Interventions to Help Asthma Clinical Adherence
Phase: NA
Conditions: Asthma in Children, Humans, Hispanic Americans, Child
Sponsor: University of California, San Francisco

ClinicalTrials.gov Uploaded Document Cover Page 
COVER PAGE 
Study Title Interventions To Help Asthma Clinical Adherence (ITHACA) 
NCT Number NCT02999789
Document Description Study Protocol 
Document Date 28 January 2019

Study Application (Version 1.10)
1.0
General Information
*Enter the full title of your study:
Interventions To Help Asthma Clinical Adherence
 
 
*Enter the study number or study alias
ITHACA
* This field allows you to enter an abbreviated version of the Study Title to quickly identify this 
study.
 
 
2.0
Add Department(s)
2.1 List the departments associated with this study. The Principal Investigator's department 
should be Primary.:
Primary 
Dept?
Department Name
UCSF - 
 - M_PEDS-ZSFG
136261
 
3.0
List the key study personnel: (Note: external and affiliated collaborators who 
are not in the UCSF directory can be identified later in the Qualifications of 
Key Study Personnel section at the end of the form)
3.1 *Please add a Principal Investigator for the study:
 
Cruz, Edward S, M.D., M.P.H.
Select if applicable
Department Chair
Resident
Fellow
If the Principal Investigator is a Fellow, the name of the Faculty Advisor must be supplied below.
 
3.2 If applicable, please select the Research Staff personnel:
 
A) Additional Investigators
Cabana, Michael D, MD, MPH 
 Other Investigator
B) Research Support Staff
Arteaga, Vanessa M 
 Study Coordinator
Valenzuela, Miriam B 
N

 Research Assistant
3.3 *Please add a Study Contact:
 
Cruz, Edward S, M.D., M.P.H. 
The Study Contact(s) will receive all important system notifications along with the Principal 
Investigator. (e.g. The project contact(s) are typically either the Study Coordinator or the Principal 
Investigator themselves).
3.4 If applicable, please add a Faculty Advisor/Mentor:
 
Cabana, Michael D, MD, MPH
3.5 If applicable, please select the Designated Department Approval(s):
 
Fuentes-Afflick, Elena MD, MPH, MD, MPH 
Scientific Reviewer
Add the name of the individual authorized to approve and sign off on this protocol from your 
Department (e.g. the Department Chair or Dean).
4.0
 Qualifications of Key Study Personnel
4.1  November, 2015 - NEW Definition of Key Study Personnel and CITI Training 
Requirements:    
  
include the Principal Investigator, other investigators and research 
UCSF Key Study Personnel 
personnel who are directly involved in conducting research with study participants or who are directly 
involved in using study participants’ identifiable private information during the course of the 
research. Key Personnel also include faculty mentors/advisors who provide direct oversight to 
        
Postdoctoral Fellows, Residents and Clinical Fellows serving as PI on the IRB application.
 
The 
IRB requires that all Key Study Personnel complete Human Subjects Protection 
Training through CITI prior to approval of a new study, or a modification in 
which KSP are being added. More information on the CITI training requirement 
can be found on our website.
    
   
List the study responsibilities and qualifications of any individuals who qualify as Key Study 
 (KSP) at UCSF and affiliated sites ONLY by clicking the "Add a new row" button. 
Personnel
This 
 
information is required and your application will be considered incomplete without it.
KSP Name
Description of Study 
Responsibilities
Qualifications
Cruz, Edward S, M.D., M.P.H.
Principal Investigator, Project 
Director, Subject Contact 
Study: Oversees all aspects of 
the proposed study, including 
design, data collection, 
analysis, recruitment, 
informed consent, and 
reporting of results.
Dr. Cruz is a MD and Assistant 
Clinical Professor at UCSF 
Department of Pediatrics. He 
has a Masters in Public Health 
and completed a primary care 
research fellowship prior to his 
faculty appointment where he 
was trained in conducting 
studies like this one.
Dr. Cabana, Michael D MD, 
MPH, MD, MPH
Co-Investigator, Faculty 
Advisor, Subject Contact 
Study: Oversees management 
of entire project, data 
collection, data management, 
protocol adherence, and 
Dr. Cabana is a MD and 
Professor at UCSF Department 
of Pediatrics. He has over 10 
years of research and clinical 
experience in conducting 
studies like this one.

dissemination of findings. Will 
help with study design, 
interpretation of results, and 
editing the manuscript.
Valenzuela, Miriam B
Research Assistant: Will assist 
in recruitment for this study, 
informed consent, data 
collection and entry, following 
up with study participants, 
troubleshooting patient 
reminder device.
Miriam Valenzuela was hired 
to be the Research Assistant 
on this study. She has 
experience doing research 
with the Health Advocates 
Program at UCSF.
Arteaga, Vanessa M
Clinical Research Coordinator: 
Will assist in recruitment for 
this study, informed consent, 
data collection and entry, 
following up with study 
participants, troubleshooting 
patient reminder device.
Vanessa Arteaga was hired to 
be the Research Coordinator 
on this study. She has 
experience doing research 
with the Health Advocates 
Program at UCSF.
5.0
 Initial Screening Questions - Updated 9/13
(Note: You must answer every question on this page to proceed).
If you are converting to the new form, check questions 5.4, 5.6, 5.7, 5.8 
and 5.10 before saving and continuing to the next section.
5.1  
 Application type:
*
Full Committee 
Expedited 
Exempt 
5.2  
 Risk level 
:
*
(Help Text updated 9/13)
Minimal risk 
Greater than minimal risk 
5.3  
 Subject contact:
*
Yes (including phone, email or web contact) 
No (limited to medical records review, biological specimen analysis, and/or data analysis) 
5.4  
 Funding (past or present):
*
Funded or will be funded (external sponsor, gift, program or specific internal or departmental funds) 
Unfunded (no specific funds earmarked for this project) 
Unfunded student project 
5.5  
The Principal Investigator and/or one or more of the key study personnel has 
 
* 
financial interests
related to this study:
  Yes   
  No
If 
, the Conflict of Interest Advisory Committee (COIAC) office may contact you for additional 
Yes
information.

5.6  
This is an investigator-initiated study:
* 
 Yes   
 No
5.7  
This study 
 involves retrospective records review and/or identifiable biospecimen analysis:
* 
ONLY
  Yes   
  No
5.8  
This is a clinical trial:
* 
 Yes   
 No
Clinical Trial Registration
"NCT" number for this trial:
5.9  * This is a multicenter study:
  Yes   
  No
5.10  
This application involves the study of 
 or 
 drugs, devices, biologics or in vitro 
* 
unapproved
approved
diagnostics:
 Yes   
 No
5.11  * This application involves a Humanitarian Use Device:
No 
Yes, and it includes a research component 
Yes, and it involves clinical care ONLY 
5.12  
This study involves human stem cells (including iPS cells and adult stem cells), gametes or 
* 
embryos:
No 
Yes, and requires CHR and GESCR review 
Yes, and requires GESCR review, but NOT CHR review 
5.13  * This is a CIRB study (e.g. the NCI CIRB will be the IRB of record):
  Yes   
  No
5.14  
This application includes a request to rely on another IRB (other than NCI CIRB):
* 
  Yes   
  No
Note: If this request is approved, the CHR will 
 review and approve this study. Another institution will 
NOT
be the IRB of record.
6.0
 Funding

6.1  Identify all sponsors and provide the funding details. If funding comes from a Subcontract, please list 
only the Prime Sponsor:        
 
Note: we require only a P Number 
 an A Number for 
OR
funding coming through UCSF. Please avoid these common errors in funding 
       
documentation: 
 
 
DO NOT add the A Number if a P Number was already provided OR update 
the A Number field when a new funding cycle begins. The IRB does NOT 
use this information or want these changes made.   
 add a grant continuation as a new funding source. 
DO NOT
External Sponsor:
View 
Details
Sponsor Name
Sponsor Type
Awardee 
Institution
Contract 
Type:
UCSF RAS 
"P 
number" 
or 
eProposal 
number 
UCSF 
RAS 
System 
Award 
Number 
("A" + 
6 
digits) 
Academic Pediatric 
Association, Inc. 
05 
UCSF 
Grant 
P0508095  
Sponsor Name:
Academic Pediatric Association, Inc. 
Sponsor Type:
05 
Sponsor Role:
Funding
CFDA Number:
 
Grant/Contract Number:
P0508095 
Awardee Institution:
UCSF 
Is Institution the Primary Grant 
Holder:
Yes 
Contract Type:
Grant 
UCSF RAS "P number" or 
eProposal number:
P0508095 
UCSF RAS System Award Number 
("A" + 6 digits):
 
Grant Number for Studies Not 
Funded thru UCSF:
 
Grant Title:
Interventions To Help Asthma Clinical Adherence (ITHACA) 
PI Name:
(If PI is not the same as identified 
on the study.)
Edward Cruz 
Significant Discrepancy:
 
Gift, Program, or Internal Funding (check all that apply):
Funded by gift (specify source below)
Funded by UCSF or UC-wide program (specify source below)
Specific departmental funding (specify source below, if applicable)
List the gift, program, or departmental funding source:
6.2    
   
If you tried to add a sponsor in the question above and it was not in the list, follow these steps:

