Clinical trial NCT02498834: Using Question Prompt Lists During Pediatric Asthma Visits to Increase Adolescent Involvement
Official title: Using Question Prompt Lists During Pediatric Asthma Visits to Increase Adolescent Involvement
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Asthma
Keywords: Communication
provider
caregiver
adolescent
Lead sponsor: University of North Carolina, Chapel Hill
Sponsor class: OTHER
Collaborators: name: Patient-Centered Outcomes Research Institute
First posted: 2015-07-15
Enrollment: 359
Sex: ALL
Minimum age (years): 11
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Number of Participants Achieving Asthma Control
timeFrame: 12 month follow-up
measure: Adolescent Asthma Management Self-efficacy Score
timeFrame: 12 month follow-up
measure: Asthma Quality-of-life Score
timeFrame: 12 month follow-up
Secondary outcomes:
Other outcomes:
Locations:
city: Chapel Hill
country: United States
facility: University of North Carolin at Chapel Hill
state: North Carolina
Study officials:
affiliation: University of North Carolina, Chapel Hill
name: Betsy L Sleath, PhD
role: PRINCIPAL_INVESTIGATOR
References: