRB Template Version February 2014 
 
 
Page 13 of 15 
Continuing Review 2015 
21. SIGNATURES: 
I am making a decision whether or not to permit my child to participate in this study. I understand that my child 
may also have to agree to participate in the study before he/she will be allowed to be in this study.  I have read 
this form, or have had it read to me in a language that I understand. I have been given enough time to make 
this decision. I have asked questions and received answers about things I did not understand.  I willingly give 
permission for my child to participate in this study.  By signing this form, I am not giving up any rights to which I 
am entitled under law. 
 
I understand that: 
• 
I can withdraw permission for participation in this study and for the use and/or disclosure of PHI by 
contacting the person in charge of the study listed on the first page of this form.   
• 
The use and/or disclosure of my child’s PHI will stop after Nemours receives the withdrawal notice.  
Information that is used or disclosed before the withdrawal may still be used. 
• 
Unless I withdraw permission, the use and/or disclosure of PHI described in this form will not have an 
expiration date.   
• 
My child’s PHI may be disclosed again by the person or organization (other than Nemours) that receives it.  
If this happens, Federal or state law may not protect the information. 
• 
I have the right to refuse to sign this permission form. 
• 
If I refuse to sign this permission form, my child will not be allowed to be in this research study. 
• 
I have the right to ask Nemours to tell me who has received my child’s protected health information.  
• 
I have the right to revoke my permission for the use and disclosure of my child’s health information at any 
time, which would end his/her participation in this study. 
• 
I will receive a signed and dated copy of this form.  
 
My signature indicates that: 
• 
As his or her parent or guardian, I give my permission for the minor child named below to participate in 
the research study described in this Parental Permission Form. 
• 
I give the researchers and Nemours permission to use and/or disclose my child’s individually 
identifiable health information for this research study as described in Section 19. 
 
Name of Participant (Print) 
 
Participant Date of Birth: 
 
 
 
 
 
 
 
Signature of  
 
Printed Name of  
 
Date 
Parent / Guardian 
 
Parent /  Guardian 
 
 
 
 
 
 
 
Check Relation to Participant:    __ Parent   __ Guardian: (Guardians must have documented authority to give 
permission for participation in a research study according to the laws of the State in which the treatment 
occurs.)  
 
I the undersigned, certify that to the best of my knowledge the parent/legal representative signing this 
permission had the study fully and carefully explained and that he/she understands the nature, risks and 
benefits of participation in this research study. 
 
Name of Person Obtaining 
permission (Investigator or Designee) 
 
Signature of Person Obtaining 
permission 
 
Date 
Copy of the signed form was provided to Parent/ Guardian on [Date] ___________ 


Approved by the Nemours IRB: 
Valid from: 
09/04/2015 
through 
09/03/2016 
IRB# JAX: 
288148 
 
Abbreviated Study Title: 
LASST 
 
IRB Template Version February 2014 
 
 
Page 14 of 15 
Continuing Review 2015 
 
NEMOURS 
ADDENDUM FOR OPTIONAL TESTING OR FUTURE USE OF SAMPLES OR DATA 
Version February 2014 
 
A. Sharing spirometry results with primary asthma care doctor: 
q 
______Yes, please send my child’s results to the doctor listed below: 
 
____________________________________________________________ 
 
____________________________________________________________ 
 
_____________________________________________________________ 
 
q 
_______No, do NOT send my child’s results to his/her doctor. 
 
B. Future Testing:   
DNA is material that contains information about our ancestors that may play a role to help in determining 
whether someone gets asthma, how severe the asthma may be, and the response to asthma treatments. 
Your decision to allow your child to provide blood for future DNA testing is voluntary and will not influence 
his/her ability to participate in the study We will draw 10 mL (2 teaspoons) of blood for this test.  We will 
isolate DNA (genetic material) in the blood to test if genes influence response to asthma drugs used in this 
study.  If your child participates in the genetic study, then the blood sample and DNA will be used for future 
studies including future genetic studies of asthma.  Because of confidential coding of specimens, you will 
not be notified of individual results from DNA tests and no results will appear in your study records or 
medical records. After this study is over, we will remove all information from the samples that could be 
used to identify your child.  This is done to keep your child’s health information private. After this happens, 
we will not know which samples belonged to your child.  This means that if you or your child wanted to 
have your child’s samples destroyed, we would not be able to do so because we would not know which 
sample(s) belonged to your child. 
 
There is the possibility that someone you did not approve sees and uses your child’s DNA information.  To 
guard against this, your child’s blood samples will be identified only by a number code and no tests will be 
done except for those associated with asthma and airway disease.   
 
A Federal law, called the Genetic Information Nondiscrimination Act (GINA), reduces the risk of 
discrimination by health insurance companies, group health plans, and most employers based on your 
(child's) genetic information. 
 
NOTIFICATION FOR FLORIDA RESIDENTS: 
By Florida law, the results of any DNA analysis, which includes DNA typing and genetic testing, are the 
exclusive property of the person tested, and may not be disclosed without your permission (as provided in 
this form).  Nemours is notifying you that the DNA analysis described in this document will be performed as 
described, and results will be provided to those individuals and / or groups noted in the section on ‘use and 
disclosure of PHI’.  At your request, Nemours will provide the results of DNA analysis that it receives to 
your child’s primary care physician.  The DNA analysis is performed strictly for research purposes and will 
not be used in any decision regarding insurability, employment, mortgage, loan, credit or education 
opportunity. 
 


Approved by the Nemours IRB: 
Valid from: 
09/04/2015 
through 
09/03/2016 
IRB# JAX: 
288148 
 
Abbreviated Study Title: 
LASST 
 
IRB Template Version February 2014 
 
 
Page 15 of 15 
Continuing Review 2015 
 Please indicate below whether you wish to have your child’s blood drawn for DNA genetic testing as 
described above. 
 
I agree to allow my child to provide blood for DNA for use in this study and to be stored for possible future 
genetic analysis: 
 
q 
Yes      Initials   ______ 
 
q 
No        Initials   ______  
 

Prot_000.pdf: 
MICT MOP 
  1 
 
 
 
 
 
Use of Mobile Devices and 
the Internet to Streamline an 
Asthma Clinical Trial (MICT) 
 
 
 
 
 
Manual of 
Procedures 
Version 1.0 
 
WORKING DOCUMENT 
Updated 08/25/2016   
 
 
 
 
 
 
 
 
 
 
 
MICT Coordinating Center 
Nemours Children’s Clinic  
Jacksonville, Florida 32207 
904-697-3925 p 
904-697-3799 f 
904-686-5047 Kathryn’s cell 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 


MICT MOP 
  2 
 
1. 
Table of Contents 
1. 
Study Overview ................................................................................................................................... 5 
1.1. 
Design and Outcome Methods ............................................................................................................. 5 
1.2. 
Eligibility Criteria..................................................................................................................................... 5 
1.2.1. 
Study Eligibility................................................................................................................................................. 5 
1.2.2. 
Randomization Eligibility ............................................................................................................................. 7 
1.3. 
Study Visit Time Windows and Data Collection Schedule ......................................................... 7 
2. 
REDCap Overview, Training, and Use ......................................................................................... 9 
2.1. 
Overview ..................................................................................................................................................... 9 
2.2. 
How to get Access to REDCap ............................................................................................................... 9 
2.3. 
Training ....................................................................................................................................................... 9 
2.4. 
MICT REDCap Testing and Real Databases ..................................................................................... 9 
2.5. 
Demonstration Study Websites ........................................................................................................ 10 
2.5.1. 
Study Consent Website ............................................................................................................................... 10 
2.5.2. 
Morning and Evening Reports Website – Demo Sites ................................................................... 10 
2.6. 
Participant ID vs. Username vs. Study Email Name ................................................................... 11 
2.7. 
Editing Data in REDCap ........................................................................................................................ 12 
3. 
Tracking Study Staff Effort (Time) on MICT and LASST..................................................... 13 
4. 
Study Visits / Participant Contacts ........................................................................................... 13 
4.1. 
General overview of order of procedures ..................................................................................... 13 
4.2. 
Screening Steps ....................................................................................................................................... 13 
4.2.1. 
Tasks to be Completed Prior to Visit 1-Part 1 ................................................................................... 13 
4.2.2. 
Visit 1-Part 1 (Webex Research Assessment Interview) .............................................................. 17 
4.2.3. 
Tasks to be Completed Prior to Visit 1-Part 2 (Clinic Visit) ........................................................ 20 
4.2.4. 
REDCap steps: Participant Discontinues Between V1 Part 1 and Part 2 ............................... 22 
4.3. 
Visit 1-Part 2 (Clinic Visit) .................................................................................................................. 23 
4.3.1. 
Study Coordinator Procedures for Visit 1 – Part 2 ......................................................................... 24 
4.3.2. 
Study Coordinator REDCap Instructions ............................................................................................ 29 
4.3.3. 
Administrative Coordinator REDCap Instructions ......................................................................... 31 
4.3.4. 
Alerts to Study Participant after Visit 1 ............................................................................................... 32 
4.4. 
Visit 2 (Virtual Visit) ............................................................................................................................. 32 
4.4.1. 
Study Coordinator Procedures for Visit 2 .......................................................................................... 32 
4.4.2. 
Study Coordinator REDCap Instructions for Visit 2 ....................................................................... 34 
4.5. 
Visit 3 (Virtual Visit) ............................................................................................................................. 36 
4.5.1. 
Study Coordinator Procedures for Visit 3 .......................................................................................... 36 
4.5.2. 
How to Conduct the Treatment Randomization .............................................................................. 39 
4.5.3. 
Study Coordinator REDCap Instructions for Visit 3 ....................................................................... 40 
4.5.4. 
RPh or Administrative Coordinator REDCap Instructions for Visit 3 ..................................... 42 
4.6. 
Visit 4 (Virtual Visit) ............................................................................................................................. 42 
4.6.1. 
Study Coordinator Procedures for Visit 4. ......................................................................................... 43 
4.6.1. 
Study Coordinator REDCap Instructions for Visit 4 ....................................................................... 44 
4.7. 
Visit 5 (Virtual Visit) ............................................................................................................................. 45 
4.7.1. 
Study Coordinator Procedures for Visit 5 .......................................................................................... 45 
4.7.2. 
Study Coordinator REDCap Instructions for Visit 5 ....................................................................... 47 
4.8. 
Visit 6 – Part 1 (Virtual Visit) ............................................................................................................. 49 
4.8.1. 
Study Coordinator Procedures for Visit 6 – Part 1 ......................................................................... 49 
4.8.2. 
Study Coordinator REDCap Instructions for Visit 6 – Part 1 ...................................................... 52 
4.9. 
Visit 6 – Part 2 (Clinic Visit) ................................................................................................................ 53 
4.9.1. 
Study Coordinator Procedures for Visit 6 – Part 2 ......................................................................... 53 
4.9.2. 
Study Coordinator REDCap Instructions for Visit 6 – Part 2 ...................................................... 55 


MICT MOP 
  3 
 
4.9.3. 
Administrative Coordinator REDCap Instructions for Visit 6 – Part 2 ................................... 58 
5. 
Screen Failures Between V1 to V3............................................................................................. 58 
5.1. 
Overview ................................................................................................................................................... 58 
5.2. 
Screen failure at V1 ............................................................................................................................... 59 
5.2.1. 
Study Coordinator REDCap Steps for Participant who Failed at Visit 1 ................................ 59 
5.3. 
Determining if the Participant has Failed Between V1 to V3 ................................................. 59 
5.4. 
Study Coordinator Procedures for Screen Failures at Visit 2 or Visit 3 ............................. 59 
5.5. 
REDCap Steps for Ending Participation at Visit 2 or Visit 3 .................................................... 60 
5.5.1. 
REDCap Steps for Participant who Failed Stable Phase but will be Rescreened ................ 60 
5.6. 
Study Coordinator Procedures for Re-screening a Participant at Visit 1 .......................... 60 
5.7. 
REDCap Step for Rescreening a Participant ................................................................................. 60 
5.8. 
Preparing the EasyOne for a Rescreen Visit 1 ............................................................................. 63 
5.9. 
Recycling a Participant (occurs at Visit 3 only) .......................................................................... 64 
6. 
Study Staff Training ........................................................................................................................ 65 
6.1. 
REDCap Data System Training with Suzanne McCahan, PhD ................................................. 65 
7. 
Study Equipment and Supplies .................................................................................................. 66 
7.1. 
Equipment and Supplies Provided by JAX to all Sites ............................................................... 66 
7.2. 
Ordered by Each Site ............................................................................................................................. 67 
8. 
Study Procedures ............................................................................................................................ 67 
8.1. 
MyNemours Account Set-up (by AC) ............................................................................................... 67 
8.2. 
Spirometry ................................................................................................................................................ 68 
8.2.1. 
EasyOne ............................................................................................................................................................ 68 
8.2.2. 
Standard Procedures for Spirometry (Acceptability / Reproducibility) ............................... 69 
8.2.3. 
Spirometry Over-Reading ......................................................................................................................... 73 
8.2.4. 
Setting up the Default Location for the EasyOne Database ......................................................... 73 
8.2.5. 
Syncing the EasyOne using the EasyWare program ....................................................................... 75 
8.2.6. 
Viewing Data and Back-up Procedures................................................................................................ 76 
8.3. 
Exhaled Nitric Oxide (NIOX MINO) [only for sites doing this procedure] .......................... 77 
8.3.1. 
Equipment and supplies for Testing ..................................................................................................... 77 
8.3.2. 
Quality Control ............................................................................................................................................... 78 
8.3.3. 
Procedure for Measuring Exhaled Nitric Oxide ................................................................................ 80 
8.4. 
Specimens ................................................................................................................................................. 81 
8.4.1. 
Overview of Specimen Collection ........................................................................................................... 81 
8.4.2. 
Supplies ............................................................................................................................................................. 81 
8.4.3. 
Blood Collection, Processing, Labeling, and Shipping for DNA, Plasma, Serum ................. 82 
8.4.4. 
General Requirements for Specimen Collections ............................................................................ 88 
8.5. 
Participant Education and Instructions ......................................................................................... 88 
8.5.1. 
Overview .......................................................................................................................................................... 88 
8.5.2. 
Asthma Action Plans (AAP) ...................................................................................................................... 88 
8.6. 
Treatment Failure .................................................................................................................................. 89 
9. 
Event Recording (AE, SAE, Administrative Events) ............................................................. 91 
9.1. 
Adverse Events ........................................................................................................................................ 91 
9.1.1. 
Study Coordinator REDCap Instructions for AE Reporting ......................................................... 93 
9.2. 
Serious Adverse Events ........................................................................................................................ 93 
9.2.1. 
Study Coordinator REDCap Instructions for SAE Reporting ...................................................... 95 
9.3. 
Unanticipated Administrative Events............................................................................................. 95 
9.3.1. 
Study Coordinator REDCap Instructions for Administrative Reporting ................................ 95 
10. 
Study Drug Description, Procurement, Storage ............................................................... 96 
10.1. 
Overview ............................................................................................................................................... 96 
10.2. 
ProAir (albuterol) .............................................................................................................................. 97 


MICT MOP 
  4 
 
10.2.1. 
RPh and AC (and Site Coordinator at PHL and PNS at Visit 1 only) REDCap Instructions 
for ProAir Drug Accountability ................................................................................................................................... 97 
10.3. 
Stable-Phase Advair 250/50 (V1 and V2) ................................................................................. 98 
10.3.1. 
RPh and AC (and Site Coordinator at PHL and PNS at Visit 1 only) REDCap Instructions 
for Stable-Phase Advair 250/50 Drug Accountability ...................................................................................... 98 
10.4. 
Study Drug (Randomized Period) (V3, V4, V5) ....................................................................... 99 
10.4.1. 
RPh and AC REDCap Instructions for Study Diskus (Randomized Period) Accountability
 
100 
10.5. 
Procurement, Receipt, and Storage of Drug .......................................................................... 101 
10.5.1. 
RPh and AC (and Site Coordinator at PHL and PNS) REDCap Instructions for Study 
Procurement/Receipt Accountability .................................................................................................................... 101 
10.6. 
Labeling and Shipment Information ........................................................................................ 102 
10.7. 
Accountability Logs in REDCap .................................................................................................. 102 
10.8. 
Temporary Withdrawal or Termination of Study Drug .................................................... 103 
11. 
REDCap Troubleshooting ...................................................................................................... 103 
11.1. 
Instructions for Participants Temporarily Without Internet Access........................... 103 
11.2. 
Correcting Entry when Diskus Started but not Indicated on Diary Report ............... 106 
11.3. 
Missing and/or Re-sending Questionnaires to Participants ........................................... 107 
12. 
REDCap Entries for LASST Participants ........................................................................... 111 
13. 
Research Assessment Interview Ratings ......................................................................... 113 
14. 
Participant Stipends (CT Payer) ......................................................................................... 114 
14.1. 
Making purchases online using CT Payer cards .................................................................. 114 
15. 
Ways to View Data on Participants in REDCap .............................................................. 115 
15.1. 
Did my Participant View the Consent Video? ....................................................................... 115 
15.2. 
Did my Participant Receive the Emails with the Links to the Questionnaires? ....... 116 
15.3. 
My participant has not completed all the questionnaires for Visit 1 ........................... 117 
15.4. 
Is my Participant Using the Diskus Like They Should? ..................................................... 118 
15.5. 
What are my Participant’s Peak Flow Values? ..................................................................... 119 
15.6. 
How Much Albuterol is my Participant Using? ..................................................................... 120 
15.7. 
Has my Participant had any Unscheduled Visits? ............................................................... 120 
15.8. 
How do I make Edits to my Participants Morning or Evening Reports? ..................... 121 
15.9. 
Has my Participant Completed Enough Morning and Evening Reports to Qualify for 
Visit 3? 123 
15.10. 
Has my Participant Taken Advair 250/50 on Enough Days to Qualify for Visit 3? . 123 
15.11. 
How do I determine the mean PEF at Visit 3 for the Study Asthma Action Plan? .... 123 
15.12. 
What are all the Alerts I have Received on my Participant? ........................................... 124 
15.12.1. 
What alerts do I need to act on? ....................................................................................................... 125 
15.13. 
How can I find out if Heights have changed on my Participant? .................................... 126 
15.14. 
How can Another Coordinator Cover Alerts when I am Out of Town? ........................ 126 
15.15. 
What Study Visits do I have Coming Up in the Next 28 Days? ......................................... 126 
15.16. 
How to Use CTPayer Card for Online or Phone Purchases?............................................. 129 
16. 
MICT Trac Site (Helpful Tools and Reference Pages [wiki pages]) ........................ 129 
 
 
 


MICT MOP 
  5 
 
 
1. Study Overview 
1.1. Design and Outcome Methods 
 
Objective 
To test the hypothesis that incorporation of mobile devices and the internet into a study design that 
tests interventions to reduce morbidity in pediatric asthma will result in a lower-cost method for 
conducting a clinical trial and encourage more families to participate. We will test two novel features 
in a streamlined clinical trial design. Results will be compared with a currently funded traditional 
clinical trial (Long-acting Beta Agonist Step Down Study (LASST) conducted by the American Lung 
Association Asthma Clinical Research Centers (ALA-ACRC) network. 
 
Study Design 
 
Trial Type Comparison 
o MICT vs. LASST (60 participants in MICT and 60 in LASST) 
 
Treatment Comparison 
o Continuation of Fluticasone/Salmeterol Diskus 250/50 mcg twice daily 
o Reduced dose Fluticasone/Salmeterol Diskus 100/50 mcg twice daily 
o Fluticasone Diskus alone 250 mcg twice daily without Salmeterol 
 
Primary Outcome 
Difference in Research Participation Assessment interview score for parental permission and assent  
at screening and at 12 weeks after randomization in parents and youths participating in the MICT 
(streamlined) trial compared with the LASST (traditional) trial 
 
Secondary Outcomes 
 
The timeliness and completion rates of study data entered online by participants at home 
into REDCap in MICT compared with data completion using paper forms in LASST. 
 
The quality of spirometry performed by children at home using the Easy One Plus and real 
FaceTime video coaching in MICT using the iPad2/3G compared with the quality  
traditional spirometry performed with coaching  in the clinic setting in LASST  
 
Differences in ACT scores for participants in MICT compared with ACT scores for 
participants in LASST 
1.2. Eligibility Criteria 
Participants whose asthma is well controlled on a moderate dose of combination ICS and LABA 
therapy. Asthma control will be determined by Asthma Control Test Scores, history of asthma 
symptoms and medication, as well as lung function. 
1.2.1. Study Eligibility 
1.2.1.1. 
Inclusion Criteria for Open-Label Stable Phase 
Gender and Age: 
 
Males and females, age 12 years or older 
 
Asthma Treatment: 
 
Physician diagnosed asthma that is well controlled on: 
o 
Fluticasone/Salmeterol Diskus – 250/50 mcg, 1 puff 2x daily 
o 
Fluticasone/Salmeterol HFA – 115/21 mcg, 2 puffs 2x daily 
o 
Budesonide/Formoterol – 160/4.5 mcg, 2 puffs 2x daily 
o 
Mometasone/Formoterol – 100/5 mcg,  2 puffs 2x daily 
 


MICT MOP 
  6 
 
Or a combination of moderate dose ICS + long-acting beta agonist: 
Moderate dose ICS (total daily dose) 
o 
Fluticasone/Salmeterol Diskus – 250/50 mcg, 1 puff 2x daily 
o 
Fluticasone HFA – greater than 264 mcg and up to 480 mcg/day 
o 
Fluticasone Diskus – greater than 300 mcg and up to 500 mcg/day 
o 
Mometasone – 400 mcg/day 
o 
Beclomethasone – greater than 240 mcg and up to 480 mcg/day 
o 
Ciclesonide – 320 mcg/day 
o 
Budesonide – greater than 600 mcg and up to 1200 mcg/day 
 
Long-acting beta agonist 
o Salmeterol Diskus – 50 mcg every 12 hours 
o Formoterol – 12 mcg every 12 hours 
 
Asthma Control Test (ACT) score greater than or equal to 20 
 
Hospitalizations for Asthma: no more than one hospitalization in the 9 months prior to enrollment  
 
In the 4 weeks prior to enrollment: 
 
No unscheduled doctor/ED/hospital visits for asthma 
 
No use of rescue prednisone (oral or IV) 
 
Pre-BD FEV1 greater than or equal to 70% predicted 
 
Females of childbearing potential: not pregnant, not lactating and agree to practice an adequate 
birth control method (abstinence, combination barrier and spermicide, or hormonal) for the 
duration of the study 
 
Smoking 
 
Less than 10 pack-year history of tobacco use 
And: 
 
Abstinence from smoking for more than 1 year 
 
Other 
 
Parent/Guardian and Participant must speak English 
1.2.1.2. 
Exclusion Criteria for Open-Label Phase 
Poor asthma control: 
 
Near fatal asthma (intubation or ICU admission for asthma) within 2 years of enrollment 
 
High risk of near fatal or fatal asthma as defined by one or more of the following criteria: 
o More than 2 hospitalizations for asthma in the previous year 
o More than 3 ED visits for asthma in previous year 
o Hospitalization for asthma in past month 
o Use of more than 2 canisters of inhaled short-acting beta2-agonist in past month 
 
 
Hospitalization or urgent care visit within 4 weeks of Visit 1. 
Smoking: 
 
History of extensive environmental tobacco exposure per judgment of investigator 
 
Other major chronic illnesses: 
 
Conditions which in the judgment of the Study Physician would interfere with participation 
in the study e.g. including but not limited to uncontrolled diabetes, uncontrolled HIV 
infection or other immune system disorder, hyperthyroidism, seizure disorders, renal 
failure, liver disease, non–skin cancer, unstable  psychiatric illness 
 
Recent active substance abuse (in past 6 months) 


MICT MOP 
  7 
 
 
Lung disease other than asthma including COPD, bronchiectasis, sarcoidosis or other 
lung disease 
 
History of known premature birth less than 33 weeks or any significant level of 
respiratory care including prolonged O2 administration or mechanical ventilation 
during the neonatal period 
 
Unstable cardiac disease (decompensated CHF, unstable angina, recent MI, atrial 
fibrillation, supraventricular or ventricular tachycardia, congenital heart disease, or 
severe uncontrolled hypertension) 
 
Medication use: 
 
Chronic oral steroid therapy 
 
Xolair (Omalizumab) therapy in the previous 6 months 
 
Tiotropium (Spiriva)  
“Drug” allergy: 
 
Drug allergies to any component of study drug or history of adverse reaction to short 
or long acting beta agonists 
Participation in clinical trial: 
 
Participation in another clinical trial within the past 30 days 
1.2.2. Randomization Eligibility 
Continues to meet all eligibility criteria for enrollment 
 
Successful completion of the fluticasone/salmeterol stable phase: 
 
No unscheduled visits, no ED visits, and  no hospitalizations for asthma 
 
No change in asthma medication for entire 8 week stable phase period 
 
Rescue beta-agonist use less than 2.3 puffs per day average (less than 16 puffs per week, 
excluding use as a pre-medication for exercise). One nebulizer use is equivalent to 2 puffs of 
beta-agonist 
 
ACT score greater than or equal to 20 at V1, V2 and V3  
 
Pre-BD FEV1 greater than or equal to 70% predicted 
 
Demonstrated adherence: 
 
Completed at least 10 days of the last 14 days of diary card entries 
 
Received treatment with Fluticasone/Salmeterol 250/50 for at least 21 days of the last 28 
days (treatment = at least one dose for the day) 
1.3. Study Visit Time Windows and Data Collection Schedule 
 
Visit 
V0 
V1 Part 1 V1 Part 2 
V2 
V3 
V4 
V5 
V6 Part 1 V6 Part 2 
Time Window (weeks) 
 
-12 to -10 
-10 to - 6 
-6 to -2 
 
2-4 
5-7 
11-13 
 
Target (week) 
 
-11 
-8 
-4 
0 
3 
6 
12 
 
Type of visit 1 
Pre V1 
Eligibility
Phone 
Clinic 
iPad/ 
FaceTime 
iPad 
FaceTime 
iPad 
FaceTime 
iPad 
FaceTime 
iPad 
FaceTime 
Clinic 
Trial Randomization 
x 
 
 
 
 
 
 
 
 
Consent 
 
x 
 
 
 
 
 
 
 


MICT MOP 
  8 
 
Eligibility evaluation2 
x 
x 
x 
 
x 
 
 
 
 
Pregnancy test 
 
 
x 
 
 
 
 
 
 
Blood (DNA, allergy) 
 
 
 
 
 
 
 
 
x 
Height and Weight3 
 
 
x 
 
 
 
 
 
x 
Vital Signs 
 
 
x 
 
 
 
 
 
x 
Physical Exam 
 
 
x 
 
 
 
 
 
x 
Treatment 
Randomization5 
 
 
 
 
x 
 
 
 
 
RPA  
 
x 
 
 
 
 
 
x 
 
Screening Form 
 
 
 
 
 
 
 
 
 
Baseline asthma and 
medical history 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
ACT 
 
 
 
 
 
 
 
 
 
CHSA-Child 
 
 
 
 
 
 
 
 
 
 
 
 
 
Clinic Visit Form 
 
 
 
 
 
 
 
 
 
EQ-5D  
 
 
 
 
 
 
 
 
 
QOL7 
 
 
 
 
 
 
 
 
 
Complete Morning and 
Evening reports on iPad
 
 
 
 
 
 
 
 
 
eNO 
 
 
x 
 
 
 
 
 
x 
Spirometry Pre and 
Post 6 
 
 
 
 
 
 
 
 
 
 
Treatment  medication 
distribution4 
 
 
x 
 
 
 
 
 
x 
iPad Daily 
Report/PEF/AAP 
review  
 
 
 
 
 
 
 
 
 
Receive/Return iPad 
and EasyOne8 
 
 
x 
 
 
 
 
 
x 
 
 Tasks completed by participants prior to FaceTime or Clinic Visit 
 
Minimum of one week required between each visit after V3 
 
(AAP) Asthma Action Plan 
(ACT) Asthma Control Test 
(CHSA) Children’s Health Survey for Asthma-Child version 
(eNO) Exhaled Nitric Oxide  
(EQ-5D) EQ-5D 5 level 
(RPA) Research Participant Assessment 
(PEF) Peak Expiratory Flow 
(QOL) Quality of Life  
 
AE and Adherence monitoring done continuously via REDCap and email alerts. 
 
1. Visit 1 (Part 1) and Visit 6 (Beginning of Part 1) are conducted via WebEx. Visit 6 (end of Part 
1) will be conducted as a virtual visit.  Visit 1 (Part 2) and Visit 6 (part 2) will be conducted in 
the clinic. Other visits are virtual visits. 
2. Participants who do not qualify for treatment randomization will be required to come to the 
clinic at Visit 3 to return the iPad2/3G and EasyOneTM Plus spirometer.  
3. Height and weight at V1 Part 2.  Height only at V2, V3, V5 and V6. Will not check height at V4 
due to short time between V3 and V4.  
4. Study treatments provided to the participant other than open-label Advair and Proair 
dispensed at Visit 1 will be mailed via FedEx . Participant will return all study drug at Clinic V 6. 


MICT MOP 
  9 
 
Current unexpired discus with remaining doses will be re-distributed to the participant. 
Participant will receive Rx for one month supply of Advair or Flovent depending on which drug 
they received at randomization 
5. Participants who qualify for randomization will be mailed study treatment to their home and 
instructed on use via FaceTime  through the iPad2/3G during Visit 3. 
6. After instruction at Visit 1, spirometry will be performed daily and 3 PEF values will be 
recorded on the Morning Report. Pre- and post- bronchodilator spirometry will be performed 
during virtual visits V2, V3, V5, and V6..  
7. Quality of Life Questionnaires for participants >  15 years old at time of enrollment . The 
system is programmed to send the questionnaire to this age group only.  
8. Participant returns EasyOne at Clinic Visit 6. Participant returns iPad which will be cleared of 
study information and returned to participant.      
 
2. REDCap Overview, Training, and Use 
2.1. Overview 
What is REDCap 
 
Nemours Bioinformatics Core facility (BCF) manages the Nemours installation 
of REDCapTM (Research Electronic Data Capture from the REDCap Consortium). 
REDCap is a secure web application that allows users to build and manage online surveys 
and databases for a variety of purposes including basic, clinical, translational and 
behavioral research, repositories and operational support.  In addition to maintaining this 
application, BCF provides training and other support so that Nemours associates can 
utilize all the tools this resource provides  
 
Reasons for Using REDCap for Study Staff and Participant Data Collection in MICT 
 
Accessibility – all study personnel can get to the data and do data entry from anywhere. 
 
Security - Data is stored on our servers, backed up nightly. Users must authenticate to 
view it. Users can be assigned different levels of permission such as read-only, add/edit 
data, delete records, etc. Users can also be restricted from viewing certain forms and 
exporting certain fields. 
 
Versatility - Data or data subsets can be easily selected, sorted, and exported in formats 
directly ready for analysis in SPSS, SAS, S+/R, or even Excel. Schedules can be 
automatically generated from defined events. 
 
Validity - Using a tool like REDCap to set up a database and data entry forms for a study is 
a valuable first step in being sure that you have covered all the devilish details that are 
inherent in designing a valid research study. The bioinformatics staff have expertise in 
database design and biostatistics and can help assure that your study is well thought out 
and implemented. 
To learn more about REDCap, send us an email, or visit the REDCap Training Resources page. 
(Note that you do not need to log into REDCap to view the tutorial videos). 
2.2. How to get Access to REDCap 
Nemours Bioinformatics Core facility (BCF) manages the Nemours installation of REDCapTM.  
Access is obtained by going to the website on the link below and completing the online form AND 
the PDF form that must be signed that is also on this page (scroll to the bottom). 
http://www.nemoursresearch.org/snap/admin_forms/redcapacct.php 
2.3. Training 
Training is provided by Nemours Bioinformatics Core facility by Suzanne McCahan, PhD. 
2.4. MICT REDCap Testing and Real Databases 
Definition 


MICT MOP 
  10 
 
 
Two parallel data systems are used.   
o Test projects (begin with “test-MICT” as the name. 
 
Allows study team members and the bioinformatics team to test and 
troubleshoot forms before they are used to collect actual study data 
 
allows new staff to experiment with test participants to see how the data are 
collected and can be viewed 
o Live projects (begin with “MICT” as the name 
 
Organization 
 
Navigation of the REDCap database occurs using the tabs on the left 
o “My Projects” takes you to all the MICT training and live databases 
o “Data Collection” allows you to select a participant by going to “Add / Edit Records” 
o “Applications” probably won’t be used much by study staff 
o “Project Bookmarks”  
 
Bookmarks that begin with “MICT…” allow for a one-click way to open a 
different MICT project 
 
Bookmarks that do not being with “MICT…” allow you to access specific 
participant information  
 
If a User Name and Password are required: 
o User Name is your Nemours login name 
o Password is MICTstudy2013 
o “Reports” have been created to provide specific information the coordinators have 
requested 
2.5. Demonstration Study Websites 
2.5.1. Study Consent Website  
Overview 
 
The study consent website houses the consent video and sidebar information in the video. 
(Click here to go to the document: Sidebar Material.) 
Viewing the Consent Website 
 
Study staff can view the video at https://www.nemoursresearch.org/mict/ 
o User Name: preconsent 
o Password: pass 
Participant Viewing 
 
Links to the study consent website are individualized for each participant 
 
The individual links allows the study staff to track viewing of the consent website by 
potential participants 
 
All data from viewing the website is stored in REDCap 
 
2.5.2. Morning and Evening Reports Website – Demo Sites 
Overview 
 
The website houses the Morning and Evening Reports 
 
Participants enter data on this website twice daily 
Viewing the Demo Reports Website 
 
Study staff can view the Morning and Evening Reports website at 
https://www.nemoursresearch.org/mict/ 
o User Name: postconsent 
o Password: pass 
Participant Data Entry 
 
The Reports website is accessed by participants using unique user names and passwords 
 
All data from the website is stored in REDCap 
 
The individual links allows the study staff to track viewing of the consent website by 
potential participants 


MICT MOP 
  11 
 
 
2.6. Participant ID vs. Username vs. Study Email Name 
Participant ID 
 
The Participant ID is generated during the recruitment process by the study recruiter in 
Jacksonville 
o The ID begins with the 3 letters indicating the study site (JAX, ORL, PNS, PHL, STL, 
WIL) followed by a 3 digit number beginning with 101 (JAX101) 
o The participant ID is used in REDCap to select your participant in “Add/Edit 
Records” and all REDCap forms and reports 
Username 
 
The username is generated by Bioinformatics sequentially  
o The user name is in the format of: 
 
Study acronym “mict” 
 
Study location “j”, “o”, “w”, “p”, “ph” 
 
Sequential number starting with “101” 
 
Example: “mictj101” 
o The user name is also the first part of the gmail email address  
o The user name is also the iPad ID 
Study Gmail Email and Apple ID and Passwords 
 
A gmail study email account is created for each participant by Nemours IT (example: 
mictj101@gmail.com) 
o The gmail address is used as the Apple ID 
 
The initial password for the gmail account and Apple account is based upon the 3 digits in 
the user name + 1234 and the study site initial  
o If the username is mictj101, the initial password for the gmail account and Apple 
account is “1335mictJ” – upper and lower case are important 
o If the participant changes their password, we are unable to tell them what it is 
 
They will need to reset their password if they cannot remember it 
 
This is done within gmail 
iPad Passcode 
 
The iPad is set up to have a 4-digit passcode in order to use the iPad.   
 
The 4-digit iPad passcode is the sum of the 3 digits in the user name + 1234 (e.g for the 
participant who is JAX101, the iPad passcode is 101+1234=1335) 
Gmail Recovery Email 
 
The participant may be asked to put in a recovery email in order to accesses their study 
gmail account  
 
The gmail recovery email is: mictsupport@nemoursresearch.org 
Finding Participant ID, Username, and Initial Passwords in REDCap 
 
Go to the MICT-web info REDCap project 
o Go to the “Data Search” section 
 
In “Choose a field to search”, put in the participant ID (this is usually the 
easiest piece of data that you remember about your participant) 
 
In “Basics”, you will find the Initial Password and the Participant ID 
 
In “Password”, you will find the Username 
Providing Participants with their Participant ID, Username, and Initial Passwords 
 
When the SC receives the iPad from JAX, inside the box will be a form that includes the 
Participant ID, Username, and Initial Passwords.  A completed copy of this form can be 
found in the folder for your site.  (Click here to go to the blank form: User name 
Passwords Gmail AppleID.docx.) 
o In this folder (Click here to go to the folder: User Name Password Form), you 
will see folders for each site.  The AC will have the participant form saved in the 
folder for your site. The SC can print extra copies of the form if needed. 


