# Presentation: 029500

## Slide 1

## Scenario

- You are a parent of a child with asthma
- A couple of days ago, your child had an appointment with his/her pediatrician

## While at the appointment, your pediatrician showed you and your child this flyer about an asthma study that wants to explore the role of air pollution and asthma

## After seeing this ad, you of course had many questions. What types of questions would you ask your child’s pediatrician? 

- After seeing this ad, you of course had many questions. What types of questions would you ask your child’s pediatrician?

## 	After answering some of your clinical questions in regards to asthma, your child’s pediatrician suggests that you contact the study number to find out more information in regards to this study. 

## You decide to check out the study’s website listed on the ad.http://www.epastudies.org 

## Slide 7

## Here is the information you found on the website for this study

- PACESThe purpose of this study is to examine the effects of particulate air pollution in the Chapel Hill/Carrboro area on the pulmonary health of moderate and severe asthmatic children ages 8-18 years old. This study includes a baseline medical evaluation with breathing and allergy tests, optional blood draw, cheek swabs, and urine and nasal fluid collections. If the baseline medical evaluation finds that the participating child is a moderate or severe asthmatic, the child will be asked to enroll in a six-week diary study. Each day during the diary study the participant will monitor their asthma symptoms using a portable breathing monitor and record their medication use with a PDA/mobile phone connected to their personal internet medical diary.

## Just based on the information you have so far, what are some of the things you might discuss with your child in deciding whether or not to call and consider being part of this study?

## You and your child decide to call the number.  The recruiter describes the study for you and then asks you a series of questions. 

## Screening Questions

- Name
- Relation to child (parent, guardian, other)
- Phone
- Name of child
- Age of child
- Does your child and you have flexible daytime hours?
- Does your child or you have plans to leave the area within 3 months?
- Is your child presently in any other studies or ever in EPA studies?
- Does your child have asthma?
- Does your child have chronic respiratory disease?
- Does your child have any major medical conditions? Accidents? Operations?
- What type of medication is your child receiving?
- Address

## In the end, you decide to make an appointment to enroll your child.  You are sent in the mail, before your child’s  appointment, a study consent form as well as study restrictions.

## Restrictions for Appointment

- Do not come with an upper respiratory infection – call and reschedule appointment
- For baseline visit have your child:
- Avoid smoky areas
- Drink plenty of fluids 24 hours before appointment
- Not consume any caffeine day of appointment
- Eat a light meal 1 hour before arriving
- No rescue medicines for 6 hours, however, do use the medicines if needed – call and reschedule if use
- Bring allergy skin test records if possible,
- Bring all meds and peak flow meter if your child has one

## The Appointment

- You bring the consent form
- Assent form
- Clinical screening for eligibility

## The Forms

## Consent

- Completed by parent or guardian
- Requirement for this study is to have both parents signature
- “Informed”
- Confidentiality
- Can refuse to participate in any aspect of study
- Can leave the study at any time

## Assent

- Completed by the child
- Child agrees to participate – parents cannot force child to participate if he/she does not want to
- Same components as consent form, not as detailed

## HIPAA Authorization

- “The Health Insurance Portability and Accountability Act of 1996” (known as “HIPAA”)
- Provides permission for researchers to access information from a participant’s medical records or health insurance records to use in this research study

## Consent to Allow Storage of Biological Samples

- Separate consent
- Have several choices
- Agree to allow storage of specimens with identifying information which might include genetic research
- Request identifying code be removed and if removed may use as in above
- Request identifying code removed and specimen can be stored but NO genetic testing
- Request specimens be disposed of

## Screening

- Blood draw
- Urine sample
- Vital signs, pulse, blood pressure, respiratory, SpO2, temperature, weight and height
- Skin prick testing for allergies
- Grass, weeds, trees, mites & insects, animals, molds
- Spirometry
- Exhaled NO measurement
- Exhaled breath condensate
- Nasal lavage
- Buccal cell collection

## Slide 21

## Urine collection

## Vital signs, pulse, blood pressure, respiratory, SpO2, temperature, weight and height

## Skin prick testing for allergies:

- grass, weeds, trees, mites & insects, animals, molds

## Spirometry

## Exhaled NO measurement 

## Exhaled breath condensate

## Nasal lavage

## Buccal cell collection

## End of screening procedures

- Given phone number to call in case of emergency
- Receives instructions to monitor for signs of adverse symptoms
- Receives compensation for screening
- Instructed that recruiters will call if eligible for second part of study

## Screening Determined Your Child Eligible for Second Part of Study

- Receive phone call to schedule follow-up visit as well as home visit to set up air monitoring

## Your presence not needed for set-up or sample collection 

- Your presence not needed for set-up or sample collection

- Home air monitor – set up to be in your yard for 1 week

## Follow-up visit: Receive instructions for use of PDA to input daily diary (once a day for 6 weeks) and for use of electronic peak flow monitor (twice a day for 6 weeks)

## After 6 weeks, return to clinic to return peak flow meter and PDA to receive full compensation