Overview

This trial is active, not recruiting.

Condition asthma
Treatment educational video and question prompt list
Sponsor University of North Carolina, Chapel Hill
Collaborator Patient-Centered Outcomes Research Institute
Start date July 2015
End date June 2017
Trial size 360 participants
Trial identifier NCT02498834, 14-2628, CDR-1402-09777

Summary

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification safety/efficacy study
Intervention model parallel assignment
Masking open label
Primary purpose treatment
Arm
(Experimental)
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
Educational Video and Question Prompt List
(No Intervention)
Standard of care will be used

Primary Outcomes

Measure
Asthma Control
time frame: 12 month follow-up

Secondary Outcomes

Measure
Adolescent Asthma Management Self Efficacy
time frame: 12 month follow-up
Adolescent Quality of Life
time frame: 12 month follow-up
Number of Questions the Adolescent Asks about Asthma or Its Treatment during the audio-tape visits.
time frame: 12 month follow-up
Providers include adolescent input into the asthma management plan.
time frame: 12 month follow-up
Adolescent Satisfaction with the Visit
time frame: 12 month follow-up
Adherence to Asthma Control Medications
time frame: 12 month follow-up
Number of parent reported medicine problems
time frame: 12 month follow-up
Number of adolescent reported medicine problems
time frame: 12 month follow-up
Emergency Department (ED) asthma visits during the past 12 months
time frame: 12 month follow-up
Unscheduled physician visits during the past 12 months
time frame: 12 month follow-up
Lung function
time frame: 12 month follow-up

Eligibility Criteria

Male or female participants from 11 years up to 17 years old.

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.

Additional Information

Official title Using Question Prompt Lists During Pediatric Asthma Visits to Increase Adolescent Involvement
Principal investigator Betsy L Sleath, PhD
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.
Trial information was received from ClinicalTrials.gov and was last updated in November 2016.
Information provided to ClinicalTrials.gov by University of North Carolina, Chapel Hill.