MICT MOP 
  12 
 
2.7. Editing Data in REDCap 
Overview 
 
REDCap tracks all editing done on the participant’s record.  The edited data will identify the 
person logged into REDCap and the date and time of the edits. 
How to Make Edits in REDCap 
Example: You need to edit the Evening Report entry.  The participant indicated they ”used oral 
or IV prednisone/steroids for asthma” but according to a conversation you had with the family they 
have not used steroids. You will want to contact the family when you see alerts that should be 
investigated with the family. Go to the record that needs editing.  
 
 
Click on the little balloon next to “Used oral or IV prednisone/steroids for asthma”.  Change the 
data to the correct entry.  Enter your comment.  There is no need to put your name or date/time 
as REDCap will have this.  Click on “Comment” to save your comment. 
 
 
 
The balloon will now be yellow to indicate an entry was made.  Click on the yellow balloon to see 
your comment and any other comments that were made for this data point: 
 
 
Then you can click on the H with the circle to view your edit: 


MICT MOP 
  13 
 
 
3. Tracking Study Staff Effort (Time) on MICT and LASST 
Overview 
 
Time spent doing study related tasks and procedure are being collected for a study 
endpoint to measure efficiency – this is a critically important endpoint for the project 
 
Any study staff working on MICT or LASST are to record time for all processes, 
procedures, phone calls etc for MICT or LASST 
 
Time is recorded on paper forms and then transferred to the MICT-data REDCap project 
after each Clinic or FaceTime visit (Under Construction-how it will be entered into REDCap 
has not been finalized) 
 
Procedures 
 
Forms are located on the S drive.  (Click here to go to the blank form for LASST: Time 
Tracking Form LASST.xlsx.) (Click here to go to the blank form for MICT: Time 
Tracking Form MICT.xlsx.)  
o Different forms are used for MICT and LASST 
o LASST has 12 study visits so you won’t need Visits 7-12 for MICT time tracking 
 
LASST time tracking will continue for all 12 visits to allow for more data to analyze 
 
If some aspect of the study are done by multiple persons, each person must be completing 
the form 
 
Stopwatches/timers are to be kept at your desk or on your person to keep accurate track of 
time when doing any study related tasks 
o Additional stopwatches/timers are available by contacting the AC 
4. Study Visits / Participant Contacts 
4.1. General overview of order of procedures 
There is no specified order of procedures except as noted under the specific visits.  However at 
V1 and V6 for those sites collecting exhaled nitric oxide data, the exhaled nitric oxide data must be 
collected before doing PFTs. 
4.2. Screening Steps 
4.2.1. Tasks to be Completed Prior to Visit 1-Part 1 
Overview 
 
Recruiter identifies participants and assigns Participant ID 
 
Administrative Coordinator (AC) sets up MyNemours accounts for family 
 
Participant views study consent video online 
 
Satisfaction Survey for consent process is sent 
 
Time Frame 
 
Target 3 weeks Visit 1, Part 2 (in clinic) 
 
Window 2-4 weeks before in-clinic screening  
 
Equipment/materials 


MICT MOP 
  14 
 
 
Ensure participant family has telephone access 
 
Ensure participant family has a personal email address  
 
Tasks: Recruiter 
 
Identify a potential MICT/LASST study participant.  
 
Randomize potential participant to MICT or LASST study using the Trial Randomization 
Database by logging in to the http://www.jhcct.org/mict/micthome.asp  
 
Contact parent of a potential study participant to discuss their child’s participation in an 
asthma research study.  
 
Speak with the family and participant regarding the only the study they are randomized to 
by the study database  
 
If family is interested, obtain verbal ACT score and review screening questions to 
determine eligibility.  
 
 If the child appears to be eligible and is randomized to LASST, follow LASST protocol  
 
If the child appears eligible and is randomized to MICT 
o verify contact information, including the best time and method to contact the parent, 
and obtain an email address from the parent so a link for the study website can be 
sent to the parent and participant.  
o If the family does not have an email account, they will receive instructions for 
setting up a personal email account.  
 
Recruiter notifies the Administrative Coordinator (AC) that the family is interested and 
gives AC the contact information, Trial Randomization number, and screening information 
(ACT, medications) 
 
Tasks: Administrative Coordinator (AC) 
REDCap Steps 
 
In the MICT-data REDCap project, 
o Click ‘Add/Edit Records’, choose the MICT arm and enter participant ID.  The first 
three letters of the participant ID must be uppercase, i.e. JAX101. 
o Enter data into ‘Patient Screening Log’ form 
 
3 fields in this form may be left blank initially, these are 
 
Main reason failed screen or not enrolled 
 
Successfully completed V1 (enrolled) 
 
Notes 
 
Set form status as ‘unverified’ if proceeding to consent process 
 
Set form status as ‘complete’ if failed screen 
 
Click ‘Save Record’ 
o Enter data into ‘Study Information’ form 
 
Enter data into all but ‘Treatment arm’ 
 
The field ‘Additional email address for alert messages’ should be 
completed if a Study Coordinator (SC) from a site other than the one 
indicated in the form will be following the participant.  Otherwise, the 
field can be left blank. 
 
Be sure to answer ‘Is this record for a rescreen? 
o ‘No’ is necessary for email invitations to be sent for the 
Satisfaction Survey and the ACT under Event:Screening.. 
 
Mark form as ‘unverified’ 
 
Click ‘Save and go to Next Form’ 
o Enter data into the fields of ‘Participant Information’ form 
 
Make sure the parent's email address has been entered into the Participant 
Info form before saving the scheduled consenting date under Screening 
[Otherwise the about the consenting appointment will bounce back (and not 
get to the parent’s email address) because it is sent immediately after 
entering the consenting appointment date and saving the form.  
 
Mark form as ‘Unverified’ 


MICT MOP 
  15 
 
 
Click ‘Save Record’ 
o Enter the date and time of the Consenting Phone Appointment in the ‘Visit Dates’ 
form under ‘Screening’. 
 
Mark form as ‘unverified’ 
 
Click ‘Save Record’ 
 
 
In the MICT-web info REDCap project  
o Click ‘Add/Edit Records’ and choose the next available ID from the dropdown list of 
incomplete records 
o Enter participant ID used in MICT-data.  The first three letters of the participant ID 
must be uppercase, i.e. JAX101. 
o Click ‘Save and Continue’ then send email as described in step called ‘Send email’ 
o Enter date the participant will be given ID 
o Set the ‘Basics’ form as ‘unverified’ 
o Click ‘Save Record’ 
o ‘Send email entitled “Subject:  Next steps for the Asthma Research Study” 
(Click this link to see all emails sent to study participants: Emails Sent to 
Participants.)  
o Email is sent to parent’s PERSONAL email address within 24 hrs after the recruiter 
has scheduled the Consenting Phone Appointment using the webpage 
https://apps.nemoursresearch.org/mict/admin/about_study_email.php.  This 
message informs the parent that they should expect a call about setting up a 
MyNemours account and includes the Consenting Phone Appointment date and 
time.   
 
In the MICT-equipment REDCap project 
o Click ‘Add/Edit Records’ and chose the username assigned this participant 
o Click ‘Tracking Information’ in left side panel under Data Collection 
o Mark that the Username is: ‘Assigned- given to potential participant’ 
o Enter the Participant ID 
o Click ‘Save Record’ 
 
MyNemours Steps (Click here to see MyNemours section in this MOP) 
 
MyNemours accounts will be set up for the parent and the child.  (Nemours typically 
sets them up for the parent on behalf of the child so for the study, the child will have a 
MyNemours account also) 
 
Both the parent and child will need to activate their individual MyNemours accounts  
 
MyNemours accounts are used to send the Parental Permission form to the parent and 
the Assent form to the child from EPIC.  This is the only time the MyNemours accounts 
are used for the study. 
 
Families can initiate setting my MyNemours accounts at 
http://www.nemours.org/patientfamily/mynemours.html.   
 
The AC can assist families with accessing the MyNemours link on the webpage, and 
with filling out the form from the “Request an Activation Code online” link on 
Nemours.org.  
**If they are not at a computer, staff will send them the link from the 
asthmaresearch@nemours.org email address with instructions and will follow up within 
48 hours. 
 
EPIC Steps 
 
The AC contacts the family after verifying whether the child has an EPIC guarantor 
account. AC will set up an EPIC account if they don’t have one. 
 
Setting up for the Consenting Phone Appointment 


MICT MOP 
  16 
 
 
Four days before the Consenting Phone Appointment, two messages will automatically be 
sent.  (Click this link to see all emails sent to study participants: Emails Sent to 
Participants.) 
o Email #1 Sent to the parent’s personal email address: 
 
Includes the date and time of the Consenting Phone Appointment, a link to 
the study video website. The email includes the user name and password 
which will allow the family to view the consenting video and other dynamic 
content on the MICT Study Website.  This message also includes 
information about the study email account assigned to the participant.   
o Email #2 Sent to the participant’s study email address 
 
Includes the date and time of the Consenting Phone Appointment, a 
description of what will happen during the phone call, a link to a pdf with an 
ice cream label and instructions to print or save the document.  These 
messages will also be blind-copied to the SC using a site specific email 
alias.   
 
Check the messages that you receive to make sure the phone appt 
date, username, password and parent’s first and last name appear 
in the messages.  When these messages are sent, fields in the 
‘Email Triggers’ form under ‘Screening’ in the REDCap project 
MICT-data will be completed. 
o To resend these messages, you may forward the copy you received or do the 
following in the MICT-data REDCap project: 
 
Click ‘Add/Edit Records’ and chose the participant ID 
 
Click the button for ‘Email Triggers’ under Screening 
 
Reset the field for the message you want to resend by clicking ‘reset’ 
 
Click ‘Save Record’ 
 
This will trigger the sending of the message the next morning if the 
Consenting Phone Appointment that is recorded in REDCap is in 4 days or 
less. 
 
The parent and participant view MICT materials (video, other dynamic content) prior to the 
Consenting Phone Call. 
o Activity on the Consenting Web Site is tracked and recorded in the MICT-quizzes 
REDCap project.  Tracked activity includes indicating who is watching, starting a 
part of the video, clicking a tab and clicking a side bar button.  To view the tracked 
activity, go to the MICT-quizzes project and click on ‘data’ under ‘Reports’ in the left 
sidebar. (Click here to see Viewing Consent Video section in this MOP). 
 
If the potential participant is no longer interested in the study, this should be recorded by 
doing the following in REDCap. 
o MICT-web info REDCap project. 
 
View the report ‘Viewing consent site and click on the appropriate 
username. 
 
Set the ‘Basics’ form as ‘complete’ 
 
Click ‘Save and go to Next Form’ 
 
Click ‘No’  in the ‘Tracking’ form 
 
Set the ‘Tracking’ form as ‘complete’ 
 
Click ‘Save Record’ 
o MICT-data REDCap project 
 
Click ‘Add/Edit Records’ and chose the participant ID 
 
Click the button for ‘Patient Screening Log” under Screening  
 
Complete this form 
 
Set form as ‘Complete’ 
 
Click ‘Save Record’ 
o MICT-equipment REDCap project 
 
Click ‘Add/Edit Records’ and choose the username assigned to this 
participant 


MICT MOP 
  17 
 
 
Click ‘Tracking Information’ in left side panel under Data Collection. 
 
Enter data for the following fields 
 
Set ‘Username is:’ to ‘Withdrawn – iPad was never delivered’. 
 
Set the form as ‘Complete’ 
 
Click ‘Save Record’ 
 
Tasks: Administrative Coordinator (AC) and Study Coordinator (SC) 
 
Parent and participant review the video and content. 
o At the end of the video they select the button that says Ready to Enroll.  
 
This generates an email to AsthmaResearch@nemours.org that participant 
# _____ is ready to enroll.  
 
This generates an email automatically sent to the participant’s study email 
address that lists the next steps for the study, including the date and time of 
the Consenting Phone Appointment, and a link to a pdf with an ice cream 
label and instructions to print or save the document. 
The AC, Study Coordinators, and PI have access to the email account folder in their Outlook 
Inbox.  
4.2.1.1. 
Follow-up Process for Consent Video Viewing Prior to Webex 
AC will check the report ‘Viewing consent site” in the MICT-web info REDCap project frequently 
during the 3 days before the scheduled Research Assessment Interview appointment and follow 
up with potential participants who have not watched the video  
 
On the day of the appointment, if the parent and participant have not watched the video by 
3PM, the AC will contact the SC to update the SC on any contacts made with the family 
and for further instructions from the SC about the appointment (rescheduling or wait and 
see).    
 
The SC or AC will contact the family to determine if the appointment needs to be 
postponed to later in the day or rescheduled to a different day 
 
If the family cannot be reached, the AC will continue to try and reach the family the next 
day 
4.2.2. Visit 1-Part 1 (Webex Research Assessment Interview) 
Overview 
 
WebEx with SC, Parent, Participant to conduct the Research Assessement Interview 
(called the Phone Consenting appointment to the families) 
 
WebEx to conduct the Newest Vital Sign 
 
Parental Permission Form and Assent sent from EPIC to MyNemours accounts 
 
Satisfaction Survey for consent process is triggered 
 
Time Frame 
 
Target 2 weeks before V1 - Part 2 (clinic visit) 
 
Window 1-3  weeks before clinic visit 
 
Duration of visit 1 to 2 hours 
 
Equipment/materials 
 
Computer access 
 
Internet / Phone access  
 
Email address 
 
Equipment/materials for recording Research Participant Assessment Interview 
 
Forms (Click this link to view the forms: Research Assessement interview forms.) 
o RESEARCH ASSESSMENT FORM – Female 
o RESEARCH ASSESSMENT FORM – Male 
 
Activated MyNemours accounts for both parent and participant  
 
Ice Cream label for Newest Vital Sign 
 


MICT MOP 
  18 
 
Tasks: Study Coordinator (SC) 
SC Tasks Prior to V1 – Part 1 (Phone/Research Assessment Interview) 
 
Verify in EPIC that both the parent and participant have activated their MyNemours 
account (Click here to see MyNemours section in this MOP.) 
 
Confirm the appointment date and time with the family prior to the date of the phone 
appointment and that the parent and child will both be available for the appointment.  
o Verify that the family has access to the Ice Cream label and a calculator, pen/pencil 
and paper. 
 
SC Tasks for V1 – Part 1 (Phone/Research Assessment Interview) (Click this link to see MOP: 
MICT Audio Recording MOP.)  
 
Contact parent and participant by phone using WebEx Meeting Center per Audio 
Recording Protocol instructions.  
o IMPORTANT: The same parent who completes the Research Assessment 
interview with the study coordinator at this visit, MUST be the same person at Visit 
6.  Please inform the family of this – you will also enter this information REDCap to 
help you remember when it is time to do the Visit 6 Research Assessment 
interview. 
 
Review the participant’s preliminary screening information obtained by the recruiter (ACT 
questions and medications/medical history) with the parent and child to confirm preliminary 
eligibility.  
 
Administer the Research Assessment form.  To avoid missing any questions, make a 
check mark after each question is asked. (Click this link to view the forms: Research 
Assessement forms.) 
o RESEARCH ASSESSMENT FORM – Female 
o RESEARCH ASSESSMENT FORM – Male 
 
Conduct the Newest Vital Sign Assessment  
o Click this link to see MICT Audio Recording MOP for details 
o Ask the parent and child if they would like to use a calculator (this is part of the 
instructions for the Newest Vital Sign) 
o Write notes on the score sheet of anything that the participant says 
 
SC notes on the Newest Vital Sign Assessment paper form will be useful for 
data analysis 
 
Scan the form and save on the S drive at S:\CP&P\CLINICAL 
TRIALS\CPTR STUDIES\MICT Grant\Forms\Newest Vital Signs 
Worksheets - With Patient Data (Click this link to see the folder location: 
Folder location for Newest Vital Sign Completed Worksheets.) 
 
After completing the entire Research Assessment Interview including answering any 
questions the family is ready to sign consent 
o Inform the family that both the parent and child will receive an email (the personal 
email address that the family has in EPIC so be sure that is the one that they will 
check) instructing them to check their MyNemours account inbox.  
 
(Click this link to see all emails sent to study participants: Emails Sent 
to Participants.)  
o Inform the family that they will sign the PPF and Assent forms electronically 
o Inform the family that after they sign the PPF and Assent forms, they will receive an 
email to the study email for the parent to complete the Satisfaction Survey for the 
consent process.  
 
Schedule Visit 1 Clinic Visit while you still have the family on the phone!  If you are 
conducting the Research Assessment Interview for a coordinator at another site, you 
should tell the family that the local coordinator will follow up to confirm the appointment. 
 
Sending the Parental Permission Form and Assent Form 
o Instruction with screen shots on how to send the PPF and assent forms from EPIC 
to the family’s MyNemours accounts for parent and child is available on the S drive. 


MICT MOP 
  19 
 
(Click this link to view the manual: Manual for Sending PPF and Assent via 
EPIC and MyNemours.) 
 
Send the PPF and Assent immediately after the Research Assessment 
interview is completed. 
 
After saving the audio files according to the steps in the MICT Audio Recording MOP 
(Click this link to see MOP: MICT Audio Recording MOP), send an email to Alex Taylor 
(Alexandra.taylor1@nemours.org and holly.antal@nemours.org) to let them know you 
have completed the recordings and saved them to the shared drive.  Include the 
Participant ID in the email. 
o Please not the “1” in Alex Taylors email (otherwise it will to to a physician in 
Delaware) 
 
The AC is to check the participant’s EPIC account encounters to view the signed 
PPF and Assent and follow up with families who have not signed 
o The AC will let the SC know when the PPF and Assent are signed because the SC 
will need to verify all the responses on the PPF and Assent and make sure that 
they have agreed to participate.    
o If after 7 days, the PPF and assent are NOT signed, the AC will ask the SC to 
follow up with the family 
o In EPIC you will be able to see when the MyNemours email was read  
 
SC REDCap Steps 
 
REDCap Instructions (for SC): 
o In the MICT-data REDCap project 
o Click ‘Add/Edit Records’ and choose the participant ID (for example JAX122) for 
this participant 
o Enter the Visit Dates form for the Screening event 
 
For the field “Actual visit date” Click the ‘Today’ button or enter the date the 
phone visit occurred. 
 
When a date is entered in this field and saved, MyNemours 
instructions are automatically sent to the study gmail address, the 
parent’s email address and the alert email addresses for the site and 
participant.  The message will automatically be sent the first the date 
is saved.  To send the message again, go to the Email Triggers 
form, reset the appropriate field and save.  Then return to the Visit 
Dates form for the Screening event, enter a date for ‘Actual visit 
date’ if there isn’t one already and click ‘Save’.  When ‘Save’ is 
clicked, the email messages will be sent. 
 
Set form as ‘Complete’ 
 
Click ‘Save’ 
o Enter the Research Assessment Interview form for visit 1. 
 
Complete the Research Assessment Interview form for visit 1 
 
PDF file with the questions to ask participants is available in this REDCap 
form. 
 
Set form as ‘Complete’   
 
Click ‘Save’ 
o Continue in REDCap to the Newest Vital Sign Assessment 
 
From the grid in REDCap 
 
Enter the form ‘Newest Vital Sign’ 
 
 Complete the Newest Vital Sign form while performing the 
assessment 
o Click ‘Save and Continue’ at any time there is a delay in the 
responses 
o The number of correct answers will automatically be 
calculated when answers to all the questions have been 
entered. 


MICT MOP 
  20 
 
 
Click ‘Save and Continue’ after completing the parent 
interview. 
 
After completing the participant’s interview, set the 
form as ‘Complete’ 
 
Click ‘Save’ 
 
4.2.3. Tasks to be Completed Prior to Visit 1-Part 2 (Clinic Visit) 
Overview 
 
Emails on how to access Gmail account automatically sent 
 
Complete the User name Passwords Gmail AppleID form to go with iPad to site 
 
Study Questionnaires sent to participant 
 
AC REDCap data entry 
 
SC reviews ACT and Screening Form completed by participant 
 
SC Reviews questionnaires completed by participant 
 
Administrative Coordinator (AC) Tasks 
AC REDCap Steps after Consents have been Signed 
 
PPF and Assent signed by parent and participant 
o MICT-data REDCap project 
 
Click ‘Add/Edit Records’ 
 
Complete the ‘Signed consent’ form (2 fields) 
 
Set form as ‘complete’ 
 
Click ‘Save’. 
 
This triggers an email (this is the 2nd time this information will have 
been sent) to the parent’s PERSONAL email account on how to 
access the study gmail account. 
 
This triggers 3 emails to the participant’s study email address with 
links to the ACT and SC forms and the Satisfaction Survey. The 
Satisfaction Survey is for the parent only. 
 
 (Click this link to see all emails sent to study participants: 
Emails Sent to Participants.) 
 
AC will check to insure that the ACT and SC forms are completed 
and call family if reminders are needed. 
 
Go to the ‘Participant Information’ form and record whether or not consent 
was given to send spirometry results to the primary physician for asthma 
care. 
 
Click ‘Save’. 
 
Setting up for V1  Part 2 (if ACT and SC forms meet eligibility criteria; see below SC 
REDCap Steps after Consents have been Signed) 
o MICT-data REDCap project 
 
Click ‘Add/Edit Records’ and choose the participant ID for this participant 
 
Enter data into the Visit Date form for Visit1 
 
Enter the Target date (can be same as scheduled date) and 
Scheduled date and time 
 
Leave the field ‘Is the scheduled visit date within 4 days?’ blank 
unless you want email messages with links to surveys for visit 1 to 
be sent immediately. 
 
Set the form as ‘Unverified’ 
 
Click ‘Save’ 
 
This will take you back to the grid for this participant 
 
Enter Target dates in the Visit Date form for Visit 2 and Visit 3 
 
These dates are necessary for the functions that display the Asthma 
Action Plan 
 
Automated REDCap steps for V1 Part 2 


MICT MOP 
  21 
 
o Four days before V1 the participant will receive  
 
another email (this is the 3rd time this information will have been sent) to the 
parent’s PERSONAL email account on how to access the study gmail 
account 
 
an invitation to complete the following forms: ACT, Baseline Assessment 
(BA), Children’s Health Survey (CHSA-Child), EQ-5D, and Quality of Life 
Questionnaires. (If age at consent is <15 years, then the Quality of Life 
Questionnaire invitation will not be sent.)   
 
It is desirable that at least 24 hours before scheduled visit 
participants will need to complete these forms, giving the coordinator 
time to review the answers prior to Visit 1.  
 
AC REDCap Steps after Visit 1 – Part 2 has been Scheduled 
To prepare for the onsite Visit 1 
In the MICT-equipment REDCap project 
o Click ‘Add/Edit Records’ and chose the username assigned this participant 
o Click ‘Name’ in left side panel under Data Collection 
 
Set form as ‘Complete’ 
 
Click ‘Save and go to Next Form’ 
o Click ‘Tracking Information’ in left side panel if not already in the form.  
o Enter data for the following fields 
 
Date iPad was delivered to participant 
 
EasyOne spirometer serial number 
 
EasyOne asset tag # 
 
Date EasyOne was delivered to participant 
 
If appropriate, Hotspot serial number and date Hotspot was 
delivered to participant 
o Click ‘Save Record’ 
 
In the MICT – DC summary REDCap  project (DC means Diary Card) 
o Click ‘Add/Edit Records’ and enter the participant ID for this participant.  
The first three letters of the participant ID must be uppercase, i.e. JAX101. 
o Enter data into ‘Participant Information’ form 
o Select from status as ‘Complete’ 
o Click ‘Save Record’ 
 
Complete the ‘User name Passwords Gmail AppleID’ form and store on the S drive and print a 
copy to be included with the iPad sent to the site.  Click here to go to the folder: User Name 
Password Form). 
 
Study Coordinator (SC) Tasks 
SC REDCap Steps after Consents have been Signed 
 
Review submitted ACT and SC forms.   
o If the ACT score is <20, the SC will have received an email alert with this 
information 
o If the SC has generated any email alerts, they need to be resolved 
 
Click here to see the Viewing All Alerts on My Participant section in 
this MOP for instructions on how to review all alerts for the participant 
o If the ACT and SC data indicate that there are issues to be resolved then the Visit 
1-Part 2 (clinic visit) may need to be rescheduled (they may be eligible for V1 in 4 
weeks). 
 
If the Visit 1-Part 2 (clinic visit) does need to be rescheduled, then be sure 
and change the date in REDCap.  Otherwise, the emails with the 
questionnaires will be sent out 4 days/3nights before the ‘scheduled date’ in 
REDCap.  This would result in confusion on the part of the participant when 
the emails are sent out for the revised Visit 1-Part 2 (clinic visit) date. 


MICT MOP 
  22 
 
 
If there are any issues that have been discussed with Dr. Blake and an 
exception has been allowed, document the exception on the ‘Protocol 
Exception’ Form under the Ongoing column. 
 
The EasyOne Spirometer can be set up with all the general information that you have on 
the participant except height and weight which are collected at the Visit 1 – Part 2 clinic 
visit 
o See Coordinator Instructions for using the Easy One.  (Click this link to view the 
manual: Coordinator Manual for EasyOne Use.) 
 
SC REDCap Steps after Visit 1 – Part 2 has been Scheduled 
 
Review participant’s responses to the ACT, Children’s Health Survey, EQ-5D, Quality of 
Life Questionnaires (if 15 yo or older) and the Baseline Asthma and Medical History and 
check the BA Form Alerts.  
 
If there are any issues that have been discussed with Dr. Blake and an exception has been 
allowed, document the exception on the ‘Protocol Exception’ Form under the Ongoing 
column. 
o To review the submitted forms, go to the MICT-data REDCap project 
 
Click ‘Add/Edit Records’ and chose the participant ID for this participant 
 
Review the following REDCap forms under Visit1 
 
Asthma Control Test – participant version 
 
Children’s Heath Survey – participant version EQ-5D from the 
EuroQol Group 
 
Quality of Life Questionnaires 
o If 15 yo or older when the consent was signed 
o This form has a notes field for your comments. 
 
Baseline Asthma and Medical History – participant version 
o This form has a notes field for your comments 
 
BA Form Alerts 
o Fields will appear in this form, depending on the answers 
given for the Baseline Asthma and Medical History 
o This form has a notes field for your comments 
o Set form as ‘Complete’ to signify that the BA Form Alerts 
were reviewed. 
 
Click ‘Save’ on each form as comments are added 
4.2.4. REDCap steps: Participant Discontinues Between V1 Part 1 and Part 2 
When a participant discontinues the study after Visit 1 – Part 1 (they have completed 
the consent process) but before they have Visit 1 – Part 1 (clinic visit), the AC 
should do the following in REDCap 
In the MICT-data REDCap project 
o Click ‘Add/Edit Records’ and choose the participant ID for this participant 
o Click the button for ‘Patient Screening Log’ under Screening 
 
Complete form 
 
Set form as ‘Complete’ 
 
Click ‘Save Record’ 
 
In the MICT-equipment REDCap project 
o Click ‘Add/Edit Records’ and choose the username assigned to this participant 
o Click ‘Tracking Information’ in left side panel under Data Collection. 
o Enter data for the following fields 
 
Set ‘Username is:’ to ‘Withdrawn – iPad was never delivered’. 
o Set the form as ‘Complete’ 
o Click ‘Save Record’ 
 
In the MICT-web info REDCap project 


MICT MOP 
  23 
 
o Click ‘Add/Edit Records’ and choose the username assigned to this participant 
o Go to the ‘Basics’ form if not already there, using the left side panel 
o Set the form as ‘Complete’ 
o Click ‘Save Record’ 
 
4.3. Visit 1-Part 2 (Clinic Visit) 
Overview 
 
Determine that iPad is ready for participant 
 
Set up EasyOne for participant 
 
Conduct Visit 1 procedures  
 
Dispense open-label Advair 250/50 and Proair 
 
Dispense other study items to participant 
 
Confirm shipping address and details for study medication delivery 
 
Time Frame 
 
Target: 8 weeks prior to Randomization (V3)  
 
Window: 6 to 10 weeks prior to Randomization (V3)  
 
Duration of V1: 2 to 4 hours  
 
Equipment/materials 
 
NIOX MINO (if being performed at your site) 
 
EasyOne Spirometer and that includes 4 spirettes 
 
Nose Clips (may need to dispense several for the participant to take home) 
 
Nemours nylon  bag   
 
Open-label Advair and Proair  
 
Pregnancy test kit  
 
Equipment agreement form. (Click here to view the form: Equipment Use Agreement.)  
 
CT Payer Information (Click here to see Participant Stipends using CT Payer section 
in this MOP.) 
 
Yardstick for measurement during virtual visits 
 
Coordinator’s iPad so physician can complete physical exam in REDCap 
 
iPad2 with Defender case 
o FaceTime Instructions on YouTube http://youtu.be/CoU38SyU8fo 
o FaceTime tutorial: http://www.youtube.com/watch?v=CoU38SyU8fo 
o Completed copy of the User name Passwords Gmail AppleID form. Click here to 
go to the folder: User Name Password Form) 
 
Procedures Overview: 
 
Note:  Any participant without an asthma care provider is to be referred to one.  
 
Conduct pregnancy testing if participant is female of childbearing potential 
 
Physical Exam including height and weight, and anthropormorphic measurements  
 
Measure exhaled nitric oxide (eNO). This must be completed before pulmonary function 
testing. 
 
Pulmonary function testing pre-and post-bronchodilator, using the participant’s EasyOne 
spirometer  
o Note: if FEV1 is less than 70% predicted participant is not eligible  
 
Administer “Ask in Private” questions to participant in a location away from parent 
 
Review Temporary Asthma Action Plan 
 
The Actual Visit Date for Visit 1 must be entered into REDCap.  Do this as soon as you can 
after arrival. 
o IMPORTANT FIRST STEP FOR PARTICIPANTS TO ACCESS THE STUDY 
WEBSITE (MORNING AND EVENING REPORTS) 
o Click here to see the Important First Step section in this MOP. 


MICT MOP 
  24 
 
 
Dispense study medication 
o Confirm shipping address and deliver details with family  
 
Dispense iPad, EasyOne and other supplies 
o Have family sign Equipment Use Agreement (Click here to view this form: 
Equipment Use Agreement.) 
 
Send the Physician Introduction Letter to primary asthma physician (Click this link to see 
IRB approved letters to participant Physicians: Physician Letters.)  
o Include copy of spirometry results 
 
Chart in EPIC with a brief summary of visit 
 
4.3.1. Study Coordinator Procedures for Visit 1 – Part 2 
4.3.1.1. 
Coordinator Review of Questionnaires 
 
If not all of the questionnaires have been completed before the participant arrives at Visit 1, 
follow the order of steps outlined in the section ‘My participant has not completed all the 
questionnaires for Visit 1’ (Click here to see the My participant has not completed all 
the questionnaires for Visit 1 section in this MOP. 
 
If there are any issues that have been discussed with Dr. Blake and an exception has been 
allowed, document the exception on the ‘Protocol Exception’ Form under the Ongoing 
column. 
4.3.1.2. 
Collect in Private 
 
Leave parent in waiting area 
 
Obtain height 
o Use the yardstick that will be provided to the family 
o Mark each 12 inches with feet notations 
 
Obtain weight (This can be done at the same time as Biometrics. (Click here to see the 
Biometrics section in this MOP) 
 
 can also do Biometrics at this time) 
 
Obtain vital signs 
 
Record the “Collect in Private” information 
o Pregnancy/birth control 
o Smoking history 
 
Record data in REDCap (Click here to see the SC REDCap Instructions section in this 
MOP) 
4.3.1.3. 
EasyOne Instructions and Practice 
 
Instruct participant on use of EasyOne using the instruction loaded onto the iPad.   
o (Click this link to see the participant EasyOne manual, EasyOne Manual for 
Participants.) 
 
Conduct the pre-bronchodilator pulmonary function testing 
o Document if it has not been 4 hours since the participant last used albuterol or 
Xopenex  
o Make sure the participant has an FEV1 ≥ 70% predicted using the predicted 
calculator found on the ACRC website at 
https://www.jhcct.org/Secure/LASST/LASSTPFT.asp 
 
Calculate the % Predicted value as 
% Predicted = 100* [FEV1 (in Liters) / Predicted FEV1 (in Liters)] 
o You will have the 3 peak flow values that you will need to generate the Temporary 
Asthma Action Plan  
 
Administer 2 puffs of ProAir  
o Wait 15 to 20 minutes for ProAir to have bronchodilator effect before doing post-
bronchodilator testing 
o Review proper technique 


MICT MOP 
  25 
 
o Use a spacer if desired 
 
Conduct the post-bronchodilator pulmonary function testing 
 
Put the EasyOne into the cradle and print the results  
o Print 2 copies (for primary care physician and for site records) 
 
Dispense EasyOne to the participant along with 4 extra spirette 
o A spirette can be used for about 2 weeks before replacing unless the participant 
has been ill, then replace sooner 
 
Record data in REDCap (Click here to see the SC REDCap Instructions section in this 
MOP ) 
 
Have family sign Equipment Use Agreement (one form for both iPad and EasyOne) (Click 
here to view this form: Equipment Use Agreement.) 
o Email or fax a completed copy of the Equipment Use Agreement form to the AC at 
(Stacey.gray@nemours.org or Fax: 904-697-3799) 
4.3.1.4. 
Exhaled Nitric Oxide 
 
Collect exhaled nitric oxide results (if your site is collecting exhaled nitric oxide) 
 
Record data in REDCap (Click here to see the SC REDCap Instructions section in this 
MOP ) 
4.3.1.5. 
Physical Exam 
 
Have physical exam done 
 
Record data in REDCap (Click here to see the SC REDCap Instructions section in this 
MOP ) 
o The physician will need to log into their REDCap account to complete the form, 
electronically sign, and lock the form 
4.3.1.6. 
Biometrics (Anthropormorphic Measurements) 
 
This can be done at the same time as “Collect in Private”.  (Click here to see the Collect 
in Private section in this MOP 
 
You will need a flexible measuring tape 
o NOTE: Many clinical measuring tapes have a “dead space” between the end of the 
tape and thenbeginning of the measuring region.  Be sure to wrap tape around the 
“zero” mark on the tape.  
 