If funding has already been awarded or the contract is being processed by the Office of 
Sponsored Research (OSR) or Industry Contracts Division (ICD), your sponsor is already in the 
system and the project has an eProposal Proposal or Award number. Check with your 
department's OSR Staff or ICD Officer to ask how the sponsor is listed in the UC sponsor list 
and what the Proposal or Award number is. Click 
 to find your OSR staff and 
 to find 
here
here
your ICD staff.
If your sponsor is not yet in the list, enter it in the box below.
Sponsor not in list 
Only if your sponsor is not yet in the list, type the sponsor's name:
If the funding is administered by the UCSF Office of Sponsored Research, your study will not 
receive CHR approval until the sponsor and funding details have been added to your 
application.
6.3  
This study is currently supported in whole or in part by Federal funding OR has received ANY 
* 
Federal funding in the past 
:
(Help Text updated 9/13)
  Yes   
  No
If 
, indicate which portion of your grant you will be attaching:
yes
The Research Plan, including the Human Subjects Section of your NIH grant or subcontract
For other federal proposals (contracts or grants), the section of the proposal describing human 
subjects work
The section of your progress report if it provides the most current information about your human 
subjects work
The grant is not attached. The study is funded by an award that does not describe specific plans for 
human subjects, such as career development awards (K awards), cooperative agreements, program 
projects, and training grants (T32 awards) OR UCSF (or the affiliate institution) is not the prime 
recipient of the award
7.0
 Sites
7.1  Institutions (check all that apply):
UCSF
China Basin
Helen Diller Family Comprehensive Cancer Center
Mission Bay
Mount Zion
San Francisco General Hospital (SFGH)
SF VA Medical Center (SF VAMC)
Blood Centers of the Pacific (BCP)
Blood Systems Research Institute (BSRI)
Fresno (Community Medical Center)
Gallo
Gladstone
Institute on Aging (IOA)
Jewish Home
SF Dept of Public Health (DPH)
7.2  Check all the other types of sites not affiliated with UCSF with which you are cooperating or 

collaborating on this project 
:
(Help Text updated 9/13)
Other UC Campus
Other institution
Other community-based site
Foreign Country
List the foreign country/ies:
7.3  Check any research programs this study is associated with:
Cancer Center
Center for AIDS Prevention Sciences (CAPS)
Global Health Sciences
Immune Tolerance Network (ITN)
Neurosciences Clinical Research Unit (NCRU)
Osher Center
Positive Health Program
8.0
 Study Design
8.1  
Study design 
:
* 
(Help Text updated 9/13)
For this pilot phase, I plan to recruit 20 children ages 5 to 17 years with a diagnosis of persistent asthma 
who require a daily inhaled corticosteroid metered dose inhaler and whose primary caregiver has limited 
English Proficiency (LEP), whose primary language is Spanish, and whose parent is the person responsible 
for administering their daily asthma medication.  Newer literature has cited that measuring Parental LEP 
was superior to primary language spoken at home in terms of measuring the impact of language barriers 
on children’s health and health care (Flores et al.).
Initially, the sample size was increased to 30 because after the SmartInhalers were purchased, it was 
noted that the Flovent-compatible device had an additional feature of a visual reminder that the Qvar-
compatible device did not have.  Both have an audio reminder built in.  This visual reminder can also 
remind study participants to take their missed medication.  Due to the Flovent SmartInhaler’s additional 
feature reminding patients, I stratified the participants into two groups according to the type of 
SmartInhaler they were using.  I was aiming to recruit 15 participants to use the Flovent SmartInhaler and 
15 participants to use the Qvar SmartInhaler.  After consented, participants received a SmartInhaler 
device (either Qvar or Flovent) and it was attached to the asthma medication device.  A participant's parent
/guardian may have been asked to approve a change of medication from Qvar to Flovent or vice-versa in 
order to be eligible for each arm if the arm they wished to enroll in was already filled. The participant's 
primary care provider or asthma care provider was asked to approve the switch also. After the study was 
completed, the parent/guardian, primary care provider, and/or asthma care provider can switch the 
medication back to the original medication they were on if they wish.  
 
On February 16, 2018, Teva Pharmaceutical Industries Ltd. announced that production of Qvar was being 
discontinued and instead the QVAR
 RediHaler
 (beclomethasone dipropionate HFA) Inhalation Aerosol 
®
™
was now being launched on the market. As a result of that change and because the dimensions of the new 
device were incompatable with the Qvar SmartInhaler, I can no longer recruit participants on Qvar 
RediHaler.  Only participants on Flovent can participate in the study.  The alternate option is to change the 
patient's daily medication from Qvar RediHaler to Flovent to be compatable with the SmartInhaler.  The 
sample size will naturally decrease to 20 as only 7 total Flovent SmartInhalers remain.   A participant's 
parent/guardian may be asked to approve a change of medication from Qvar to Flovent in order to be 
initially eligible for the study or continue being in the study. The participant's primary care provider or 
asthma care provider will be asked to approve the switch also.
 
During the first six-weeks of the study, I will determine baseline daily asthma medication rates using the 
Smart-Inhaler device with the reminder system inactivated and also assess baseline asthma symptom 
control.  During the subsequent six-week period, I will turn on the reminder system for half of the study 
participants and continue to keep the reminder system off for the other half.  Once the reminder system is 
on, data regarding daily asthma medication adherence can be obtained using the SmartInhaler and sent to 

1.  
2.  
3.  
our data center. During the final six-weeks of the intervention period, I will turn on the reminder system 
for the remaining fifteen participants.  During the final visit for all participants, I will assess asthma 
symptom control, collect the SmartInhaler devices and obtain patient feedback on its usefulness.
 
Flores, G., Abreu, M., & Tomany-Korman, S. C. (2005). Limited english proficiency, primary language at 
home, and disparities in children's health care: how language barriers are measured matters. Public health 
,
(4), 418.
reports 120
8.2  If this is a clinical trial, check the applicable phase(s) 
:
(Help Text updated 9/13)
Phase I
Phase II
Phase III
Phase IV
9.0
 Scientific Considerations
9.1  Hypothesis 
:
(Help Text updated 9/13)
This study has a hypothesis:
 Yes   
 No
If yes, state the hypothesis or hypotheses:
 
The reminder system intervention will increase daily asthma medication adherence for children with 
persistent asthma whose parents have Limited English proficiency (LEP) and whose primary 
language spoken at home is Spanish compared to baseline medication adherence rates.
The reminder system intervention will help improve adherence, affect self-management, asthma 
symptom control, parental self-efficacy, and improve parental and child quality of life (QOL) in 
children with persistent asthma whose parents have Limited English Proficiency (LEP) and whose 
primary language spoken at home is Spanish compared to baseline.
The reminder system device will be most useful for those patients are characterized as ‘forgetful’ 
and who do not unilaterally manipulate their own medication regimen.
 
9.2  
List the specific aims:
* 
The 
 is to conduct a pilot test to estimate the effect of a novel reminder system in improving 
overall aim
daily asthma medication adherence rates in children whose parents have Limited English Proficiency (LEP) 
and whose primary language spoken at home is Spanish.  The 
 aim is to determine if a novel reminder 
first
system can improve daily asthma medication adherence during a six-week evaluation period when 
compared to baseline medication adherence rates during a six-week period in the same group.  The second
aim is to determine whether a novel reminder system can improve asthma symptom control during a short-
term, six-week evaluation period.  The 
 aim is to assess if there are specific, patient behavior 
third
characteristics which are associated with the success of a novel asthma medication reminder system.  
 
9.3  Statistical analysis: 
For Aim 1, we recognize that some patients may already have high levels of adherence and it may be 
difficult to improve levels that are already close to 100%.  As a result, we will use the run-in adherence 
percentage as the ‘baseline’ adherence for each patient. We will compare the medication adherence 
percentage during the study period with the medication adherence during the run-in period. The difference 
between the medication adherence percentages during the two time periods (Adherence Delta) will be 
calculated for each patient.  Assuming a normal distribution, we will compare the mean “adherence delta” 
for each group using a student t-test.  

 
For Aim 2, we will use the run-in asthma symptom control measure and the run-in asthma QOL measures 
as the ‘baselines’ for each patient.  We will compare the asthma symptom control measure and QOL 
measures during the study period and the run-in period. We will use the Childhood Asthma Control Test 
(C- ACT) which is for patients 4 to 11.  We will not be using the regular Asthma Control Test (ACT) 
because this is geared for adolescents who self-administer their daily asthma medication and this study is 
only recruiting patients whose parents or guardians administer their daily asthma medication.  The C-ACT 
is a 7 item scale, with scores ranging from 0 (poor asthma control) to 27 (complete asthma control). In 
general, a C-ACT score >19 indicates well-controlled asthma. The difference between the asthma control 
during the two time periods (asthma symptom control Delta) will be calculated for each patient.  We will 
compare the mean C-ACT differences for each group using a student t-test.
In regards to QOL, we will use the Pediatric Asthma Quality of Life Questionnaire (PAQLQ), an asthma-
specific quality of life scale that has been validated in children and adolescents aged seven to 17 
years.   We will also use the Pediatric Asthma Caregiver Quality of Life Questionnaire (PACQLQ).  It 
measures issues that caregivers may be experiencing as a result of their child’s asthma.  The PAQLQ 
measures overall quality of life with asthma using 23 questions (Juniper et al.). Each answer is evaluated 
on a seven-point Likert scale, resulting in a total score that could range from 23 (lowest quality of life) to 
161 (highest quality of life). The scale includes measurement of the impact of asthma in three areas: 
activity limitation (five questions, score range 5–35), symptoms (10 questions, score range 10–70), and 
emotional function (8 questions, score range 8–56).  The PACQLQ contains 13 questions with a seven-
point Likert scale resulting in a total score of 13 (lowest) to 91 (highest).  Both the PACQLQ and the 
PAQLQ have good validity and a change in score greater than 0.5 on the seven-point Likert scale can be 
considered clinically important. Overall PAQLQ/PACQLQ domain scores will be calculated for each 
participant during the study period and the run-in periods.  Overall and domain-specific PAQLQ/PACQLQ 
scores will be compared using general linear model repeated measures ANOVA.  
In regards to measuring parental self-efficacy, we will use the Parent Asthma Management Self-efficacy 
(PAMSE) scale.  The questionnaire measures parental self-efficacy for the management and prevention of 
acute asthma exacerbations. (Bursch et al.)  This scale consists of 13 questions. Each answer is evaluated 
on a five-point Likert scale, resulting in a total score of 65 with the higher score indicating higher parental 
self-efficacy.  The scale has reliability and validity.  PAMSE scores will be calculated for each parent during 
the study period and the run-in periods.   Overall scores will be compared using general linear model 
repeated measures ANOVA.
 
