Using Question Prompt Lists During Pediatric Asthma Visits to Increase Adolescent Involvement
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT02498834|
Recruitment Status : Completed
First Posted : July 15, 2015
Results First Posted : January 16, 2019
Last Update Posted : January 16, 2019
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.
|Condition or disease||Intervention/treatment||Phase|
|Asthma||Behavioral: Educational Video and Question Prompt List||Not Applicable|
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 :||Interventional (Clinical Trial)|
|Actual Enrollment :||359 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Using Question Prompt Lists During Pediatric Asthma Visits to Increase Adolescent Involvement|
|Study Start Date :||July 2015|
|Actual Primary Completion Date :||November 2017|
|Actual Study Completion Date :||November 2017|
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.
Behavioral: Educational Video and Question Prompt List
Educational Video and Question Prompt List
No Intervention: Control group
Standard of care will be used
- 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".
- 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.
- Asthma Quality-of-life Score [ Time Frame: 12 month follow-up ]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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02498834
|United States, North Carolina|
|University of North Carolin at Chapel Hill|
|Chapel Hill, North Carolina, United States, 27599|
|Principal Investigator:||Betsy L Sleath, PhD||University of North Carolina, Chapel Hill|