Detailed instructions are available at http://www.cdc.gov/nchs/data/nhanes/bm.pdf.  A 
video from the CDC on how to perform the measurements is available at 
http://www.cdc.gov/nchs/nhanes/nhanes3/anthropometric_videos.htm   
 
Waist measurement: just above hip bone 
o Have participant stand 
o Hold shirt/blouse above the waist and lower pants and underclothing slightly to 
expose the waist area 
o Palpate the hip area to locate the right ilium (see diagram below) 
o Draw a horizontal line just above the uppermost lateral border of the right ilium and 
then cross the line to indicate the midaxillary line of the body (per NHANES 
protocol http://www.cdc.gov/nchs/data/nhanes/bm.pdf.  ) 
o Place the measuring tape snugly around the trunk in a horizontal plane at the level 
marked 
o Make sure the measuring tape is horizontal with the floor 
o Make the measurement at the end of a normal expiration 
o Measure to the nearest centimeter 
 
 


MICT MOP 
  26 
 
 
 
 
Hip measurement: at the widest point 
o Have participant stand with feet together (helps show protuberance of the area 
when viewed in  profile) 
o Place tape measure over largest part – make sure tape measure is horizontal, 
tighten, but do not compress the skin 
o Measure to the nearest centimeter 
 
Neck measurement: just below the Adam’s apple 
o Definitions 
 
Frankfort Horizontal Plane – head parallel to the floor looking straight ahead 
 
Laryngeal prominence – also kown as the Adams apple, located in the 
throat 
o Participant sits or stands uprigtht with the head in the Frankfort Horizontal Plane 
o Apply tape around the neck just below the laryngeal prominence 
o Measurement is made perpendicular to the long axis of the neck (which is not 
necessarily in the horizontal plane) 
o Tape should be placed in such a way as to minimize the measurement 
o Measurement should be completed in less than 5 seconds, to avoid participant 
discomfort 
o Circumference of the neck is measured to the nearest centimeter 
4.3.1.7. 
Pregnancy Test 
 
Obtain the pregnancy test whenever is convenient using a urine test kit 
4.3.1.8. 
Temporary Asthma Action Plan (Print and Review) 
 
Obtain the pregnancy test whenever is convenient using a urine test kit 
 
Print the Temporary Asthma Action Plan out of REDCap  
o The Visit 1 date AND the “target” Visit 2 and target Visit 3 dates MUST be entered 
into REDCap in order for the Temporary Asthma Action Plan to be printed 
o Go to MICT-data REDCap project 
 
Under “Project Bookmarks” select “Print Asthma Action Plan” 


MICT MOP 
  27 
 
 
Enter the Participant ID  
 
Print AAP 
4.3.1.9. 
iPad Review 
 
Obtain the pregnancy test whenever is convenient using a urine test kit 
 
Verify that family has home wifi 
o If not, provide and set up a HotSpot (this should already be known from previous 
contact with the family) 
o The video for setting up a Sprint Hotspot is available on the participant’s iPad in the 
‘Home Videos’ section of videos. http://www.youtube.com/watch?v=AoV1jMb0utE. 
 
Provide the family with the completed form “User name Passwords Gmail 
AppleID.docx”. Click here to go to the folder: User Name Password Form) 
o A completed copy of this form can be found in the folder for your site.  (Click here 
to go to the blank form: User name Passwords Gmail AppleID.docx.) 
 
In this folder (Click here to go to the folder: User Name Password 
Form), you will see folders for each site.  The AC will have the participant 
form saved in the folder for your site. The SC can print extra copies of the 
form if needed. 
 
Review all use of the iPad with the parent and participant 
o The family will receive an email after Visit 1 – Part 2 instructing them on how to 
access the website if they want to use a computer or smart phone 
 
A step-by-step guide has been prepared for the coordinator to use in teaching the family all 
the study related content on the iPad.  (Click this link to view the guide click: 
Coordinator Instructions for Training Participants to use iPad at Visit 1)  to ensure all 
necessary areas of using the iPad are covered 
 
Study email 
o Show how to access study email on iPad and confirm that they have changed the 
password  
o Tap the Safari icon and go to gmail.com.  Follow instructions for changing the 
password 
o If they have forgotten their original password, they will need to contact the AC 
o  or pull up the email sent to their personal email account that had this information 
 
If the iPad has “remember me”, suggest that the family place a check in that box to store 
the information 
 
Practice connecting via FaceTime 
 
Wifi 
o Explain that wifi signal can fluctuate even in their own home and that moving to 
various locations within their home (or location) may improve the connectivity  
 
Have family sign Equipment Use Agreement (one form for both iPad and EasyOne) (Click 
here to view this form: Equipment Use Agreement.) 
o Email or fax a completed copy of the Equipment Use Agreement form to the AC at 
(Stacey.gray@nemours.org or Fax: 904-697-3799) 
4.3.1.10. Dispense Advair 250/50 and ProAir 
 
Dispense open-label study drugs (Advair 250/50 and ProAir)  
 
Instruct on the proper use of Advair 
o Demonstrate using the video on the iPad (Click this link to view the guide: 
Coordinator Instructions for Training Participants to use iPad at Visit 1.) 
 
Remind participant that these study drugs replace the ICS/LABA and rescue 
medications they have been using.   
 
Remind them that the dose of Advair is only 1 inhalation 2 times a day (as some ICS/LABA 
are 2 inhalations for each dose). 
 
Adherence Monitoring of Advair 250/50 
o Steps to ensure REDCap adherence monitoring starts off correctly for the 
participant 


MICT MOP 
  28 
 
 
If Visit 1 is in the morning (before 3PM) and the participant will take their 
first Advair 250/50 dose in the clinic with you 
 
Have the participant complete their first Morning Report in the 
clinic with you 
 
Instruct the participant to answer ‘Yes’ to the question ‘Did you 
start your new Diskus with this dose?’ 
 
Instruct the participant that after taking their evening dose that 
night at home, the participant will be prompted to enter the 
Diskus counter number.  Instruct the participant that they should 
enter 58 since they will have now had 2 doses (58 is the number 
that should show in the counter window of the Advair Diskus). 
 
Instruct the participant to submit the Morning Report and that if 
they need to revise the entry, they can do so until 3PM 
 
If Visit 1 is in the afternoon (after 3PM) and they have already taken 
their morning dose of their personal medicine before the appointment 
and the participant will take the first dose of Advair 250/50 with their 
evening dose at home: 
 
Instruct the participant to answer ‘Yes’ to the question ‘Did you 
start your new Diskus with this dose?’ on their Evening Report 
that night. 
 
Instruct the participant to enter 59 when prompted to enter the 
Diskus counter number (59 is the number that should show in 
the counter window of the Advair Diskus) on their Evening 
Report that night. 
o At Visit 1, do not have them take their “evening” dose in the clinic if it is before 
3PM (if they have already taken their morning dose of their personal medicine 
before the appointment).  This is because they will only be able to complete the 
Morning Report at this time on the iPad, yet this will be an “evening” dose of 
study medication. 
o The Diskus counter number is only prompted for on the Evening Report.  
 
REDCap will perform automatic adherence monitoring during the study.  
Every 4 days, the Evening Report will prompt the participant to enter 
their Diskus counter number.  They should answer this question AFTER 
they answer the question “Did you take the evening study Diskus dose?”  
DO NOT tell the participant we are monitoring adherence. 
 
The study coordinator will receive an alert on the evening of Visit 1 after the participant 
submits the Evening Report stating that a new Diskus was started. This email just indicates 
that the participant took their first dose from their study Advair Diskus.  
 
CONFIRM STUDY MEDICATION SHIPPING ADDRESS AND FEDEX DELIVERY 
INSTRUCTIONS 
o Discuss with family what address study medication should be delivered to 
o Instruct family to notify study coordinator if they move 
o Discuss with family if the package can be left at the door, or if there are other 
instructions 
4.3.1.11. Dispense CT Payer Card 
 
Review instruction for using CT Payer 
o Review instances that may incur a fee on their CT Payer card. 
o Inform participants there are certain fees that could occur.  Review the Cardholder 
FAQ.  (Click this link to view the FAQ click the link: Cardholder FAQs & Fee 
Schedule.pdf .) 
o Email the MICT # on the card to the AC (Stacey.gray@nemours.org) 
 
The MICT # is where the cardholder name would normally appear (e.g. 
Nemours MICT 22) 
 
The AC needs this to process payments for participants 


MICT MOP 
  29 
 
4.3.1.12. Chart in EPIC 
 
Chart in EPIC with a brief summary of visit 
4.3.2. Study Coordinator REDCap Instructions 
During Visit 1 Part 2 (Clinic Visit), SC should complete the following. 
 
The Visit 1 date must be entered into REDCap.  Do this as soon as you can after arrival. 
o IMPORTANT FIRST STEP FOR PARTICIPANTS TO ACCESS THE STUDY 
WEBSITE (MORNING AND EVENING REPORTS) 
 
If you still encounter a problem with the participant accessing the study website, go to 
MICT-data REDCap project, Screening, Signed Consent form 
o Make sure that “Successfully completed consent process” is set to ‘Yes’ 
 
If you are still having trouble follow the same steps as found in this section on what to do if 
your participant has not completed all the questionnaires prior to Visit 1 (Click here to 
see the My participant has not completed all the questionnaires for Visit 1 section 
in this MOP ).  Per this link you may need to reset the iPad to clear out any cookies; you 
will then need to re-log in with the username and password but after logging in this time, 
the participant won’t have to put in their username and password next time. 
 
In the MICT-data REDCap project 
o Click ‘Add/Edit Records’ and chose the participant ID for this participant 
o Go to the ‘Visit Dates’ form under Visit 1 
 
Complete the field for ‘Actual visit date’ 
 
Set form as ‘Complete’  
 
Click ‘Save’ 
 
Note: When a date for this field has been saved, the participant is automatically 
given access to the Trial website (and Morning and Evening Reports) when 
logging in.  If no date has been saved, the participant only has access to the 
Consent website when logging in.  The email “Completing Morning and Evening 
Report When You Don’t Have Wireless Internet Access” will automatically be 
sent at 4 am the day after the date stored in ‘Actual visit date’.   
o Go to the ‘Collect in private’ form 
 
 
o Go to the ‘Collect in private’ form 
 
Complete the fields as the information is collected 
 
Set form as ‘Complete’ 
 
Click ‘Save and go to Next Form’. 
o Go to the ‘Biometrics’ form if not already there 
 
Complete the fields as the information is collected 
 
Set form as ‘Complete’ 
 
Click ‘Save and go to Next Form’ 
o Go to the ‘Nitric Oxide’ form if not already there 
 
Complete the fields as the information is collected. 
 
Set form as ‘Complete’ 
 
Click ‘Save and go to Next Form’ 
o Go to the ‘Pulmonary Function Testing’ form if not already there (this information is 
needed for the Asthma Action Plan (AAP) so that you can demonstrate the AAP to the 
family during the visit) 
 
Complete the fields as the information is collected. 
 
During this process, you will go to 
https://www.jhcct.org/Secure/LASST/LASSTPFT.asp 
 
Log in with the generic user name and password you would use to 
access the ACRC Website. 
 
Set form as ‘Complete’ 
 
Click ‘Save and go to Next Form’ 
o Go to the ‘Temp Asthma Action Plan’ form if not already there. 


MICT MOP 
  30 
 
 
Complete the fields as the information is collected. 
 
Click ‘Save and Continue’   
 
NOTE: This must be done for the Temporary Action Plan to appear on the 
following link and on the Trial website when the participant logs in. 
 
Follow the link to https://apps.nemoursresearch.org/mict/admin/actionPlan.php 
 to print the Temporary Asthma Action Plan for the participant on an 8.5x11 
page.  A link to this web page (‘Print Asthma Action Plan’) is also available in 
the left sidebar under Project Bookmarks. 
User name and password for this site is your REDCap user name and 
password.  
o Go to the ‘Drug Accountability Log’ form 
 
Click on the circle to see records 
 
Enter information in the following sections of this form 
 
First Proair albuterol inhaler provided 
 
First diskus provided – Advair 250/50 
 
Complete the appropriate fields from the below options: 
 
Drug name 
 
Expiration date 
 
Lot number 
 
Mode of transport 
 
Tracking number (if shipped) 
 
Delivery Status 
 
PDF of delivery confirmation 
 
Date of study drug return 
 
Set to ‘Unverified’ 
 
Click ‘Save Record’ 
o Go to the ‘MICT – drug accountability by site’ form under Project Bookmarks (note: you 
are NOT in a specific participant’s record, this is a Center Level record) 
Purpose: To enter data (when receiving or dispensing drug): 
 
Click ‘Add/Edit Records’ and click ‘Add new record’ - (Underneath ‘Incomplete 
Records’ and ‘Complete Records’ 
 
Complete the ‘Drug Accountability Log’ form (this is for the Center Level drug 
accountability) 
 
Manufacturer 
o GlaxoSmithKline is the manufacturer for Advair 250/50 
o Teva Respiratory, LLC is the manufacturer for Proair 
 
Number of Diskus in this transaction, enter ‘1’ 
 
Click ‘Dispensed’ 
o Click ‘Dispensed to participant’ 
 
Remaining balance…. 
o Enter the number of Advair 250/50 you now have remaining 
at your site (this is why you need the information from the 
‘MICT – drug accountability by site’ form) 
 
Set the form status as ‘Complete’ 
 
Click ‘Save’ or click ‘Save and Continue’ if creating a pdf for the transaction 
 
Repeat above steps for the ProAir dispensed 
To view a report of transactions for a singe medication 
 
Click on the name of the report in the left panel under ‘Reports’ 
o To print report, click ‘Print page’ 
o To download report as an Excel file, click ‘Microsoft Excel 
(CVS)’ 
To create a pdf file of a single transaction 
 
Enter a record by doing one of the following: 
o Click ‘Add/Edit Records’ and select the records from the 
drop-down list. 


MICT MOP 
  31 
 
o Click on the Entry ID in a report of transactions 
o Click ‘Save and Continue’ after entering data 
 
Click the ‘Download PDF of instrument(s)’ button 
 
Select ‘This data entry form with saved data’ 
 
Click the radio  button next to ‘Save File’ 
 
Click OK 
 
During Visit 1 Part 2 (Clinic Visit), the physician performing the physical exam should 
complete the following. 
 
Log into REDCap 
In the MICT-data REDCap project 
o Click ‘Add/Edit Records’ and chose the participant ID for this participant 
o Click the button for ‘Physical Exam’ under Visit1 
o Complete the fields in this form as the exam is performed. 
o Set the form as ‘Complete’ 
o Check the ‘Lock’ and ‘E-signature’ options. 
o Click Save ‘Record’ 
Log out of REDCap 
 
Notes: Any physician with a REDCap username and access to the REDCap project can e-
sign the Physical Exam form of any participant at any time.  E-signing in REDCap consists of 
checking the boxes next to 'Lock' and 'E-signature' and saving the record.  The status of the 
form can be set to 'Incomplete', 'Unverified' or 'Complete' when the form is e-signed and the 
status is locked along with the other fields on the form.  Once a form is e-signed, it must be 
unlocked before any changes can be made. 
 
Only REDCap users who have the user right to lock and e-sign a form can see the check 
boxes for locking and e-signing the form.  Forms that are locked and e-signed will have a 
padlock and green shield (with check) in the event grid.  Also, forms that are locked and e-
signed will not have buttons for saving the form at the bottom of the page when viewing the 
form. 
 
Study coordinators can change the status of the Physical Exam form before the form is e-
signed. 
 
 
In EPIC, the physician will need to go to the participants record “Allergies” and complete that 
allergies were reviewed on the Visit 1 date.  This is important because at Visit 6 you may want 
the physician to call in a Rx for a 30 day supply of the controller medication they were one during 
the study (to last them until they can be seen by their asthma PCP).  If this is not done in EPIC, 
then the Rx will not be able to be sent to the pharmacy as allergies must be reviewed every 180 
days in EPIC. 
4.3.3. Administrative Coordinator REDCap Instructions 
In the MICT-data REDCap project, 
o Click ‘Add/Edit Records’ and chose the participant ID 
o Click the button for ‘Patient Screening Log’ under Consent 
o Complete form 
o Set form as ‘Complete’ 
o Click ‘Save Record’ 
 
After adding $25 is added to participant’s CTPayer account (within 24 hours of visit), record this in 
REDCap. 
In the MICT – DC summary REDCap  project 
o Click ‘Add/Edit Records’ and chose the participant ID for this participant 


MICT MOP 
  32 
 
 
CTPayer account number can be viewed in ‘Participant Information’ form  
o Click the button for ‘Clinic and FaceTime Visits’ 
o Record whether credit was added to form and date this was done 
o Click ‘Save Record’ 
 
In the MICT-equipment REDCap project 
o Click ‘Add/Edit Records’ and chose the username assigned this participant 
o Click ‘Tracking Information’ in left side panel under Data Collection. 
o Enter data for the following fields 
 
Participant ID 
 
Date iPad was delivered to participant 
 
EasyOne spirometer serial number 
 
EasyOne asset tag # 
 
Date EasyOne was delivered to participant 
 
If appropriate, Hotspot serial number and date hotspot was delivered to 
participant 
o Set the form as ‘Unverified’ 
o Click ‘Save Record’ 
4.3.4. Alerts to Study Participant after Visit 1 
The day after visit 1, an email message with instructions that Morning and Evening Reports can be 
completed on any computer or smart phone with internet access will automatically be sent to the 
participant’s study email address.  This is because we know that they may not have the iPad every 
time they need to complete the morning or evening reports and this provides an alternative way to 
input the data.  (Click this link to see all emails sent to study participants: Emails Sent to 
Participants.) 
4.4. Visit 2 (Virtual Visit) 
Overview 
 
Ensure participant meets criteria for continuation (view the ‘Assessment for Stable Phase’ 
form in REDCap 
 
Review questionnaires prior to FaceTime visit 
 
Conduct FaceTime Visit 
 
Do pre- and post-bronchodilator spirometry 
 
Do a random check of PEF values on participants EasyOne 
o Select a date for PEF value from “Peak Flow Report” in REDCap (note the date 
and PEF value) 
 
Time Frame 
 
Target: 4 weeks prior to Randomization (V3)  
 
Window: 4 to 6 weeks prior to Randomization (V3)  
 
Duration of V2: 1 hour  
 
Equipment/materials 
 
iPad 
 
Coordinator EasyOne Spirometer (in case you need to show them anything via FaceTime) 
 
Visit 1 height and weight data (to compare with Visit 2) 
 
Latest data on Advair Diskus counter number from REDCap 
4.4.1. Study Coordinator Procedures for Visit 2 
 
If there are any issues that have been discussed with Dr. Blake and an exception has been 
allowed, document the exception on the ‘Protocol Exception’ Form under the Ongoing 
column. 
 
Ask participant for current height and weight  
o If height and weight have changed since V1, then you will need to do at least 1 


MICT MOP 
  33 
 
effort before you can update the height and weight data 
 
Changing height and weight data will change it for the present test and all 
subsequent tests 
 
Click here to see a summary of height data: Height Data Summary in 
REDCap. 
 
 EasyOne Spirometry – follow the instructions in the Coordinator EasyOne Manual (Click 
this link to view the manual: Manual for Coordinator EasyOne Instructions.)  
o Document if it has not been 4 hours since the participant last used albuterol or 
Xopenex  
o Have participant do 3 pre-bronchodilator efforts.   
o Take picture of the flow volume curves using your iPad by holding down the power 
button at the same time as holding down the home key 
 
These are saved to ensure we have data should the EasyOne get lost or 
broken 
 
Save the photos on the shared drive at this location (Click this link to see 
the location: Folder for iPad Photos.) 
 
Use the following format for creating a folder name for file saving: 
JAX102\JAX102V5_07-10-14 
o Record the PFT Data using the MICT PFT Worksheet.  (Click here to view the 
PFT FaceTime Worksheet.) 
 
Ensure FEV1 is still ≥ 70% predicted using the predicted calculator found on 
the ACRC website at https://www.jhcct.org/Secure/LASST/LASSTPFT.asp 
 
Calculate the % Predicted value as 
% Predicted = 100* [FEV1 (in Liters) / Predicted FEV1 (in Liters)] 
 
Have participant take 2 puffs of ProAir and wait 15 minutes 
 
Can end FaceTime and restart in 15 minutes 
 
Have participant do 3 post-bronchodilator efforts using same procedure as 
for pre-bronchodilator testing 
 
Save the handwritten PFT Worksheet until the end of the study. 
 
This worksheet will be needed inorder to reconcile all the PFT data 
downloaded from the EasyOne device at Visit 6 with the data 
entered into REDCap. 
 
Do a random check of PEF values on participants EasyOne 
o From the REDCap “Peak Flow Report”, select 3 dates and write down the 3 PEF 
values for each of the 3 dates. Or you can print the Peak Flow Report.  Do this 
when getting prepared for the FaceTime visit (you can do this a day or two before 
the visit date). 
o Instruct the participant turn on EasyOne 
 
Go to “View Results” on EasyOne by pressing the right arrow key and 
pressing “Enter” 
 
Use the right arrow button to tab to “Date” 
 
Have the participant enter the first date you have selected and press “Enter” 
 
Ask the participant to tell you the date on the screen; it will be under FVC 
Test (for example, 8/22/2014 in the image below) 
o 
 
 
If the participant DID do the PEF, then the date on the screen will 
match the date you asked them to enter 
 
If the participant DID NOT actually do the PEF on the EasyOne on 


MICT MOP 
  34 
 
that date (even though they entered data on the Morning Report for 
that date, i.e. they made up numbers on the iPad Morning Report), 
the EasyOne will search for the closest date prior to the date you 
instructed the participant to enter.   
 
Press “Enter” again and the results will show up on the EasyOne screen 
 
 
 
Ask the participant to tell you the PEF number (387 in the image 
above) 
 
Compare the 3 PEF values that were entered into REDCap with the PEF 
that is on the EasyOne.  If they actually did the PEF on that date, then one 
of the 3 values in REDCAP will match with the value that they show on the 
EasyOne. 
 
Note: Unfortunately, the EasyOne will only show you the PEF that is 
associated with the best sum of the FVC and FEV1 which is not 
always the highest PEF.  But when you download all the data from 
the EasyOne, you can see every effort that that the participant made 
on the EasyOne for that date. 
 
Repeat the above for the other 2 dates (and 3 PEF values for each date) 
you selected from the REDCap data  
 
If the participant tells you that they don’t have that date for any of the 3 
dates viewed and the PEFs don’t match up, then counsel the participant to 
enter only REAL values into the Morning Report. 
 
Important for triggering their Asthma Action Plan to pop up on the 
iPad 
 
Important for us to monitor their safety 
 
View counter on Advair Diskus and confirm that it is consistent with what is in REDCap 
 
Review any adverse effects, alerts, or any other issues 
 
Review criteria included on the ‘Assessment for Stable Phase’ form in REDCap Visit 2 
o If the participant meets any of these criteria, they are not eligible to continue but 
may be re-screened.  Click here to see Rescreening section in this MOP. 
 
Confirm Visit 3 FaceTime date and time 
o Please make every effort to complete Visit 3 BEFORE the participant would run out 
of the 2nd provided diskus of Advair 250/50 
 
Confirm study medication shipping address and fedex delivery instructions 
o If there are any changes from previous visit, notify the Pharmacist (at WIL or ORL) 
or AC (for other sites)  
 
Remind participant to check emails every few days and 4 days before Visit 3 for the 
upcoming visit questionnaires  
 
Remind participant to have height and weight done before the Visit 3 FaceTime visit 
 
Chart in EPIC with a brief summary of visit 
 
4.4.2. Study Coordinator REDCap Instructions for Visit 2 
Four days prior to the scheduled date, the participant will receive email messages with links to the 
ACT and Pre-Clinic Visit Survey and instructions to complete these at least 24 hours before their 
appointment. 
 
Prior to visit 2, SC should review participant’s responses in the following forms: Asthma Control 
Test - participant version and Clinic Visit – participant version. 


MICT MOP 
  35 
 
 
In the MICT-data REDCap project 
o Click ‘Add/Edit Records’ and chose the participant ID for this participant 
o Review the following REDCap forms under Visit2-virtual 
 
Asthma Control Test – participant version 
 
The ACT status form has a notes field for your comments 
 
Clinic Visit – participant version 
 
This form has a notes field for your comments 
 
 Assessment for Stable Phase 
 
This form has some checks that may indicate the visit should be 
delayed/ 
 
This form will need to be reviewed and completed when visit 2 is 
finished. 
Click ‘Save’ on each form as comments are added 
 
After completing Visit 2 (FaceTime), SC should complete the following. 
 
In the MICT-data REDCap project 
o Click ‘Add/Edit Records’ and chose the participant ID for this participant 
o Click the button for ‘Visit Dates’ under Visit2-virtual 
 
Complete the field for ‘Actual visit date’ 
 
Set form as ‘Complete’  
 
Click ‘Save’ 
o Click the button for ‘Pulmonary Function Testing’ under Visit2-virtual 
 
Complete the fields as the information is collected. 
 
During this process, you will go to 
https://www.jhcct.org/Secure/LASST/LASSTPFT.asp 
 
Set form as ‘Complete’ 
 
Click ‘Save and go to Next Form’ 
o Go to the ‘Assessment for Stable Phase’ if not already there 
 
Complete the fields in this form.  This will include: 
 
Reviewing clinic visit form (if prompted) 
 
Reviewing diary card alerts 
 
A summary of alerts can be viewed in the report ‘data’ 
in the REDCap project, MICT-alerts.  Click here to 
see Alerts About My Participant section in this 
MOP. 
 
Summary of diary card submission date and dose 
taken can be viewed with the tool at 
https://apps.nemoursresearch.org/mict/admin/diary_s
ubmission.php.  Click here to see Viewing Study 
Drug Use and Reports section in this MOP. 
 
A summary of “urgent and unscheduled medical 
attention” alerts can be viewed as a report in the 
MICT-diary cards project and selecting “Questions 
about urgent unscheduled medical attention” in the 
Reports section on the left side 
 
Set form as ‘Complete’ 
 
Click ‘Save’ 
 
Note: If any of the items on this form are checked, the participant does not 
meet criteria for “stable phase” and is NOT eligible to continue in the study.  
The run-in period must be extended or the participant must be removed 
from the study and come to the clinic to turn in their iPad and spirometer. 
Click here to see Rescreening section in this MOP for more information. 
o Click the button for ‘Visit Dates’ under Visit3-virtual 


MICT MOP 
  36 
 
 
If visit 3  is not scheduled : 
 
Enter a date and time into ‘Scheduled date and time’.  
o TIP: When determining the date for visit 3, try and schedule it 
a few days BEFORE the diskus would be expected to run out 
(if the participant was 100% adherent) or 30 days from visit 2.  
There is a +/- window of 2 weeks from visit 2, so schedule 
earlier (suggest 7 days earlier).  This will provide a cushion of 
diskus doses in case the visit 3 date has to be moved further 
out for some reason.  We want to avoid having to send out 
an extra Advair 250/50 diskus to bridge a short number of 
days between when when their visit 2 Advair 250/50 diskus 
would run out and having their visit 3.  Advair 250/50 diskus 
costs about $310.  
 
Set form as ‘Unverified’ 
 
Click ‘Save and Continue’ 
 
If visit 3 is already scheduled, confirm date and time with participant 
 
If date of appointment is changed, enter new date and time into 
‘Scheduled date and time’ 
 
Click ‘Save and Continue’ 
 
Note: Visit 3 will be via FaceTime if participant is qualified to continue in the 
study or the visit will be in the clinic if participant is not eligible to continue in 
the study. 
 
4.5. Visit 3 (Virtual Visit) 
Overview 
 
Ensure participant meets criteria for continuation and treatment randomization 
 
Review questionnaires prior to FaceTime visit 
 
Conduct FaceTime Visit 
 
Do pre- and post-bronchodilator spirometry 
 
Do a random check of PEF values on participants EasyOne 
o Select a date for PEF value from “Peak Flow Report” in REDCap (note the date 
and PEF value) 
 
Randomize to study treatment  
 
Time Frame 
 
Duration of V3: 1 hour  
 
Equipment/materials 
 
iPad 
 
Coordinator EasyOne Spirometer (in case you need to show them anything via FaceTime) 
 
Visit 2 height and weight data (to compare with Visit 3) 
 
Latest data on Advair Diskus counter number from REDCap 
 
Latest data on ProAir counter number from REDCap 
 
Review all data (alerts, PEF, Diary card submissions, albuterol use, etc) in REDCap that 
affects whether or not the participant can be randomized to treatment. Click here to see 
How to View Participant Data section in this MOP. 
4.5.1. Study Coordinator Procedures for Visit 3 
 
Prior to FaceTime, resolve any outstanding issues that would affect treatment 
randomization.  Click here to see How to View Participant Data section in this MOP. 
o ACT scores at V1, V2, and V3 ≥ 20 
o No unscheduled ED visits or hospitalizations for asthma 
o Rescue albuterol use less than 2.3 puffs per day average (less than 16 puffs per 
week excluding pre-medication for exercise).  One nebulizer use is equivalent to 2 


MICT MOP 
  37 
 
puffs of beta-agonist.  Cannot exceed more than 10 puffs per day on 2 consecutive 
days 
o Completed 10 of the last 14 days of diary card entries (at least 1 entry per day) 
o Adherent with Advair 250/50 by taking at least 1 dose per day for 21 of the last 28 
days 
o Review the completed CV form that the participant submitted for Visit 3 
 
If there are any issues that have been discussed with Dr. Blake and an exception has been 
allowed, document the exception on the ‘Protocol Exception’ Form under the Ongoing 
column. 
 
Ask participant for current height and weight  
o If height and weight have changed since V2, then you will need to do at least 1 
effort before you can update the height and weight data 
 
Changing height and weight data will change it for the present test and all 
subsequent tests 
 
Click here to see a summary of height data section in this MOP: Height 
Data Summary in REDCap. 
 
EasyOne Spirometry – follow the instructions in the Coordinator EasyOne Manual (Click 
this link to view the manual: Manual for Coordinator EasyOne Instructions.) 
o Document if it has not been 4 hours since the participant last used albuterol or 
Xopenex  
o Have participant do 3 pre-bronchodilator efforts.   
o Take picture of the flow volume curves using your iPad by holding down the power 
button at the same time as holding down the home key 
 
These are saved to ensure we have data should the EasyOne get lost or 
broken 
 
Save the photos on the shared drive at this location (Click this link to see 
the location: Folder for iPad Photos ) 
 
Use the following format for creating a folder name for file saving: 
JAX102\JAX102V5_07-10-14 
o Record the PFT Data using the MICT PFT Worksheet.  (Click here to view the 
PFT FaceTime Worksheet ) 
 
Ensure FEV1 is still ≥ 70% predicted using the predicted calculator found on 
the ACRC website at https://www.jhcct.org/Secure/LASST/LASSTPFT.asp 
 
Calculate the % Predicted value as 
% Predicted = 100* [FEV1 (in Liters) / Predicted FEV1 (in Liters)] 
o Have participant take 2 puffs of ProAir and wait 15 minutes 
 
Can end FaceTime and restart in 15 minutes 
o Have participant do 3 post-bronchodilator efforts using same procedure as for pre-
bronchodilator testing 
 
Do a random check of PEF values on participants EasyOne 
o From the REDCap “Peak Flow Report”, select 3 dates and write down the 3 PEF 
values for each of the 3 dates. Or you can print the Peak Flow Report.  Do this 
when getting prepared for the FaceTime visit (you can do this a day or two before 
the visit date). 
o Instruct the participant turn on EasyOne 
 
Go to “View Results” on EasyOne by pressing the right arrow key and 
pressing “Enter” 
 
Use the right arrow button to tab to “Date” 
 
Have the participant enter the first date you have selected and press “Enter” 
 
Ask the participant to tell you the date on the screen; it will be under FVC 
Test (for example, 8/22/2014 in the image below) 


MICT MOP 
  38 
 
o 
 
 
If the participant DID do the PEF, then the date on the screen will 
match the date you asked them to enter 
 
If the participant DID NOT actually do the PEF on the EasyOne on 
that date (even though they entered data on the Morning Report for 
that date, i.e. they made up numbers on the iPad Morning Report), 
the EasyOne will search for the closest date prior to the date you 
instructed the participant to enter.   
 
Press “Enter” again and the results will show up on the EasyOne screen 
 
 
 
Ask the participant to tell you the PEF number (387 in the image 
above) 
 
Compare the 3 PEF values that were entered into REDCap with the PEF 
that is on the EasyOne.  If they actually did the PEF on that date, then one 
of the 3 values in REDCAP will match with the value that they show on the 
EasyOne. 
 
Note: Unfortunately, the EasyOne will only show you the PEF that is 
associated with the best sum of the FVC and FEV1 which is not 
always the highest PEF.  But when you download all the data from 
the EasyOne, you can see every effort that that the participant made 
on the EasyOne for that date. 
 
Repeat the above for the other 2 dates (and 3 PEF values for each date) 
you selected from the REDCap data  
 
If the participant tells you that they don’t have that date for any of the 3 
dates viewed and the PEFs don’t match up, then counsel the participant to 
enter only REAL values into the Morning Report. 
 
Important for triggering their Asthma Action Plan to pop up on the 
iPad 
 
Important for us to monitor their safety 
 
View counter on Advair Diskus and confirm that it is consistent with what is in REDCap 
 
View counter on ProAir and confirm that it is consistent with what is in REDCap 
 
Review any adverse effects, alerts, or any other issues 
 
Confirm Visit 4, Visit 5, and Visit 6 FaceTime date and time 
 
Confirm study medication shipping address and fedex delivery instructions 
o If there are any changes from previous visit, notify the Pharmacist (at WIL or ORL) 
or AC (for other sites)  
 
Remind participant to check emails every few days and 4 days before Visit 4 for the 
upcoming visit questionnaires  
 
Remind participant to have height and weight done before the Visit 4 FaceTime visit 
 
Chart in EPIC with a brief summary of visit 


MICT MOP 
  39 
 
4.5.2. How to Conduct the Treatment Randomization 
The treatment randomization will be conducted after confirming that the participant is eligible 
to be randomized at the FaceTime Visit 3 appointment. The online randomization should be 
completed after all V3 procedures (including questionnaires, review Diary Cards and lung 
function testing) have been performed. 
 
 
Go to the ALA-ACRC website at http://cctrials.org/alaacrc/ 
 
Click on Information for Investigators 
o If prompted for login and password: 
 
Login: alaacrc 
 
Password: golst 
 
Click on MICT link shown below (you’ll need to scroll down): 
 
 
Type in User Name and Password 
o User Name: mictstaff 
o Password: mict4lasst! 
 
Select “TREATMENT Randomization” link as shown below: 
 
 
Type in User Name and Password (same as before) 
 
You will see this but click “Here” to login anyway 
 
 
Select Nemours as the clinic and enter your ALAACRC Pin and Password 
 
 
 Complete the information and do the TREATMENT Randomization 


MICT MOP 
  40 
 
 
 
When you get the screen that shows the treatment randomization, print  the file as a 
Microsoft XPS document.  It won’t actually print, you will save that document to your 
desktop and email it to the administrative coordinator, Stacey Gray 
(Stacey.gray@nemours.org).  You don’t need to actually print a hard copy or save it.  You, 
as the coordinator, will immediately get an email verifying the treatment for the participant. 
 
The AC will open the file in adobe acrobat and save it as a pdf and save it in a folder on 
the S drive. 
4.5.3. Study Coordinator REDCap Instructions for Visit 3 
Four days (3 nights) prior to the scheduled date, the participant will receive email messages with 
links to ACT, Children’s Health Survey, EQ-5D, Quality of Life Questionnaires (if 15 yo or older) 
and Pre-Clinic Visit Survey and instructions to complete these at least 24 hours before their 
appointment. 
 
In the MICT-data REDCap project 
o Click ‘Add/Edit Records’ and chose the participant ID for this participant 
o Review the following REDCap forms under Visit3-virtual 
 
Asthma Control Test – participant version 
 
The ACT status form has a notes field for your comments 
 
Children’s Heath Survey – participant version 
 
EQ-5D from the EuroQol Group 
 
Quality of Life Questionnaires 
 
If 15 yo or older when the consent was signed 
 
This form has a notes field for your comments 
 
Clinic Visit – participant version 
 
This form has a notes field for your comments 


MICT MOP 
  41 
 
o Click ‘Save’ on each form as comments are added 
 
After completing Visit 3 (FaceTime), SC should complete the following. 
 
In the MICT-data REDCap project 
o Click ‘Add/Edit Records’ and chose the participant ID for this participant 
o Click the button for ‘Visit Dates’ under Visit3-virtual 
 
Complete the field for ‘Actual visit date’ 
 
When a date is in this field, the Asthma Study Asthma Action Plan 
appears on the Trial website when the participant logs in and on the 
link (https://apps.nemoursresearch.org/mict/admin/actionPlan.php) 
used by study staff to print the Asthma Action Plan. 
 
Set form as ‘Complete’  
 
Click ‘Save’ 
o Click the button for ‘Pulmonary Function Testing’ under Visit3-virtual 
 
Complete the fields as the information is collected. 
 
During this process, you will go to 
https://www.jhcct.org/Secure/LASST/LASSTPFT.asp 
 
Set form as ‘Complete’ 
 
Click ‘Save and go to Next Form’ 
o Go to the ‘Asthma Study Asthma Action Plan’ form if not already there. 
 
Complete the fields as the information is collected. 
 