For Aim 3, to assess if there are specific, patient behavior characteristics which are associated with the 
success of a novel asthma medication reminder system, we will identify those patients whose adherence 
rates increased by at least 20%. We will compare the scores of the Reported Adherence Medication (RAM) 
Scale for those patients with a change in adherence compared to those patients with no improvement in 
adherence (Wroe, 2002).  We will use a chi-squared test to assess if the RAM scores which suggest 
‘forgetful nonadherence’ are associated with improved adherence rates during exposure to the reminder 
system.
 
 
9.4  If this study has undergone scientific or scholarly review, please indicate which entity performed the 
review:
Cancer Center Protocol Review Committee (PRC) (Full approval is required prior to final CHR approval 
for cancer-related protocols.)
CTSI Clinical Research Center (CRC) advisory committee
Departmental scientific review
Other:
Specify 
:
Other
10.0
 Background
10.1  Background:
Asthma, a chronic inflammatory disease of the lungs, contributes to significant child morbidity through 
decreased quality of life, school absenteeism, emergency room visits, exercise limitation, hospitalizations 
and death.  Medicaid-enrolled children have disparities in asthma care and increased adverse events 
secondary to asthma as compared to children with private insurance. (Vila, 2010; Liu, 2009; Lin, 2007; 

Chabra, 1998)  Enhancing patient medication adherence is a key component of successful asthma 
management and treatment (NAEPP, 2007). Adherence is the final common pathway by which all 
innovations are translated into improved patient outcomes (Osterberg, 2005).  However, current patient 
medication adherence rates are only 40-70% in practice (Bozek, 2010; Latry, 2008; vanDellen, 2008; 
Clerisme-Beaty, 2011).  These low rates of patient adherence lead to poor asthma control (Lasmar, 2009, 
Krishnan, 2004), preventable morbidity, and unnecessary health care utilization (Williams, 2004; Bender, 
2004).
Methods to improve patient asthma medication adherence could enhance current therapies and impact 
disease morbidity (Cabana, 2011).  Overall, there are a dearth of methods to improve medication 
adherence that have been rigorously evaluated. If successful, these techniques can be translated into 
practical strategies to influence everyday asthma management. There are several small studies of different 
adherence interventions, such as:  supportive accountability (Burgess, 2010), altered expectation (Wise, 
2009) reminder systems (Strandbygaard, 2010), tailoring treatment schedules (Chappuy, 2010) and 
motivational interviewing (Riekert, 2009). Selection of a specific adherence intervention depends on a 
‘match’ with the (a) study population, (b) intervention, (c) context or reason for non-adherence, as well as 
(d) the importance and novelty of the intervention for asthma care.
There are different reasons for non-adherence which may be more amenable to specific types of 
interventions.  For example,
’ or ‘Intelligent’ nonadherence is associated with patient lack of 
 ‘Deliberate
agreement or motivation.  In this case, motivational interviewing may be an appropriate intervention. ‘Unin
’ or ‘Unwitting’ nonadherence occurs when a patient incorrectly interprets medication instructions, 
tentional
which then leads to non-adherence. In this case, enhanced asthma education may be the most appropriate 
intervention.  ‘
’ or ‘Erratic’ nonadherence is associated with patient intent to take the medication, 
Forgetful
but the inability to remember to use the medication. In this case, a reminder system may be the most 
appropriate intervention. ‘Forgetful’ nonadherence is reported to be the most common cause of 
nonadherence (Weinstein, 2005).
One potential intervention to address the most common reason for nonadherence (‘forgetful’ 
nonadherence) is a ‘smart’ reminder system device that monitors medication use and can send messages 
to patients to remind them to take their medications With the ubiquitous nature of text-messaging 
. 
capabilities in cell phones, short-text messaging (STM) systems coupled with a medication device monitor 
can potentially be used to remind patients about daily medication adherence (Strandbygaard, 2010).
The proposed pilot study in digital health represents a new area of investigation for our team.  Our team 
has developed, evaluated and published successful interventions to help improve physician counseling 
about asthma, as well as patient medication adherence.  The effect of new technologies to track patient 
symptoms and medication use may have positive or negative effects on the provider-patient 
relationship.  Devices that unobtrusively collect adherence data can help providers assess the effects of 
prescribed medications and frequency of use, which can make patient management and communication 
more clear and efficient; however, patient feedback about adherence needs to be provided in a 
constructive manner. This new monitoring information creates a new dimension in the provider-patient 
relationship. The proposed study represents the first pilot study by our team to develop experience using 
these digital health interventions.  Overall, this study is the first step in developing interventions that 
combine physician counseling and the use of digital health tools to track and measure adherence.  
Due to language and cultural barriers, Latino patients have had little access to new technologies such as 
patient reminder systems.  We have developed a partnership with Adherium (formerly called Nexus6 
from Auckland, New Zealand) to modify a medication monitoring system to send reminder messages in 
Spanish. There are no studies that have used a novel monitoring system to transmit reminder messages to 
Spanish-speaking guardians of children with persistent asthma.
As a result, we are proposing a pilot trial to assess the effectiveness of a novel digital health patient 
reminder system (SmartInhaler) in improving asthma medication adherence in children whose parents 
have LEP and are monolingual Spanish-speaking.  The proposed nterventions o 
elp sthma linical dh
I
T
H
A
C
A
erence (ITHACA) pilot study is a key step in evaluating asthma medication reminder systems, assessing 
which patients benefit from such interventions, and understanding the potential magnitude of such 
effects.  
 
 
 
10.2  Preliminary studies:
The promising nature of the reminder system intervention for asthma was confirmed by a recent 
systematic review.  The systematic review was conducted by using all titles of published clinical trials in 
the National Library of Medicine focused on reminder systems and asthma medication adherence.  894 
potential articles were reviewed and 7 patient-level intervention studies were found for medication 
adherence (as opposed to immunization reminders or physician-oriented reminders). The studies used 
outmoded systems with reminders that were ‘infrequent’ and/or ‘non adaptable’ and would send reminders 
regardless of patient adherence. Despite the use of outdated technology in these studies, all studies 
suggested higher patient medication adherence for those patients randomized to the ‘reminder’ group, 
compared to the control group. The mean difference in adherence between groups was 18% in the follow-
up periods.  None of the studies routed reminders to cell phones/e-mail and the inhaler. New advances in 

cell phone technology and routing systems, offer an opportunity to improve adherence rates and tailor 
systems to patient preferences.  New systems offer the ability to deliver reminders to patients only when 
necessary, as well as to multiple settings (cell phone call, text message, e-mail, etc.) based on patient 
preferences.
Members of our team has experience in asthma care, health education and the development 
and evaluation of interventions to improve physician management of asthma.  For example, One 
member of our team developed the Physician Asthma Care Education (PACE) program (Cabana, 2006). 
The PACE intervention consists of interactive physician seminars sessions to review asthma guidelines, 
specific communication techniques and key asthma educational messages. We conducted a national, 
cluster-randomized controlled trial with 101 primary care providers and a random sample of 870 of their 
asthma patients in 10 regions in the US. At each site, we recruited a local instructional team and 
standardized the PACE curriculum.   As part of the evaluation, we interviewed a random sample of each of 
the asthma patients of the 101 providers. One year after the intervention, compared to controls, parents 
reported that physicians in the intervention group were more likely to inquire about patients’ asthma 
concerns (OR 1.73; 95% CI: 1.17, 2.58); encourage patients to be active (OR: 1.71; 95% CI: 1.13, 2.59); 
and set treatment goals (OR: 1.50; 95% CI: 1.02, 2.24).  Patients of physicians that attended the PACE 
program had a greater decrease in days limited by asthma symptoms (8.5 vs. 15.6 days; p< 0.05), and 
decreased ED asthma visits (0.30 vs. 0.55 visits/year; p< 0.05). (Cabana, ‘06) During the PACE 
evaluation, we developed data collection tools which include a parent telephone survey, and a self-
administered physician survey.
Although the patient reminder system's effect on asthma medication adherence has not been studied in 
Spanish-speaking patients, preliminary studies in children and adolescents have found increased 
adherence when using a patient reminder system. (Chan, 2015)  The effect of new digital health 
technologies to track patient symptoms and medication use may have positive or negative effects on the 
provider-patient relationship.  Overall, the proposed ITHACA study represents our team’s systematic 
approach to the incorporation, development and evaluation of digital health technology to complement 
asthma patient education and counseling.
 
10.3  References:
Bender BG, BG, et al. Medication non-adherence. 
. 2004; 4: 191-195.
Curr Opin Allergy Clin Immunol
Bozek A, Jarzab J. Adherence to asthma therapy in elderly patients. 
. 2010; 47: 162-165.
J Asthma
Bursch, B., Schwankovsky, L., Gilbert, J., & Zeiger, R. (1999). Construction and validation of four 
childhood asthma self-management scales: parent barriers, child and parent self-efficacy, and parent 
belief in treatment efficacy. Journal of Asthma, 36(1), 115-128.
Burgess SW, Sly PD, Devadason SG. Providing feedback on adherence increases use of preventive 
medication by asthmatic children. 
. 2010; 47: 198-201.
J Asthma
Cabana MD, et al.  Recent developments in asthma education. 
. 2011; 11:132-6.
Curr Opin All Clin Immunol
Cabana MD, Slish KK, Evans D, Mellins RB, Brown RW, Lin X, Kaciroti N, Clark NM.  Impact of physician 
asthma care education on patient outcomes.  
  2006;117:2149-57.
Pediatrics.
Chabra A, Chavez GF, Adams EJ, Taylor D. Characteristics of children having multiple Medicaid-paid 
asthma hospitalizations. 
Dec 1998;2(4):223-229.
Maternal and child health journal. 
Chan AH, Stewart AW, Harrison J, Camargo CA Jr, Black PN, Mitchell EA.  The effect of an electronic 
monitoring device with audiovisual reminder function on adherence to inhaled corticosteroids and school 
attendance in children with asthma: a randomised controlled trial. 
. 2015; 3:210-9.
Lancet Respir Med
Chappuy H, Treluyer JM, Faesch S, Giraud C, Cheron G. Length of the treatment and number of doses per 
day as major determinants of child adherence to acute treatment. 
. 2010; 99:433-437.
Acta Paediatrica
Clerisme-Beaty EM, et al. The Madison Avenue effect: how drug presentation stype influences and 
outcome in patient s with asthma.  
.  2011; 127: 406-411.
JACI
Juniper, E. F., Guyatt, G. H., Feeny, D. H., Ferrie, P. J., Griffith, L. E., & Townsend, M. (1996). Measuring 
quality of life in children with asthma.
, (1), 35-46.
Quality of life research 5
Juniper, E. F., Guyatt, G. H., Feeny, D. H., Ferrie, P. J., Griffith, L. E., & Townsend, M. (1996). Measuring 
quality of life in the parents of children with asthma. 
, (1), 27-34.
Quality of Life Research 5
Krishnan JA, Riekert KA, McCoy JV, Stewart DY, Schmidt S, Chanmugam A, Hill P, Rand CS. Corticosteroid 
Use after Hospital Discharge among High-risk Adults with Asthma. 
. 2004; 170: 
Am J Respir Crit Care Med
1281-1285.
Lasmar L, Camargos P, Champs NS, Fonseca MT, Fontes MJ, Ibiapina C, Alvim C, Moura JAR.  Adherence 
rate to inhaled corticosteroids and their impact on asthma control.  
. 2009; 64: 784-789.
Allergy
Latry P, Pinet M, Labat A, Magand JP, Peter C, Robinson P, Martin-Latry K, Molimard M. Adherence to anti-
inflammatory treatment for asthma in clinical practice in France. 
. 2008; 30: 1058-1068.
Clin Ther
Liu SY, Pearlman DN. Hospital readmissions for childhood asthma: the role of individual and neighborhood 
factors. 
Jan-Feb 2009;124(1):65-78.
Public Health Rep. 
Lin RY, Pitt TJ, Lou WY, Yi Q. Asthma hospitalization patterns in young children relating to admission age, 
infection presence, sex, and race. 
Feb 2007;98(2):139-145.
Ann Allergy Asthma Immunol. 

National Asthma Education and Prevention Program: Expert Panel Report 3: Guidelines for the Diagnosis 
and Management of Asthma. Bethesda, MD: U.S. Department of Health and Human Services, National 
Institutes of Health, National Heart, Lung, and Blood Institute; 2007.
Osterberg L, Blaschke T. Adherence to medication. 
. 2005; 353:487-497.
New Engl J Med
Riekert KA, Borrelli B, Bilderback A, Rand CS. The development of a motivational interviewing intervention 
to promote adherence among inner-city, African-American adolescents with asthma.  
. 
Patient Educ Coun
2011; 82: 117-122.
Strandbygaard U, Tomsen SF, Backer V. A daily SMS reminder increases adherence to asthma treatment: 
a three-month follow-up study. 
. 2010; 104: 166-171.
Resp Med
Van Dellen QM, et al. Adherence to inhaled corticosteoroids in children with asthma and their parents. Resp
. 2008; 102: 755-763.
Med
Vila D, Rand CS, Cabana MD, et al. Disparities in asthma medication dispensing patterns: the case of 
pediatric asthma in Puerto Rico. The Journal of asthma : official journal of the Association for the Care of 
Dec 2010;47(10):1136-1141.
Asthma. 
Weinstein AG. Should patients with persistent severe asthma be monitored for medication adherence? Ann 
 2005; 94:251-7.
Allergy Asthma Immunol.
Williams LK, et al.  Relationship between adherence to inhaled corticosteroids and poor outcomes among 
adults with asthma.  
.  2004; 114: 1288-93.
JACI
Wise RA, Bartlett SJ, Brown ED, et al. Randomized trial of the effect of drug presentation on asthma 
outcomes: the American Lung Association Asthma Clinical Research Centers. 
2009; 124: 436-444.
JACI. 
Wroe AL, et al. Intentional and unintentional nonadherence: a study in decision making. J. Behavioral 
Medicine. 2002; 25:355-372.
 
 
 
 
If you have a separate bibliography, attach it to the submission with your other study documents. 
11.0
 Sample Size and Eligibility
11.1  Number of subjects that will be enrolled at UCSF and affiliated institutions:
20
11.2  Total number of subjects that will be enrolled at all sites 
:
(Help Text updated 9/13)
20
11.3  Estimated number of people that you will need to consent and screen here (but not necessarily 
enroll) to get the needed subjects:
270
11.4  Explain how and why the number of subjects was chosen 
:
(Help Text updated 9/13)
The sample size is limited by budget limitations.  Based on cost-efficiency and limitations, we will recruit 
20 patients to give us a general estimate of the effectiveness of this intervention (Bacchetti, 2008). These 
results will be used for the power calculations for a future, larger randomized controlled trial, which will be 
proposed through an R01 mechanism.  Assuming a positive effect of reminder systems and a baseline 
adherence rate of 60%, with 20 patients, with a power of 0.80, an alpha of 0.05, there be enough power 
to detect a 15% change in adherence. This percentage change translates to a Number Needed to Treat 
(NNT) of 6 patients.
 
Bacchetti P, McCulloch CE, Segal MR. Simple, defensible sample sizes based on cost efficiency. Biometrics. 
2008; 64: 557-85.
 

11.5  * Eligible age range(s):
0-6 years
7-12 years
13-17 years
18+ years
11.6  Inclusion criteria:
1. We will recruit 20 children ages 5 to 17 years with a diagnosis of persistent asthma who require a daily 
inhaled corticosteroid metered dose inhaler and whose guardian is the person responsible for administering 
their daily asthma medication during the study period.
2. We will recruit only patients who have received or receive care at San Francisco General Hospital’s 6M 
Children’s Health Center.  
3. We will recruit patients whose daily inhaled corticosteroid are Flovent (fluticasone propionate) HFA 
(Hydrofluoroalkane) metered dose inhalers (MDI) only.  A participant's parent/guardian may be asked to 
approve a change of medication from Qvar to Flovent in order to be eligible for the study.  The 
participant's primary care provider or asthma care provider will be asked to approve the switch.  
4. We will also recruit only patients whose guardian responsible for administering their daily asthma 
medication has Limited English Proficiency (LEP) and whose primary language is Spanish.  
 
11.7  Exclusion criteria:
1. We will exclude patients whose guardian responsible for administering their daily asthma medication 
does not have a Bluetooth enabled cell phone capable of receiving text messages.
2. We will exclude patients whose guardian responsible for administering their daily asthma medication 
does not have an available reliable power outlet where they can recharge the battery of their 
SmartInhaler.  
3. We will exclude patients whose guardian responsible for administering their daily asthma medication is 
unable to demonstrate correct medication technique based on standard evaluation (Press, 2011) after 
completion of a standard teaching protocol.  In the case that the guardian always supervises the child but 
the child is the one who administers the medication, the child may be excluded if he/she is unable to 
demonstrate correct medication technique.
5. We will exclude patients with chronic lung disease.
6. We will exclude patients who do not have an operating system of iOS or Android on their cell phone and 
who have no data plan with their cellular phone plan.
7. We will exclude patients whose asthma medication regimen is being managed by an asthma 
subspecialist or health provider outside of the 6M Children’s Health Center at San Francisco General 
Hospital.
8. We will exclude patients who are using an inhaled long acting beta-agonist (LABA) as part of their 
asthma management plan.  
 
Press VG, et al. Misuse of respiratory inhalers in hospitalized patients with asthma or COPD.  J Gen Int Med.
2011; 26: 635-642.
 
11.8  There are inclusion or exclusion criteria based on gender, race or ethnicity:
 Yes   
 No
If
, please explain the nature and rationale for the restrictions:
 yes
Latino patients have had little access to digital technologies due to cultural and language barriers.  There 
are no studies that have used a novel monitoring system to transmit reminder messages to Spanish-
speaking guardians of children with persistent asthma.  We are restricting our inclusion criteria in order to 
study whether the SmartInhaler can improve daily asthma medication adherence in children with 
persistent asthma whose parents have Limited English Proficiency (LEP) and are monolingual Spanish-
speaking.  
12.0
 Drugs and Devices

12.1  
Investigational drugs or biologics will be used 
approved drugs or biologics will be studied 
* 
OR 
under this application:
  Yes   
  No
12.2  
edical devices or in vitro diagnostics will be used 
 approved medical devices or 
* Investigational m
OR
in vitro diagnostics will be studied under this application:
 Yes   
 No
12.3  
A Non-Significant Risk (NSR) determination is being requested for an investigational device:
* 
  Yes   
  No
12.4  
  If the sponsor’s protocol does not list the IND/IDE number, you 
Verification of IND/IDE numbers:
must submit documentation from the sponsor or FDA identifying the IND/IDE number for this study. 
Attach this documentation in the Other Study Documents section of the Initial Review Submission 
Packet.
13.0
 Study Device Details
13.1  List the medical devices or in vitro diagnostics to be studied or used and attach any FDA or sponsor 
correspondence relating to the device to the application in the Study Documents section:   (Note: 
Device category descriptions added to the Help link December, 2014)
View 
Details
Device Name
Is the Device FDA 
Approved
Is this a new 
device or a new 
use of an already 
approved device
IDE Number
SmartInhaler 
Yes 
No 
 
Manufacturer/Supplier of Device
Nexus6 
Medicare Category
A
B
Where will the Devices Be Stored
 
Will Devices be supplied at no Cost
Yes 
Is this a HUD (HDE)
No 
HDE Number
 
Is the Device FDA Approved
Yes 
Is this a new device or a new use 
of an already approved device
No  
Is an IDE necessary
No  
IDE Number
 
