Asthma
Conditions
Keywords
Communication, provider, caregiver, adolescent
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.
Interventions
Educational Video and Question Prompt List
Sponsors
Patient-Centered Outcomes Research Institute
University of North Carolina, Chapel Hill
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
11 Years to 17 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants Achieving Asthma Control | 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 | 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 | 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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: Educational Video and Question Prompt List | 185 |
| Control Group Standard of care will be used | 174 |
| Total | 359 |
Baseline characteristics
| Characteristic | Educational Video and Question Prompt List | Control Group | Total |
|---|---|---|---|
| Adolescent asthma management self-efficacy score | 55.9 score on a scale STANDARD_DEVIATION 8 | 56.0 score on a scale STANDARD_DEVIATION 8.2 | 55.9 score on a scale STANDARD_DEVIATION 8.1 |
| Age, Continuous | 13.2 years STANDARD_DEVIATION 1.9 | 13.2 years STANDARD_DEVIATION 1.9 | 13.2 years STANDARD_DEVIATION 1.9 |
| Asthma quality-of-life score | 5.7 score on a scale STANDARD_DEVIATION 1.2 | 5.8 score on a scale STANDARD_DEVIATION 1.2 | 5.7 score on a scale STANDARD_DEVIATION 1.2 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 26 Participants | 19 Participants | 45 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 159 Participants | 155 Participants | 314 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Number of Participants Achieving Asthma Control Controlled | 101 Participants | 105 Participants | 206 Participants |
| Number of Participants Achieving Asthma Control Not controlled | 84 Participants | 69 Participants | 153 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 24 Participants | 17 Participants | 41 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 4 Participants | 4 Participants |
| Race (NIH/OMB) Black or African American | 71 Participants | 63 Participants | 134 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 30 Participants | 20 Participants | 50 Participants |
| Race (NIH/OMB) White | 60 Participants | 70 Participants | 130 Participants |
| Region of Enrollment United States | 185 Participants | 174 Participants | 359 Participants |
| Sex: Female, Male Female | 76 Participants | 78 Participants | 154 Participants |
| Sex: Female, Male Male | 109 Participants | 96 Participants | 205 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 185 | 0 / 174 |
| other Total, other adverse events | 0 / 185 | 0 / 174 |
| serious Total, serious adverse events | 0 / 185 | 0 / 174 |
Outcome results
Primary
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
Population: One intervention group patient was excluded because they had to leave immediately after the final visit and did not complete the 12-month survey.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Educational Video and Question Prompt List | Adolescent Asthma Management Self-efficacy Score | 58.9 score on a scale | Standard Deviation 8.6 |
| Control Group | Adolescent Asthma Management Self-efficacy Score | 59.7 score on a scale | Standard Deviation 7.2 |
Primary
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
Population: One intervention group patient was excluded because they had to leave immediately after the final visit and did not complete the 12-month survey.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Educational Video and Question Prompt List | Asthma Quality-of-life Score | 6.1 score on a scale | Standard Deviation 1.2 |
| Control Group | Asthma Quality-of-life Score | 6.2 score on a scale | Standard Deviation 0.98 |
Primary
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
Population: One intervention group patient was excluded because they had to leave immediately after the final visit and did not complete the 12-month survey.
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Educational Video and Question Prompt List | Number of Participants Achieving Asthma Control | Controlled | 121 Participants |
| Educational Video and Question Prompt List | Number of Participants Achieving Asthma Control | Not controlled | 53 Participants |
| Control Group | Number of Participants Achieving Asthma Control | Controlled | 128 Participants |
| Control Group | Number of Participants Achieving Asthma Control | Not controlled | 36 Participants |