You will need to go to 
https://apps.nemoursresearch.org/mict/admin/baselinePEF.php  to have 
REDCap calculate the average PEF for the last 14 days.  This link is on the 
Visit 3 Asthma Study Asthma Action Plan also.  Please note that if the 
current day PEF is needed to have 10 PEF values from the last 14 days to 
meet the randomization eligibility criteria then the calculation from that link 
will not include the current day.  This is because the data updates at 4AM 
each day.  Therefore you will need to copy and paste the 9 available days 
into Excel, then get the day’s current PEF and add it to Excel.  Have Excel 
calculate the mean PEF for the 10 of the last 14 days of PEF data. 
 
Some of the fields on this form are calculated. 
 
Click ‘Save and Continue’   
 
NOTE:  The ‘Asthma Study Asthma Action Plan’ form must be saved for the 
Asthma Study Action Plan to appear on the following link and on the Trial 
website when the participant logs in. 
 
Follow the link to ‘https://apps.nemoursresearch.org/mict/actionPlan/php to 
print the Asthma Study Asthma Action Plan for the participant on an 8.5x11 
page.  This printout can be mailed to the participant.  A link to this web page 
(‘Print Asthma Action Plan’) is also available in the left sidebar under Project 
Bookmarks. 
o Go to the ‘Randomization form. 
 
Complete the fields in this form.  This will include: 
 
Reviewing clinic visit form (if prompted) 
 
Reviewing diary card alerts 
 
A summary of alerts can be viewed in the report ‘data’ 
in the REDCap project, MICT-alerts 
 
Summary of diary card submission date and dose 
taken can be viewed with the tool at 
https://apps.nemoursresearch.org/mict/admin/diary_s
ubmission.php 
 
A summary of “urgent and unscheduled medical 
attention” alerts can be viewed as a report in the 
MICT-diary cards project and selecting “Questions 


MICT MOP 
  42 
 
about urgent unscheduled medical attention” in the 
Reports section on the left side 
 
Set form as ‘Complete’ 
 
Click ‘Save’ 
 
Note: If any of the items on this form are checked, the participant does not 
meet criteria for “stable phase” and is NOT eligible to continue in the study.  
The run-in period must be extended or the participant must be removed 
from the study and come to the clinic to turn in their iPad and spirometer. 
o Go to the ‘Study Information’ form under Ongoing in the grid 
 
Complete the ‘Treatment arm field’ 
 
Set the form as ‘Complete’ 
 
Click ‘Save’ 
o Click the button for ‘Visit Dates’ under Visit4-virtual 
 
Enter a date for ‘Target date’. 
 
Enter a date and time into ‘Scheduled date and time’ 
 
Set form as ‘Unverified’ 
 
Click ‘Save’ 
o Click the button for ‘Visit Dates’ under Visit5-virtual 
 
Enter a date for Target date 
 
Set form as ‘Unverified’ 
 
Click ‘Save’ 
o Click the button for ‘Visit Dates’ under Visit6-virtual 
 
Enter a date for Target date 
 
Set form as ‘Unverified’ 
 
Click ‘Save’ 
o Click the button for ‘Visit Dates’ under Visit6-clinic 
 
Enter a date for Target date 
 
Set form as ‘Unverified’ 
 
Click ‘Save’ 
 
4.5.4. RPh or Administrative Coordinator REDCap Instructions for Visit 3 
RPh or AC should do the following when visit 3 is complete. 
In the MICT-data REDCap project 
o Click ‘Add/Edit Records’ and chose the participant ID for this participant 
o Go to the ‘Drug Accountability Log’ form under Ongoing 
 
Enter information in the following sections of this form 
 
The next Diskus to be provided (which will be for the randomized 
treatment). 
 
Click ‘Save Record’ 
Ship drug to participant 
 
4.6. Visit 4 (Virtual Visit) 
Overview 
 
Ensure participant meets criteria for continuation  
 
Review questionnaires prior to FaceTime visit 
 
Conduct FaceTime Visit 
 
Do a random check of PEF values on participants EasyOne 
o Select a date for PEF value from “Peak Flow Report” in REDCap (note the date 
and PEF value) 
 
Time Frame 
 
Target: 3 weeks after Randomization (V3)  
 
Window: 2 to 4 weeks after Randomization (V3)  


MICT MOP 
  43 
 
 
Duration of V4: 1 hour  
 
Equipment/materials 
 
iPad 
 
Coordinator EasyOne Spirometer (to check validity of PEFs participant has entered into 
Morning Reports and in case you need to show them anything via FaceTime) 
 
Visit 3 height and weight data (to compare with Visit 4) 
 
Latest data on Advair Diskus counter number from REDCap 
4.6.1. Study Coordinator Procedures for Visit 4. 
 
If there are any issues that have been discussed with Dr. Blake and an exception has been 
allowed, document the exception on the ‘Protocol Exception’ Form under the Ongoing 
column. 
 
Do a random check of PEF values on participants EasyOne 
o From the REDCap “Peak Flow Report”, select 3 dates and write down the 3 PEF 
values for each of the 3 dates. Or you can print the Peak Flow Report.  Do this 
when getting prepared for the FaceTime visit (you can do this a day or two before 
the visit date). 
o Instruct the participant turn on EasyOne 
 
Go to “View Results” on EasyOne by pressing the right arrow key and 
pressing “Enter” 
 
Use the right arrow button to tab to “Date” 
 
Have the participant enter the first date you have selected and press “Enter” 
 
Ask the participant to tell you the date on the screen; it will be under FVC 
Test (for example, 8/22/2014 in the image below) 
o 
 
 
If the participant DID do the PEF, then the date on the screen will 
match the date you asked them to enter 
 
If the participant DID NOT actually do the PEF on the EasyOne on 
that date (even though they entered data on the Morning Report for 
that date, i.e. they made up numbers on the iPad Morning Report), 
the EasyOne will search for the closest date prior to the date you 
instructed the participant to enter.   
 
Press “Enter” again and the results will show up on the EasyOne screen 
 
 
 
Ask the participant to tell you the PEF number (387 in the image 
above) 
 
Compare the 3 PEF values that were entered into REDCap with the PEF 
that is on the EasyOne.  If they actually did the PEF on that date, then one 
of the 3 values in REDCAP will match with the value that they show on the 
EasyOne. 


MICT MOP 
  44 
 
 
Note: Unfortunately, the EasyOne will only show you the PEF that is 
associated with the best sum of the FVC and FEV1 which is not 
always the highest PEF.  But when you download all the data from 
the EasyOne, you can see every effort that that the participant made 
on the EasyOne for that date. 
 
Repeat the above for the other 2 dates (and 3 PEF values for each date) 
you selected from the REDCap data  
 
If the participant tells you that they don’t have that date for any of the 3 
dates viewed and the PEFs don’t match up, then counsel the participant to 
enter only REAL values into the Morning Report. 
 
Important for triggering their Asthma Action Plan to pop up on the 
iPad 
 
Important for us to monitor their safety 
 
View counter on Advair Diskus and confirm that it is consistent with what is in REDCap 
 
Review any adverse effects, alerts, or any other issues 
 
Remind participant to 
o Use the Asthma Action Plan for symptom management 
o Contact primary asthma care doctor for asthma management issues 
 
Confirm Visit 5 FaceTime date and time 
 
Confirm study medication shipping address and fedex delivery instructions 
o If there are any changes from previous visit, notify the Pharmacist (at WIL or ORL) 
or AC (for other sites)  
 
Confirm study medication shipping address and fedex delivery instructions 
o If there are any changes from previous visit, notify the Pharmacist (at WIL or ORL) 
or AC (for other sites)  
 
Remind participant to check emails every few days and 4 days before Visit 3 for the 
upcoming visit questionnaires  
 
Remind participant to have height and weight done before the Visit 5 FaceTime visit 
 
Chart in EPIC with a brief summary of visit 
 
4.6.1. Study Coordinator REDCap Instructions for Visit 4 
Three days prior to the scheduled date, the participant will receive email messages with links to 
the ACT and Pre-Clinic Visit Survey and instructions to complete these at least 24 hours before 
their appointment. 
 
Prior to visit 4, SC should review participant’s responses in the following forms: Asthma Control 
Test - participant version and Clinic Visit – participant version. 
 
In the MICT-data REDCap project 
o Click ‘Add/Edit Records’ and chose the participant ID for this participant 
o Review the following REDCap forms under Visit4-virtual 
 
Asthma Control Test – participant version 
 
The ACT status form has a notes field for your comments 
 
Clinic Visit – participant version 
 
This form has a notes field for your comments 
o Click ‘Save’ on each form as comments are added 
 
After completing Visit 4 (FaceTime), SC should complete the following. 
 
In the MICT-data REDCap project 
o Click ‘Add/Edit Records’ and chose the participant ID for this participant 
o Click the button for ‘Visit Dates’ under Visit4-virtual 
 
Complete the field for ‘Actual visit date’ 
 
Set form as ‘Complete’  
 
Click ‘Save’ 
o Go to the ‘Assessment for Treatment Failure’ 


MICT MOP 
  45 
 
 
Complete the fields in this form.  This will include: 
 
Reviewing clinic visit form 
 
Reviewing diary card alerts 
 
A summary of alerts can be viewed in the report ‘data’ 
in the REDCap project, MICT-alerts 
 
Summary of diary card submission date and dose 
taken can be viewed with the tool at 
https://apps.nemoursresearch.org/mict/admin/diary_s
ubmission.php 
 
A summary of “urgent and unscheduled medical 
attention” alerts can be viewed as a report in the 
MICT-diary cards project and selecting “Questions 
about urgent unscheduled medical attention” in the 
Reports section on the left side 
 
Set form as ‘Complete’ 
 
Click ‘Save’ 
 
Note: If the answer to any of the questions on this form is ‘Yes’, then the 
participant meets the criteria for treatment failure. 
o Click the button for ‘Visit Dates’ under Visit5-virtual 
 
If visit 5 is not scheduled : 
 
Enter a date and time into ‘Scheduled date and time’ 
 
Set form as ‘Unverified’ 
 
Click ‘Save’ 
 
If visit 5 is already scheduled, confirm date and time with participant 
 
If date of appointment is changed, enter new date and time into 
‘Scheduled date and time’ 
 
Click ‘Save’ 
 
4.7. Visit 5 (Virtual Visit) 
Overview 
 
Ensure participant meets criteria for continuation  
 
Review questionnaires prior to FaceTime visit 
 
Conduct FaceTime Visit 
 
Do pre- and post-bronchodilator spirometry 
 
Do a random check of PEF values on participants EasyOne 
o Select a date for PEF value from “Peak Flow Report” in REDCap (note the date 
and PEF value) 
 
Remind participant’s parent to schedule follow up apt with PCP after Visit 6 
 
Time Frame 
 
Target: 6 weeks after Randomization (V3)  
 
Window: 5 to 7 weeks after Randomization (V3)  
 
Duration of V5:1 hour  
 
Equipment/materials 
 
iPad 
 
Coordinator EasyOne Spirometer (in case you need to show them anything via FaceTime) 
 
Visit 4  
 
 and weight data (to compare with Visit 5) 
 
Latest data on Advair Diskus counter number from REDCap 
4.7.1. Study Coordinator Procedures for Visit 5 
 
If there are any issues that have been discussed with Dr. Blake and an exception has been 
allowed, document the exception on the ‘Protocol Exception’ Form under the Ongoing 


MICT MOP 
  46 
 
column. 
 
Ask participant for current height and weight  
o If height and weight have changed since V3, then you will need to do at least 1 
effort before you can update the height and weight data 
 
Changing height and weight data will change it for the present test and all 
subsequent tests 
o Click here to see a summary of height data section in this MOP: Height Data 
Summary in REDCap. 
 
EasyOne Spirometry – follow the instructions in the Coordinator EasyOne Manual (Click 
this link to view the manual: Manual for Coordinator EasyOne Instructions.) 
o Document if it has not been 4 hours since the participant last used albuterol or 
Xopenex  
o Have participant do 3 pre-bronchodilator efforts.   
o Take picture of the flow volume curves using your iPad by holding down the power 
button at the same time as holding down the home key 
 
These are saved to ensure we have data should the EasyOne get lost or 
broken 
 
Save the photos on the shared drive at this location (Click this link to see 
the location: Folder for iPad Photos.) 
 
Use the following format for creating a folder name for file saving: 
JAX102\JAX102V5_07-10-14 
o Record the PFT Data using the MICT PFT Worksheet.  (Click here to view the 
PFT FaceTime Worksheet.) 
 
Ensure FEV1 is still ≥ 70% predicted using the predicted calculator found on 
the ACRC website at https://www.jhcct.org/Secure/LASST/LASSTPFT.asp 
 
Calculate the % Predicted value as 
% Predicted = 100* [FEV1 (in Liters) / Predicted FEV1 (in Liters)] 
 
Have participant take 2 puffs of ProAir and wait 15 minutes 
 
Can end FaceTime and restart in 15 minutes 
 
Have participant do 3 post-bronchodilator efforts using same procedure as 
for pre-bronchodilator testing 
 
Save the handwritten PFT Worksheet until the end of the study. 
 
This worksheet will be needed inorder to reconcile all the PFT data 
downloaded from the EasyOne device at Visit 6 with the data 
entered into REDCap. 
 
Do a random check of PEF values on participants EasyOne 
o From the REDCap “Peak Flow Report”, select 3 dates and write down the 3 PEF 
values for each of the 3 dates. Or you can print the Peak Flow Report.  Do this 
when getting prepared for the FaceTime visit (you can do this a day or two before 
the visit date). 
o Instruct the participant turn on EasyOne 
 
Go to “View Results” on EasyOne by pressing the right arrow key and 
pressing “Enter” 
 
Use the right arrow button to tab to “Date” 
 
Have the participant enter the first date you have selected and press “Enter” 
 
Ask the participant to tell you the date on the screen; it will be under FVC 
Test (for example, 8/22/2014 in the image below) 
o 
 


MICT MOP 
  47 
 
 
If the participant DID do the PEF, then the date on the screen will 
match the date you asked them to enter 
 
If the participant DID NOT actually do the PEF on the EasyOne on 
that date (even though they entered data on the Morning Report for 
that date, i.e. they made up numbers on the iPad Morning Report), 
the EasyOne will search for the closest date prior to the date you 
instructed the participant to enter.   
 
Press “Enter” again and the results will show up on the EasyOne screen 
 
 
 
Ask the participant to tell you the PEF number (387 in the image 
above) 
 
Compare the 3 PEF values that were entered into REDCap with the PEF 
that is on the EasyOne.  If they actually did the PEF on that date, then one 
of the 3 values in REDCAP will match with the value that they show on the 
EasyOne. 
 
Note: Unfortunately, the EasyOne will only show you the PEF that is 
associated with the best sum of the FVC and FEV1 which is not 
always the highest PEF.  But when you download all the data from 
the EasyOne, you can see every effort that that the participant made 
on the EasyOne for that date. 
 
Repeat the above for the other 2 dates (and 3 PEF values for each date) 
you selected from the REDCap data  
 
If the participant tells you that they don’t have that date for any of the 3 
dates viewed and the PEFs don’t match up, then counsel the participant to 
enter only REAL values into the Morning Report. 
 
Important for triggering their Asthma Action Plan to pop up on the 
iPad 
 
Important for us to monitor their safety 
 
View counter on Advair Diskus and confirm that it is consistent with what is in REDCap 
 
Review any adverse effects, alerts, or any other issues 
 
Remind participant to 
o Use the Asthma Action Plan for symptom management 
o Contact primary asthma care doctor for asthma management issues 
 
Confirm Visit 6 FaceTime date and time 
 
Confirm study medication shipping address and fedex delivery instructions 
o If there are any changes from previous visit, notify the Pharmacist (at WIL or ORL) 
or AC (for other sites)  
 
Remind participant to check emails every few days and 4 days before Visit 3 for the 
upcoming visit questionnaires  
 
Remind participant to have height and weight done before the Visit 6 FaceTime visit 
 
Remind parent (may need to send to study email account if parent is not present) to 
schedule appointment with primary asthma care doctor for follow-up after Visit 6 (provide 
them with Visit 6 date so they know when to schedule). 
 
Chart in EPIC with a brief summary of visit 
4.7.2. Study Coordinator REDCap Instructions for Visit 5 
Three days prior to the scheduled date, the participant will receive email messages with links to 
the ACT, Children’s Health Survey, EQ-5D, Quality of Life Questionnaires (if 15 yo or older) and 


MICT MOP 
  48 
 
Pre-Clinic Visit Survey and instructions to complete these at least 24 hours before their 
appointment. 
 
Prior to visit 5, SC should review participant’s responses in the following forms: Asthma Control 
Test - participant version, Children’s Health Survey - participant version, Quality of Life 
Questionnaires and Clinic Visit – participant version. 
 
In the MICT-data REDCap project 
o Click ‘Add/Edit Records’ and chose the participant ID for this participant 
o Review the following REDCap forms under Visit5-virtual 
 
Asthma Control Test – participant version 
 
The ACT status form has a notes field for your comments 
 
Children’s Heath Survey – participant version 
 
EQ-5D from the EuroQol Group 
 
Quality of Life Questionnaires 
 
If 15 yo or older when the consent was signed 
 
This form has a notes field for your comments 
 
Clinic Visit – participant version 
 
This form has a notes field for your comments 
o Click ‘Save’ on each form if comments are added 
 
After completing Visit 5 (FaceTime), SC should complete the following. 
 
In the MICT-data REDCap project 
o Click ‘Add/Edit Records’ and chose the participant ID for this participant 
o Click the button for ‘Visit Dates’ under Visit5-virtual 
 
Complete the field for ‘Actual visit date’ 
 
Set form as ‘Complete’  
 
Click ‘Save’ 
o Click the button for ‘Pulmonary Function Testing’ under Visit5-virtual 
 
Complete the fields as the information is collected. 
 
During this process, you will go to 
https://www.jhcct.org/Secure/LASST/LASSTPFT.asp 
 
Set form as ‘Complete’ 
 
Click ‘Save’ 
o Go to the ‘Assessment for Treatment Failure’ 
 
Complete the fields in this form.  This will include: 
 
Reviewing clinic visit form 
 
Reviewing diary card alerts 
 
A summary of alerts can be viewed in the report ‘data’ 
in the REDCap project, MICT-alerts 
 
Summary of diary card submission date and dose 
taken can be viewed with the tool at 
https://apps.nemoursresearch.org/mict/diary_submiss
ion.php 
 
A summary of “urgent and unscheduled medical 
attention” alerts can be viewed as a report in the 
MICT-diary cards project and selecting “Questions 
about urgent unscheduled medical attention” in the 
Reports section on the left side 
 
Set form as ‘Complete’ 
 
Click ‘Save’ 
 
Note: If the answer to any of the questions on this form is ‘Yes’, then the 
participant meets the criteria for treatment failure. 
o Click the button for ‘Visit Dates’ under Visit6-virtual 


MICT MOP 
  49 
 
 
If visit 6 is not scheduled : 
 
Enter a date and time into ‘Scheduled date and time’ 
 
Set form as ‘Unverified’ 
 
Click ‘Save’ 
 
If visit 5 is already scheduled, confirm date and time with participant 
 
If date of appointment is changed, enter new date and time into 
‘Scheduled date and time’ 
 
Click ‘Save’ 
4.8. Visit 6 – Part 1 (Virtual Visit) 
Overview 
 
WebEx with SC, Parent, Participant to conduct the Research Participant Assessement 
Interview  
 
Review questionnaires prior to FaceTime visit 
 
Conduct FaceTime Visit 
 
Do pre- and post-bronchodilator spirometry 
 
Do a random check of PEF values on participants EasyOne 
o Select a date for PEF value from “Peak Flow Report” in REDCap (note the date 
and PEF value) 
 
Conduct the onsite clinic visit 
 
Time Frame 
 
Target: 12 weeks after Randomization (V3)  
 
Window: 11 to 13 weeks after Randomization (V3)  
 
Duration of V6:1 hour for Part 1; 1 hour for Part 2  
 
Equipment/materials 
 
Computer access 
 
Internet / Phone access  
 
Equipment/materials for recording Research Assessment Interview 
 
Forms (Click this link to view the forms: Research Assessment interview forms.) 
o RESEARCH ASSESSMENT FORM – Female 
o RESEARCH ASSESSMENT FORM – Male 
 
iPad 
 
Coordinator EasyOne Spirometer (in case you need to show them anything via FaceTime) 
 
Visit 5 height and weight data (to compare with Visit 6) 
 
Latest data on Advair Diskus counter number from REDCap 
4.8.1. Study Coordinator Procedures for Visit 6 – Part 1 
 
Webex Research Assessment Interview 
 
Contact parent and participant by phone using WebEx Meeting Center per Audio 
Recording Protocol instructions.   (Click this link to see MOP: MICT Audio Recording 
MOP.)  
o IMPORTANT: The same parent who completes the Research Assessment 
interview with the study coordinator at this visit, MUST be the same person at Visit 
6.  Please inform the family of this – you will also enter this information REDCap to 
help you remember when it is time to do the Visit 6 Research Assessment 
interview. 
 
Administer the Research Assessment form.  To avoid missing any questions, make a 
check mark after each question is asked. (Click this link to view the forms: Research 
Assessment interview forms.) 
o RESEARCH ASSESSMENT FORM – Female 
o RESEARCH ASSESSMENT FORM – Male 


MICT MOP 
  50 
 
 
Note: you do NOT need to conduct the Newest Vital Sign Assessment  
 
After completing the WebEx, disconnect the call and then begin the FaceTime portion of 
the visit 
 
FaceTime Visit 
 
If there are any issues that have been discussed with Dr. Blake and an exception has been 
allowed, document the exception on the ‘Protocol Exception’ Form under the Ongoing 
column. 
 
Ask participant for current height and weight  
o If height and weight have changed since V5, then you will need to do at least 1 
effort before you can update the height and weight data 
 
Changing height and weight data will change it for the present test and 
all subsequent tests 
 
Click here to see a summary of height data section in this MOP: 
Height Data Summary in REDCap. 
 
EasyOne Spirometry – follow the instructions in the Coordinator EasyOne Manual (Click 
this link to view the manual: Manual for Coordinator EasyOne Instructions.) 
o Document if it has not been 4 hours since the participant last used albuterol or 
Xopenex  
o Have participant do 3 pre-bronchodilator efforts.   
o Take picture of the flow volume curves using your iPad by holding down the 
power button at the same time as holding down the home key 
 
These are saved to ensure we have data should the EasyOne get lost or 
broken 
 
Save the photos on the shared drive at this location (Click this link to 
see the location: Folder for iPad Photos.) 
 
Use the following format for creating a folder name for file saving: 
JAX102\JAX102V5_07-10-14 
 
Record the PFT Data using the MICT PFT Worksheet.  (Click here to view 
the PFT FaceTime Worksheet.) 
 
Ensure FEV1 is still ≥ 70% predicted using the predicted calculator 
found on the ACRC website at 
https://www.jhcct.org/Secure/LASST/LASSTPFT.asp 
 
Calculate the % Predicted value as 
% Predicted = 100* [FEV1 (in Liters) / Predicted FEV1 (in Liters)] 
 
Have participant take 2 puffs of ProAir and wait 15 minutes 
 
Can end FaceTime and restart in 15 minutes 
 
Have participant do 3 post-bronchodilator efforts using same procedure 
as for pre-bronchodilator testing 
 
Save the handwritten PFT Worksheet until the end of the study. 
 
This worksheet will be needed inorder to reconcile all the PFT 
data downloaded from the EasyOne device at Visit 6 with the 
data entered into REDCap. 
 
Do a random check of PEF values on participants EasyOne 
o From the REDCap “Peak Flow Report”, select 3 dates and write down the 3 PEF 
values for each of the 3 dates. Or you can print the Peak Flow Report.  Do this 
when getting prepared for the FaceTime visit (you can do this a day or two before 
the visit date). 
o Instruct the participant turn on EasyOne 
 
Go to “View Results” on EasyOne by pressing the right arrow key and 
pressing “Enter” 
 
Use the right arrow button to tab to “Date” 
 
Have the participant enter the first date you have selected and press “Enter” 
 
Ask the participant to tell you the date on the screen; it will be under FVC 
Test (for example, 8/22/2014 in the image below) 


MICT MOP 
  51 
 
o 
 
 
If the participant DID do the PEF, then the date on the screen will 
match the date you asked them to enter 
 
If the participant DID NOT actually do the PEF on the EasyOne on 
that date (even though they entered data on the Morning Report for 
that date, i.e. they made up numbers on the iPad Morning Report), 
the EasyOne will search for the closest date prior to the date you 
instructed the participant to enter.   
 
Press “Enter” again and the results will show up on the EasyOne screen 
 
 
 
Ask the participant to tell you the PEF number (387 in the image 
above) 
 
Compare the 3 PEF values that were entered into REDCap with the PEF 
that is on the EasyOne.  If they actually did the PEF on that date, then one 
of the 3 values in REDCAP will match with the value that they show on the 
EasyOne. 
 
Note: Unfortunately, the EasyOne will only show you the PEF that is 
associated with the best sum of the FVC and FEV1 which is not 
always the highest PEF.  But when you download all the data from 
the EasyOne, you can see every effort that that the participant made 
on the EasyOne for that date. 
 
Repeat the above for the other 2 dates (and 3 PEF values for each date) 
you selected from the REDCap data  
 
If the participant tells you that they don’t have that date for any of the 3 
dates viewed and the PEFs don’t match up, then counsel the participant to 
enter only REAL values into the Morning Report. 
 
Important for triggering their Asthma Action Plan to pop up on the 
iPad 
 
Important for us to monitor their safety 
 
View counter on Advair Diskus and confirm that it is consistent with what is in REDCap 
 
Review any adverse effects, alerts, or any other issues 
 
Remind participant to 
o Use the Asthma Action Plan for symptom management 
o Contact primary asthma care doctor for asthma management issues 
 
Confirm Visit 6 Clinic Visit date and time 
o The Visit 6 Clinic Visit should be within 7 days of the Visit 6 FaceTime visit 
 
Remind participant to bring all used and unused study drug (ProAir, all Diskuses), 
EasyOne and EasyOne stand, HotSpot if they used one during the study, and iPad to the 
clinic visit.  We will delete study information from the iPad at the clinic visit. 
 
Chart in EPIC with a brief summary of visit 
 


MICT MOP 
  52 
 
4.8.2. Study Coordinator REDCap Instructions for Visit 6 – Part 1 
Four days prior to the scheduled date, the participant will receive email messages with links to the 
ACT, EQ-5D, Children’s Health Survey, Quality of Life Questionnaires (if 15 yrs or older) and Pre-
Clinic Visit Survey and instructions to complete these at least 24 hours before their appointment. 
 
Prior to visit 6-virtual, SC should review participant’s responses in the following forms: Asthma 
Control Test - participant version, Children’s Health Survey - participant version, Quality of Life 
Questionnaires and Clinic Visit – participant version. 
 
In the MICT-data REDCap project 
o Click ‘Add/Edit Records’ and chose the participant ID for this participant 
o Review the following REDCap forms under Visit 6-virtual 
 
Asthma Control Test – participant version 
 
The ACT status form has a notes field for your comments 
 
Children’s Heath Survey – participant version 
 
EQ-5D from the EuroQol Group 
 
Quality of Life Questionnaires 
 
If 15 yo or older when the consent was signed 
 
This form has a notes field for your comments 
 
Clinic Visit – participant version 
 
This form has a notes field for your comments 
o Click ‘Save’ on each form if comments are added 
 
After completing Visit 6 (FaceTime), SC should complete the following. 
 
In the MICT-data REDCap project 
o Click ‘Add/Edit Records’ and chose the participant ID for this participant 
o Click the button for ‘Visit Dates’ under Visit6-virtual 
 
Complete the field for ‘Actual visit date’ 
 
Set form as ‘Complete’  
 
Click ‘Save Record’ 
o Click the button for ‘Research Assessment Interview’ form under Visit 6-virtual 
 
Complete the Research Assessment Interview form  
 
A PDF file with the questions to ask participants is available in this REDCap 
form. 
 
Set form as ‘Complete’. . 
 
Click ‘Save Record’ 
o Click the button for ‘Pulmonary Function Testing’ under Visit6-virtual 
 
Complete the fields as the information is collected. 
 
During this process, you will go to 
https://www.jhcct.org/Secure/LASST/LASSTPFT.asp 
 
Set form as ‘Complete’ 
 
Click ‘Save’ 
o Go to the ‘Assessment for Treatment Failure’ 
 
Complete the fields in this form.  This will include: 
 
Reviewing clinic visit form 
 
Reviewing diary card alerts 
 
A summary of alerts can be viewed in the report ‘data’ 
in the REDCap project, MICT-alerts 
 
Summary of diary card submission date and dose 
taken can be viewed with the tool at 
https://apps.nemoursresearch.org/mict/admin/diary_s
ubmission.php 
 
A summary of “urgent and unscheduled medical 
attention” alerts can be viewed as a report in the 


MICT MOP 
  53 
 
MICT-diary cards project and selecting “Questions 
about urgent unscheduled medical attention” in the 
Reports section on the left side 
 
Set form as ‘Complete’ 
 
Click ‘Save’ 
 
Note: If the answer to any of the questions on this form is ‘Yes’, then the 
participant meets the criteria for treatment failure. 
o Click the button for ‘Visit Dates’ under Visit6-clinic 
 
If the clinic portion of visit 6 is not scheduled : 
 
Enter a date and time into ‘Scheduled date and time’ 
 
Set form as ‘Unverified’ 
 
Click ‘Save’ 
 
If the clinic portion of visit 6 is already scheduled, confirm date and time with 
participant 
 
If date of appointment is changed, enter new date and time into 
‘Scheduled date and time’ 
 
Click ‘Save’ 
4.9. Visit 6 – Part 2 (Clinic Visit) 
Overview 
 
Conduct Visit 6 procedures  
 
Retrieve study medications and EasyOne 
 
Blood draw for DNA and Phadiatop 
 
Prepare iPad to give to participant 
 
End of study satisfaction surveys for parent and child 
 
Time Frame 
 
Target: 7 days after Visit 6 – Part 1 (Virtual)   
 
Duration of V1: 1 hour 
 
Equipment/materials 
 
NIOX MINO (for sites conducting exhaled nitric oxide procedure) 
 
Coordinator’s iPad so physician can complete physical exam in REDCap 
 
Procedures Overview: 
 
Confirm participant’s and parent’s email addresses 
 
Physical Exam including height and weight  
 
Measure exhaled nitric oxide (eNO). This must be completed before pulmonary function 
testing (if applicable for your site) 
 
Blood draw for DNA and Phadiatop, processing, storage/shipment 
 
Retrieve all used and unused study drug (ProAir, all Diskuses), EasyOne and EasyOne 
stand 
 
Download and reconcile EasyOne data with PFT data in REDCap 
 
Send the Physician Study Closure Letter to primary asthma physician. (Click this link to 
see IRB approved letters to participant Physicians: Physician Letters.). Include copy 
of spirometry results 
 
Chart in EPIC with a brief summary of visit 
4.9.1. Study Coordinator Procedures for Visit 6 – Part 2 
4.9.1.1. 
Email Addresses 
 
Email invitations with links to the End of Study Satisfaction Survey will be sent the day after 
Visit6-Clinic to both the parent and participant.    
 
Confirm the participant’s and parent’s email addresses that we have in REDCap for these 


MICT MOP 
  54 
 
messages.   
o Parent and Participant may choose to use the same email address.   
o They may continue to use the study gmail account if they desire. 
 
Click here to see SC REDCap Instructions for Visit 6 section in this MOP) 
4.9.1.2. 
Exhaled Nitric Oxide 
 
Collect exhaled nitric oxide results (if your site is collecting exhaled nitric oxide) 
 
Record data in REDCap (Click here to see SC REDCap Instructions for Visit 6 section 
in this MOP). 
4.9.1.3. 
Physical Exam 
 
Have physical exam done 
 
Record data in REDCap (Click here to see SC REDCap Instructions for Visit 6 section 
in this MOP). 
o The physician will need to log into their REDCap account to complete the form, 
electronically sign, and lock the form 
4.9.1.4. 
Collect Study Medication 
 
Collect all study medication and return to pharmacist (ORL and WIL) or document receipt 
in REDCap (Click here to see SC REDCap Instructions for Visit 6 section in this 
MOP). 
4.9.1.5. 
Collect the EasyOne Spirometer and Download/Reconcile Results 
 
Put the EasyOne into the cradle 
o Download all study records 
 
After the study is over, the SC will need to reconcile the PFT results (FVC, 
FEV1, and PEF) with the data that was entered into REDCap during the 
FaceTime visits. 
 
To reconcile the data, the SC will need to view the PFTs collected at 
FaceTime V2, V3, V4, V5, and V6 downloaded from the EasyOne (this 
won’t be much fun). 
 
If the REDCap data are different from the EasyOne data, the SC will 
need to correct the Pulmonary Function Testing form in REDCap  
o Add a comment for any correction made 
o Print 3 copies of the Visit 6 results (for primary care physician, participant copy, and 
for site records) 
4.9.1.6. 
Collect Blood Specimens 
 
Click here to see Blood Collection and Processing for DNA, plasma and serum 
section in this MOP. 
4.9.1.7. 
Preparing iPad to give to Participant for Keeps 
 
Remove the shortcut to the MICT website 
o Touch and hold until you get an “X” on the icon, and then touch “X” to delete 
 
Remove the shortcut to the morning diary report 
o Touch and hold until you get an “X” on the icon, and then touch “X” to delete 
 
Remove the shortcut to the evening diary report 
o Touch and hold until you get an “X” on the icon, and then touch “X” to delete 
 
Open FaceTime 
o Remove all study-related contacts (your name and any other coordinator’s name 
that is in their list of contacts) 
 
Open the Videos app and delete the study-related help videos (these are just the 
instructional videos we put in the iPad for the participants) 
o FaceTime video 
o Hotspot video 


MICT MOP 
  55 
 
o EasyOne video 
o Discus Inhaler video 
o MDI inhaler video 
 
Open the iBooks app 
o Delete the EasyOne Participant Instructions pdf document 
 
Gmail 
o Have the participant log into their study gmail account to have them change their 
recovery email 
 
Click on the gear icon in the upper right corner (below the blue person icon) 
 
 
 
Go to “Settings” 
 
 
 
Go to “Accounts and Import” 
 
 
 
Go to “Change password and recovery options” and have them put in any 
alternative email address that they have (a personal one) 
 
 
4.9.2. Study Coordinator REDCap Instructions for Visit 6 – Part 2 
 
SC REDCap Steps in Preparation for Visit 6 – Part 1 (Clinic Visit) 
In the MICT-equipment REDCap project 
o Go to ‘Data Search’ in the middle of the page 
 


MICT MOP 
  56 
 
 
o In ‘Choose a field to search’, select ‘Participant ID’  
 
o In the ‘Search Query’ box, enter the ‘Participant ID’ (e.g. JAX163, PNS114) 
o Click ‘Tracking Information’ in left side panel under Data Collection. 
o Check for equipment that was given to participant that needs to be returned. 
 
EasyOne spirometer  
 
Hotspot serial number if they received one 
 
Physician REDCap Steps During Visit 6 
To Complete the Physical Exam: 
Log into REDCap 
In the MICT-data REDCap project 
o Click ‘Add/Edit Records’ and chose the participant ID for this participant 
o Click the button for ‘Physical Exam’ under Visit6-clinic 
o Complete the fields in this form as the exam is performed. 
o Set the form as ‘Complete’ 
o Check the ‘Lock’ and ‘E-signature’ options. 
o Click Save ‘Record’ 
Log out of REDCap 
 
Notes: Any physician with a REDCap username and access to the REDCap project can e-
sign the Physical Exam form of any participant at any time.  E-signing in REDCap consists of 
checking the boxes next to 'Lock' and 'E-signature' and saving the record.  The status of the 
form can be set to 'Incomplete', 'Unverified' or 'Complete' when the form is e-signed and the 
status is locked along with the other fields on the form.  Once a form is e-signed, it must be 
unlocked before any changes can be made. 
 
Only REDCap users who have the user right to lock and e-sign a form can see the check 
boxes for locking and e-signing the form.  Forms that are locked and e-signed will have a 
padlock and green shield (with check) in the event grid.  Also, forms that are locked and e-
signed will not have buttons for saving the form at the bottom of the page when viewing the 
form. 
 