Who holds the IDE
N/A  
IDE Details
 
In the opinion of the sponsor, 
select the level of risk associated 
with this device
No Significant Risk  
SmartTouch Qvar 
Yes 
No 
 
Manufacturer/Supplier of Device
Adherium (Formerly called Nexus6 Limited) 

Medicare Category
A
B
Where will the Devices Be Stored
Principal Investigator's locked private office 
Will Devices be supplied at no Cost
Yes 
Is this a HUD (HDE)
No 
HDE Number
 
Is the Device FDA Approved
Yes 
Is this a new device or a new use 
of an already approved device
No  
Is an IDE necessary
No  
IDE Number
 
Who holds the IDE
N/A  
IDE Details
 
In the opinion of the sponsor, 
select the level of risk associated 
with this device
No Significant Risk  
SMARTTOUCH AV FLOVENT 
Yes 
No 
 
Manufacturer/Supplier of Device
Adherium (Formerly called Nexus6 Limited) 
Medicare Category
A
B
Where will the Devices Be Stored
Principal Investigator's locked private office 
Will Devices be supplied at no Cost
Yes 
Is this a HUD (HDE)
No 
HDE Number
 
Is the Device FDA Approved
Yes 
Is this a new device or a new use 
of an already approved device
No  
Is an IDE necessary
No  
IDE Number
 
Who holds the IDE
N/A  
IDE Details
 
In the opinion of the sponsor, 
select the level of risk associated 
with this device
No Significant Risk  
14.0
 Other Approvals and Registrations
14.1  
 
Do any study activities take place on patient care units:
* 
 Yes   
 No
If 
, attach a letter of support for the study from the involved patient care manager(s).
Yes
14.2  
Does your protocol involve any radiation exposure to patients/subjects? The UCSF Radiation 
* 
 
Safety Committee requires review of your protocol if it includes administration of radiation as part of 
standard of care 
 research exposures:
OR
  Yes   
  No

14.3  
This study may generate genetic data that may be broadly shared (e.g. submitted to NIH for 
* 
 in 
, 
, etc):
Genome-Wide Association Studies (GWAS)
dbGaP TCGA
  Yes   
  No
14.4  
This study involves administration of vaccines produced using recombinant DNA technologies to 
* 
human subjects:
  Yes   
  No
14.5  
This study involves human gene transfer (NOTE: Requires NIH Recombinant DNA Advisory 
* 
Committee (RAC) review prior to CHR approval):
  Yes   
  No
14.6  This study involves other regulated materials and requires approval and/or authorization from the 
following regulatory committees:
Institutional Biological Safety Committee (IBC)
Specify BUA #:
Institutional Animal Care and Use Committee (IACUC)
Specify IACUC #:
Radiation Safety Committee
Specify RUA #:
Radioactive Drug Research Committee (RDRC)
Specify RDRC #:
Controlled Substances
15.0
 Procedures
15.1  
Procedures/Methods 
* 
(Help Text updated 9/13)   For clinical research list all study procedures, test 
and treatments required for this study, including when and how often they will be performed. If 
there are no clinical procedures, describe the Methods:
This will be a pilot trial on the effect of a novel asthma medication reminder system device on patient daily 
asthma medication adherence.  Because the intervention is a reminder system, it will not be possible to 
‘blind’ the participants.  After consent, participants will receive a SmartInhaler device and it will attach to 
the asthma medication device.  The SmartInhaler Reminder System (Adherium) can be attached to the 
asthma medication device.  It features an audiovisual reminder, which can also route messages or 
reminders to a patient’s cellular phone or e-mail in English and Spanish. The user interface includes LED 
technology and a 4-button menu system with a built-in clock.  The screen can be used for reminders or 
questionnaires. The audio ring tone reminder is modifiable to include different ring tones and various 
volumes. The system can be modified for any type of dosing regimen (e.g., bid, tid).  
The Smartinhaler can be attached to all the commonly used asthma medication devices, including the 
traditional multi-dose inhaler, the discus and the turbohaler. The SmartInhaler can unobtrusively record 
every time the asthma daily medication is taken by the study participant. The SmartInhaler then 
communicates this information to patient’s cell phone via BlueTooth which in turn relays the information to 

the study center. The SmartInhaler then communicates this information to study center.  This information 
can also be downloaded via a USB cord at the study visits.  The Smartinhaler battery needs to be 
recharged when depleted so an electric power cord can recharge the battery when plugged into an 
electrical outlet.
If the patient does not take their daily asthma medication, the SmartInhaler provides a reminder for 
missed medications to the study participant via an audio-visual reminder on the device, or via a text 
message to the study participant’s cell phone or e-mail account.  The way the reminder is sent (via e-mail, 
cell phone or through audiovisual function on the inhaler) can be tailored to a study participant’s 
preference. If the patient does take their daily medication, a ‘congratulations’ message can also be sent to 
the patient.
For the proposed study, the primary outcome is daily asthma medication adherence. Data regarding daily 
asthma medication adherence can also be obtained using a SmartInhaler, which can unobtrusively collect 
medication adherence data and send data back to the study center.  Medication adherence for each 
medication will be calculated as a percentage of total number of doses received during the study period 
divided by the total number of doses prescribed.  As a result, this percentage can range from 0 to 100.  
Patients will be recruited at the 6M Children's Health Center at San Francisco General Hospital. If the 
patient requires a change of their daily asthma medication from Qvar to Flovent to participate in the study, 
we will need both the primary care provider and/or asthma care provider and patient's guardian/parent to 
agree with the switch prior to proceeding with the study.  Once the change is approved, we can proceed 
with the consent process.  Once consented, we will collect demographic data on the patient's (e.g., age, 
gender, age of asthma diagnosis, occupation, languages spoken at home, relatives with asthma, smoking 
exposure) and the characteristics of the patient’s disease (e.g., severity, medications used, previous 
hospitalizations, current provider, subspecialty provider for asthma [if any], duration of use of current 
medications) which may affect adherence to the medication or asthma symptom control. The subject's 
guardian will then complete a few baseline surveys including the Pediatric Asthma Quality of Life 
Questionnaire (PAQLQ), the Pediatric Asthma Caregiver Quality of Life Questionnaire (PACQLQ), the Parent 
Asthma Management Self-efficacy (PAMSE) scale and a survey that includes self-described medication 
taking behavior and decision-making (a modified Reported Adherence to Medication (RAM) Survey). The 
RAM Survey, is a 3 question instrument, which will help describe and predict potential types of 
nonadherence behavior (Wroe, 2002; Horne, 1999). The PAQLQ is an asthma-specific quality of life scale 
that has been validated in children and adolescents aged seven to 17 years and it has officially been 
translated into Spanish (Juniper, 1996).  The PACQLQ is an asthma-specific quality of life scale for 
caregivers of children with asthma.  (Juniper, 1996).The PAMSE measures parental self-efficacy for the 
management and prevention of acute asthma exacerbations. (Bursch, 1996) Since the RAM survey and 
PAMSE scale are available in English only, they will be translated into Spanish using a systematic approach 
(Brislin, Lonner & Thorndike, 1973). Subject's guardian will also complete the Childhood Asthma Control 
Test (C-ACT).  Although the C-ACT is used for only patients 4 to 11, we will use this for children older than 
11 because this version is only to be filled out by the parent or guardian.  This study will only recruit 
patients whose parents or guardians are the ones administering the daily asthma medication. The C-ACT is 
a 7 item scale, with scores ranging from 0 (poor asthma control) to 27 (complete asthma control). In 
general, a C-ACT score >19 indicates well-controlled asthma. The final step prior to end of the initial visit 
will be giving the participant and guardian the SmartInhaler device. The activated reminder system will 
initially be deactivated but the SmartInhaler must still be turned on. A power cord will be given to the 
participants and guardians so they can recharge the battery of the SmartInhaler when it is depleted.  The 
guardians of the participants will be compensated with a $20 gift card for their time.  
During the run-in period of 6 weeks, baseline daily asthma medication rates will be determined using the 
SmartInhaler system without the activated reminder system. Baseline asthma symptom control will also 
be assessed.  A visit will be scheduled prior to the intervention period to have the subject's guardian 
repeat the PAMSE, PAQLQ, PACQLQ, and RAM surveys in Spanish and the C-ACT instrument.  At the end of 
the run-in visit, the participants will be randomized by a block design to ensure participants are equally 
distributed among both study groups.  The CTSI was consulted to assist in creating the randomization 
through computer generated random numbers.  Once those numbers were generated, they were placed in 
envelopes by non-study personnel. I have chosen a staggered implementation design in order to offer the 
intervention to all participants. Half the patients will be randomly selected to have the reminder system 
activated during this visit.  The reminder system will be activated and data regarding daily asthma 
medication adherence can be obtained using the SmartInhaler and sent to our data center.  The other half 
will NOT have the reminder system activated in order to provide for a concurrent control group.  They will 
have delayed activation at their next visit.  All the guardians of the participants will be compensated with a 
$20 gift card for their time.
During the intervention period of 6 weeks, the reminder system will be activated and data regarding daily 
asthma medication adherence can be obtained using the SmartInhaler and send it to our data center.  At 
the third visit, the subject's guardian will once again complete the PAMSE, PAQLQ, PACQLQ, and RAM 
Surveys in Spanish. We will also assess asthma symptom control, based on the C-ACT instrument.  For the 
group that had the SmartInhaler reminder system activated, we will collect the SmartInhaler devices and 
collect patient feedback about their usefulness.   For the group who did not have it the reminder system 
on, it will be activated.  The guardians of all the participants will be compensated with a $20 gift card for 
their time.
During the delayed activation group’s intervention period of 6 weeks, data regarding daily asthma 
medication adherence can be obtained using the SmartInhaler and send it to our data center.   At the 
conclusion of the 6 weeks, the subject's guardian will once again complete the PAMSE, PAQLQ, PACQLQ, 

1.  
2.  
3.  
4.  
5.  
6.  
7.  
and RAM Surveys in Spanish. We will also assess asthma symptom control, based on the C-ACT 
instrument.  For the group that had the SmartInhaler reminder system activated, we will collect the 
SmartInhaler devices and collect patient feedback about their usefulness.   The guardians of the 
participants will be compensated with a $20 gift card for their time. We will use all this pilot data as 
preliminary results for a larger randomized controlled trial in this population.
At the end of the study, the parent/guardian, primary care provider, and/or asthma care provider can 
switch back to original asthma daily medication they were on originally if they were switched. 
 
Any participant who had previously enrolled in the study in the Qvar arm may continue in the study if 
switched to the Flovent arm.  For that to occur, we will need both the primary care provider and/or asthma 
care provider and patient's guardian/parent to agree with the switch prior to proceeding in the study.  
 
Brislin RW, 
, 
. 1973.
Lonner WJ Thorndike RM. Cross-cultural research methods
Horne R, Weinman J. Patients' beliefs about prescribed medicines and their role in adherence to treatment 
in chronic physical illness. J Psychosom Res. 2999; 47: 555-567.
Juniper, E. F., Guyatt, G. H., Feeny, D. H., Ferrie, P. J., Griffith, L. E., & Townsend, M. (1996). Measuring 
quality of life in children with asthma.
, (1), 35-46.
Quality of life research 5
Juniper, E. F., Guyatt, G. H., Feeny, D. H., Ferrie, P. J., Griffith, L. E., & Townsend, M. (1996). Measuring 
quality of life in the parents of children with asthma. 
, (1), 27-34.
Quality of Life Research 5
Bursch, B., Schwankovsky, L., Gilbert, J., & Zeiger, R. (1999). Construction and validation of four 
childhood asthma self-management scales: parent barriers, child and parent self-efficacy, and parent 
belief in treatment efficacy. 
, 
(1), 115-128.
Journal of Asthma 36
Wroe AL, et al. Intentional and unintentional nonadherence: a study in decision making. J. Behavioral 
Medicne. 2002; 25:355-372.
 
If you have a procedure table, attach it to the submission with your other study documents.
15.2  Interviews, questionnaires, and/or surveys will be administered or focus groups will be conducted:
 Yes   
 No
List any standard instruments used for this study:  
Reported Adherence to Medication (RAM) Survey: A 3 item survey instrument, which can help 
determine the likelihood of behavior due to forgetful medication non-adherence versus intentional 
non-adherence.
Childhood Asthma Control Test (c-ACT): A 7 item scale, with scores ranging from 0 (poor asthma 
control) to 27 (complete asthma control).  In general, a C-ACT score > 19 indicates well-controlled 
asthma.  The C-ACT is used for patients 4 to 11 years of age.
Short-Test of Functional Health Literacy in Adults in Spanish (S-TOFHLA): A 36 item instrument to 
measure parents’ ability to read and understand health-related materials. The score can range from 
0 to 36.  A score of 0-16 means the patient’s functional health literacy is inadequate.  A score of 17-
22 means the patient’s functional health literacy is marginal.  A score of 23-36 means the patient’s 
functional health literacy is adequate.
Pediatric Asthma Quality of Life Questionnaire (PAQLQ): A 23 item, 7-point Likert scale covering 
three domains: symptoms, emotional function, and activity limitation.  A total score can range from 
23 (lowest quality of life) to 161 (highest quality of life).
Pediatric Asthma Caregiver Quality of Life Questionnaire (PACQLQ): A 13 item, 7-point Likert scale 
with a total score ranging from 13 (lowest quality of life) to 91 (highest quality of life).
Parent Asthma Management Self-efficacy (PAMSE): A 13 item, 5-point Likert scale that measures 
parental self-efficacy for the management and prevention of their child’s asthma attacks.  A total 
score can range from 13 (lowest self-efficacy) to 65 (highest self-efficacy).
Medication Technique Assessment: A standardized approach to assess asthma medication device 
technique utilizing detailed checklists by an observer.
Attach any non-standard instruments at the end of the application.
15.3  Conduct of study procedures or tests off-site by non-UCSF personnel:
  Yes   
  No

If yes, explain:
15.4  Sharing of experimental research test results with subjects or their care providers:
 Yes   
 No
If yes, explain:
The patient’s primary care provider or asthma subspecialist may be informed of results of their patient’s 
daily asthma medication adherence.  They may also be informed of other information obtained during the 
screening or study such as poor health literacy, purposeful non-adherence, and poor asthma medication 
delivery technique.  All of this information may be pertinent in improving the management of their 
asthma.  The patient and their guardians may be informed of the results of their daily asthma medication 
adherence as it may serve to modify and improve their nonadherence behavior. If a change in medication 
is necessary for the trial the child's primary care physician or asthma care provider will be contacted to 
ensure they are in agreement with that change before consent and enrollment.
15.5  
Specimen collection for future research and/or specimen repository/bank administration:
* 
  Yes   
  No
15.6  Time commitment (per visit and in total):
The visits after the run-in period for both groups would take 1 hour in order to fill out questionnaires, 
review inhaler technique, and upload data to the study computer.
An approximation of total time commitment would be 5 to 7 hours.
15.7  Locations:
The study locations will be mainly at San Francisco General Hospital and may include the investigators’ 
private offices, conference rooms assigned to the General Pediatrics department and/or patient/provider 
rooms at the 6M Children’s Health Center.  On occasions, the study visits could occur at the participants’ 
home or residence or at a nearby café only if this is easier for the participant.  
15.8  Describe the resources in place to conduct this study in a way that assures protection of the rights 
and welfare of participants:
All study data will be directly labelled/recorded with the personal identifying information when 
acquired.  The database with all personal identifying information will reside on REDCap.  REDCap is a way 
to provide medical researchers with a professionally managed, secure, web based, HIPAA compliant 
environment for building and managing web-based projects.  Only study personnel will have access to this 
REDCap database including the principal investigator, co-investigator, and research assistant.
On occasions, a study visit could occur at a participant’s residence or at a nearby café.  On these 
occasions, a secure encrypted laptop will be used to record all necessary data.  The data would be de-
identified on this laptop.  All asthma medication adherence data will be uploaded using a USB cable to the 
SmartInhalerLive software via the internet.  The SmartInhalerLive program would not contain personal 
identifying information only data with a numerical code.  All personal identifying information will reside 
exclusively on REDCap.  
 
 
 
 
 
 
 
 
16.0
 Alternatives

16.1  Study drug or treatment is available off-study:
Yes 
No  
Not applicable 
16.2  
Is there a standard of care (SOC) or usual care that would be offered to prospective subjects at 
* 
UCSF (or the study site) if they did not participate:
 Yes   
 No
If yes, describe the SOC or usual care that patients would receive if they choose not to participate:
All participation in research studies is voluntary.  If a patient and his/her guardian decide not to 
participate, that will not impact their ability to receive medical care at the 6M Children's Health Center or 
San Francisco General Hospital.
16.3  Describe other alternatives to study participation that are available to prospective subjects:
17.0
 Risks and Benefits
17.1  
Risks and discomforts:
* 
Participation in research will mean a loss of privacy.   Subjects and their guardians will be asked personal 
information that may be uncomfortable talking about, including information about their daily asthma 
medication adherence.   Subjects and their guardians will be asked to keep in touch with study 
 
personnel
both via phone and in person at 3-4 scheduled visits depending on the group they are assigned to.
Other risks of participating in the study could occur from malfunction of the SmartInhaler.  The 
SmartInhaler will have an audiovisual reminder that will be activated a maximum of twice daily reminding 
the subject's parent/guardian to administer their daily medication.  The reminder system will be set up to 
alarm twice daily as chosen by the subject's parent/guardian.  The reminder system will alert the parent
/guardian every minute for 15 minutes at the time the medication is due and then stop.  If the device 
malfunctions, the audiovisual reminder does not activate at all or the audiovisual reminder activates more 
than twice, the parent/guardian should let the study investigators know as soon as possible. Although 
there may be a risk of the subject not receiving their daily asthma medication because of the audiovisual 
reminder malfunctioning or the 15 minutes passing and the alarm stopping, parents/guardians of the 
subjects will be instructed to administer the medication only twice daily regardless of whether a reminder 
is given or not.  
If the subject's parent/guardian's cellular phone malfunctions, the parent/guardian will not be able to 
receive a text message reminder.  Nontheless, the SmartInhaler itself will still provide an audiovisual 
reminder.  
If the subject is asked to switch medication from Qvar to Flovent, there are no risks in this change as both 
are approved, equally therapeutic, and their dosages and concentrations are equivalent.
 
 
 
 
 
 
 
 
 
 
17.2  Steps taken to minimize risks to subjects:
Subjects and their guardians will not have to answer any questions that make them feel 
uncomfortable.   All study questionnaires will be done on paper only and will be identifiable via a 
study ID number.  All subjects’ information and study data will be on REDCap which is a secure, web-

based, HIPAA compliant server on the UCSF website. Subjects' personal names will not be used in 
any published reports about the study. All subjects and their guardians will be given copies of the 
study consent form and the Experimental Subject’s Bill of Rights to keep for their records.  Study 
subjects can terminate their participation in the study at any point in time.  Once the study has 
ended, data has been analyzed and results approved for publication, all personal identifiers will be 
deleted from the data.
 
