Using Question Prompt Lists During Pediatric Asthma Visits to Increase Adolescent Involvement
The purpose of this study is to conduct a randomized controlled trial with English and Spanish-speaking adolescents to compare the effectiveness of an adolescent "asthma question prompt list" with a supportive educational video intervention with usual care.
The hypothesis of this study is that by showing the parents and adolescents the educational video and then providing the adolescents with the one-page "asthma question prompt lists" to use during their visits will improve: (a) asthma control, (b) adolescent self-efficacy in managing asthma, and (c) adolescent quality-of-life.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
The study uses a randomized controlled trial design stratified by provider to assess the impact of an adolescent "asthma question prompt list" combined with a supportive educational video emphasizing the importance of adolescent involvement and question-asking on communication during pediatric visits. This application is based on Social Cognitive Theory. Self-confidence or self-efficacy is a central component of Social Cognitive Theory (SCT) Application of Social Cognitive Theory (SCT) in asthma populations has shown that technical advice from providers is one external factor that can improve asthma management self-efficacy. Additionally, personal beliefs, such as outcome expectations, and family factors, such as parent and adolescent responsibility for asthma self-management, have been shown to affect adolescent self-efficacy and disease management outcomes. Prior work has found that adolescent self-efficacy in asthma management correlates strongly with health status, adherence, asthma medication device technique, asthma symptoms, and impact of illness on the family.
All adolescents will have their medical visits audio recorded. The adolescent will be interviewed after his/her medical visit while his/her caregiver/parent completes a survey at the time of study enrollment. This same procedure will be used when the adolescent and caregiver/parents return for the 6- and 12-month follow-up visits.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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North Carolina
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Chapel Hill, North Carolina, United States, 27599
- University of North Carolin at Chapel Hill
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- ages 11 to 17 years;
- speak and read English or Spanish;
- have persistent asthma;
- are present for an acute or follow-up asthma visit or a well-child visit;
- and have previously visited the clinic at least once for asthma.
Adolescents' parents will be eligible if they are at least 18 years of age, speak and read English or Spanish, and are the legal guardian of the adolescent.
Exclusion Criteria:
- present for gastrointestinal complaints or other non-asthma related acute illness.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Educational Video and Question Prompt List
Parents and adolescents in this group will watch a short educational video in English or Spanish on an iPad about the importance of encouraging adolescents to ask questions and to be involved during their pediatric asthma visits to improve their self-management skills.
Also, the adolescents in this group will be handed a question prompt list to complete, which will be collected after the medical visit.
|
Educational Video and Question Prompt List
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No Intervention: Control group
Standard of care will be used
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Number of Participants Achieving Asthma Control
Time Frame: 12 month follow-up
|
This will be measured via the 5-item Asthma Control Test, responses are summed to indicate a score ranging from 5 (poor asthma control) to 25 (complete asthma control).
A higher score means a better outcome.
A score of above 19 is considered "well controlled".
|
12 month follow-up
|
|
Adolescent Asthma Management Self-efficacy Score
Time Frame: 12 month follow-up
|
Adolescent asthma management self-efficacy was measured using a 14-item scale that has been shown to have a reliability of 0.87.
Prior work in asthma has found asthma management self-efficacy to change in response to an intervention.
Scores range from 14 to 70 and a higher score means a better outcome.
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12 month follow-up
|
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Asthma Quality-of-life Score
Time Frame: 12 month follow-up
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Adolescent quality-of-life was measured as a continuous variable.
The investigators used the standardized version of the Juniper pediatric asthma quality-of-life questionnaire.
The questionnaire contains 23 items and has a reliability of 0.84.
Scores can range from 1.0 to 7.0, and a higher score means a better outcome.
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12 month follow-up
|
Collaborators and Investigators
Collaborators
Investigators
- Principal Investigator: Betsy L Sleath, PhD, University of North Carolina, Chapel Hill
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 14-2628
- CDR-1402-09777 (Other Identifier: PCORI)
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