Study coordinators can change the status of the Physical Exam form before the form is e-
signed. 
 
 
If a physician does not have REDCap access yet: 
o Go to the ‘Physical Exam’ form if not already there. Print blank form. SC to 
complete demographic and vital sign information by hand. Physician will complete 
the exam portion and print and sign in designated areas. The SC will then enter the 
data into the form in REDCap.   
 
Complete the fields 
 
Set form as ‘Complete’ 
 
Click ‘Save and go to Next Form’ 
 
After completing Visit 6 – Part 2 (Clinic Visit), SC should complete the following. 
 
In the MICT-data REDCap project 


MICT MOP 
  57 
 
o Click ‘Add/Edit Records’ and chose the participant ID for this participant 
o Click the button for ‘Participant Info’ under Ongoing 
 
Check the ‘Participant’s email address’ 
 
If the participant will continue to use the study gmail address, this 
may be entered in the field ‘Participant’s email address’. 
 
If the participant will not have his/her own email address, insert the 
parent’s email address in the field ‘Participant’s email address’ if the 
participant does not want to use the study gmail address 
 
Check the ‘Parent’s email address’ 
 
If the parent wishes to continue using the study gmail address, this 
may be used. Enter the study gmail address into the field 
‘parent/guardian’s email-address’. 
o The parent’s personal email will still be visible by clicking the 
history icon (the H in a circle). 
o Click the button for ‘Visit Dates’ under Visit6-clinic 
 
Complete the field for ‘Actual visit date’ (must do this in order for the End of 
Study Satisfaction Survey’s to be sent at 4AM the next day). 
 
Set form as ‘Complete’  
 
Click ‘Save’ 
o The day after the ‘Actual visit date’, email invitations will be sent to the participant’s 
and the parent’s email addresses for the End of Study Satisfaction Surveys.  
AsthmaResearch@nemours.org will receive a copy of these messages. If the 
‘Actual visit date’ is not saved the day the visit takes place or if the participant 
finished the study previously, the email invitations will not be sent automatically. 
Click here to see how to manually ‘send email invitations to a participant or 
parent for the End of Study Satisfaction Survey’ section in this MOP: Missing 
and/or Re-sending Questionnaires to Participants.  
 
After a survey is completed it gets a green check in the list of instruments 
in the left side bar and the Event grid 
 
The survey invitations for these surveys are sent the day after the ‘actual 
visit date’ for visit 6-clinic by computer code that is outside of 
REDCap.  This means that these messages will not be listed in REDCap’s 
survey invitation log.   The invitation for the parent is sent to the address 
stored in the parent’s email address field.  The invitation for the participant 
is sent to the address stored in the participant’s email address field. 
o After collecting specimen, go to the ‘Specimen Collection’ form  
 
Indicate the samples that were collected and scan in barcodes 
 
Set form as ‘Complete’ 
 
Click ‘Save’ 
o Go to the ‘Nitric Oxide’ form if not already there 
 
Complete the fields as the information is collected. 
 
Set form as ‘Complete’ 
 
Click ‘Save Record’ 
o Go to the ‘Drug Accountability Log’ form under Ongoing 
 
Record information about returned inhalers and Diskus 
 
Set form as ‘Complete’ 
 
Click ‘Save and go to Next Form’ 
o Go to the ‘Treatment Termination’ form under Ongoing if not already there 
 
Complete this form 
 
Set form as ‘Complete’ 
 
Click ‘Save Record’ 
NOTE: When the field ‘Type of termination’ is completed, the participant will not be 
able to log in to the Trial website or submit diary reports. 
 
In the MICT-equipment REDCap project 
o Click ‘Summary’ report under ‘Reports’ in the left side panel 


MICT MOP 
  58 
 
o Click on the username for this participant 
 
This will take you to the ‘Name’ form 
 
Set form as ‘Complete’ if it isn’t already 
 
Click ‘Save and go to Next Form’ 
o Go to the ‘Tracking’ form if not already there 
 
Set ‘Username is:’ to ‘Complete – iPad permanently given to participant’ 
 
Enter date EasyOne was returned 
 
Enter date hotspot was returned, if appropriate 
 
Set form as ‘Complete’ 
 
Click ‘Save Record’ 
 
 
4.9.3. Administrative Coordinator REDCap Instructions for Visit 6 – Part 2 
Administrative Coordinator (AC) Tasks 
After completing Visit 6 – Part 2 (Clinic Visit), AC should complete the following. 
When $25 is added to participant’s CTPayer account.  Record this REDCap. 
In the MICT – DC summary REDCap  project 
o Click ‘Add/Edit Records’ and chose the participant ID for this participant 
 
CTPayer account number can be viewed in ‘Participant Information’ form  
o Click the button for ‘Clinic Visits, FaceTime Visits, Satisfaction Survey’ 
o Record whether credit was added to card and date this was done 
o Click ‘Save Record’ 
 
In the MICT-equipment REDCap project 
o Click ‘Add/Edit Records’ and chose the username assigned this participant 
o Click ‘Tracking Information’ in left side panel under Data Collection. 
o Enter data for the following fields 
 
Set ‘Username is:’ to ‘Complete-iPad permanently given to participant’ 
 
Date EasyOne was returned 
 
If appropriate, date hotspot was returned 
o Set the form as ‘Complete’ 
o Click ‘Save Record’ 
 
In the MICT-web info REDCap project 
o Click ‘Add/Edit Records’ and chose the username assigned to this participant 
o Go to the ‘Basics’ form if not already there, using the left side panel 
o Set the form as ‘Complete’ 
o Click ‘Save Record’ 
 
After participant and parent complete the End of Study Satisfaction Surveys, record 
sending compensation. 
In the MICT – DC summary REDCap project 
o Click ‘Add/Edit Records’ and chose the participant ID for this participant 
 
CTPayer account number can be viewed in ‘Participant Information’ form  
o Click the button for ‘Clinic Visits, FaceTime Visits, Satisfaction Survey’ 
o Record when credit was added to form and date this was done 
o Record that Walmart card was sent and date this was done 
o Click ‘Save Record’ 
 
5. Screen Failures Between V1 to V3 
5.1. Overview 
 
To identify participants who have met the criteria for screen failure during the open-label stable 
phase of the study (Visit 1 up to Visit 3) 


MICT MOP 
  59 
 
 
To identify participants who are interested in being rescreened and begin the processes for 
rescreening 
5.2. Screen failure at V1 
 
At Visit 1, the main criteria that would be unexpected is an ACT <20 or FEV1 <70% of 
predicted.  All the other criteria should have been assessed by the SC using the Screening 
form and Baseline Asthma and Medical History form.   
5.2.1. Study Coordinator REDCap Steps for Participant who Failed at Visit 1 
In the MICT-data REDCap project, SC should: 
o Click ‘Add/Edit Records’ and choose the participant ID for this participant 
o Go to the ‘Treatment Termination’ form under Ongoing in the grid 
 
Complete this form 
 
Set form as ‘Unverified’ (Collection of Diskuses will be recorded when 
participant comes in to clinic to return equipment.) 
 
Click ‘Save Record’ 
NOTE: When the field ‘Type of termination’ is completed, the participant will not be 
able to log in to the Trial website or submit diary reports.  This will also prevent any 
alerts from being generated. 
5.3. Determining if the Participant has Failed Between V1 to V3 
 
At Visit 1, review the ‘Assessment for Stable Phase’ form (under the Visit 2 forms in REDCap) 
to determine if a participant must discontinue the study (they may be interested in being 
rescreened in 4 weeks) 
o At Visit 1, the main criteria that would be unexpected is an ACT <20 or FEV1 <70% of 
predicted.  All the other criteria should have been assessed by the SC using the 
Screening form and Baseline Asthma and Medical History form.   
 
At Visit 2, review the ‘Assessment for Stable Phase’ form (under the Visit 2 forms in REDCap) 
to determine if a participant must discontinue the study (they may be interested in being 
rescreened in 4 weeks) 
 
At anytime between Visit 1 and Visit 3, a participant may meet the criteria for screen failure 
o Use the ‘Assessment for Stable Phase’ under Visit 2 to review criteria 
 
SC may have received alerts that some these criteria (corticosteroid use, 
unscheduled visits, excessive albuterol use) may have been met  
 
Contact the PI, Dr. Blake, with questions if there are issues related to 
asthma stability and whether or not the participant can continue in the 
study.  This will be handled on a participant by participant basis with 
consultation with the study physician 
 
If the participant meets the criteria for screen failure 
o They may keep the iPad (for now), if the SC is very confident that they will continue 
with the study and be re-screened, otherwise, schedule an appointment for the 
participant to return the iPad, EasyOne Plus, study medication 
 
Ensure that the participant has some personal controller medication (required 
for the study) and rescue medication to use until they can be rescreened. 
5.4. Study Coordinator Procedures for Screen Failures at Visit 2 or Visit 3 
 
Complete procedures, forms and questionnaires for the visit 
 
Complete steps required in REDCap (this will stop all alerts as well) 
 
DO NOT delete any data from the forms in REDCap 
 
After 4 weeks the participant may be rescreened as a new participant 


MICT MOP 
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5.5. REDCap Steps for Ending Participation at Visit 2 or Visit 3 
5.5.1. REDCap Steps for Participant who Failed Stable Phase but will be 
Rescreened 
These steps should be performed for any participant who has completed visit 1 and not completed 
visit 3.  (This can be before or after visit 2.) 
 
Study Coordinator (SC) Tasks 
In the MICT-data REDCap project, SC should: 
o Click ‘Add/Edit Records’ and choose the participant ID for this participant 
o Go to the ‘Treatment Termination’ form under Ongoing in the grid 
 
Complete this form 
 
Set form as ‘Unverified’ (Collection of Diskuses will be recorded when 
participant comes in to clinic to return equipment.) 
 
Click ‘Save Record’ 
NOTE: When the field ‘Type of termination’ is completed, the participant will not be 
able to log in to the Trial website or submit diary reports. This will also prevent any 
alerts from being generated. 
 
When the participant is in the clinic, the old Diskus will be collected and equipment (iPad, 
spirometer, Hotspot) will be returned, do the following in REDCap: 
In the MICT-equipment RedCap project, AC should: 
o Click ‘Add/Edit Records’ and choose the username assigned to this participant 
o Click ‘Tracking Information’ in left side panel under Data Collection. 
 
Record any equipment returns that occurred. 
o Click ‘Save Record’ 
 
Study Coordinator (SC) Tasks when the participant comes to the clinic 
In the MICT-data REDCap project, SC should 
o Click ‘Add/Edit Records’ and choose the participant ID for this participant 
o Go to the ‘Drug Accountability Log’ form under Ongoing 
 
Record the date for all the Diskus that were returned 
 
Set form as ‘Complete’ 
 
Click ‘Save and go to Next Form’ 
o Go to the ‘Treatment Termination’ form if not already there 
 
Finish completing this form 
 
Set form as ‘Complete’ 
 
Click ‘Save Record’ 
5.6. Study Coordinator Procedures for Re-screening a Participant at Visit 1 
Overview  
 
Follow all the same procedures as for the original Visit 1 but you do not need to repeat the 
Webex to conduct the Research Assessment interview  
o You will do the Research Assessment Interview at Visit 6  
 
The Visit 6 Research Assessment interview is assessing how much they 
retained about the study while participating from V1 to V6. 
 
SC Procedures 
Refer to steps for Visit 1 (Click here to see Screening Steps and  Visit 1 - Part 2 Steps 
sections in this MOP). 
5.7. REDCap Step for Rescreening a Participant 
Overview 
 
The participant will be given an new Participant ID, which will be based on their original ID  
o If the original was JAX102, the new will be JAX102a 
 
The participant will continue to use the same login username and password (the password 


MICT MOP 
  61 
 
that they created) they used before being placed on hold  
 
Administrative Coordinator (AC) Tasks 
In the MICT-web info REDCap project 
o Click ‘Add/Edit Records’ and chose the username for the participant 
o Go to the ‘Basics’ form if not already there, using the left side panel 
o Enter the new ‘Participant ID’ 
 
This will be the old Participant ID with an ‘a’ added to the end. 
 
If an ‘a’ has already been added, replace it with a ‘b’. 
 
The first three letters of the participant ID must be uppercase and the letter 
added to the end must be lowercase, i.e. JAX101a. 
o Click ‘Save Record’ 
 
 
In the MICT-data REDCap project 
o Click ‘Add/Edit Records’, chose Arm1:MICT, type the new Participant ID and select 
‘Enter’ 
 
This should be the same as the participant ID that was entered into MICT-
web info in the steps above. 
 
The first three letters of the participant ID must be uppercase and the letter 
added to the end must be lowercase, i.e. JAX101a 
o Go to the ‘Patient Screening Log’ form and enter data 
 
3 fields in this form may be left blank initially, these are 
 
Main reason failed screen or not enrolled 
 
Successfully completed V1 (enrolled) 
 
Set form status as ‘unverified’ 
 
Click ‘Save Record’ 
o Go to the ‘Study Information‘ form 
 
Enter data into all but ‘Treatment arm’ 
 
Be sure to answer ‘Yes’ for ‘Is this record for a rescreen?’ 
 
The field ‘Additional email address for alert messages’ should be 
completed if a SC from a site other than the one indicated in the 
form will be following the participant.  Otherwise, the field can be left 
blank. 
 
Set from status as ‘Unverified’ 
 
Click ‘Save and go to Next Form’ 
o Go to the ‘Participant Information form’ 
 
Enter data for all fields 
 
It is critical that the following fields are completed as some functions depend 
on the data 
 
Participant’s first and last name 
 
Study email address 
 
Parent/guardian’s email address 
 
Physician’s first name 
 
Physician’s last name 
 
Physician’s phone number 
 
Set form as ‘Complete’ (or ‘Unverified’ if data entry is not completed) 
 
Click ‘Save Record’ 
o Go to the ‘Signed Consent’ form 
 
Enter ‘Yes’ for “Successfully completed consent process” 
 
When this is saved, email messages  will be NOT be sent if ‘Yes’ 
has been saved for ‘Is this record for a rescreen?’ in the ‘Study 
Information’ form:  
o Screening form under Screening 
o Reminder with gmail account information 


MICT MOP 
  62 
 
 
Enter date consent was signed. 
 
Enter participant’s age on the date the consent was signed 
 
Set form status as ‘Complete’ 
 
Click ‘Save Record’ 
 
NOTE.   
 
 
o Go to the ‘Visit Dates’ form under Screening 
 
These fields are for the Consenting Phone Visit.   Because this is not being 
repeated, these field should be left blank 
 
Enter a note that Consenting Phone Visit information is stored under 
Participant ID X.  (and enter ID in place of X) 
 
Set form status as ‘Complete’ 
 
Click ‘Save Record’ 
o Go to the ‘Visit Dates’ form under Visit 1 
 
If visit 1 has not been scheduled yet, skip this section and complete this 
section later 
 
If visit 1 has been scheduled, enter data for the following fields 
 
Target date 
 
Scheduled date and time 
o An email reminder with gmail account information will be 
automatically sent to the parent’s email address when the 
scheduled visit date is within 6 days. 
o Email invitations for the surveys to be completed before visit 
1 will automatically be sent when the scheduled visit date is 
within 4 days 
 
Leave the field ‘Is the scheduled visit date within 4 days?’ blank unless you 
want email messages with links to surveys for visit 1 to be sent immediately. 
 
Set form status as ‘Unverified’ 
 
Click ‘Save Record’ 
 
If visit 1 has been scheduled, also enter target dates under Visit2-virtual and 
Visit3-virtual, set each form status to ‘Unverified’ and click ‘Save Record’. 
 
These target dates are necessary for the functions that display the 
Asthma Action Plan 
o Go to the ‘Research Assessment Interview’ form under Visit1 
 
Complete this form with information that was collected during the 
Consenting Phone Appointment 
 
Enter a note indicating that the interview took place when the participant ID 
was X (and enter ID in place of X). 
 
Set form status as ‘Complete’ 
 
Click ‘Save and go to Next Form’ 
o Go to the Research Assessment evaluation forms under Visit1 
 
Forms for Research Assessment evaluation are the following 
 
Research Assessment Caregiver – AT 
 
Research Assessment Child – AT 
 
Research Assessment Caregiver – HA 
 
Research Assessment Child - HA 
 
Enter a note indicating that evaluation of the visit 1 interview is to be stored 
under Participant ID X.  (and enter ID in place of X) 
 
Set form status as ‘Unverified’ if the evaluation has not been completed.  
Set form status as ‘Complete’ if the evaluation has been completed. 
 
Click ‘Save and go to Next Form’. 
o Go to the ‘Newest Vital Sign’ form under Visit1 if not already there. 
 
Enter a note at the end of the form indicating that results of this test are 
stored under Participant ID X. (and enter ID in place of X) 
 
Set form status as ‘Complete’ 


MICT MOP 
  63 
 
 
Click ‘Save Record’ 
 
 
In the MICT-DC summary REDCap project 
o Click ‘Add/Edit Records’ and enter the new participant ID for this participant 
 
The first three letters of the participant ID must be uppercase and the letter 
added to the end must be lowercase, i.e. JAX101a. 
o Enter data into the ‘Participant Information’ form 
o Set from status as ‘Complete’ 
o Click ‘Save Record’ 
 
5.8. Preparing the EasyOne for a Rescreen Visit 1 
Overview 
 
Delete all the current records for that participant off the EasyOne.   
o Those data will not be used and therefore do not need to be saved anywhere. 
o You need to do this otherwise there won’t be enough memory to store PFTs for the 
next 20 weeks. 
 
This can be done when they come in to return equipment after screen failure or if you let 
them keep the device after screen failing, you will need to do this a the Visit 1 rescreen 
 
SC Procedures 
 
Connect the EasyOne to the cradle and your computer and download the files.   
o The files will download automatically to the EasyWare program but we won’t be 
using them for any data analysis 
 
To delete records off the EasyOne, turn on the EasyOne, and then press 159.  This 
information is not anywhere in the manual.  We got it from the manufacturer.  
 
 
 
You can use the right arrow button to scroll to “in interval”.  This will allow you to put in the 
interval of PFT records to delete.  You won’t be deleting all the demographic information 
you put in at Visit 1.  However, when the participant comes back in at the rescreen Visit 1, 
you will need to update height and weight.   


MICT MOP 
  64 
 
 
 
 
Put in the start date for the participant 
 
Put in the end date.  You can put in the current date if you have just retrieved the EasyOne 
from the participant at their rescreen Visit 1. 
 
 
 
Press ENTER to delete the records. 
 
5.9. Recycling a Participant (occurs at Visit 3 only) 
Definition  
Recycling is an additional attempt to randomize a participant into the trial who had successfully 
passed the stable phase (Visit 1 up to Visit 3) but had failed to meet randomization criteria at V3.  
 
Comment 
 
Recycling will be used only on a case by case basis  
 
Contact the the PI, Dr. Blake, for permission and specific instructions 
 
A participant may be recycled one time 
 
Note: A participant ineligible for randomization and for recycling may be re-screened 
(restarted at V1) The waiting period to rescreen will vary regarding reason for failure to be 
randomized (use of rescue medication, hospitalization, adherence, etc.) 
o The waiting period will be a minimum of 4 weeks 


MICT MOP 
  65 
 
6. Study Staff Training 
Overview 
 
Provide study-specific training and documentation that staff at the main Clinical Center in 
Jacksonville and satellite centers have the required approvals, facilities, equipment, 
personnel, and training necessary to conduct the MICT trial  
 
Ensure consistent conduct of study procedures over time within and across clinics so that 
findings from all clinics are comparable 
 
When 
 
Before a Clinical Center may schedule participants and conduct study procedures for the 
MICT study   
 
Procedures 
 
Obtain approval of protocol and consents from the IRB and approval of staff at each study 
site Before a Clinical Center may schedule participants and conduct study procedures for 
the MICT study   
 
Review of MICT protocol, manual of procedures, and forms 
 
Completion of training by all personnel involved in MICT who will be performing the 
following tasks as Study Coordinator 
o EasyOne spirometry testing 
o Exhaled nitric oxide training using NIOX MINO if being conducted at your site.  
 
Operators are not required to be certified but do need to be trained by an 
Aerocrine representative or someone previously trained by Aerocrine 
 
REDCap training by Suzanne McCahan, PhD 
 
iPad training 
 
6.1. REDCap Data System Training with Suzanne McCahan, PhD 
Access to the MICT data system will be restricted to those who have taken MICT REDCap 
training and who have REDCap log in and passwords.  Each Clinical Center will be required to 
have at least one person certified for data entry, although having more than one person 
certified is advised. The Clinical Coordinator must be certified. 
 
Staff members who are experienced data system operators for previous REDCap studies must 
also receive  training  to be granted access to the MICT study in REDCap. 
Study staff who are not familiar with the REDCap system can watch a short (15 minute) video 
that gives a nice overview of data entry in REDCap. The video is called 'Data Entry Overview' 
and can be found on the following web page. The videeo can be viewed without logging into 
REDCap. 
https://apps.nemoursresearch.org/redcap/index.php?action=training 
 
Study staff who do not have a access to REDCap will complete the online form at the following 
link to request a REDCap account. 
http://www.nemoursresearch.org/admin/redcapacct.php 
 
After the REDCap account is set up, the new user will be granted rights to the REDCap project. 
The user will receive email verification from REDCap team that their username is activated for 
MICT data entry 
 
The data system will be accessed via the internet from the REDCap web page at 
http://www.nemoursresearch.org/admin/redcapacct.php 
 
Access to any part of the MICT data system requires a username and password. Once a staff 
member has completed MICT training his or her username and  password  will be authorized for 
data entry.  If the staff member was previously certified for data entry they should use their 


MICT MOP 
  66 
 
unique password to enter the REDCap data system.  If the staff member was not previously 
granted access, the temporary password should be used as the default password. The system 
will instruct the user to create a unique password the first time that user logs in to the data 
system. From that time forward, only the user’s unique password will work. 
 
*  If a coordinator has been granted access to REDCap  they do not need to redo the log in 
request  fo MICT. In this case, please notify REDCap staff of this when submitting other 
certification materials. 
7. Study Equipment and Supplies 
The JAX site will obtain all of the following supplies and ship them to sites as needed. 
7.1. Equipment and Supplies Provided by JAX to all Sites 
 
iPad 2 
o For the participant with Otter Box case: iPad 2 and Otterboxes are sent to the site 
by the AC at the Jacksonville site after logging the serial numbers for each piece of 
equipment. (Click this link to see the iPad distribution logs: iPad Distribution 
Log.) 
o For the Study Coordinator with Otter Box case: These iPads are sent the same 
way as the participant’s equipment. 
 
EasyOne Spirometer  
o These are shipped to the study site by the Jacksonville AC after property tags and 
serial numbers are logged into the file located on the JAX S drive. (Click this link 
to see the EasyOne spirometer and cradle distribution logs: EasyOne 
Spirometer and Cradle Distribution Log.) 
 
EasyOne Spirometer cradle - one for each site:   
o This is shipped each coordinator and logged in the EasyOne file on the JAX S 
drive (Click this link to see the EasyOne spirometer and cradle distribution 
logs: EasyOne Spirometer and Cradle Distribution Log.) 
 
EasyOne Mouthpieces: 4 Spirettes are included with each EasyOne Spirometer  
o A spirette can be used for 2 weeks unless the participant is ill, then it should be 
replaced sooner. 
o JAX can send additional spirettes upon request. 
 
Blood draw supplies 
o Tourniquet, gauze, alcohol prep pads, bandaids, needles, etc. 
o Collection and storage tubes 
 
Blood - for plasma for storage and paced cells for DNA 
 
 Collection: Vacutainer K2 EDTA 10.8mg-6mL (1 tube)–(BD368661) 
 
Storage: 2.0mL cryovials, orange top (2 tubes) 
 
Blood - for serum Phadiatop test 
 
Collection: SST™ Tube with Silica Clot Activator, Polymer Gel, 
Silicone-Coated Interior (2 tubes) (BD367986) 
 
Storage: 5mL Sarstedt vials, red cap (2 tubes) 
o Cryo pen 
o Labels for blood draw tubes and storage 
 
NIOX MINO (exhaled nitric oxide) for those sites doing the test 
o Sensors (test kit)- can order 50, 100, 300,or 600 tests per kit. Note:The sensors 
have a 12 month shelf life  
o Scrubber -  Note: the scrubber is good for 12 months or 1000 tests, whichever 
comes first) 
o NIOX filters -  are included with the Sensor test kits 
 
Sample pricing – Subject to change 
09-1000 NIOX MINO (Shipping $30) $2,995 


MICT MOP 
  67 
 
(Contains: Unit, Adapter, Manual, USB Cable, USB Drive 
with Visual Incentive Program, NO Scrubber, and QC Plug) 
 
Test Kits: $15.96 per test 
03-4002-US NIOX MINO Test Kit 50 (Shipping $20) $798 
(Contains: 1 Sensor for 50 tests and 100 NIOX Filters) $15.95 per test 
03-4000-US NIOX MINO Test Kit 100 (Shipping $25) $1,595 
(Contains: 1 Sensor for 100 tests and 150 NIOX Filters) $11.65 per test 
03-4001-US NIOX MINO Test Kit 300 (Shipping $40) $3,495 
(Contains: 1 Sensor for 300 tests and 350 NIOX Filters) $9.83 per test 
03-4003-US NIOX MINO Test Kit 600 (Shipping $80) $5,895 
(Contains: 2 Sensors for 300 tests and 650 NIOX Filters) 
 
Accessories: 
09-1005 NIOX MINO Power Supply Unit $95 
09-1010 NIOX MINO USB Cable $40 
09-1020 NIOX MINO Bag $50 
09-1025 NIOX MINO USB Visual Incentive Program $150 
09-1026 NIOX MINO Data Management Program $199 
09-1300 NIOX MINO NO Scrubber $70  
EPM-000109 NIOX MINO User Manual N/C 
7.2. Ordered by Each Site 
 
Dry ice for specimen shipping 
 
Shipping containers 
8. Study Procedures 
8.1. MyNemours Account Set-up (by AC) 
Overview 
 
Each user has a personal MyNemours account with a unique ID number and password, 
which means a family could have three different accounts (for mom, dad, and child), with 
three different passwords   
 
Nemours requires proof of guardianship in the medical record for access to be granted to 
the Legal Guardian. This can be the Delaware Care Giver form or appropriate court 
documentation  
 
Parents and Legal Guardians can have access to their child’s medical record when the 
child is under 18. When the child is between the ages of 12 and 17 certain aspects of the 
medical record are no longer viewable. This is because federal and state laws require us to 
protect certain aspects of an adolescent’s medical record 
 
At age 18 your child is legally an adult and MyNemours access for the parent will 
automatically terminate 
 
Patient’s can have access to their own MyNemours account at any age 
 
Parents, Legal Guardians and Patients can grant access to MyNemours for other 
individuals by filling out the “Authorization to Disclose PHI to a Name Individual via 
MyNemours”. This form is available at Nemours and can be filled out online. 
https://mynemours.nemours.org/default.asp?mode=stdfile&option=faq#EQ_what 
 
When 
 
MyNemours accounts for a parent and participant need to be set up before the WebEx for 
the Research Assessment interview is conducted. 
 
Procedures 
 
Obtain approval of protocol and consents from the IRB and approval of staff at each study 


MICT MOP 
  68 
 
site Before a Clinical Center may schedule participants and conduct study procedures for 
the MICT study   
 
How to Sign Up 
o A parent (or legal guardian) can sign up for MyNemours to gain online access 
portions of your child's medical record 
 
What is Needed 
o Internet connection with an updated browser 
o Access code 
 
How does a Family get an Access Code 
o The AC will work with the family to get MyNemours set up 
o In a usual clinic setting, the parent would let the office staff know they want access 
to access MyNemours. The parent will sign the necessary Patient User, Proxy 
User, and/or Assent agreements and will also create a security question. 
Remember it because they will use it later when you create a MyNemours account 
 
Setting up MyNemours Account for the Study 
o Check EPIC to see if they have registered for MyNemours 
 
In Patient Demographics, look in the Appointment Desk page at the top. 
The MyNemours status will be Activated, Inactive, or have no information 
 
If inactive with no further information, the parent has never set up an 
account 
 
If you see “Activation Code Generated First Time but not Used”, the 
parent has set up the account but not activated it. 
 
Suggested Script when Discussing Setting up a MyNemours for the MICT Project 
(suggested by the MyNemours team at Nemours) 
o I am excited to share with you how MyNemours will make it easier for you to 
access and review the documents that are required to participate in the MICT 
study. This program is a free, confidential, internet based tool that gives families 
interested in participating in our study the ability to review and sign consent for a 
study with only a few steps without coming into the clinic and meeting with a 
coordinator.  
o MyNemours does require you to register which I can assist with; you will have a 
unique User ID and password to access confidential patient information in 
MyNemours as well as study consents. 
o Some of the other benefits of registering are  
 
Communicate with your doctor 
 
Access your test results 
 
Research related medical information 
o If you have access to a computer and have an internet connection let’s get started; 
first you’ll need an activation code to create you’re my Nemours account. (above 
you say that they are required to register “which I can assist you with, will your staff 
be creating the accounts or will you be directing them to this link) Please connect to 
the internet and go to www.Nemours.Org once on the website look for the 
MyNemours link in the purple box on the left you can Request an Activation Code 
online, provide the necessary information, and receive an activation code via email 
within 3 days.  
o Once you receive the activation code there are three steps you’ll have to complete 
at https://mynemours.nemours.org/accesscheck.asp to gain access to your 
account.  
 
8.2. Spirometry 
8.2.1. EasyOne  
Overview 
• The EasyOne is a hand held light-weight spirometer that participants will use for home 


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measurement of peak expiratory flow (each morning) and PFT (at each study visit in clinic 
or by FaceTime).  The EasyOne minimizes the need for maintenance due to its unique 
ultrasound technology. EasyOne does not need calibration and remains consistently 
accurate over years. The spirette breathing tube assures perfectly hygienic conditions for 
every patient even if the spirometer is frequently used. 
Training 
 
Study staff will be trained by the JAX study coordinator on set up and use of the EasyOne.   
8.2.2. Standard Procedures for Spirometry (Acceptability / Reproducibility) 
Purpose 
• Measure FEV1 (the amount of air expired in the first second during a forced expiratory 
maneuver) and FVC (forced vital capacity). 
When 
 
All clinic and FaceTime visits   
 
Standardization 
 
Equipment and procedures are based on the ATS recommendations for accuracy and 
precision  
 
All personnel certified pulmonary function technologists (National Board of Respiratory 
Care) or receive sufficient instruction from qualified instructors to perform the procedure 
according to acceptable standards 
 
All sites will use EasyOne Plus Spirometer.  
 
There are instructions for the coordinator for EasyOne set up and use.  
o (Click this link to view the coordinator EasyOne manual: Manual for 
Coordinator EasyOne Instructions.) 
 
There are instructions for the participant for EasyOne use.  
o (Click this link to view the participant EasyOne manual: Manual for 
Participant EasyOne Instructions.) 
 
The participant EasyOne manual is pre-loaded on the iPad. 
 
Predicted Values 
 
Calculated according to the published predicted values (Hankinson et al).  Calculate online 
using the LASST pulmonary function calculator. To access the online calculator go to the 
LASST website: http://www.jhcct.org/Secure/LASST/LASSTHome.asp and follow the link to 
the LASST data system page and then to the LASST calculator  
 
Participant Preparation 
 
No use of albuterol or xopenex within 4 hours 
 
Participant is seated with feet flat on floor 
 
Participant is wearing nose clips 
 
Restrictive clothing is loosened 
 
Testing Procedure 
 
Participant Instructions 
o Full inhalation to capacity 
o Seal lips around spirette to avoid leaks around lips and take care not to block the 
spirette opening with teach or tongue. 
o Blast out as hard and fast as possible  
o Continue blowing until lungs are completely empty and for at least 6 seconds 
 
Recognizing a Poor Effort 
o Observe the participant 
o View Quality messages displayed on device after each effort 
o Review proper technique with participant 
 
Coordinator should use enthusiastic coaching techniques to use during the 
maneuver to maximize your chances of getting quality results with a minimum 


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number of efforts 
 
Caution: Pulmonary function tests require maximum effort on the part of the patient and may 
lead to dizziness or giddiness 
 
Acceptability Criteria 
o Test start: The peak flow should be sharp on Flow Volume curve. Participants may 
need coaching to get this right (e.g. BLAST it out) 
o Cough: This can cause flow irregularities. Reject test when cough is within the first 
one second (FEV1 will not be accurate). Cough in the later part of the VC is not a 
reason per se to reject the effort. Often cough can be reduced by asking the 
participant to exhale SLIGHTLY less forcefully 
o End of expiration: When the expiratory effort lasts at least 6 seconds. Participants 
with severe obstructive lung disease may continue to exhale for 10 or more 
seconds. Occasionally, premature glottis closure causes abrupt test end. 
Participants may need to relax and try again with slightly less than maximum effort  
o Forced inspiration: Maximum inspiratory effort following the end of expiration as 
shown on flow-volume curves [NOTE: we are not doing inspiratory maneuvers but if 
the participant does it reflexively then that is fine.] 
 
Reproducibility Criteria 
o Definition: Using the two criteria of FVC and FEV1 to determine how well each 
acceptable effort compares with the largest acceptable effort  
o The EasyOne selects the best test as the maneuver with the highest SUM of the 
FVC and FEV1.  This is not the procedure for MICT. 
 
You will need to calculate the difference between FVC and FEV1 values per 
the bullets below 
o FVC: The second largest FVC should be within .15 L of the largest acceptable FVC  
o FEV1: The second largest FEV1 should be within .15 L of the largest acceptable 
FEV1  
o At least 3 acceptable and 2 reproducible efforts should be obtained. If this cannot 
be obtained after approximately 8 attempts, then the testing should be halted  
 
The EasyOne selects the best test as the maneuver with the highest SUM 
of the FVC and FEV1.  This is not the procedure for MICT. 
 
You will need to calculate the difference between FVC and FEV1 values per 
the bullets above 
o The largest acceptable FEV1 and FVC are recorded on the data collection form. 
These do not have to be taken from the same maneuver  
o Inspiration may or may not be required but is shown in figure below. 
 
 


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 
Pre- and Post-bronchodilator Testing follow the instructions in the Coordinator EasyOne 
manual.  (Click this link to view the coordinator EasyOne manual: Manual for 
Coordinator EasyOne Instructions.) 
o Document if it has not been 4 hours since the participant last used albuterol or 
Xopenex  
o Have participant do 3 pre-bronchodilator efforts.   
o Take picture of the flow volume curves using your iPad by holding down the power 
button at the same time as holding down the home key 
 
These are saved to ensure we have data should the EasyOne get lost or 
broken 
 
Save the photos on the shared drive at 
 
Use the following format for file saving: JAX102\JAX102V5_07-10-14 
o Record the PFT Data using the MICT PFT Worksheet.  (Click here to view the 
PFT FaceTime Worksheet.) 
 
Ensure FEV1 is still ≥ 70% predicted using the predicted calculator found on 
the ACRC website at https://www.jhcct.org/Secure/LASST/LASSTPFT.asp 
 
Calculate the % Predicted value as 
% Predicted = 100* [FEV1 (in Liters) / Predicted FEV1 (in Liters)] 
 
Have participant take 2 puffs of ProAir and wait 15 minutes 
 
Can end FaceTime and restart in 15 minutes 
 
Have participant do 3 post-bronchodilator efforts using same procedure as 
for pre-bronchodilator testing 
 
Save the handwritten PFT Worksheets until the end of the study. 
 
This worksheet will be needed inorder to reconcile all the PFT data 
downloaded from the EasyOne device at Visit 6 with the data 
entered into REDCap. 
 
Troubleshooting 
• Refer to Troubleshooting Tips in the manufacturer’s Easy One Plus user manual. (Click 
this link to view the EasyOne manufacturer’s Operator’s (not the technical) manual: 
EasyOne Operator's Manual.) 
 