If we meet a Subject and their guardian at a cafe for study purposes, confidentiality will be 
maintained.  Patient identifiers will not be displayed on any device or paper questionnaire and they 
will only be identified by an ID code.  All patient identifiers will be securely stored on REDCap 
only.  All computers used in a cafe will be securely encrypted according to UCSF guidelines to 
protect the data and also protect against loss/theft of device.  Strong passwords will be used on the 
encrypted device to protect against unauthorized access.  Any devices used will be routinely and 
regularly reviewed and updated according to UCSF data security procedures. If paper questionnaires 
are used, no patient identifiers will be on them and only a numerical ID code will be used on the 
questionnaire. At the cafe, no data transmission involving patient identifiers will occur.  Since all 
SmartInhaler data is relayed to the SmartInhaler website via the participant's guardian's own cell 
phone bluetooth connection, no other bluetooth connection will be used to do this.  If data needs to 
be uploaded directly from the SmartInhaler to the SmartInhaler Live website because the guardian's 
cell phone was unable to do this, data will be uploaded via a USB cable onto a secure encrypted 
device to the SmartInhaler website.  If a wireless connection is used at the cafe, it would only be to 
transmit coded date from the SmartInhaler itself to the SmartInhaler live website through a USB cord 
that connects to the encrypted secure laptop.  As mentioned before, the SmartInhaler website has no 
patient identifiers and only coded data.  All patient identifiers are only on REDCap and would only be 
accessed using a secure transmission process such as the UCSF internet servers. 
 
17.3  Benefits to subjects:
 
 Yes   
 No
If yes, describe:
The SmartInhaler device may directly benefit study subjects by improving their asthma medication 
adherence and their overall symptom control.
17.4  Benefits to society:
Asthma, a chronic inflammatory disease of the lungs, contributes to significant child morbidity through 
decreased quality of life, school absenteeism, emergency room visits, exercise limitation, hospitalizations 
and death.  The proposed pilot study in digital health represents a new area of investigation.  Our goal is 
to develop interventions that combine data from digital health technologies, (such as asthma reminder 
systems) with programs that improve how providers effectively discuss, counsel and manage patients with 
poor medication adherence for Spanish-speaking patients who do not have easy access to these 
devices.  The proposed pilot study will provide general estimates of the effectiveness of the reminder 
system device in improving asthma adherence. In addition, the proposed pilot study will deliver new 
technologies to a monolingual Spanish-speaking population that has traditionally not had access to due to 
language and cultural barriers.  
17.5  Explain why the risks to subjects are reasonable: 

Although participation in research will mean a loss of privacy; however, all subjects' personal information 
and records will be handled as confidentially as possible.  The information obtained in this study may 
greatly benefit the management and treatment of asthma and reduce morbidity to asthma thus 
outweighing study risks.
18.0
 Data and Safety Monitoring Plan
18.1  Describe the plan for monitoring data and safety 
:
(Help Text updated 9/13)
Study personnel will monitor study progress and any negative implications it may be having.  Personnel 
will be monitoring data in 2 week intervals and at all scheduled visits.  
18.2  This study requires a Data and Safety Monitoring Board:
Yes 
No or not sure 
If 
, press 
 to move to the next section of the application.
yes
SAVE and CONTINUE
18.3  If 
, provide rationale:
No
Social/Behavioral research 
Phase I trial 
Treatment IND/Compassionate Use Trial 
Other (explain below) 
If 
 explain:
Other,
This study will involve use of a FDA-approved medical device that provides a patient reminder to take their 
daily asthma medication.  It does not involve the trial of a new medication or device.  The device will be 
used according to the manufacturer's recommendations only.  
19.0
 Confidentiality and Privacy
19.1  Plans for maintaining privacy in the research setting:
All study questionnaires will be done on paper identifying them with a participant ID number only.  All 
subject’s record and study data will be entered and kept on REDCap which is a secure, web-based, HIPAA 
compliant server on the UCSF website.  Subjects’ personal names will not be used in any published reports 
about the study.
19.2  Possible consequences to subjects resulting from a loss of privacy:
No personal information can be shared with anyone without written consent by the subjects' guardian's 
permission.  No personal names will be used in any published study results.  
19.3  Study data are:
Derived from the Integrated Data Repository (IDR) or The Health Record Data Service (THREDS) at 
SFGH
Derived from a medical record (e.g. APeX, OnCore, etc. Identify source below)
Added to the hospital or clinical medical record
Created or collected as part of health care
Used to make health care decisions
Obtained from the subject, including interviews, questionnaires
Obtained from a foreign country or countries only

Obtained from records open to the public
Obtained from existing research records
None of the above
If 
, identify source:
derived from a medical record
Electronic Clinical Works, LCR
19.4  Identifiers may be included in research records:
 Yes   
 No
If 
, check all the identifiers that may be included:
yes
Names
Dates
Postal addresses
Phone numbers
Fax numbers
Email addresses
Social Security Numbers*
Medical record numbers
Health plan numbers
Account numbers
License or certificate numbers
Vehicle ID numbers
Device identifiers or serial numbers
Web URLs
IP address numbers
Biometric identifiers
Facial photos or other identifiable images
Any other unique identifier
* Required for studies conducted at the VAMC
19.5  Identifiable information might be disclosed as part of study activities:
  Yes   
  No
If 
, indicate to whom identifiable information may be disclosed:
yes
The subject's medical record
The study sponsor
Collaborators
The US Food & Drug Administration (FDA)
Others (specify below)
A Foreign Country or Countries (specify below)
If 
, specify:
Others
19.6  Indicate how data are kept secure and protected from improper use and disclosure (check all that 
apply):   NOTE: Whenever possible, do not store subject identifiers on laptops, PDAs, or other 
portable devices. If you collect subject identifiers on portable devices, you MUST encrypt the devices.
Data are stored securely in My Research

Data are coded; data key is destroyed at end of study
Data are coded; data key is kept separately and securely
Data are kept in a locked file cabinet
Data are kept in a locked office or suite
Electronic data are protected with a password
Data are stored on a secure network
Data are collected/stored using REDCap or REDCap Survey
Data are securely stored in OnCore
19.7  Additional measures to assure confidentiality and protect identifiers from improper use and 
disclosure, if any:
19.8  This study may collect information that State or Federal law requires to be reported to other officials 
or ethically requires action:
  Yes   
  No
Explain:
19.9  This study will be issued a Certificate of Confidentiality:
  Yes   
  No
20.0
 Subjects
20.1  Check all types of subjects that may be enrolled:
Inpatients
Outpatients
Healthy volunteers
Staff of UCSF or affiliated institutions
20.2  Additional vulnerable populations:
Children
Subjects unable to consent for themselves
Subjects unable to consent for themselves (emergency setting)
Subjects with diminished capacity to consent
Subjects unable to read, speak or understand English
Pregnant women
Fetuses
Neonates
Prisoners
Economically or educationally disadvantaged persons
Investigators’ staff
Students
Explain why it is appropriate to include the types of subjects checked above in this particular study:
Asthma is a chronic inflammatory disease of the lungs affecting nearly 10.1 million children causing 
significant morbidity.  Medicaid-enrolled children have disparities in asthma care and increased adverse 
events secondary to asthma as compared to children with private insurance.  Research including children 

with public insurance is crucial to decreasing adverse outcomes due to asthma especially in disadvantaged 
populations.  Due to language and cultural barriers, monolingual Spanish-speaking patients have had little 
access to new technologies such as patient reminder systems.  The proposed study will deliver new 
technologies to a population that has traditionally not had access to due to language and cultural barriers.
Describe the additional safeguards that have been included in the study to protect the rights and welfare 
of these subjects and minimize coercion or undue influence:
All participants will be given the Subject's Bill of Rights for participating in a research study in Spanish.
21.0
 Inclusion of Children in Research
21.1  This study will enroll children who can legally consent for themselves:
  Yes   
  No
If 
 explain why they can consent for themselves in the research setting:
yes,
If you will 
 be enrolling children who can legally consent for themselves, press 
ONLY
SAVE and 
 to skip the rest of this section.
CONTINUE
21.2  Select all the regulatory categories that apply:
No greater than minimal risk (45 CFR 46.404, 21 CFR 50.51)
Greater than minimal risk but presenting prospect of direct benefit (45 CFR 46.405, 21 CFR 50.52)
Greater than minimal risk (though only a minor increase over minimal risk) and no prospect of direct 
benefit but likely to yield generalizable knowledge about the subjects disorder or condition (45 CFR 
46.406, 21 CFR 50.53)
Research not otherwise approvable which presents an opportunity to understand, prevent, or alleviate 
a serious problem affecting the health or welfare of children (45 CFR 46.407, 21 CFR 50.54)
Explain why the research in this study falls under the above category or categories:
There is a dearth of research regarding patient reminder systems in children and adolescents with 
asthma.  Due to the significant morbidity due to asthma in children, research attempting to decrease 
asthma morbidity and increase quality of life is imperative.  Direct benefits to the subjects include 
increasing asthma control due to the device's reminder system.  Study results may also benefit the 
treatment and management of childhood asthma overall.
21.3  Parental permission or waiver:
Parental permission will be obtained
Waiver of parental permission is requested: Parental permission is not a reasonable requirement
Waiver of parental permission is requested: The waiver meets the provisions for a waiver of consent 
set forth in 45 CFR 46.116, Subpart A
If you are requesting a 
, explain why the study meets the regulatory 
waiver of parental permission
criteria for this waiver:
21.4  Assent of children or waiver:
Assent of children old enough to provide assent will be obtained
Waiver of assent is requested: Children cannot be consulted or the research has prospect of direct 
benefit only available in the study
Waiver of assent is requested: The waiver meets the provisions for a waiver of consent set forth in 45 
CFR 46.116, Subpart A

If you are requesting a 
, explain why the study meets the regulatory criteria for 
waiver of child's assent
this waiver:
Children younger than 7 years old eligible for the study cannot assent.  Since we are also looking to recruit 
5 and 6 year olds, we request a waiver of assent for them however their parent/guardian will sign and 
consent for them.
21.5  Documentation of permission and assent (select all that will be used):
Permission form addressed to the parents
Simplified assent form addressed to the child, 7-12 years old (parents get separate form)
Assent form addressed to the child, 13 years and older (for subjects and parents)
Assent form addressed to the child, 13 years and older (parents get separate form)
Check one:
One parent's signature will be obtained 
Two parents' signatures will be obtained 
If this study is approvable under .404 or .405 and you plan to get permission from only one parent, 
explain why you think one parent's permission is sufficient:
21.6  This study may enroll wards of the state:
  Yes   
  No
22.0
 Inclusion of Non-English Speaking Subjects
22.1  Indicate which method(s) you will use to consent non-English speaking subjects:
Preferred Method—Consent form and other study documents will be available in the subject’s primary 
language Personnel able to discuss participation in the patient’s language will be present for the 
consent process.
Short-Form—A qualified interpreter will translate the consent form verbally, and subjects will be given 
the Experimental Subject’s Bill of Rights in their primary language, following instructions in Those Who 
do not Read, Speak or Understand English for required witnessing and signatures
22.2  Explain how you will maintain the ability to communicate with non-English speakers throughout 
their participation in the study:
The principal investigator and research assistant are native fluent Spanish speakers.  Whenever the co-
investigator communicates with the subjects, he will use a qualified Spanish interpretor.  
23.0
 Recruitment
23.1  
 Methods (check all that apply):
*
Study investigators (and/or affiliated nurses or staff) recruit their own patients directly in person or by 
phone.
Study investigators recruit their own patients by letter. Attach the letter for review.
Study investigators send a “Dear Doctor” letter to colleagues asking for referrals of eligible patients. If 
interested, the patient will contact the PI or the PI may directly recruit the patients (with documented 
permission from the patient). Investigators may give the referring physicians a study information 
sheet for the patients.

Study investigators provide their colleagues with a “Dear Patient” letter describing the study. This 
letter can be signed by the treating physicians and would inform the patients how to contact the study 
investigators. The study investigators may not have access to patient names and addresses for mailing
Advertisements, notices, and/or media used to recruit subjects. Interested subjects initiate contact 
with study investigators. Attach ads, notices, or media text for review. In section below, please explain 
where ads will be posted.
Study investigators identify prospective subjects through chart review. (Study investigators request a 
Waiver of Authorization for recruitment purposes.)
Large-scale epidemiological studies and/or population-based studies: Prospective subjects are 
identified through a registry or medical records and contacted by someone other than their personal 
physician. (Study investigators request a Waiver of Authorization for recruitment purposes.)
Direct contact of potential subjects who have previously given consent to be contacted for participation 
in research. Clinic or program develops a CHR-approved recruitment protocol that asks patients if they 
agree to be contacted for research (a recruitment database) or consent for future contact was 
documented using the consent form for another CHR-approved study.
Study investigators list the study on the School of Medicine list of UCSF Clinical Trials website or a 
similarly managed site. Interested subjects initiate contact with investigators.
Study investigators recruit potential subjects who are unknown to them through methods such as 
snowball sampling, direct approach, use of social networks, and random digit dialing.
Other
If 
, explain:
Other
23.2  
How, when, and by whom eligibility will be determined:
* 
Once a potential subject is identified, the investigators will screen the patient and primary guardian for 
eligibility using inclusion and exclusion criteria as determined by the study team.  The patient will also be 
excluded if they are unable to demonstrate correct medication technique based on standard evaluation 
(Press, 2011) after completion of a standard teaching protocol.
 
Press VG, et al. Misuse of respiratory inhalers in hospitalized patients with asthma or COPD.  J Gen Int Med.
2011; 26: 635-642.
 
23.3  
How, when, where and by whom potential subjects will be approached:
* 
Subjects who are patients of 6M clinic will be screened initially utilizing electronic clinical works (eCW) or 
LCR at SFGH. Children with asthma are frequently seen in the 6M clinic and as such, we will work with 
nursing/clinician assistance to identify families who may meet the study criteria and approach them to 
discuss the study while they are waiting for their physician. Study staff will identify potential subjects in 
the clinic schedules via a brief screen of the electronic medical record for wheezing/asthma symptoms and 
medication history. The potential subject will be approached for screening during clinic visits with the 
permission of the physician in direct care with the patient. If the patient agrees to be screened, they will 
be asked about the child’s wheezing/asthma history and given more information about the study and study 
personnel will follow up with the patient via telephone. If the patient is not eligible, they will be asked if 
they would like to be contacted for future research studies.  Letters will also be sent to potential subjects who 
have previously given consent to be contacted for participation in research or who have been identified through medical 
records as potential subjects.  
23.4  * Protected health information (PHI) will be accessed prior to obtaining consent:
 Yes   
 No
24.0
 Waiver of Consent/Authorization for Recruitment 
Purposes
This section is required when study investigators (and/or affiliated 
nurses or staff) recruit their own patients directly.

24.1  
Study personnel need to access protected health information (PHI) during the recruitment process 
* 
and it is not practicable to obtain informed consent until potential subjects have been identified:
Yes 
If 
, a waiver of consent/authorization is NOT needed.
no
24.2  
 A waiver for screening of health records to identify potential subjects poses no more than minimal 
* 
risk to privacy for participants:
Yes 
If 
, a waiver of authorization can NOT be granted.
no
24.3  
Screening health records prior to obtaining consent will not adversely affect subjects' rights and 
* 
welfare:
Yes 
If 
, a waiver of authorization can NOT be granted.
no
24.4  
Check all the identifiers that will be collected prior to obtaining informed consent:
* 
Names
Dates
Postal addresses
Phone numbers
Fax numbers
Email addresses
Social Security Numbers*
Medical record numbers
Health plan numbers
Account numbers
License or certificate numbers
Vehicle ID numbers
Device identifiers or serial numbers
Web URLs
IP address numbers
Biometric identifiers
Facial photos or other identifiable images
Any other unique identifier
None
Note: HIPAA rules require that you collect the minimum necessary.
24.5  
 Describe any health information that will be collected prior to obtaining informed consent:
*
Prior to informed consent, the patient's medical record may be reviewed to screen if eligible per inclusion 
and exclusion criteria.  Demographic information, medication lists, problem lists, medical history, and 
progress notes may all be reviewed for eligibility purposes.  
Note: HIPAA requires that you collect the minimum necessary.
24.6  
Describe your plan to destroy the identifiers at the earliest opportunity consistent with the 
* 

research 
 provide a health or research justification for retaining the identifiers, or indicate and 
or
explain that retention is required by law:
Once the study has concluded, the data will be analyzed and results will be submitted for 
publication.  Once a research paper has been approved for publication, the identifiers will be destroyed and 
only unique codes will be retained.
25.0
 Informed Consent
25.1  * Methods (check all that apply):
Signed consent will be obtained from subjects and/or parents (if subjects are minors)
Verbal consent will be obtained from subjects using an information sheet or script
Electronic consent will be obtained from subjects via the web or email
Implied consent will be obtained via mail, the web or email
Signed consent will be obtained from surrogates
Emergency waiver of consent is being requested for subjects unable to provide consent
Informed consent will not be obtained
25.2  
Process for obtaining informed consent:
* 
Once potential eligible participants for the study have been identified and they meet inclusion criteria, the 
process of informed consent will begin.  The process of consenting the patient's guardian will occur in 
Spanish in designated study areas at San Francisco General Hospital. Designated areas will include the 
Children's Health Center, Investigators' offices or private conference rooms.  Once consented, all 
participants and their guardian will receive a copy of the consent form in Spanish along with the 
Experimental Subject's Bill of Rights in Spanish.ights to keep.
25.3  
How investigators will make sure subjects understand the information provided to them:
* 
Investigators will consent all participants and their guardians in Spanish and provide all study materials in 
Spanish.  Materials in English will be translated into Spanish using a systematic approach.  
26.0
 Financial Considerations
26.1  Subjects payment or compensation method (check all that apply):
Payments will be (check all that apply):
Subjects will not be paid
Cash
Check
Debit card
Gift card
Reimbursement for parking and other expenses
Other:
Specify 
:
Other
26.2  Describe the schedule and amounts of payments, including the total subjects can receive for 
completing the study. If deviating from recommendations in Subject Payment Guidelines, include 
specific justification below. 
Gift Cards of $20 will be given to each participant after completion of a study visit.  Study subjects can 
receive up to $80 if they complete 4 visits.  

26.3  Costs to Subjects:  Will subjects or their insurance be charged for any study procedures?
  Yes   
  No
If 
 describe those costs below, and compare subjects’ costs to the costs associated with alternative 
yes,
care off-study. Finally, explain why it is appropriate to charge those costs to the subjects.
27.0
 CTSI Screening Questions
27.1  
This study will be carried out at one of the UCSF Clinical Research Services (CRS) centers or will 
* 
utilize CRS services. CRS centers are at the following sites:
SFGH Clinical Research Center
Moffitt Adult Clinical Research Center
Moffitt Hospital Pediatrics & NCRC
Mount Zion Hospital Clinical Research Center
Tenderloin Center
CHORI Children's Hospital Pediatrics & Adult Clinical Research Center
Kaiser Oakland Research Unit
SF VA Medical Center Clinical Research Unit
  Please note: Effective 3/1/14, the CRS form will no longer be completed and submitted in iRIS. The 
CRS budget request form can be found at: https://accelerate.ucsf.edu/files/crs
 
/BudgetRequest2015.docx. Follow the instructions on the form to submit.  Even if you click 'Yes' to 
this question, the form will no longer proceed to the Clinical Research Services (CRS) Application 
Form section.
 Yes   
 No
27.2  This project involves community-based research:
  Yes   
  No
27.3  This project involves practice-based research:
  Yes   
  No
28.0
 End of Study Application
28.1  End of Study Application Form   To continue working on the Study 
: Click on the section you need to edit in the left-hand menu. Remember to save 
Application
  
through the entire Study Application after making changes.  If you are done working on the 
: Click Save and Continue. If this is a new study, you will automatically 
Study Application
enter the Initial Review Submission Packet form, where you can attach consent forms or 
other study documents. Review the 
 for a list of required 
Initial Review Submission Checklist
 
attachments.   Answer all questions and attach all required documents to speed up your 
 
approval.