An interventional study of Educational Video and Question Prompt List in Asthma, sponsored by University of North Carolina, Chapel Hill. Completed at 1 site in United States. Open to participants aged 11 Years to 17 Years. Per ClinicalTrials.gov, last updated 2019-01-16.
Sponsored by University of North Carolina, Chapel Hill · Not applicable, Interventional, and Treatment
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.
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.
3,921 studies on the registry are indexed under Asthma; 507 are open to participants now.
This study's enrollment of 359 is above the median of 83 across 2,752 interventional studies indexed under Asthma.
Browse Asthma studies →University of North Carolina, Chapel Hill is the lead sponsor of 1,340 studies on the registry; 133 are open to participants now.
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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:
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
Standard of care will be used
Educational Video and Question Prompt List
Number of Participants Achieving Asthma Control
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".
Time frame: 12 month follow-up
Adolescent Asthma Management Self-efficacy Score
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.
Time frame: 12 month follow-up
Asthma Quality-of-life Score
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.
Time frame: 12 month follow-up
| Milestone | Educational Video and Question Prompt List | Control Group |
|---|---|---|
| Started | 185 | 174 |
| Completed | 175 | 164 |
| Not completed | 10 | 10 |
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".
| Participants | Educational Video and Question Prompt List | Control Group |
|---|---|---|
| Controlled | 121 | 128 |
| Not controlled | 53 | 36 |
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.
| score on a scale | Educational Video and Question Prompt List | Control Group |
|---|---|---|
| Adolescent Asthma Management Self-efficacy Score | 58.9 ± 8.6 | 59.7 ± 7.2 |
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.
| score on a scale | Educational Video and Question Prompt List | Control Group |
|---|---|---|
| Asthma Quality-of-life Score | 6.1 ± 1.2 | 6.2 ± 0.98 |
Collected over Up to approximately 1 year following enrollment. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Educational Video and Question Prompt List | 0/185 (0%) | 0/185 (0%) | 0/185 (0%) |
| Control Group | 0/174 (0%) | 0/174 (0%) | 0/174 (0%) |
| Age, Continuous(years) | Educational Video and Question Prompt List | Control Group | Total |
|---|---|---|---|
| Mean | 13.2 ± 1.9 | 13.2 ± 1.9 | 13.2 ± 1.9 |
| Sex: Female, Male(Participants) | Educational Video and Question Prompt List | Control Group | Total |
|---|---|---|---|
| Female | 76 | 78 | 154 |
| Male | 109 | 96 | 205 |
| Ethnicity (NIH/OMB)(Participants) | Educational Video and Question Prompt List | Control Group | Total |
|---|---|---|---|
| Hispanic or Latino | 26 | 19 | 45 |
| Not Hispanic or Latino | 159 | 155 | 314 |
| Unknown or Not Reported | 0 | 0 | 0 |
| Race (NIH/OMB)(Participants) | Educational Video and Question Prompt List | Control Group | Total |
|---|---|---|---|
| American Indian or Alaska Native | 24 | 17 | 41 |
| Asian | 0 | 4 | 4 |
| Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 |
| Black or African American | 71 | 63 | 134 |
| White | 60 | 70 | 130 |
| More than one race | 0 | 0 | 0 |
| Unknown or Not Reported | 30 | 20 | 50 |
| Region of Enrollment(Participants) | Educational Video and Question Prompt List | Control Group | Total |
|---|---|---|---|
| United States | 185 | 174 | 359 |
| Number of Participants Achieving Asthma Control(Participants) | Educational Video and Question Prompt List | Control Group | Total |
|---|---|---|---|
| Controlled | 101 | 105 | 206 |
| Not controlled | 84 | 69 | 153 |
| Adolescent asthma management self-efficacy score(score on a scale) | Educational Video and Question Prompt List | Control Group | Total |
|---|---|---|---|
| Mean | 55.9 ± 8.0 | 56.0 ± 8.2 | 55.9 ± 8.1 |
| Asthma quality-of-life score(score on a scale) | Educational Video and Question Prompt List | Control Group | Total |
|---|---|---|---|
| Mean | 5.7 ± 1.2 | 5.8 ± 1.2 | 5.7 ± 1.2 |
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University of North Carolina, Chapel Hill