Quality Messages in EasyOne 
• The quality messages assist you in conducting the measurement. After each test, they provide 
information as to whether the test is acceptable or what to do to improve the result  
 
Message 
Criterion 
Recommended action 
Don't hesitate 
Back-extrapolated volume greater than 
150 ml or 5% of FVC whichever is 
greater (for age <= 6: 80ml or 12.5% of 
FVC whichever 
The patient must exhale all air at once 
and not exhale in short bursts. 
Blast out faster 
Time until peak flow greater than 120 
ms 
The patient must exhale more explosively 
and as firmly and quickly as possible. 
Blow out longer 
Expiration time less than 2 seconds or 
vo- lume during last 0.5 seconds >40 
ml when expiration time is <6 
The patient stopped exhaling too early. The 
pa- tient must exhale still further and force 
as much air as possible out of his or her 
Good effort, do next 
Test meets above criteria 
Good test. Only one to two more good tests 
and the test is complete. 
Blast out harder (only 
in 
Frontline mode) 
Peak flow not reproducible. Difference 
with respect to best test greater than 
1.0 l/s 
The test differs greatly from previous best 
test. The patient can blow even more 
firmly and achieve a higher peak flow. 


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Wait until buzz 
before blowing out 
The time to peak flow (PEFT) is less than 
25ms 
Instruct the patient to wait until the baseline 
setting is finished and the device signals 
that the trial can start 
Cough 
detected. Try 
i
A cough has been detected 
Instruct the patient to avoid coughing 
during the first second. 
Deeper breath 
FEV1 or FVC* not reproducible. 
Difference with respect to best test 
greater than 150 ml or 100ml if FVC is 
< 1.0L. (for age <= 6: 
100ml or 10% of FEV1 or FVC* 
The test differs greatly from previous tests. 
The patient can inhale even more deeply 
and exhale even more air. 
Test complete 
QC grade A or B reached. After 5 trials 
loo- sened to include QC grade C. See 
QC grade documentation. 
The test is complete. An adequate 
number of good tests is available. 
 
• The The EasyOne will assign grades for flow (FEV1) and volume (FVC) and will provide an 
assessment of the overall session as follows: 
 
: 
Rating 
Criteria in Diagnostic mode 
Criteria in Frontline and NLHEP mode 
A 
At least 3 acceptable tests (for age < 6: 2 ac- 
ceptable) AND the difference between the best 
two FEV1 and FVC values is equal to or less 
than 100ml (80ml if FVC < 1.0 L; for age < 6: 
80ml or 8% of FVC whichever is greater) 
At least 2 acceptable tests AND the difference 
between the two FEV1 and FEV6 values is equal 
to or less than 100ml 
B 
At least 3 acceptable tests (for age < 6: 2 ac- 
ceptable) AND the difference between the best 
two FEV1 and FVC values is equal to or less 
than 150ml (100ml if FVC < 1.0 L; for age < 6: 
100ml or 10% of FVC whichever is greater) 
At least 2 acceptable tests AND the difference 
between the two FEV1 and FEV6 values is equal 
to or less than 150 ml 
C 
At least 2 acceptable tests AND the difference 
between the best two FEV1 and FVC values is 
equal to or less than 200ml (150ml if FVC < 1.0 
L; for age < 6: 150ml or 15% of FVC whichever is 
greater) 
At least 2 acceptable tests AND the difference 
between the two FEV1 and FEV6 values is equal 
to or less than 200 ml 
D 
At least 2 acceptable trials but the results are 
not reproducible. Quality message "Result not 
reproducible" OR only one acceptable trial. 
Quality message: "Only one acceptable trial" 
At least 2 acceptable trials but the results are not 
reproducible. Quality message "Result not repro- 
ducible" OR only one acceptable test. Quality 
message "Only one acceptable trial" 
F 
No acceptable test available 
No acceptable test available 
 
 


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73
 
8.2.3. Spirometry Over-Reading 
Overview 
• The Data Coordinating Center at Johns Hopkins will be providing an overread of all the 
spirometry results to determine if the quality of spirometry by participants using the 
EasyOne is no different than the quality of spirometry done at the clinic sites 
• Details on how we will send the PFT data are not yet fully worked out.  More to come 
later. Under Construction 
 
8.2.4. Setting up the Default Location for the EasyOne Database 
Overview 
• The EasyWare database is stored by default on the C: drive of your computer.  This 
means that the database is NOT backed up by our Nemours server. 
• The EasyWare program allows you to change the default location of the database 
Procedure 
• Step 1: Copying the EasyWare database to the Jax S drive where it will be backed up 
o Open the EasyWare program on your computer 
o Go to File, then select “Preferences” 
. 
 
o Notice that “Database path and name” is set to 
“C:\ProgramData\ndd\EasyWare.mdb”. 
o Navigate to your database on at “C:\ProgramData\ndd\EasyWare.mdb”. 
 
You will need to close the EasyWare program for these next steps 


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74
 
o The name of the database is “EasyWare.mdb” 
o Right click on the name of the file and select “copy” 
o Navigate to the Jax S drive server 
o Navigate to the folder for your site (Jacksonville, Olrando, Pensacola, 
Philadelphia, St. Louis, Wilmington) in MICT Grant\Other Information\EasyOne 
Databases for Coordinators.  (Click this link to go to the folder location: 
EasyOne Databases by Site.) 
 
 
 
o Right click and Paste the file into the folder for your site 
o Rename the file to “EasyWare_JAX.mdb” with JAX being your site abbreviation 
(JAX, ORL, PNS, PHL, STL, WIL). 
• Step 2: Changing the path that the EasyWare database uses to the Jax S drive  
o Open the EasyWare program on your computer 
o Go to File, then select “Preferences” 


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75
. 
 
 
 
o Click on the three dots to the right of “C:\ProgramData\ndd\EasyWare.mdb”. 
o Navigate to the Jax S drive server 
o Navigate to the folder for your site in in MICT Grant\Other Information\EasyOne 
Databases for Coordinators.  (Click this link to go to the folder location: 
EasyOne Databases by Site.) 
o Click on the database that you just moved there “EasyWare_JAX.mdb” 
o Select “Open” at the bottom of the window 
o The “Database path and name” is now set to store all your participants records 
on the S drive (see below). 
 
 
 
 
8.2.5. Syncing the EasyOne using the EasyWare program 
Visit 1 
 
After the participant has completed the pre- and post-spirometry, connect the EasyOne 
cradle to the computer with the EasyWare program.  Put the participant’s EasyOne to 
the into the EasyOne cradle. The windows AutoPlay will open but just close it.   


MICT MOP 
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76
 
 
Open the EasyWare program 
 
All the files for that participant will be automatically downloaded  
 
Select the pre- and post-spirometry tests to print to send to the primary care doctor if the 
family has provided consent to do so.  Unfortunately because of the way the EasyWare 
is set up, each test is individual rather than having a pre- and post- all in one result. 
 
Keep a printed copy for your records 
 
Visit 6 
 
Repeat the process at Visit 6 
 
All the PFTs from Visit 2 through Visit 6 will be automatically downloaded. 
 
Select the pre- and post-spirometry tests to print to send to the primary care doctor if the 
family has provided consent to do so.  Unfortunately because of the way the EasyWare 
is set up, each test is individual rather than having a pre- and post- all in one result. 
 
 
8.2.6. Viewing Data and Back-up Procedures 
Viewing All the PFTs from your Participants 
The EasyWare database stores ALL the PFTs from all your study participants.   
 
Open the EasyWare program (without the cradle or any device being attached). 
 
Select view, then select “Select Device in DB” 
 
 
You will now see all the devices for all your participants listed as shown below: 


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77
 
You can select the device number for the participant you wish to view.  A spreadsheet lists all 
the devices that have been sent to each site (Click this link to go to the folder location: 
EasyOne Devices by Study Site.) Use the excel filters to see data just for your site. 
8.3. Exhaled Nitric Oxide (NIOX MINO) [only for sites doing this procedure] 
Purpose 
• Measure the fractional concentration of NO in exhaled breath (eNO) using the NIOX 
MINO® 
 
When 
 
All Visit 1 and Visit 6 before spirometry   
 
Overview 
 
Exhaled NO will be measured with a portable eNO device, the NIOX MINO®. The NIOX 
MINO® measures eNO at an exhalation pressure range of 10 to 20cm H2O and an 
exhalation flow rate of 50±5 mL/s  
 
8.3.1. Equipment and supplies for Testing 
 
NIOX MINO® unit 
 
The Initial NIOX MINO test supply kit (50 NIOX patient 
filters, one 
50 t
t
d t
NIOX® patient 
filt
NIOX 
MINO® 
NIOX MINO® 
test card 
(bl
)


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78
 
cards are 
provided for 
each ACRC 
Clinical 
Center. 
 
 
 
8.3.2. Quality Control 
 
Equipment for Quality Control 
 
NIOX MINO® QC card (white) 
 
NIOX MINO® QC filter for Weekly QC testing 
 
 
 
Quality Control requirements for the NIOX MINO® 
 
Calibration by the user is not required  
 
The NIOX MINO® has standardized internal procedural controls that cannot be 
influenced by the user. Whenever a potential deviation is detected, the appropriate 
message is presented on the display making it impossible to continue the measurement 
or alternately, the procedure is aborted. A measurement result is only presented to the 
operator when the device handling and measurement processes are correctly executed 
 
The QC test for the NIOX MINO® is a biologic control (Normal Control Tester) 
 
A “daily” QC test is required on the days when eNO testing is done 
 
An extended/Weekly QC test should be performed at initial set-up, every 7 days, and 
when a new sensor is placed in the NIOX MINO® 
 
Selection of Normal Control Testers for QC  
 
Identify staff members who will serve as the Biologic Control (Normal Control Tester) and 
who fulfill the following criteria  
o Over 18 years of age 
o No ongoing respiratory or sinus infection or known airway disease 
o Nonsmoker 
o Expected stable eNO values between 5 and 40 ppb 
o Preferably no chronic sinonasal disease or asthma 


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79
 
Initial “Qualification” of Normal Control Tester  
 
Each Normal Control Tester should have a White QC card with their name written on it. 
 
With the White QC card inserted into the NIOX MINO, the selected staff member will 
perform a total of three eNO measurements. 
 
Only one eNO measurement should be performed per day and all three measurements 
should be completed within seven days. 
 
A mean value is calculated from the three measurements. If the mean value is between 5-
40ppb it is considered acceptable and the Normal Control Tester is “Qualified”. 
 
Subsequent QC test results from this Normal Control Tester must be within ± 10ppb of the 
mean value to be a PASS. 
 
Each normal control tester must perform a QC procedure (daily or extended/weekly) at least 
once every 28 days to maintain his/her qualification status.  
 
Performing the QC tests  
 
Before any QC measurement, the Normal Control Tester should: 
o Avoid nitrate rich food for 3 hrs 
o Avoid any strenuous exercise at least 1 hour 
 
A Normal Control Tester should not perform a measurement in case of: 
o Ongoing respiratory infection 
o Acute seasonal allergies 
The “Daily” QC procedure  
 
“Daily” is a misnomer; a Daily QC is required only on days the NIOX MINO® is to be used 
for participant testing. (A twinkling star next to the breathing cloud on the NIOX MINO® 
screen indicates the Daily QC needs to be conducted.) 
 
The Daily QC consists of a standard eNO test performed by a qualified Normal Control 
Tester with his/her White personal QC card inserted into the NIOX MINO®. 
 
The steps for the Daily QC test are as follows: 
o Remove the Blue Test card from the NIOX MINO® device and insert the White 
personal QC card of the qualified Normal Control Tester doing the QC test. 
o The Normal Control Tester should conduct a standard exhalation test (see below 
for Test Procedures) and wait (1:40 min.) for the screen to display the result. 
o The screen displays the mean value (Χ) and the difference (Δ) between the mean 
value and the day’s QC test value. 
o If the difference (Δ) is within ± 10 ppb of the Tester’s mean value, then the test 
result is approved and the Daily QC procedure is complete. 
o Remove the White personal QC card and reinsert the Blue NIOX MINO® test card  
o Press the return arrow for return to the menu screen. 
o If the difference between the Tester’s mean value and the day’s QC test value is 
more  han ±10 ppb, restart the QC procedure with another qualified tester 
o If the second testers result is not approved, do not proceed with eNO testing. 
Contact Aerocrine at service.US@aerocrine.com or call (866)275-6469. 
 
The Weekly/Extended QC test 
 
The Weekly QC test, also known as the Extended QC procedure, needs to be done as 
part of the initial set-up, every 7 days, and when a new sensor is placed in the MINO. (An 
alternating QC icon and breathing cloud on the MINO screen indicates a 
Weekly/Extended QC procedure needs to be conducted.) 
 
The Weekly/Extended procedure consists of: 
o A normal control measurement completed by a qualified normal tester (as done 


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80
for the daily QC) 
o A measurement of a nitric oxide free sample using the NIOX MINO® QC filter. 
(The NIOX MINO® QC filter produces a nitric oxide free sample. When the 
instrument completes its analysis of this sample, it should display a result below 
the detection limit (< 5 ppb) of the instrument.) 
 
After completing the procedure for the “daily” QC test as above, without 
removing the White personal QC card, attach the QC filter to the NIOX 
MINO patient filter opening, then attach the NIOX filter to the QC filter. 
 
Touch the display screen to activate the instrument. 
 
Perform an exhalation test (see below for Test Procedures) and wait (1:40 
min.) for the result. 
 
If the reading is < 5 ppb, the extended/weekly QC test is complete. 
 
Remove the QC filter and the White Personal care from the NIOX MINO. 
 
Insert the Blue NIOX MINO card. 
 
If the reading is not < 5 ppb, the QC has failed and you need to contact 
Aerocrine at service.US@aerocrine.com or call (866)275-6469. 
Note: tests performed with the NIOX MINO® unit during the QC procedures will not 
affect the number of remaining tests on the NIOX MINO® sensor. 
 
8.3.3. Procedure for Measuring Exhaled Nitric Oxide 
Participant Preparation   
 
Study participants should be instructed to avoid any food or drink for one hour prior to 
eNO 
 
testing. 
 
Study participants also should avoid any strenuous exercise or smoking for one hour 
prior to eNO 
 
testing. 
 
If possible, participants should avoid bronchodilator use for 2 hours before eNO testing 
 
eNO measurement should be done before spirometry 
 
If the participant has an acute upper and/or lower respiratory infection, note this on the 
NO form. 
 
If participant used inhaled or oral corticosteroids on the day of the test, record time of 
most recent use on NO form. 
 
Do NOT use nose plugs. 
Test Procedures   
 
KEEP DEVICE POWERED AT ALL TIMES (including overnight). 
 
Make sure the NIOX MINO® sensor is in place. 
 
Insert a NIOX MINO® patient filter into the unit. 
 
Make sure the participant is seated during the entire procedure. 
 
Touch the display screen. When the top light on the unit is lit, the unit is ready for 
measurement of eNO. 
 
The participant empties the lungs first, and then inhales deeply through the filter to total 
lung capacity. The cloud on the display is inflated and the top light is turned off during 
inhalation. Next, the participant exhales slowly through the NIOX® filter. Visual guidance 
is provided by the top light and there is also a continuous sound to guide the participant. 
The participant can also view the display using a mirror. 
 
You can instruct the participant as follows; 
o First empty your lungs by breathing out as much as possible 
o Next inhale deeply through the filter to total lung capacity 


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81
o Then exhale with steady pressure through the NIOX MINO® filter 
 
As the participant exhales, listen to the sound signals and watch the top light – a 
continuous sound and a steady light means the test is OK. 
 
Correct exhalation display 
Exhalation too hard (left) or too low 
(right) 
 
 
When the exhalation is approved, the sound ceases with a click, and the top light turns 
off. 
 
Wait (1:40min.) for the result to be displayed on the screen. 
 
Record the result on the Nitric Oxide (NO) form. 
 
If result of eNO <5 ppb, record “0” ppb. 
 
Repeat the test and record results from second test on NO form 
 
If results are not consistent between tests, note this on NO form and comment on 
possible problems. 
8.4. Specimens 
8.4.1. Overview of Specimen Collection  
Visit 1 – Part 2   
 
Pregnancy test for women of childbearing potential 
 
Visit 6 – Part 2   
 
Blood for DNA and Phadiatop testing and future studies  
8.4.2. Supplies 
Provided by the JAX site to all sites 
 
Blood - for plasma for storage and packed cells for DNA 
o  Vacutainer K2 EDTA 10.8mg-6mL (2 tubes)–[BD368661:Vacutainer, 13 x 
100mm, 6.0mL, Plus Plastic EDTA Tube, Lavender Conventional Stopper & 
Paper Label] 
 
2 tubes 
o 2.0mL cryovials, orange top (2 tubes) 
 
2 tubes 
 
Blood - for serum Phadiatop test 
o SST™ Tube with Silica Clot Activator, Polymer Gel, Silicone-Coated Interior -
5mL (2 tubes) [BD367986: Vacutainer Plus SST Plastic Venous Blood Collection 
Serum Tube with Gold Hemogard Closure] 
 
2 tubes 
o 5mL Sarstedt vials, red cap (2 tubes) 
 
2 tubes 
 


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82
 
Pre-printed, barcoded labels (one label sheet per participant), which are: 
o Participant specific 
o Specimen specific for cryovials (plasma), vacutainer (packed cells) and 
Sarstedt tubes (serum for Phadiatop) and indicate aliquot # 
 
Provided by the study site 
 
Styrofoam box with outer cardboard box (shipper) 
 
Plastic biohazard specimen bag 
 
Absorbent sheet 
 
FedEx air bill 
 
Cold pack to maintain cool temperature 
 
Dry ice 
8.4.3. Blood Collection, Processing, Labeling, and Shipping for DNA, 
Plasma, Serum 
8.4.3.1. 
Blood Collection 
 
Supplies needed 
o Tourniquet, gauze, alcohol prep pads, bandaids, needles, etc. 
o Collection and storage tubes 
 
Blood - for plasma for storage and packed cells for DNA 
 
 Collection: Vacutainer K2 EDTA (purple) 10.8mg-6mL (2 tubes)–
(BD368661) 
 
Storage: 2.0mL cryovials, orange top (2 tubes) 
 
Blood - for serum Phadiatop test 
 
Collection: SST™ Tube with Silica Clot Activator, Polymer Gel, 
Silicone-Coated Interior (2 tubes) (BD367986) 
 
Storage: 5mL Sarstedt vials, red cap (2 tubes) 
o Cryo pen 
o Labels 
o Cup of ice 
 
Order of processing 
o Blood for phadiatop (serum) can be sitting to clot while the blood for the 
DNA/plasma is being processed 
o Try and process specimens within 2 hours of collection 
o After collecting EDTA, mix well by gently inverting 5 to 10 times 
 
Keep the EDTA (purple) tubes for DNA and plasma on ice for about 10 
minutes before processing 
 
This will keep the leukocytes from becoming anerobic 
 
For sites without a refrigerated centrifuge (instructions on how to take a regular 
centrifuge and make it cold) 
o Remove and place the swinging rotor/buckets in wet ice (ice+water slurry). 
 
Should reach 4°C in 15 minutes.   
 
Do not submerge (you want to keep the inside of rotor/bucket dry) 
 
If you get water in the rotor/bucket, the water must be completely 
removed prior to the run, otherwise, the tube might break or the 
centrifuge will be out of balance 
8.4.3.2. 
Labels for Collection Tubes and Shipment/Storage Tubes 
 
See label sheet below for which labels to use for collection tubes and shipment/storage 


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83
tubes 
 
Labeling the tubes: 
o Tubes must be clean, dry and at room temperature! 
o Enter the date on the label 
o Affix the label to the tube taking care to orient the barcode LENGTHWISE 
 
If the barcode is oriented around the circumference of the tube instead of 
lengthwise, then the barcode reader will not be able to read the code.  If 
this accidently happens, then apply a duplicate label over the old label 
taking care to orient the barcode lengthwise.  See the diagram below for 
correct orientation of barcodes. 
 
 
 
 
 
Label sheets: 
o Ed Mougey (904-697-3781, emougey@nemours.org) will print the labels to be 
sent to the sites.  Contact Ed Mougey if labels are needed. 
 
8.4.3.3. 
Blood Processing and Shipping Instructions 
 
See table below for processing and shipping instructions 
 
IMPORTANT NOTE ABOUT TUBES WHEN FREEZING (see table below) 
 
Important to make sure the tubes (especially the purple top) freeze while laying 
horizontally 
o Otherwise, there is a HIGH probability that the tubes will crack!!! 
o This is also likely true for serum tubes, unless actual cryovials (rather than 
polystyrene tubes) are used 
 
 
 


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Specimen Collection Tube 
Label 
Processing 
Action 
DNA and 
plasma 
 
(DNA is 
saved for 
genotyping 
and 
plasma is 
saved for 
future use) 
Vacutainer K2 
EDTA 
10.8mg-6mL –
(BD368661) 
 
2 6mL tubes 
Designated 
labels on 
Vacutainer 
Label Sheet 
and Cryovial 
Label Sheet 
 Centrifuge the 6mL 
vacutainer K2 
EDTA  tube for 7 
min at 2000g, 4°C 
 Immediately 
remove plasma 
from Vacutainer 
tube and aliquot 
into 2mL orange 
cryovials. Label 
cryovials. 
 Firmly replace 
HemoGuard 
closure on the 
Vacutainer 
 Freeze Vacutainer 
(containing the 
packed cells) and 
cryovials at         -
(minus) 80°C.  If 
no (minus) -80°C 
freezer available, 
then freeze in 
(minus) -20°C non 
frost-free freezer 
for up to 1 week 
before shipping. 
 Note:  To prevent 
packed cells tube 
breakage, lay 
tube horizontally 
in the (minus) -
80°C [or (minus) -
20°C] freezer for 
20 minutes, or 
until frozen,  prior 
to storing then in 
freezer boxes 
Batch ship both plasma 
and packed cells together 
on dry ice (frozen) priority 
overnight to: 
Pharmacogenetics Center 
c/o Ed Mougey 
Research,  9th floor 
Nemours Children’s 
Clinic 807 Children’s 
Way 
Jacksonville,  FL 32207 
Upon shipment, send 
email to:  
emougey@nemours.org 


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85
Phadiatop 
(serum).  
While 
phadiatop 
is clotting, 
the DNA/ 
plasma 
tube can 
be 
processed. 
SST™ Tube 
with Silica Clot 
Activator, 
Polymer Gel, 
Silicone-
Coated Interior 
(BD367986) 
Cryovial 
Label 
sheet 
 Allow sample to clot 
for about 30 
minutes at room 
temperature. 
 Centrifuge at 1000g 
for 10 minutes at 
room temperature (it 
is OK to use the 
centrifuge if it is still 
cold after 
processing DNA/ 
plasma.) 
 Place a 
minimum of 
0.5mL of serum 
into each of 
the 5mL red top 
tube(s) 
(Sarstedt  Inc.) 
 Sample is to be 
divided between 2 
tubes (unless there 
is  less than 1mL 
of serum).  If <1mL 
of serum, then just 
put it all in 1 tube to 
send to DACI. If 
there is enough for 
2 tubes, send the 
2nd tube to JAX (Ed 
Mougey, PhD) 
 Store in (minus) -
80°C freezer. If 
no (minus) -80°C 
freezer available, 
then freeze in 
(minus) -20°C non 
frost-free freezer 
for up to 1 week 
before shipping. 
 Can be shipped 
on cold packs or 
with dry ice 
 Note:  To prevent 
tube breakage, lay 
serum tubes 
horizontally in the 
freezer for 20 
minutes, or until 
frozen, prior to 
Samples for Phadiatop 
will be shipped to 
Nemours and Nemours 
will ship them to the DACI 
lab at the end of the trial.  
Samples are to be kept in 
storage at the site until 
shipment to Nemours.  
The results can be 
included in the 
participant’s medical 
record. 
 
DACI lab: 
Robert G. Hamilton, Ph.D., 
JHU DACI Reference Laboratory 
Johns Hopkins Asthma and 
Allergy Center 
Room 1A20 
5501 Hopkins Bayview Circle 
Baltimore, MD 21224, USA 
Tel: 410-550-2029 


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86
Specimen Collection Tube 
Label 
Processing 
Action 
storing then in 
freezer boxes. 
 
8.4.3.1. 
General Shipping Instructions 
 
Batch ship frozen samples (serum, plasma and packed cells) every three months if 
stored at -80°C; otherwise if stored at -20°C then need to ship within 1 week. 
o Ship on Monday, Tuesday, or Wednesday only, and not within 3 days of a 
holiday 
 
Make sure clinic staff members preparing shipments 
o are up-to-date with current IATA and DOT regulations regarding human blood 
shipments 
o have completed compliance training 
 
the course is available on Nemours University (Shipping Hazardous 
Materials-Infectious and Biological Substances) 
 
After course completion, send document to Michael Primiani, Regulatory 
Affairs Manger (Michael.primiani@nemours.org) and he will send you a 
certificate. 
 
Affix proper labels on outside of cardboard box 
o UN3373 label 
o Dry ice label (UN1845) 
 
Bubble wrap should be wrapped around specimen bags to provide additional protection 
o Ship Priority Overnight 
o For item #6, Special Handling, indicate “Yes, Shipper’s Declaration not required” 
o For item #6, Special Handling, check "Dry Ice" and fill in weight of dry ice in 
kilograms (10 lbs = 4.4 kg) 
o Immediately upon shipment, notify lab by sending email to:  
emougey@nemours.org 
 
Include tracking number for shipment in email 
 
Include Specimen Transmittal Form 
o Complete Specimen Transmittal Form(Click here to view the Lab Specimen 
Transmittal Form to ship to Nemours) 
o Upon receipt of the samples, Ed Mougey, PhD (Jacksonville) and the person at 
DACI will complete the confirmation of specimen receipt on the Speciman 
Transmittal Sheet 
 
Dr. Mougey will email a copy of the transmittal form to the study 
coordinator 
 
The study coordinator will upload the transmittal form into the participant’s 
record in REDCap 
o Example of completed transmittal form 
 
 


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8.4.4. General Requirements for Specimen Collections 
GCP   
 
Gloves must be worn at all times when handling specimens. This includes during 
removal of the rubber stopper from the blood tubes, centrifugation, pipetting, disposal 
of contaminated tubes, and clean-up of any spills. 
 
Tubes, needles, and pipets must be properly disposed of in biohazard containers, in 
accordance with institutional requirements. 
 
Universal precautions and OSHA (Occupational Safety and Health Administration) and 
institutional requirements (http://www.osha.gov/SLTC/biologicalagents/index.html) 
should be followed, including gloves, eye protection or working in a biosafety cabinet 
for blood processing. 
 
To maintain samples at 4°C, sample can be placed on ice, in ice bath or in 
refrigerator (if at 4°C/39°F) 
 
8.5. Participant Education and Instructions 
8.5.1. Overview 
To Provide Information to Coordinator for Instructing Participants 
 
Temporary Asthma Action Plan (TAP) 
 
MICT Asthma Action Plan (AAP) 
 
Instructions for MICT Morning and Evening Reports  
 
MICT Schedule of Visits  
8.5.2. Asthma Action Plans (AAP) 
Purpose 
 
To inform participants of appropriate management of asthma symptoms 
 
When 
 
At all in clinic and FaceTime visits 
 
Tasks and Functions 
 
Temporary Asthma Action Plan (Visit 1 – Part 2 (Clinic)) 
o When the REDCap procedures are followed, the AAP will prepopulate with the 
participants 
 
Name (name is NOT shown on the iPad for the participant due to HIPAA 
requirements) 
 
Date 
 
Personal best PEF based on PFTs done at the visit 
 
Red, Yellow, and Green zone PEF limits 
 
Primary asthma care doctor name and phone number 
 
Study coordinator name and phone number 
o Print a color copy for the participant at Visit 1 – Part 2 (Clinic) 
 
Go to MICT-data REDCap project 
 
Under “Project Bookmarks” select “Print Asthma Action Plan” 
 
Enter the Participant ID  
 
Print AAP 
o The AAP in full color is available on their iPad 
o This AAP will appear from Visit 1 until Visit 3 
o HINT: The completed Temporary Asthma Action Plan will only display if the following 


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information is entered: 
 
The Pulmonary Function Testing form: The highest of 3 PEF efforts has 
been entered (the Temp Asthma Action Plan form will prepopulate with 
the red, yellow and green zone values) 
 
Study Information form: Study Coordinator name and phone number 
 
Participant Information form: Participant name, Physican name and phone 
number 
 
Visit Date form: Target dates for Visit 1 and Visit 3; actual date for Visit 1 
 
 
Study Asthma Action Plan (Visit 3) 
o When the REDCap procedures are followed, the AAP will prepopulate with same 
information as above except 
 
The PEF values will be based upon a mean of the 10 of the last 14 days 
of Morning Report PEF data 
o Print a color copy and mail to the participant with the randomized study drug 
 
The coordinator may have to print it and provide to the pharmacist; the 
AC will print it for sites that JAX is managing drug shipment 
o This AAP will appear from Visit 3 to Visit 6 
o HINT: The completed Temporary Asthma Action Plan will only display if the 
following information is entered: 
 
The Pulmonary Function Testing form: The highest of 3 PEF efforts has 
been entered (the Temp Asthma Action Plan form will prepopulate with 
the red, yellow and green zone values) 
 
Study Information form: Study Coordinator name and phone number 
 
Participant Information form: Participant name, Physican name and phone 
number 
 
Visit Date form: Target dates for Visit 1 and Visit 3; actual date for Visit 1 
and Visit 3 
 
 
The AAP is programmed to appear on the iPad anytime a PEF below 85% is entered on 
the Morning Report (indicating they are in the yellow zone) 
 
 
The AAP is always available to the SC on the REDCap site at 
https://apps.nemoursresearch.org/mict/admin/actionPlan.php 
o Enter your Nemours user name 
o Enter password “MICTstudy2013”; select Enter 
o Enter the Participant ID  
OR  
o Go to MICT-data REDCap project 
 
Under “Project Bookmarks” select “Print Asthma Action Plan” 
 
Enter the Participant ID  
 
Print AAP 
 
8.6. Treatment Failure 
Purpose 
 
To identify a treatment failure 
 
Definition 
 
Treatment failure is defined as the occurrence of the following after participant has been 
randomized to study treatment (from V3 to V6).   For purposes of this study, a “treatment 


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failure” will include any and all of the following events that occur between visits 
o Asthma exacerbation 
 
Hospitalization or urgent medical care visit for asthma initiated by the 
participant or physician (REDCap sends alert email to coordinator when 
entered on Evening Report) 
 
Use of systemic corticosteroids for asthma or increase in controller 
therapy as determined by Study Physician or asthma care provider 
(REDCap sends alert email to coordinator when entered on Evening 
Report) 
 
Decrease in pre-bronchodilator FEV1 to  more than 20% below 
baseline (pre-BD FEV1 at Randomization) at any time during study 
(you will need to calculate this – Use the PFT Worksheet.  (Click here 
to view the PFT FaceTime Worksheet.) 
 
Decrease in morning PEF to more than 35% below baseline mean PEF 
on two consecutive days (REDCap sends alert email to coordinator if 
value entered on Morning Report meets this criteria) 
 
Baseline mean PEF is the mean PEF during the final 2 weeks of 
open-label Advair  (stable phase) 
 
Use of 10 or more puffs per day of rescue beta-agonist for 2 consecutive 
days (excluding uses as a pre-medication for exercise). One nebulizer 
use is equivalent to 2 puffs of beta- agonist.  (REDCap sends alert email 
to coordinator when entered on Evening Report) 
o Participant refusal to continue due to medication intolerance or failure of the 
treatment to provide symptomatic relief (REDCap sends alert email to coordinator 
when entered on Evening Report) 
o Judgment by physician that participant should be withdrawn from study treatment 
for reasons of safety 
When to Assess 
 
The coordinator should assess for treatment failure anytime one of the above alerts is 
received 
 
The coordinator should assess at each FaceTime visit using the REDCap form 
“Assessment for Treatment Failure” 
 
Procedures 
 
The participant can continue with study procedures through Visit 6 if the participant has 
been randomized at Visit 3 
o Following first treatment failure, participant is to be treated according to best 
medical judgment and may continue in the same treatment group. 
 
Participants who experience an exacerbation of their asthma or have other 
significant signs of worsening of their asthma will be referred to their 
primary care physician or asthma provider for re-evaluation of their asthma 
regimen. 
 
If their personal provider is unavailable in a timely manner the clinical 
center physician will evaluate the participant’s treatment regimen and make 
recommendations for treatment. 
o If an individual participant has two treatment failures (e.g. asthma exacerbations) 
requiring the use of systemic corticosteroids, the participant will be taken off study 
treatment and continue in the study on alternate treatment according to best 
medical judgment.  Alternate treatment will be according to the discretion of his/her 
treating physician or by Study Physician if personal asthma care provider is 


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unavailable. 
o The goal is to continue with all follow-up visits, for all participants that are 
randomized 
o If a participant is being withdrawn from the study, complete Visit 6 procedures 
 
Guidelines for Suggested Treatment Failure Response 
 
Final decision to be made by treating physician or study physician.  All treatment 
decisions should be made according to best medical judgement 
 
Treatment Failure Occurrence 
Respons
e
Change in asthma* 
Acute Exacerbation** 
None 
1 
Change in treatment if in best medical 
judgment
1+ 
None 
Continue treatment with study drug 
1 
1 
Change in treatment if in best medical 
judgment
2 
None 
None 
2 
Two treatment failures that require use of 
systemic corticosteroids results in 
participant 
being taken off study treatment. Proceed with 
new treatment according to best medical
*change in asthma 
 
Decrease of Pre-BD FEV1 to more than 20% below baseline AND/OR 
 
Decrease in morning PEFR to more than 35% below baseline (at V3) AND/OR 
 
Use of 10 puffs or more of rescue medication (e.g. albuterol for 2 consecutive days) 
**Acute Exacerbation 
 • Use of oral/systemic corticosteroids or increase in controller therapy AND/OR 
 • Hospitalization for asthma AND/OR 
 • Hospitalization (severe—ICU/intubation) for asthma 
9. Event Recording (AE, SAE, Administrative Events) 
9.1. Adverse Events 
Purpose 
 
To report an adverse event 
Definition 
 
Any untoward medical occurrence associated with the use of a drug in humans, whether 
or not considered drug related 
 
Unexpected or Unanticipated Problem 
o “unexpected” if it is not listed in the investigator brochure or is not listed at the 
specificity or severity that has been observed; or an investigator brochure is not 
required or available, is not consistent with the risk information described in the 
general investigational plan or elsewhere in the current application, as amended. 
 
Relatedness (determined by the study physician) 
o Relatedness refers to the extent to which an adverse event is considered to be 


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related to the intervention or study procedures. An adverse event is considered 
related if there is a reasonable possibility that the event may have been caused 
by the procedure. The following definitions apply: 
 
Unrelated 
 
Adverse event is clearly due to extraneous causes (e.g., 
underlying disease, environment) 
 
Unlikely (Adverse event must have 2 of the following): 
 
Does not have temporal relationship to intervention, 
 
Could readily have been produced by the subject’s clinical state, 
 
Could have been due to environmental or other interventions, 
 
Does not follow known pattern of response to intervention, 
 
Does not reappear or worsen with reintroduction of intervention 
 
Possible (Adverse event must have 2 of the following): 
 
Has a reasonable temporal relationship to intervention, 
 
Could not readily have been produced by the subject’s clinical 
state, 
 
Could not readily have been due to environmental or other 
interventions, 
 
Follows a known pattern of response to intervention 
 
Probable (Adverse event must have 3 of the following): 
 
Has a reasonable temporal relationship to intervention, 
 
Could not readily have been produced by the subject’s clinical 
state or have been due to environmental or other interventions, 
 
Follows a known pattern of response to intervention 
 
Disappears or decreases with reduction in dose or cessation of 
intervention 
 
Definite (Adverse event must have 4 of the following): 
 
Has a reasonable temporal relationship to intervention, 
 
Could not readily have been produced by the subject’s clinical 
state or have been due to environmental or other interventions, 
 
Follows a known pattern of response to intervention, 
 
Disappears or decreases with reduction in dose or cessation of 
intervention and recurs with re-exposure 
When to Assess 
 
Adverse events are assessed on a continual basis through the study from data collected 
on the Morning/Evening Reports, FaceTime appointments, onsite appointments, etc. 
Study Physician Role 
 
Reviews AE 
 
Determines severity 
 
Determines relatedness to study drug 
Procedures 
 
The Adverse Events Worksheet is under the column “Ongoing” 
o All adverse events will be recorded on this form throughout the particpant’s trial 
participation 
 
Follow the instructions on the form 
 
If the “Outcome of event” is “ongoing” at the time the form is completed, it can be 
updated to one of the other choices at a later date when an outcome is known. 
o When making changes to the “Outcome of event” from “ongoing” to another 
outcome choice, you must include a short explanation in the call out bubble. 


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 
This information will then be stored in the event history along with the 
person making the change 
 
The physician will be required to complete:  
o Whether the event serious 
o Whether the event was related to the study drug or a study procedure 
 
If there are multiple events, a second adverse event form will become available as soon 
as data is entered into “Adverse event name” 
Report to the IRB  
 
Use the form ‘Report of Unanticipated Problems’ on IRBNet 
 
Report events that (All 3 criteria must be met) 
o Unanticipated, unforeseen or unexpected.  
 
For adverse events, or clinical information, this means that this 
information was not available in the material available to the IRB, not in 
the consent documents, or not expected for this disease or condition.  
o Related to the research 
 
For adverse events, this means there is a reasonable possibility that the 
adverse event or problem may have been caused by the test article (study 
drug/biologic/device) or research participation 
o Indicates that participants or others are at increased risk of harm 
9.1.1. Study Coordinator REDCap Instructions for AE Reporting 
 
In the MICT-data REDCap project 
o Click ‘Add/Edit Records’ and chose the participant ID for this participant 
o Click the button for ‘Adverse Events Worksheet’ under Ongoing 
 
Complete the form as described above under Procedures 
 
Set form as ‘Incomplete’  
 
Click ‘Save’ 
 
You will see a popup to provide a value for 
 
Was event serious (SAE)? 
 
AE related to study drug or procedure? 
 
Investigator will sign electronically in REDCap 
 
Click “Ignore and leave record” 
o Contact the physician to review the event and to complete the required questions 
 
Was the event serious 
 
Was the AE related to study drug or study procedures 
o The physician will login to REDCap using their login and password 
 
The physician will review the AE and complete the required questions 
 
Instruct the physician to leave the form as “Incomplete”  
 
Instruct the physician to Click “Save” 
9.2. Serious Adverse Events 
Purpose 
 
To report a serious adverse event 
Definition 
 
An adverse event or suspected adverse reaction is considered “serious” if, in the view of 
either the investigator or sponsor, it results in any of the following outcomes: 
o death 
o a life-threatening adverse event, 
o inpatient hospitalization or prolongation of existing hospitalization 


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o a persistent or significant incapacity or substantial disruption of the ability to 
conduct normal life functions, 
o a congenital anomaly/birth defect 
o pregnancy 
 
Important medical events that may not result in death, be life-threatening, or require 
hospitalization may be considered serious when, based upon appropriate medical 
judgment, they may jeopardize the patient or subject and may require medical or surgical 
intervention (treatment) to prevent one of the outcomes listed in this definition.  Examples 
include: 
o allergic bronchospasm requiring intensive treatment in an emergency room or at 
home 
o blood dyscrasias (e.g., leukemia) or convulsions that do not result in inpatient 
hospitalization, or 
o development of drug dependency or drug abuse 
When to Assess 
 
Adverse events are assessed on a continual basis through the study from data collected 
on the Morning/Evening Reports, FaceTime appointments, onsite appointments, etc. 
Study Physician Role 
 
Reviews SAE 
 
Determines severity 
 
Determines relatedness to study drug 
 
Determines medical care required 
o Continuation or discontinuation of study drug 
o Other asthma treatment 
Procedures 
 
The Serious Adverse Events Worksheet is under the column “Ongoing” 
o All serious adverse events will be recorded on this form throughout the 
participant’s trial participation 
 
Follow the instructions on the form 
 
If the “Outcome of event” is “ongoing” at the time the form is completed, it can be 
updated to one of the other choices at a later date when an outcome is known. 
o When making changes to the “Outcome of event” from “ongoing” to another 
outcome choice, you must include a short explanation in the call out bubble. 
 
This information will then be stored in the event history along with the 
person making the change 
 
The physician will be required to complete:  
o Severity of intensity of event 
o Relationship of adverse event to study drug (if the participant was on study drug) 
o Was adverse event related to a study procedure or the study design, other than 
study drug 
 
If there are multiple events, a second adverse event form will become available as soon 
as data is entered into “Adverse event name” 
Reporting 
 
To the PI as soon as known 
 
Report to the IRB as described under Adverse Events (within 5 days of discovery, or 
within 24 hours if an unforeseen death). (Click here to see Adverse Events section in 
this MOP). 
 


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9.2.1. Study Coordinator REDCap Instructions for SAE Reporting 
 
In the MICT-data REDCap project 
o Click ‘Add/Edit Records’ and chose the participant ID for this participant 
o Click the button for ‘Serious Adverse Event Report’ under Ongoing 
 
Complete the form as described above under Procedures 
 
Set form as ‘Incomplete’  
 
Click ‘Save’ 
o Contact the physician to review the event and to complete the required questions 
 
Severity of intensity of event 
 
Relationship of adverse event to study drug (if the participant was on 
study drug) 
 
Was adverse event related to a study procedure or the study design, 
other than study drug 
o The physician will login to REDCap using their login and password 
 
The physician will review the SAE and complete the required questions 
 
Instruct the physician to leave the form as “Incomplete”  
 
Instruct the physician to Click “Save” 
 
9.3. Unanticipated Administrative Events 
Purpose 
 
To report an event that is neither an adverse event nor serious adverse event using the 
Report of Unanticipated Administrative Event form (Click here to see Adverse Events 
and Serious Adverse Events section in this MOP). 
Definition 
 
Occurrences of breaches of confidentiality, destruction of study records, unaccounted for 
study drug, irregularities in the randomization process, or other such problem/deviation.  
Some unusual events may require IRB reporting.  Visits outside of window do not need 
to be reported. 
Procedures 
 
This form is NOT saved under an individual participant’s REDCap data file 
o It is stored as a general document because some reported events may relate to 
multiple participants 
 
Summarize this event using the Report of Unanticipated Administrative Event form (Click 
here to go to the document Report of Unanticipated Administrative Event form). 
 
Follow the instructions on the form for completing and saving the file 
o Save the document on the shared drive in your site folder.  (Click here to go to 
the folder to save the file Report of Unanticipated Administrative Event 
form) 
o Upload the document to the REDCap file repository (Click here for instructions 
on uploading the form to REDCap Upload Instructions). 
Reporting 
 
Report to the IRB as described under Adverse Events (within 5 days of discovery, or 
within 24 hours if an unforeseen death). (Click here to see Adverse Events section in 
this MOP). 
 
9.3.1. Study Coordinator REDCap Instructions for Administrative Reporting 
 
In the MICT-data REDCap project 


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o Under Applications click on ‘File Repository’ 
 
 
o Click to Upload New File 
 
 
o Browse to the folder that has the completed form in your site folder 
o Type the file name in the box ‘Name/Label’ 
 
o Click ‘Upload File’ 
 
10. Study Drug Description, Procurement, Storage 
Insert info here 
10.1. 
Overview 
Study Site Pharmacist (ORL and WIL) will follow institution procedures to: 
 
Purchase of all study drug 
 
Manage center level (MICT – drug accountability by site) and participant level drug 
accountability (Drug Accountability Log) logs in REDCap 
 
Manage  disposal of all returned drug 
Administrative Coordinator (for JAX, PNS, PHL) 
 
Will be responsible for purchase and distribution of all study drug  
o Will distribute Advair 250/50 and ProAir to the sites to have on hand for V1 
o Will prepare and ship study drug directly to study participants 
 
All shipments will be verified by a licensed nurse or pharmacist and at note 
will be recorded in REDCap 
 
Manage center level (MICT – drug accountability by site) and participant level drug 


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accountability (Drug Accountability Log) logs in REDCap 
 
Manage  disposal of all returned drug according to Nemours policy and procedures 
Study Site Coordinator (at the JAX, PNS, PHL sites) 
 
Will be responsible for completing the ‘MICT – drug accountability site’ form (in MICT-data 
project) 
o When drug is received from the JAX site (Visit 1 drug supplies of Advair 250/50 
and Proair) 
o When drug is dispensed to participant at Visit 1 (Advair 250/50 and Proair) 
 
Will be responsible for completing the ‘Drug Accountability Log’ for each participant 
when Advair 250/50 or Proair is dispensed at Visit 1 
 
10.2. 
ProAir (albuterol) 
Dispensing 
 
1 ProAir will be provided at Visit 1 and additional ProAir will be provided based upon 
usage 
 
REDCap will send an alert to the SC when the ProAir counter number reaches 30 or 
lower on the Evening Report 
o Notify pharmacist or AC that another ProAir needs to be sent 
o The amount of ProAir used can be viewed for each participant.  (Click here to 
see Participant albuterol use section in this MOP). 
10.2.1. 
RPh and AC (and Site Coordinator at PHL and PNS at Visit 1 
only) REDCap Instructions for ProAir Drug Accountability 
The Site Coordinators can view Visit 1 instructions (Click here to see Visit 1 Study 
Coordinator REDCap Instructions section in this MOP – see the part about Drug 
Accountability) 
 
In the MICT-data REDCap project 
o Click ‘Add/Edit Records’ and choose the participant ID 
o Click the button for ‘Drug Accountability Log” under Ongoing  
o Complete this form 
 
Medication dispensed 
 
Under ‘Medicine Dispensed’ the drug for shipment/dispensing 
must be verified by a licensed nurse or pharmacist  
o Verify correct participant, correct drug, correct dose, 
correct dosing instructions, correct lot number, correct 
expiration date 
 
enter a note in the callout button 
 
Date dispensed 
 
Scheduled start date 
 
Lot number 
 
Expiration date 
 
How provided 
 
Delivery status 
 
If drug was FEDExed: 
o Check the FEDEx airbill number after shipment to confirm 
delivery 
 
Date of drug return 


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98
 
Will be completed most likely at Visit 6 when the participant 
returns to the clinic with all the used study drug 
o Set form as ‘Unverfied’ 
 
At Visit 6, after documenting all returned drug, set form as ‘Complete’ 
 
o Click ‘Save Record’ 
 
10.3. 
Stable-Phase Advair 250/50 (V1 and V2) 
Dispensing 
 
1 Advair 250/50 will be provided at Visit 1 and additional Advair 250/50 will be provided 
based upon usage or 30 days after the V1 Advair was opened from the foil pouch  
o Please try and schedule V2 FaceTime visit before the V1 Advair runs out.  This is 
because if the participant does not meet criteria for study continuation, then we 
will not need to send another Advair 250/50. 
o Please try and schedule Ve FaceTime visit before the Vw Advair runs out.  This is 
because if the participant does not meet criteria for study continuation, then we 
will not need to send another Advair 250/50 because they would be randomized to 
study drug within a few days. 
 
Participant Instructions 
o The SC will remind the participant that the Advair 250/50 is to be used as 1 
inhalation twice daily 
o The SC will remind the participant that the Advair 250/50 takes the place of their 
regularly used asthma controller medication 
o The SC will inform the participant that each diskus must remain in its sealed 
pouch until the date indicated on the participant instruction form  ((Click here to 
view the MICT Drug Instructions for Participant Insert form included when 
mailing study drug: Study Drug Instruction Insert.) - unless for some reason it 
needs to be started at an earlier date 
 
REDCap will send an alert to the SC when the Diskus counter number reaches 14 or 
lower on the Evening Report 
o Notify pharmacist or AC that another Advair 250/50 needs to be sent 
o The amount of Advair 250/50 used can be viewed for each participant.  (Click 
here to see Diskus use section in this MOP). 
10.3.1. 
RPh and AC (and Site Coordinator at PHL and PNS at Visit 1 
only) REDCap Instructions for Stable-Phase Advair 250/50 Drug 
Accountability 
The Site Coordinators can view Visit 1 instructions (Click here to see Study Coordinator 
REDCap Instructions section in this MOP – see the part about Drug Accounability) 
 
In the MICT-data REDCap project 
o Click ‘Add/Edit Records’ and choose the participant ID 
o Click the button for ‘Drug Accountability Log” under Ongoing  
o Complete this form 
 
Medication dispensed 
 
Under ‘Medicine Dispensed’ the drug for shipment/dispensing 
must be verified by a licensed nurse or pharmacist  
o Verify correct participant, correct drug, correct dose, 
correct dosing instructions, correct lot number, correct 
expiration date 


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99
 
enter a note in the callout button 
 
Date dispensed 
 
Scheduled start date 
 
Lot number 
 
Expiration date 
 
How provided 
 
Delivery status 
 
If drug was FEDExed: 
o Check the FEDEx airbill number after shipment to confirm 
delivery 
 
Date of drug return 
 
Will be completed most likely at Visit 6 when the participant 
returns to the clinic with all the used study drug 
o Set form as ‘Unverfied’ 
 
At Visit 6, after documenting all returned drug, set form as ‘Complete’ 
 
o Click ‘Save Record’ 
10.4. 
Study Drug (Randomized Period) (V3, V4, V5) 
Randomization 
 
The SC at each site, RPh,  AC, and PI  will receive an email from the MICT server when a 
participant is randomized.  The email will identify the participant by their Participant ID 
and the treatment arm to which they were randomized. 
  
 
Dispensing 
 
1 study diskus will be mailed after treatment randomization has determined the study 
drug arm at Visit 3.  Additional study diskus will be provided based upon usage or 30 days 
after the last study diskus was started as determined from the Morning or Evening Report 
“Did you start your new Diskus with this Dose?”  
 
REDCap will send an alert to the SC when the Diskus counter number reaches 14 or 
lower on the Evening Report 
o Notify pharmacist or AC that another study diskus needs to be sent 
o The amount of study diskus used can be viewed for each participant.  (Click here 
to see Diskus use section in this MOP). 
o The SC will inform the participant that each diskus must remain in its sealed 
pouch until the date indicated on the participant instruction form  (Click here to 
view the MICT Drug Instructions for Participant Insert form included when 
mailing study drug: Study Drug Instruction Insert.) - unless for some reason it 


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100 
needs to be started at an earlier date 
 
Advair 250/50 Diskus 
The device should be discarded 1 month after removal from the 
moisture-protective foil overwrap pouch or after all blisters 
have been used (when the dose indicator reads “0”), whichever 
comes first. Do not attempt to take the device apart. 
Advair 100/50 Diskus 
The device should be discarded 1 month after removal from the 
moisture-protective foil overwrap pouch or after all blisters 
have been used (when the dose indicator reads “0”), whichever 
comes first. Do not attempt to take the device apart. 
Flovent 250 Diskus 
FLOVENT DISKUS should be discarded 6 weeks (50-mcg strength) 
or 2 months (100- and 250-mcg strengths) after removal from the 
moisture-protective foil pouch or after all blisters have been used 
(when the dose indicator reads “0”), whichever comes first. Do not 
attempt to take the device apart. 
 
Treatment Arms 
There are 3 study arms for randomized drug treatment 
 
Advair 250/50 – 1 inhalation twice daily 
 
Advair 100/50 – 1 inhalation twice daily 
 
Flovent 250 – 1 inhalation twice daily 
10.4.1. 
RPh and AC REDCap Instructions for Study Diskus 
(Randomized Period) Accountability 
In the MICT-data REDCap project 
o Click ‘Add/Edit Records’ and chose the participant ID 
o Click the button for ‘Drug Accountability Log” under Ongoing  
o Complete this form 
 
Medication dispensed 
 
Under ‘Medicine Dispensed’ the drug for shipment/dispensing 
must be verified by a licensed nurse or pharmacist  
o Verify correct participant, correct drug, correct dose, 
correct dosing instructions, correct lot number, correct 
expiration date 
 
enter a note in the callout button 
 
Date dispensed 
 
Scheduled start date 
 
Lot number 
 
Expiration date 
 
How provided 
 
Delivery status 
 
If drug was FEDExed: 
o Check the FEDEx airbill number after shipment to confirm 
delivery 
 
Date of drug return 
 
Will be completed most likely at Visit 6 when the participant 
returns to the clinic with all the used study drug 
o Set form as ‘Unverfied’ 
 
At Visit 6, after documenting all returned drug, set form as ‘Complete’ 
 


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101 
o Click ‘Save Record’ 
10.5. 
Procurement, Receipt, and Storage of Drug 
Procurement 
 
ORL and WIL pharmacists will order drug to have in stock 
o Suggest keeping minimal drug in stock to avoid drug expiring before it has been 
dispensed 
 
AC will order drug for JAX, PNS, and PHL 
o Stable phase Advair 250/50 and ProAir will be shipped to PNS and PHL so that 
the sites have some on hand for V1 
o Randomized drug treatment will be mailed directly to the participant by the RPh at 
ORL and WIL and by the AC for JAX, PNS, PHL 
Receipt 
 
ORL and WIL pharmacists will maintain center and participant drug accountability logs on 
REDCap 
 
AC will maintain center and participant drug accountability logs on REDCap for JAX, 
PNS, PHL 
Storage 
 
ProAir 
o Store at controlled room temperature, 59° to 77° F 
 
Advair and Flovent 
o Store at controlled room temperature, 68° to 77° F 
 
10.5.1. 
RPh and AC (and Site Coordinator at PHL and PNS) REDCap 
Instructions for Study Procurement/Receipt Accountability 
These steps are to be completed anytime drug is received or dispensed by the pharmacy (in 
ORL and WIL) or by the study sites from JAX 
 
Center Level Drug Accountability Log 
In the MICT-drug accountability by site REDCap project 
o To enter data (when receiving drug) 
 
Click ‘Add/Edit Records’ and click ‘Add new record’ 
 
Complete the ‘Drug Accountability Log’ form 
 
Select/record Study Site location 
 
Select medication 
o Advair 250/50 (60blister/Diskus), Advair 100/50mcg Diskus 
(60 blisters), Flovent 250mcg Diskus (60 blisters) or ProAir 
90 mcg/actuation 8.5g 
 
Select manufacturer 
 
Enter Lot Number 
 
Enter expiration date from the package 
 
Enter number of Diskus in this transaction 
 
Select “received” or “dispensed” 
o For “received”, select appropriate choice (site or 
manufacturer) 
 
Enter remaining balance at the site 
 
Add any relevant notes 
o E.g. whether Advair is for run-in or randomization 
 
Set status to ‘Ccomplete’ 


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102 
 
Click ‘Save’ or click ‘Save and Continue’ if creating a pdf for the 
transaction 
 
Start a new record for each receipt/dispense of study drug 
o To view a report of transactions for a single medication (e.g. Proair, Advair 
250/50, randomized drug) 
 
Click on the name of the report in the left panel under ‘Reports’ 
 
To print report, click ‘Print page’ 
 
To download report as an Excel file, click ‘Microsoft Excel (CVS)’ 
o To create a pdf file of a single transaction 
 
Enter a record by doing one of the following: 
 
Click ‘Add/Edit Records’ and select the records from the drop-
down list. 
 
Click on the Entry ID in a report of transactions 
 
Click ‘Save and Continue’ after entering data 
 
Click the ‘Download PDF of instrument(s)’ button 
 
Select ‘This data entry form with saved data’ 
 
Click the radio  button next to ‘Save File’ 
 
Click OK 
 
Repeat the steps above for all drugs when received (ProAir, Advair 250/50, Advair 100/50, 
Flovent 250) 
10.6. 
Labeling and Shipment Information 
Information Included on Study Drug Label 
 
ORL and WIL pharmacists will label drug according to state  law and Nemours policy 
 
AC will label drug according to state law and Nemours policy for JAX, PNS, and PHL 
o Labels for drug can be viewed in the Administrative Logs folder (Click here to 
view the MICT Drug Instructions for Participant Insert form included when 
mailing study drug: Study Drug Labels.) 
o Note that the drug label for JAX, PNS, and PHL does not include the Lot number 
or Expiration date as this information is on the drug product itself 
Information Included on Study Drug Shipment 
 
Participant instructions for study drug use are included in the shipment box to the 
participant.  (Click here to view the MICT Drug Instructions for Participant Insert 
form included when mailing study drug: Study Drug Instruction Insert.) - unless for 
some reason it needs to be started at an earlier date 
FEDex Study Drug Shipment 
 
FEDex is used to ship the drug directly from the pharmacy at ORL and WIL and from the 
JAX site for JAX, PFN, and PHL 
 
A copy of the tracking receipt can be found in MICT-data REDCap project Drug 
Accountability Log 
10.7. 
Accountability Logs in REDCap 
Purpose 
 
To manage drug accountability both at the participant level and center level 
Procedures 
 
Participant Level Drug Accountability Log 
o Click here to see ProAir section Participant Level ProAir REDCap 
Instructions in this MOP). 
o Click here to see Stable Phase Advair 250/50 REDCap section Participant 


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103 
Level Stable Phase Advair 250/50 REDCap Instructions in this MOP). 
o Click here to see Randomized Drug REDCap section RPh and AC REDCap 
Instructions for Study Diskus (Randomized Period) Accountability in this 
MOP). 
 
Center Level Drug Accountability Log 
o Click here to see Center Level Drug Accountability section Study 
Procurement/Receipt REDCap Instructions in this MOP). 
 
10.8. 
Temporary Withdrawal or Termination of Study Drug 
Definition 
 
Study treatment drug refers to the drug randomly assigned to the participant 
Purpose 
 
To set criteria for the temporary withdrawal or termination of study drug administration 
When 
 
Any time after completion of randomization visit (V3) when study drug is temporarily or 
permanently stopped due to adverse event, participant request, lost to follow-up, 
pregnancy, or other reason  
 
At end of study (completion of V6) 
Tasks 
 
Unscheduled temporary study drug termination 
o Record information relating to the hiatus in study on the next Clinic Visit form for 
the upcoming visit in REDCap 
o Record a note in the Notes field of the Diary Card for the date that the participant 
stopped taking the drug (Click here to see Participant Morning or Evening 
Report editing section in this MOP.) 
o Complete the Adverse Event, Serious Adverse Event or Unanticipated 
Administrative Event form as appropriate 
 
Unscheduled permanent study drug termination before end of study 
o If participant experiences moderate or severe side effects, the Study Physician 
will: 
 
Evaluate severity of symptoms as rated by participant 
 
Decide if side effects are suspected to be related to study drug 
 
Determine if study drug should be terminated 
o Complete the Adverse Event, Serious Adverse Event or Unanticipated 
Administrative Event form as appropriate 
o Complete Treatment Termination form in REDCap 
o Collect all study treatment diskuses (including any unused study diskus) from 
participant 
o Complete Drug Dispensing and Counting (DD) form 
o Continue to follow participant for all study visits (i.e., continue all relevant study 
o procedures) through V6 
 
11. REDCap Troubleshooting 
11.1. 
Instructions for Participants Temporarily Without Internet Access 
Participant may relay Diary Report data to Clinical Coordinator via text, email or phone call. 
 


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104 
Enter data into MICT-diary cards REDCap project 
The ID for the records in this project has the format, ‘participant ID_date’.  The format of the 
date must be YYYY-MM-DD and the letters must be uppercase.  Here is an example ID.  
JAX105_2013-01-05.  (This date is January 5, 2013.)   
 
Click ‘Add/Edit Records’ 
 
If the participant has submitted either a morning card or evening card for the day to be 
altered, choose the record. 
 
If the participant has not submitted anything for the day, a new record will need to be 
created. 
o Enter a new record using the format above and hit the ‘Enter’ key on the 
keyboard. Make sure you put the ID in the “Enter a new or existing…” box and 
not in the box in the “Data Search” section (see below). 
 
 
 
 
Enter data into the fields in the form ‘Day’ if they are empty.  Edit any data that the 
participant has entered incorrectly.  Enter notes for any field by clicking the dialog 
symbol next to the data entry box, type your comments and click ‘Comment’. Click ‘Save 
and go to the Next Form’ if you added or changed any data.  If the form was already 
filled out and you didn’t change any data, click the dot next to ‘Morning’ in the left side 
panel. 
 
Enter data into the fields in the form ‘Morning’ if they are empty.  Edit any data that the 
participant has entered incorrectly.  Enter notes for any field by clicking the dialog 
symbol next to the data entry box, type your comments and click ‘Comment’.  Click 
‘Save and go to the Next Form’ if you added or changed any data.  If the form was 
already filled out, click the dot next to ‘Evening’ in the left side panel. 
 
Enter data into the fields in the form ‘Evening’ if they are empty.  Edit any data that the 


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105 
participant has entered incorrectly.  Enter notes for any field by clicking the dialog 
symbol next to the data entry box, type your comments and click ‘Comment’.  Click 
‘Save and go to the Next Form’ if you added or changed any data.  If the form was 
already filled out, click the dot next to ‘Notes’ in the left side panel. 
 
Enter your notes into the textbox on this form.  
 
Set the form as ‘Complete’. 
 
Click ‘Save’ 
 
If the date/timestamp for submission of the morning and/or evening diary card was blank when 
data was entered into the MICT-diary cards REDCap project in the steps above, go to the 
MICT-DC summary REDCap project. 
View report called ‘data’. 
 
In left sidebar under ‘Reports’, click the link called ‘data’ 
 
Find data for the participant, then look for the first day of the week (far right of the 
table) for which you entered diary card data. 
 
 
 
o If data for the week is not in the table yet, do nothing more. 
o If data for the week is in the table, note which Event Name the week is 
assigned. 
 
Click the participant ID in the report.  This will take you to the event 
grid. 
o 
 
o  
 
Then enter the ‘Diary Card Submission Summary’ for the appropriate 
event. 


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106 
o 
 
 
If credit for this week has already been added to the CTPayer 
card, contact the Administrative Coordinator. 
 
If credit for this week has not been added to the CTPayer card 
o Enter the appropriate data. 
o Click ‘Save Record’. 
 
11.2. 
Correcting Entry when Diskus Started but not Indicated on Diary 
Report 
If a new Diskus was started and not indicated in a diary report submission by the 
participant 
 
Record this in the MICT-diary cards REDCap project as described above (Click here to 
see Enter data into MICT-diary cards REDCap project section in this MOP.) 
o The field, ‘Expected counter number on Diskus’, will not be updated 
automatically.  If there as any data in this field after the date the new Diskus was 
started, the Clinical Coordinator must either manually deleted the incorrect data 
or manually replace the incorrect values with correct values.  
 
To see the data that has been entered for ‘Expected counter number on 
Diskus’, click on ‘Diskus counter’ under Reports in the left side.  Then 
scroll to the records for the appropriate participant. 
 
Record the date the new Diskus was started in the MICT-data REDCap project 
o In the MICT-data REDCap project, click ‘Add/Edit Records’ and choose the 
participant 
o Click on the dot in the grid for the ‘Drug Accountability Log’ under the event 
‘Ongoing’. 
o Enter the date the new Diskus was started into the field ‘Most recent date a new 
study Diskus was started’ at the top of the form. 
o Enter notes by clicking the dialog symbol next to the data entry box, type your 
comments and click ‘Comment’. 
o Click ‘Save Record’ 
 


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107 
11.3. 
Missing and/or Re-sending Questionnaires to Participants 
Asthma Control Test 
The participant needs to complete the ACT in one sitting.  You can provide them with a 
link to the questionnaire from within REDCap. 
In the MICT-data REDCap project: 
o Click ‘Add/Edit Records’ and choose the participant ID for this participant 
o Click on the dot in the grid for the Asthma Control Test under the appropriate 
event 
o Click on the ‘Compose survey invitation’ button, this will pop up a template for an 
email message 
 
Select the participant’s study email address from the dropdown list next to 
‘To:’ 
 
Type a subject line for the message.  This can be something like “Link to 
the Asthma Control Test” 
 
Type a message into the box and click ‘Send Email’.  Your message will 
be in the body of the email that is sent.   The following text will follow your 
message: 
“You may open the survey in your web browser by clicking the link 
below: 
Use of Mobile Devices and the Internet to Streamline An Asthma 
Clinical Trial Asthma Control Test™ 
If the link above does not work, try copying the link below into your 
web browser: 
https://apps.nemoursresearch.org/redcap/surveys/?s=XXXXXXXX 
 
This link is unique to you and should not be forwarded to others. 
 
Baseline Asthma and Medical History 
If the participant loses the email with instructions to complete this questionnaire, you can 
provide them with the following link: 
https://apps.nemoursresearch.org/mict/BA_home.php 
If they are not already logged into the Asthma Research Study website, they will be 
prompted to log in before they can see the questionnaire. 
 
The Baseline Asthma and Medical History questionnaire does not need to be completed in 
one sitting.  To stop and come back at another time, click the 'Save and Exit' button at the 
bottom of the page.  When the participant is ready to go back to this questionnaire, you 
can provide them with the following link: 
https://apps.nemoursresearch.org/mict/BA_home.php 
If they are not already logged into the Asthma Research Study website, they will be 
prompted to log in before they can see the questionnaire. 
 
EQ-5D  
The participant needs to complete the EQ-5D in one sitting.  If the participant loses the 
email with instructions to complete this questionnaire, you can provide them with the 
following link: 
https://apps.nemoursresearch.org/mict/eq5d-eq.php 
If they are not already logged into the Asthma Research Study website, they will be 
prompted to log in before they can see the questionnaire. 
 


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108 
If the participant is given the message “You don’t have an upcoming visit within 4 days.”, 
check the scheduled visit date and actual visit date that are recorded in REDCap. 
 
If this is for Visit 6 – Part 2 (i.e. they need to complete the EQ-5D while at the 
clinic) because they did not complete the EQ-5D for Visit 6 – Part 1 (FaceTime), 
then follow the below instructions for changing the Scheduled visit date and 
time in Visit Dates Visit 6 Virtual.  Make sure you pick a time that is a future time 
(for example, if the visit is at 3PM pick a time for the visit at 6PM) You will need 
to delete the Actual Visit Date in Visit Dates Visit 6 Virtual also per the 
instructions below.  When you are done, go back and re-enter the correct Actual 
Visit Date in the Visit 6 Virtual.  Put a note in the comments field as to why you 
did this (because it will be tracked in the history field). 
 
 In the MICT-data REDCap project: 
 
Click ‘Add/Edit Records’ and choose the participant ID for this participant. 
 
Click on the dot in the Event Grid for ‘Visit Dates’ under the appropriate event. 
 
Any date can be entered for Target date. 
 
Check the Scheduled visit date and time. 
o If this is incorrect, enter the correct date. 
o This questionnaire is available 4 days before the Scheduled visit date, up 
to and including the Scheduled visit date. 
 
Check the Actual visit date 
o This field should be left blank. If this has a date, delete the date. 
 
Click ‘Save Record’ 
 
After participant completes the EQ-5D, enter and save the Actual visit date. 
 
Eligibility Questionnaire (aka Screening Form), Children’s Health Survey, Quality of Life 
Questionnaires, and Pre-Clinic Visit Questionnaire (aka Clinic Visit form) 
If the participant loses the email with instructions to complete this questionnaire and has 
not started the survey, you can provide them with a link to the survey via email from 
within REDCap. 
In the MICT-data REDCap project: 
o Click ‘Add/Edit Records’ and choose the participant ID for this participant 
o Click on the dot in the Event Grid for the appropriate survey and event 
o Click on the ‘Compose survey invitation’ button, this will pop up a template for an 
email message 
 
Select the participant’s study email address from the dropdown list next to 
‘To:’. 
 
Insert a subject line for the message.  This can be something like “Link to 
Asthma Study questionnaire” 
 
Insert a brief message to the participant and click ‘Send Email’.  Your 
message will be in the body of the email that is sent.  The following text 
will follow your message. 
“You may open the survey in your web browser by clicking the link 
below: 
<div style="font-size:16px">Use of Mobile Devices and the Internet to 
Streamline An Asthma Clinical Trial</div><br /><br /><div 
align="center"><b>Asthma Control Test™</b></div> 
 


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109 
If the link above does not work, try copying the link below into your 
web browser: 
https://apps.nemoursresearch.org/redcap/surveys/?s=XXXXXXXX 
 
This link is unique to you and should not be forwarded to others. 
 
 
A link to the questionnaire will be automatically included in the message. 
o Click ‘Send Email’ 
 
If a participant clicks the ‘Save & Return Later’ button on a REDCap survey (Eligibility 
(Screening Form), Children’s Health Survey, Quality of Life Questionnaires, or Pre-clinic 
visit (Clinic Visit)) and has trouble returning to the survey, you can provide them with a 
link to the survey and the Return Code via email from within REDCap.  
In the MICT-data REDCap project: 
o Click ‘Add/Edit Records’ and choose the participant ID for this participant 
o Enter the Participant Information form 
o Copy the study email address 
o Click on the Participant ID in the left sidebar to return to the Event Grid 
o Click on the dot in the grid for the appropriate survey and event 
o Click on the ‘Email survey link’ button, this will pop up a template for an email 
message 
 
Paste the study email address in the To: section of the message 
 
Delete the following sentence from the message “A survey admin can 
provide you with a validation code so that you may complete the survey 
from where you left off.” 
 
Insert a sentence that contains the Return Code, like the following:  
                                          “After you follow this link, enter this code into the web page: 
                                          SC or AC should paste Return Code here” 
o Click ‘Send Email’ 
 
 
Sending email invitations for participants to complete the Screening form (aka Eligibility 
Questionnaire), ACT, Children’s Health Survey for Asthma or Quality of Life 
Questionnaires for the events Unscheduled1, Unscheduled2, Unscheduled3, 
Unscheduled4 or Unscheduled5 
 
In the MICT-data REDCap project: 
 
Click ‘Add/Edit Records’ and choose the participant ID for this participant 
 
Click on the Participant ID in the left sidebar to return to the Event Grid 
 
Click on the dot in the Event Grid for the appropriate survey and event 
 
Click on the ‘Compose survey invitation’ button, this will pop up a template for an email 
message 
o Specify when the message should be sent. 
o Select the participant’s study email address from the dropdown list next to ‘To:’. 
o Insert a subject line for the message. 
o Insert a brief message to the participant and click ‘Send Email’.  Your message 
will be in the body of the email that is sent.  
o A link to the questionnaire will automatically be included in the message that is 
sent. 
 
Click ‘Send Email’ 


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110 
 
 
To send email invitations to a participant for the additional Screening form, ACT or 
Children’s Health Survey for Asthma with text approved by the IRB automatically. 
 
In the MICT-data REDCap project: 
 
Click ‘Add/Edit Records’ and choose the participant ID for this participant. 
 
Click on the dot for ‘Send Additional Surveys’ under Screening. 
 
Set the field that you want to send an invitation for to Yes. 
 
Set the form status as ‘Unverified’. 
 
Click ‘Save Record’ 
o The email invitation will be sent immediately. 
 
To send email invitations to a participant or parent for the End of Study Satisfaction 
Survey.  (AC) 
 
The messages are sent to AsthmaResearch@nemours.org when they are originally sent to the 
participant and parent.  The messages to the participant and the participant each have a link to 
the appropriate survey.  If these messages are available, they can be sent to the appropriate 
email addresses.  If these messages are not available do the following: 
 
 
In the MICT-data REDCap project: 
 
Click ‘Add/Edit Records’ and chooe the participant ID for this participant. 
o Click on the dot for ‘Parent End Satisfaction-MICT’ under Visit6-clinic. 
o Click ‘Survey options’ and then ‘Compose survey invitation’. 
o In the ‘Compose message’ section: 
 
Choose ‘AsthmaResearch@nemours.org’ for ‘From’. 
 
Enter the parent’s email address next to ‘Or provide another email:’ 
 
Enter “End of Study Satisfaction Questionnaire to complete – for the 
Parent” next to ‘Subject:’ 
 
Enter the following for the content of the message 
Dear [Parent_First_Name Parent_Last_Name], 
 
Thank you for your participation in this Asthma Research Study.  
Now that your child has completed the study, we would like you, the 
parent, to complete a questionnaire to tell us about your experience 
in the study.  Please complete the End of Study Satisfaction 
Questionnaire as soon as you can within the next 5 days.  We will 
send you a $10 Walmart gift card upon return of the questionnaire. 
 
This questionnaire will take approximately 10 minutes.     
 
If you have any questions, or if you'd like to speak with someone 
right away, call: 
800-767-5437 extension 55-3925  
Or 
 904-697-3925  
You can also send an email to asthmaresearch@nemours.org.  


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111 
 
Thank you for your participation in this study. 
 
The Nemours Asthma Study Staff 
 
 
Click ‘Send Invitation’ 
 
Click on the dot for ‘Youth End Satisfaction – MICT’ under Visit6-clinic. 
 
Click ‘Survey options’ and then ‘Compose survey invitation’ 
 
In the ‘Compose message’ section: 
 
Choose ‘AsthmaResearch@nemours.org’ for ‘From’. 
 
Enter the participant’s email address next to ‘Or provide another email:’ 
 
Enter “End of Study Satisfaction Questionnaire to complete – for the 
Adolescent” next to ‘Subject:’ 
 
Enter the following for the content of the message 
Dear [Participant_First_Name Participant_Last_Name] 
 
Thank you for your participation in this Asthma Research Study.  
Now that you have completed the study, we would like you to 
complete a questionnaire to tell us about your experience in the 
study.  Please complete the End of Study Satisfaction Questionnaire 
as soon as you can within the next 5 days. We will send you a $10 
study MasterCard upon return of the questionnaire. 
 
This questionnaire will take approximately 10 minutes.     
 
If you have any questions, or if you'd like to speak with someone 
right away, call: 
800-767-5437 extension 55-3925  
Or 
 904-697-3925  
You can also send an email to asthmaresearch@nemours.org.  
 
Thank you for your participation in this study. 
 
The Nemours Asthma Study Staff 
 
 
Click ‘Send Invitation’ 
12. REDCap Entries for LASST Participants 
 
When potential participant has been identified and randomized to LASST arm, do the 
following: 
 
In the MICT-data REDCap project, 
o Click ‘Add/Edit Records’, choose the LASST arm and enter the LASST ID as the 
participant ID.   
o Enter data into ‘Patient Screening Log’ form 
 
3 fields in this form may be left blank initially, these are 


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112 
 
Main reason failed screen or not enrolled 
 
Successfully completed V1 (enrolled) 
 
Notes 
 
Set form status as ‘Unverified’ if proceeding to consent process 
 
Set form status as ‘Complete’ if failed screen 
 
Click ‘Save Record’ 
o Enter data into ‘Study Information’ form 
 
Enter the ID used to randomize the participant to the LASST arm if the 
participant was randomized.  If the participant was not randomized, leave 
this field blank. 
 
Do not answer ‘Send email invitation for consent Satisfaction Survey for 
the LASST arm?’ until an email address has been entered in the 
Participant Information form. 
 
Set form status as ‘unverified’ 
 
Click ‘Save and go to Next Form’ 
o Enter data into all fields of ‘Participant Information’ form 
 
Enter the PARENT’S PERSONAL email address into the ‘study’ email 
address field.  This will be used to send an email invitation for the consent 
Satisfaction Survey (LASST version). 
 
Mark form as ‘complete’ 
 
Click ‘Save Record’ 
 
When the participant has consented, send an email invitation to complete the 
Satisfaction Survey by doing the following: 
o In the MICT-data REDCap project, 
 
Click ‘Add/Edit Records’, choose the LASST arm and then choose the 
participant ID. 
 
Click the button for ‘Study Information’ 
 
Click ‘Yes’ for the field ‘Send email invitation for Satisfaction Survey for 
the LASST arm?’ 
 
The parent’s email address should appear in red text.  To change 
this email address, edit the study email address entry in the 
Participant Information form before continuing with these steps. 
 
Set form status as ‘Complete’ 
 
Click ‘Save Record’ 
 
When the participant has returned the Satisfaction Survey the AC will send a $10 
Walmart gift card. 
 
When Research Assessment and Newest Vital Sign have been administered during Visit 
1, do the following: 
o In the MICT-data REDCap project, 
 
Click ‘Add/Edit Records’, choose the LASST arm and then choose the 
participant ID. 
 
Enter data into ‘Research Assessment Interview’ form under Visit1 
 
Set form status as ‘Complete’ 
 
Click ‘Save Record’ 
 
 
 
 
Enter data into the ‘Baseline Asthma and Medical History – participant 
version’ form under Visit 1. 


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113 
 
 
 
 
Obtain the ethnicity and race data from the ACRC database 
 
 
 
 
Set form status as ‘Complete’ 
 
 
 
 
Click ‘Save Record’. 
 
When the participant has completed the study, send email invitations for the participant 
and parent to complete the End of Study Satisfaction Surveys by doing the following: 
o In the MICT-data REDCap project, 
 
Click ‘Add/Edit Records’, choose the LASST arm and then choose the 
participant ID. 
 
Click the button for ‘Study Information’ 
 
Click ‘Yes’ for the field ‘Send email invitations for the End of Study 
Satisfaction Survey for the LASST arm?’ 
 
The parent’s email address should appear in red text.  To change 
this email address, edit the study email address entry in the 
Participant Information form before continuing with these steps. 
 
Set form status as ‘Complete’ 
 
Click ‘Save Record’ 
 
Two messages will be sent to the parent’s email address.  One 
will be addressed to the adolescent and one will be addressed to 
the parent. 
 
13. Research Assessment Interview Ratings 
REDCap steps for psychologists rating of Research Assessment interviews (both MICT 
and ancillary LASST arms). 
 
In the MICT-data REDCap project 
o Form names with AT are for Alex Taylor to record her ratings 
o Form names with HA are for Holly Antal to record her ratings 
o For each participant, there are 4 forms for collecting ratings 
 
2 for the child  
 
one for AT 
 
 one for HA 
 
2 for the caregiver (parent/guardian) 
 
one for AT 
 
one for HA 
o Each form should be completed for 2 events (or visits) 
 
Visit1 for both MICT and LASST 
 
Visit6-virtual for MICT or Visit6 for LASST 
o Click ‘Add/Edit Records’ and choose the participant ID for this participant 
o Click the button for the appropriate form under the appropriate event 
 
Complete the Research Assessment form  
 
Set form as ‘Complete’ 
 
Click ‘Save Record’ 
o Click the button for another form and repeat until all the Research Assessment 
forms are completed. 
o To choose another participant ID, click ‘Add/Edit Records’ in the left sidebar. 
 
NOTE: When choosing a participant, the list of participants in the dropdown box is for 


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114 
the MICT arm by default.  Change this to a list of participants for the LASST arm by 
clicking the dropdown box next to ‘Arm 1: MICT’ and choose ‘Arm 2:LASST’. 
14. Participant Stipends (CT Payer) 
Overview 
 
Participant stipends are paid using the CT Payer system (www.ctpayer.com)  
 
CT Payer offers anonymous, reloadable, prepaid cards (Mastercard with the Nemours 
logo) for patient stipends and reimbursements along with personalized, reloadable, 
prepaid debit cards 
 
 
Process for Paying Participants 
 
The AC loads all cards with payments for all study sites 
 
Cards are loaded with $25 after each onsite and FaceTime visit 
o The AC determines when a study visit has occurred by monitoring REDCap 
 
Participants receive $1 for each Report (Morning or Evening) entered 
o The AC tallies the number of data entries every two weeks 
o Cards are loaded on Mondays  
o If there needs to be manual adjustments for Report payments (eg the participant 
was without internet access but did keep paper records), notify the AC and an 
adjustment will be made 
14.1. 
Making purchases online using CT Payer cards 
Participants can may purchases online using their CT Payer cards.   
 
Participants may want to make purchases on iTunes using their CT Payer card.  To make a 
purchase, the participant will need the following information.   
 
Birthday: January 1970; for the day, use the last 2 digits in the UserName  
o Example micto131 would have a birthday of January 31, 1970 
o If the UserName last two digits are 32 or higher, then the birthday will just be the 
final digit.  For example micto132 would have a birthday of January 2, 1970. 
 
Apple won’t let an invalid birthdate be entered so January 32, 1970 would 
not be valid 
 
First Name: Asthma 
 
Last Name: Study 
 
Email address: the participants gmail address 
o <UserName>@gmail.com 
o Example mictj108@gmail.com;  
 
Password: initial password assigned to participant  (Click here to see Participant 
gmail and password section in this MOP). 
 
Security Questions: 


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115 
o Name of first pet: Spot 
o Favorite children’s book: Hobbit 
o Favorite sports team: Eagles 
15. Ways to View Data on Participants in REDCap 
15.1. 
Did my Participant View the Consent Video? 
In the MICT-quizzes REDCap project, scroll to “Reports” and click on “data” 
 
You will see all the participants so you will need to scroll down to find yours.  They are listed by 
Participant ID. 
 
 
99 means that they started watching the video and for JAX102 it was watched by the 
parent and child. 
 
1-12 are the quiz questions (there are 12 questions on the video).  You can see which 
ones they got right and wrong. 
 
The long number of digits to the right of the Participant ID are date/time stamps (in 
seconds).  If you want to find out how long they spend watching the video, you can 
subtract the value for question 99 (start) from the value for question 12 (finish). For 


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116 
example 1382664095 – 1382654903 = 9192 seconds = 153 minutes.   
 
15.2. 
Did my Participant Receive the Emails with the Links to the 
Questionnaires? 
In the MICT-data REDCap project go to “Data Collection” select “Manage Survey Participants”: 
 
 
Click on “Survey Invitation Log”: 
 
 
You can see the emails sent and if the participant has responded.  You can click on the “view 
email” to see actual email sent. 
 
 
To resend surveys: Click here to see "Missing and/or Re-sending Questionnaires to 
Participants" section in this MOP. 
 


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117 
15.3. 
My participant has not completed all the questionnaires for Visit 1 
Try and contact them to complete all the questionnaires before they come in.  If they arrive for 
the appointment and some questionnaires need to be completed, then follow these steps: 
 
Make sure that REDCap has that the consents have been signed.  The AC does this but 
recommend checking this as a first step. 
o In the MICT-data REDCap project 
 
Click ‘Add/Edit Records’ and chose the participant ID for this participant 
 
Look in the Screening column 
 
Click on \‘Signed Consent’ 
 
Make sure ‘Successfully completed consent process’ is “yes” and saved. 
 
 
 
Determine which questionnaires have not been completed. You can view this in MICT-
data REDCap project under Visit 1.   
o If either the “Baseline Asthma and Medical History - participant version” and “EQ-
5D” has not been completed then the participants will need to do these steps first 
 
In the MICT-data REDCap project 
 
Go to ‘Visit Dates’ under Visit 1 
o Delete the data in the ‘Actual visit date’ field 
 
This must be blank for the BA and EQ-5D forms 
to be available 
 
o Have the participant log into the iPad 
o Have the participant go to their study gmail account (the icon on the iPad dock at 
the bottom) and open the emails with the links to the questionnaires 
o There is a separate email for each questionnaire 
o Have the participant complete all questionnaires 
 
For the “Baseline Asthma and Medical History - participant version” and 
“EQ-5D”, the participant will need to log into the study website to do these 
 
For all others, they will just click the link in the email 
 
Once all the questionnaires are complete, enter the ‘Actual visit date’ into ‘Visit Dates’ for 
Visit 1
 
o In the MICT-data REDCap project 
 
Click ‘Add/Edit Records’ and choose the participant ID for this participant 
 
Go to the ‘Visit Dates’ form under Visit 1 
 
Complete the field for ‘Actual visit date’ 
 
Set form as ‘Complete’  
 
Click ‘Save’ 
 
Note: When a date for this field has been saved, the participant is 
automatically given access to the Trial website (and Morning and Evening 


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118 
Reports) when logging in.  If no date has been saved, the participant only 
has access to the Consent website when logging in. 
 
Complete all the study procedure up to the point of demonstrating the features of the 
Trial website 
 
PFT data must be entered to obtain the Temporary Asthma Action Plan and have it 
available on the iPad  (Click here to see Study Coordinator REDCap Instructions for 
Visit 1 (Clinic) section in this MOP). 
o  
 
Completely shut down and restart the participant’s iPad  
o Hold down the Hold down the Sleep/Wake button for several seconds. 
 
o The iPad will prompt you to slide a button to power off the iPad. Follow the 
directions on the screen by sliding the button from the left side to the right to 
reboot the iPad. 
o If the iPad is frozen or stuck, hold down both the Sleep/Wake button and 
the Home button. This will force the iPad to power down. 
 
o The iPad screen will display the circle of dashes which indicates it is busy. Once 
the iPad has finished shutting down completely, the screen will go completely 
black. 
o Once the iPad's screen is completely black, hold down the Sleep/Wake button for 
several seconds. This will allow you to restart the iPad. 
o When the Apple logo appears in the middle of the screen, you can release the 
Sleep/Wake button. The iPad will restart shortly after the logo appears. 
o This will reset any cookies that have been saved and allow the participant to 
access the Trial website by entering their user name and password 
o The participant should now enter their user name and password and access the 
Trial website so that you can show them the Morning and Evening report (follow 
the instructions in section “iPad Review” (Click Click here to see “iPad 
Review” section in this MOP. Click this link to view the guide: Coordinator 
Instructions for Training Participants to use iPad at Visit 1. 
15.4. 
Is my Participant Using the Diskus Like They Should? 
Go to the MICT-DC Summary REDCap project and under Reports, click on “Med and diary 
reporting summary”. 
OR 
Go to MICT-data REDCap project and under Project Bookmarks, click on “Peak Flow report” 
 
Enter Nemours Username and password (MICTstudy2013) and you can see the 
counter number reported by your participant and what the expected counter 
number is based upon when the participant indicated they started a new diskus.   


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119 
 
 
15.5. 
What are my Participant’s Peak Flow Values? 
 
Go to the MICT-DC Summary REDCap project Under Reports, click on “Med and diary reporting 
summary”. 
OR 
Go to MICT-data REDCap project and under Project Bookmarks, click on “Peak Flow report” 
 
 
Enter Nemours Username and password (MICTstudy2013) and you can see the 
counter number reported by your participant and what the expected counter 
number is based upon when the participant indicated they started a new diskus.   
 
 
You will see the 65% and 85% limits for both the Temporary Asthma Action Plan (used from V1 to V3) 
and the Asthma Study Asthma Action Plan (used from V3 to V6).  The actual values will be green, yellow, 
or red to make it easy to view which zone a peak flow falls in.   


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120 
 
 
15.6. 
How Much Albuterol is my Participant Using? 
Go to the MICT-diary cards REDCap project 
 
Under Reports, click on “Drug use for quick relief” and you can see all the values for MDI and 
nebulizer.  If you use the find feature (ctr F) your participant ID will be highlighted and easier to 
see among all the others. 
 
 
15.7. 
Has my Participant had any Unscheduled Visits? 
Go to the MICT-diary cards REDCap project 
Under Reports, click on “Questions about urgent unscheduled medical attention” and you can 
see all the Evening Report questions and the participant responses.  If you use the find feature 
(ctr F) your participant ID will be highlighted and easier to see among all the others.  You will 
also have alerts sent to your email with these alerts but here you can see them all in one place. 
 
An alternative to see all alerts on your participant: 
Go to the MICT-diary cards REDCap project 
 
Under Project Bookmarks, click on “Alerts Summary”.  Enter Nemours Username 
and password (MICTstudy2013) and you can see the all the alerts that you have 
been sent by email over the study duration for your participant.   


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121 
15.8. 
How do I make Edits to my Participants Morning or Evening 
Reports? 
Go to the MICT-diary cards REDCap project 
Under Data Collection, click on “Add / Edit Records”.  Then look down to “Data Search” and 
“Choose a field to search”.  Select “record (Record) this is the primary key…” 
 
 
In the “Search Query” field start typing in the participant ID and date of interest in this format: 
orl131_2014-05-23 (upper or lower case for orl/wil/jax/pns/phl is fine).  You will see rows (15 
rows) of dates you can choose from as you start to type in.  If you only type in orl131_2014-05, 
you will see dates from May 1 to May 15. This search box only holds 15 rows. Type in the 
complete date to get to the record you want.   
 


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122 
 
 
In this example the date for ORL131_2014-0508 was selected: 
 
 
Select “morning” or “evening” (on the left) for the report you need to correct.  To correct an 
entry, make the change that is needed.  Then click on the little callout icon (like in comics for a 
character speaking). 
 
In the Comments box, write the justification for making the change (e.g., spoke the parent and 
the child did not go to the ED”).  You don’t need to sign your name because you will see that 
you are the user.  Your note will now show up under the comments for anyone else who logs 
into that record.  The “H” in the circle will show you the history of all the changes to that field. 
 


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123 
 
Also: Click here to see “Correcting Entry when Diskus Started but not Indicated on Diary 
Report” section in this MOP. 
15.9. 
Has my Participant Completed Enough Morning and Evening Reports 
to Qualify for Visit 3? 
Go to the MICT-data REDCap project 
Under Project Bookmarks, click on “Med and diary reporting summary”.  Enter Nemours 
Username and password (MICTstudy2013).  You will need to enter the participant ID (use caps 
for letters) and start and end date.  Make sure you use the correct format. 
 
Remember that in order to qualify for Visit 3, the participant must have completed 10 of the last 
14 days of diary entries (at least one Morning or Evening entry on 10 of the 14 days). 
 
15.10. 
Has my Participant Taken Advair 250/50 on Enough Days to Qualify 
for Visit 3? 
Go to the MICT-data REDCap project 
Under Project Bookmarks, click on “Med and diary reporting summary”.  Enter Nemours 
Username and password (MICTstudy2013).  You will need to enter the participant ID (use caps 
for letters) and start and end date.  Make sure you use the correct format. 
 
Remember that in order to qualify for Visit 3, the participant must have taken at least 1 dose per 
day for 21 of the last 28 days. 
 
15.11. 
How do I determine the mean PEF at Visit 3 for the Study Asthma 
Action Plan? 
Go to the MICT-data REDCap project 
Under Project Bookmarks, click on “Calculate mean PEF (for 14 days)”.  Enter Nemours 
Username and password (MICTstudy2013).  You will need to enter the participant ID (use caps 
for letters).  
 
TIP: 


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124 
Please note that if the current day (the day of Visit 3) PEF is needed to have 10 PEF values 
from the last 14 days to meet the randomization eligibility criteria then the calculation from that 
link will not include the current day.  This is because the data updates at 4AM each day.  
Therefore you will need to copy and paste the 9 available days into Excel, then get the day’s 
current PEF and add it to Excel.   
 
To get the current day’s PEF: 
Go to the MICT-diary cards REDCap project 
Under Reports, click on “Peak flow” and scroll to the participant and today’s date. You can also 
select “Ctrl F” and search in this format “JAX102_2014-01-08” [year-month-day]. 
 
Have Excel calculate the mean PEF for the 10 of the last 14 days of PEF data. 
15.12. 
What are all the Alerts I have Received on my Participant? 
Go to the MICT-data REDCap project 
Under Project Bookmarks, click on ‘MICT-alerts’, then under Project Bookmarks, click on “Alerts 
summary”.  Enter the Participant ID and the date range you are interested in.  
 
 
You will see all the alerts and from what type of entry it was generated from (eg. screening form, 
morning or evening report, etc).   
 
 
To see if you or another coordinator resolved the alert (if it needs to be resolved) (see the alert 
on 7/6/2014 about not being accessible by telephone), you will need to go to the original data 
form (e.g. screening form shown below) and click the balloon icon which will be yellow (vs. 
clear) if an entry has been made: 


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125 
 
 
You will be able to see who made the correction and what the resolution was (just looking at an 
entry (e.g. kblake on 8/18/2014) does not generate a new entry for this item): 
 
 
Note that the “Study staff notes” on the right are NOT the notes that you may have entered 
when you corrected the alert message on a Morning or Evening Report or study form.  You will 
need to go to the actual form (screening or morning or evening report) of the date of interest to 
view the comments. However, once you have edited the diary report or questionnaire as 
needed, you can return to this form to enter “Resolved” in the “Study Staff notes”.  To enter 
“resolved”, click on the link under the column “Record ID”.  Doing this step will then allow you to 
quickly see which alerts have been resolved as the participant progresses through the study. 
 
15.12.1. 
What alerts do I need to act on? 
15.12.1.1. Medical Issues  
Medical issues and adverse events need to be acted upon by the study coordinator 
immediately.  See Adverse Events section in this MOP. 
 
When to Assess 
 
Adverse events are assessed on a continual basis through the study from data collected 
on the Morning/Evening Reports, FaceTime appointments, onsite appointments, etc. 
 
(Click here to see Adverse Events section in this MOP). 
Medication Adherence: The parent should be notified if 
 
Adherence is below 70% consistently (over several days – use your judgment) 
 
If study medication has been missed for more than 14 days in a row (for either morning 
or evening doses (this would indicate that adherence is <50%) 
 
Missed Morning and Evening Reports: 
 
Review at the next FaceTime visit.  If morning reports are missed, remind the participant 
that we need their PEF in order to have their asthma action plan pop up on the iPad to 
help prevent an asthma exacerbation.  If evening reports are missed, remind the 
participant that this is the place they let us know about any medical events that have 
happened so that we can help with management right away.   
 
 


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126 
15.13. 
How can I find out if Heights have changed on my Participant? 
Go to the MICT-diary cards REDCap project 
Under Reports, click on “Height summary”.  Use “Ctrl F” to search by Participant ID and you can 
see all the heights recorded in REDCap. 
 
15.14. 
How can Another Coordinator Cover Alerts when I am Out of Town? 
Go to the MICT-data REDCap project.  You will need to add the email address of the 
coordinator who will be covering to each of your study participants “Study Information” form.  
This may be tedious but it is the only way. 
 
Select your first active participant and go to the “Study Information” form: 
 
 
 
Once the form is open, scroll down to where you will add the covering study coordinator: 
 
 
When you have returned, you can delete the covering study coordinator(s) email address. 
15.15. 
What Study Visits do I have Coming Up in the Next 28 Days? 
Go to the MICT-data REDCap project.  There are 2 ways to view your upcoming appointments.   
Viewing your upcoming appointments in REDCap is important because if you have changed the 
date between you and the participant, but have not updated REDCap to reflect the correct date, 
then the forms and questionnaires will be sent out either too soon (if the the actual visit date is 
LATER than in REDCap) OR won’t be sent in time for the visit if the actual visit date is 
SOONER than in REDCap). 
 
Method 1: 
Under Project Bookmarks, click on “Visits coming in the next 28 days”. 


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127 
 
Type in your Nemours user name and the password “MICTstudy2013”. 
 
 
Select your site. 
 
 
These are your visits in the next 28 days.  This will give you time to adjust REDCap to send out 
the forms at the correct date for your visit if needed. 


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128 
 
 
Method 2: 
Under Reports, click on “Visit dates – target, scheduled and actual”. 
 
 
Use “Ctrl F” to open the “find” window and type in your participant ID (for example ORL117) 
 
 
Under “Event Name”, you will see all the visit types such as Screening, Visit 1, etc.  Double 
check that the dates shown here are what you have in your outlook calendar.  If the dates in 


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129 
REDCap are incorrect please put the correct date in the visit dates field for your participant 
shown below. 
 
 
15.16. 
How to Use CTPayer Card for Online or Phone Purchases? 
You can cut and paste the below to email to the participant: 
 
When making a purchase online or over the phone, you must enter the billing address 
associated with your card.  The billing address is located on the card carrier that came with your 
card.   When making a purchase for an amount greater than your available balance, instruct the 
merchant to charge an amount equal to your available balance and then pay the remainder 
using another form of payment. 
Name for the Card should be listed: Nemours MICT 
The billing address listed on the card insert: 807 Children’s Way Jacksonville, FL 32207  
Enter your shipping name and address during the check out process. 
16. MICT Trac Site (Helpful Tools and Reference Pages [wiki 
pages]) 
 
Links to administrative web pages 
 
There are links to these web pages in various places in REDCap.  Many are in the left sidebar 
of the project MICT-data.  Some are within forms where the link would be used in the work flow. 
 
Each staff member has a single login name and password for these web pages.  Contact 
Suzanne or Chris if you need help remembering your login name or password.c 
Username: Nemours login 
Password: MICTstudy2013 
You’ll enter the username and password twice, then you will then to enter the Participant ID. 
 
LIVE web pages 
Send email message to parent’s email address with info about next phone call and consenting 
phone appointment date. 
https://apps.nemoursresearch.org/mict/admin/about_study_email.php 
 


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130 
List the visits for all participants that are scheduled in the next 28 days. This has links to each 
record in REDCap. This link is hard coded with a REDCap version number. REDCap currently 
converts the URL to the most recent REDCap version. When there are major upgrades to 
REDCap, this link should be checked to see if it is still being redirected to the correct url. 
https://apps.nemoursresearch.org/mict/admin/upcoming_visits.php 
 
Generates a report summarizing diary card submissions, study meds and Diskus counts taken 
for custom time frames for a single participant. 
https://apps.nemoursresearch.org/mict/admin/diary_submission.php 
 
Generates a report summarizing alerts for custom time frames for a single participant 
https://apps.nemoursresearch.org/mict/admin/alerts.php 
 
Generates a report summarizing peak flow measurements for custom time frames for a single 
participant. 
https://apps.nemoursresearch.org/mict/admin/peakflow_report.php 
 
Calculates the Baseline PEF for the past 14 days for a single participant. 
https://apps.nemoursresearch.org/mict/admin/baselinePEF.php 
 
Displays the Asthma Action Plan for a single participant. (This can be printed.) The Temporary 
Asthma Action Plan is displayed if the participant has completed visit 1 and not completed visit 
3. The Asthma Study-Asthma Action Plan is displayed if the participant has completed visit 3. 
https://apps.nemoursresearch.org/mict/admin/actionPlan.php 
 
 
TEST web pages 
Send email message to parent’s email address with info about next phone call and consenting 
phone appointment date. 
https://www.nemoursresearch.org/mict/admin/about_study_email.php 
 
List the visits for all participants that are scheduled in the next 28 days. This has links to each 
record in REDCap. REDCap currently converts the URL to the most recent REDCap version. 
When there are major upgrades to REDCap, this link should be checked to see if it is still being 
redirected to the correct url. 
https://www.nemoursresearch.org/mict/admin/upcoming_visits.php 
 
Generates a report summarizing diary card submissions, study meds and Diskus counts taken 
for custom time frames for a single participant. 
https://www.nemoursresearch.org/mict/admin/diary_submission.php 
 
Generates a report summarizing alerts for custom time frames for a single participant 
https://www.nemoursresearch.org/mict/admin/alerts.php 
 
Generates a report summarizing peak flow measurements for custom time frames for a single 
participant. 
https://www.nemoursresearch.org/mict/admin/peakflow_report.php 
 
Calculates the Baseline PEF for the past 14 days for a single participant. 
https://www.nemoursresearch.org/mict/admin/baselinePEF.php 
 


MICT MOP 
            │  131 
 
 
131 
Displays the Asthma Action Plan for a single participant. (This can be printed.) The Temporary 
Asthma Action Plan is displayed if the participant has completed visit 1 and not completed visit 
3. The Asthma Study-Asthma Action Plan is displayed if the participant has completed visit 3. 
https://www.nemoursresearch.org/mict/admin/actionPlan.php 
 
 
 
THE END! 

ICF_004.pdf: 
Approved by the Nemours IRB: 
Valid from: 
04/04/2014 
through 
04/03/2015 
IRB# JAX: 
332965 
 
 
 
 
 
 
Abbreviated Study Title: 
LASST RPA Ancillary 
 
Template Version Date: 03-13 
Document Revision 04/19/2013 
Page 1 of 2 
 
ADOLESCENT ASSENT FORM FOR YOUTH AGES 12-17 
 
Your parent has given permission for you to be in a project called a research study. But first, we 
want to tell you all about it so you can decide if you want to be in it. If you don’t understand, please 
ask questions. You can choose to be in the study, not be in the study or take more time to decide. 
 
What is the name of the study? 
Long-Acting Beta Agonist Step Down Study (LASST) – Ancillary Study “Assessment of the Research 
Consent Process” 
 
Who is in charge of the study? 
The doctor in charge of the study is Kathryn Blake, PharmD.  
 
What is the study about? 
We know that it is sometimes difficult to understand all the medical information a doctor may give to 
you when you are at a doctor’s appointment.  We are trying to find better ways of communicating 
with children about medical information.  We would like to find out how well you understand the 
information given to you about the study called “Long-Acting Beta Agonist Step Down Study”. 
 
Why are you asking me to be in this study? 
You are being asked to be in the study because you are interested in being in the study called 
“Long-Acting Beta Agonist Step Down Study”. 
 
What will happen to me in the study? 
At today’s visit, we will have you read over the form that explains the “Long-Acting Beta Agonist Step 
Down Study”.  Then you and the study staff will sit in a room with your parent, and the study staff will 
ask you questions about the “Long-Acting Beta Agonist Step Down Study”.  You will have lots of 
chances to ask your questions about the study too.  We will be audio recording your conversations 
with the study staff.  This part will take about 15 minutes.  After this part is over, we will ask you to 
look at some health information and then ask you a few questions about that information.  This part 
will take about 3 to 5 minutes. 
 
If you decide to be in the “Long-Acting Beta Agonist Step Down Study” you will do the same 
questions with the study nurse again at Visit 6.  We will audio record it then too.  The same parent 
who is with you at this visit will need to come with you at Visit 6.  This will help us understand how 
well the study staff tells you about the study while you have been in it. 
 
There is no benefit to you for being in this study.  There are no risks for you being in this study 
either.  
 
Will I be paid to be in this study? 
You will receive a $10 Walmart gift card at this visit and Visit 6 for participating in this audio-
recording of the communication between you and the study staff. There is additional payment if you 
participate in the main study, “Long-Acting Beta Agonist Step Down Study” which is described in the 
documents for that study. 


Approved by the Nemours IRB: 
Valid from: 
04/04/2014 
through 
04/03/2015 
IRB# JAX: 
332965 
 
 
 
 
 
 
Abbreviated Study Title: 
LASST RPA Ancillary 
 
Template Version Date: 03-13 
Document Revision 04/19/2013 
Page 2 of 2 
 
Do I have to be in the study?   
You don’t have to do the study if you don’t want to. If you are in the study, you can stop being in it at 
any time. Nobody will be upset with you if you don’t want to be in the study or if you want to stop 
being in the study. The doctors and nurses will take care of you as they have in the past. If you have 
any questions or don’t like what is happening, please tell the doctor or nurse. 
 
You have had the study explained to you. You have been given a chance to ask questions. By 
writing your name below, you are saying that you want to be in the study. 
 
 
Adolescent’s Signature 
 
Date 
 
 
 
 
 
 
 
 
 
 
 
 
Name of Person Obtaining Assent 
 
Signature of Person Obtaining Assent 
 
Date 
 

ICF_006.pdf: 
Approved by the Nemours IRB: 
Valid from: 
02/05/2016 
through 
02/04/2017 
IRB# JAX: 
332965 
 
 
 
 
 
 
Abbreviated Study Title: 
MICT 
 
Revised 09/06/2013  
1 
 
NEMOURS 
ADOLESCENT ASSENT FORM FOR YOUTH AGES 12-17 for the Asthma Research Study 
(revision date 09/23/2013) 
 
Title of Study: 
Use of Mobile Devices and the Internet to Streamline an Asthma Clinical Trial  
 
 
I have had the study explained to me.  I have been given a chance to ask questions.  By answering the 
question below, I am saying whether or not I want to be in the study. 
 
 
 
What is your decision about participating in this study called “Use of Mobile Devices and the Internet 
to Streamline an Asthma Clinical Trial”? 
 
 
q 
Yes, I want to participate in this study. 
 
q 
No, I do not want to participate in this study. 
 
Please type your first name in the box: 
This is your electronic signature. 
 
 
 
Please type your last name in the box: 
 
 
 

SAP_001.pdf: 
 
1 
Statistical Analysis Plan for “Use of Mobile Devices and the Internet to Streamline an Asthma Clinical Trial” 
 
Power and Statistical Analysis  
A sample size was determined for Specific Aim 1 (comprehension and retention following PPA between 
participants enrolled in MICT and LASST), with subsequent assessment of dwetectable differences for Specific 
Aims 2 and 3 using that sample size. Because our hypothesis is that our novel PPA process will be at least as 
good as the conventional process, we have elected to use a non-inferiority design.  We used the preliminary 
parent data described above (Section B Innovation), assumed normalcy of the data, and defined the non-
inferiority margin as 2.4, which corresponds to 0.5 standard 
deviation to calculate the power for a range of sample sizes (see 
Table 3).  
 
Based on these calculations and other considerations discussed 
below, we propose to randomize 120 participants: 60 participants 
into the MICT project and 60 participants into the LASST study.  
This will give us greater than 80% power to reject the hypothesis 
that the novel PPA process is worse than the conventional 
process at a threshold of 2.4 units on the questionnaire scale, 
after allowing for approximately 10% loss to follow-up. 
 
For Aim 2, because we are unaware of meaningful measures to establish non-inferiority margins for 
completeness and quality of data collection, we will use 0.5 SD as a qualitative measure of non-inferiority.  We 
anticipate this sample size will allow us to estimate the proportion of study days with diary data with a 95% 
confidence interval width of 15%.  For example, in a recently completed ALA-ACRC pediatric trial, the 
proportion of days with a diary card entry was 90%, the corresponding 95% confidence interval would be 
82.5% to 97.5%.  If the upper bound of the 95% confidence for study days with diary card data for participants 
assigned to MICT exceeds the lower bound of the participants enrolled in LASST, we will accept the non-
inferiority hypothesis.  The second objective of Aim 2 is to evaluate the comparability of the quality of 
spirometry from MICT and LASST.  We will employ the spirometry review system currently used in an ALA-
ACRC trial, which grades each spirometry session with a letter grade (A to F).  For initial spirometry sessions, 
the current overall Grade Point Average (GPA) is 3.68, with a standard deviation of 0.67.  Using these values, 
with a sample size of 60 in each of LASST and MICT, we expect to be able to estimate spirometry quality using 
a similar review system with a 95% confidence interval ranging from approximately 3.51 to 3.85, which should 
be adequate to allow us to compare spirometry quality in the two groups. 
 
For Aim 3, we will have greater than 90% power to detect a clinically meaningful difference of 3 in the ACT 
score 123,124 between one of the treatment arms in LASST and the corresponding treatment arm in MICT, 
assuming a mean score of 19 with a standard deviation of 4 (data from ALA-ACRC trial).  We plan to perform 
these analyses using a non-inferiority approach; that is, as long as the MICT result is not worse than the 
corresponding LASST result, we will conclude that the streamlined approach has not impaired study conduct. 
 
We will compare the Research Participation Assessment scores of those participating in MICT with those 
participating in LASST (Specific Aim 1) and data completeness and quality GPA (Specific Aim 2) using t-tests 
without adjustment.  We will consider the novel interactive consent process to be non-inferior to the traditional 
process if the upper bound of the 95% confidence interval for the difference L-M (LASST minus MICT) is less 
than 2.4, our a priori margin of non-inferiority as determined from pilot data using the assessment. We will use 
a similar approach for the evaluating non-inferiority of data quality.   
 
For Aim 3, we will compare ACT scores within each treatment group between the LASST and MICT groups, 
using a multivariate regression model that incorporates both trial and treatment group.  We will evaluate the 
contrast for each treatment group and determine if there is evidence to support an interaction between 
treatment group and trial.  If there is not sufficient evidence to support an interaction, we will perform the test of 
the trial effect on the change in ACT score without including an interaction term.  In all cases, primary analyses 
will use crude (unadjusted) comparisons, although we will also report analyses that include adjustments for 
possible differences between the MICT and LASST groups in important demographic characteristics. 
Table 3. Sample Size Determination 
Effect Size:  2.4 (0.5 standard deviation) 
Total N 
N Per Group 
Power* 
90 
45 
0.761 
100 
50 
0.799 
110 
55 
0.832 
120 
60 
0.859 
130 
65 
0.883 
140 
70 
0.903 
*Type I error rate (1-sided) of .05 


 
2 
 
Interim Reviews  
No interim analyses for MICT are planned.