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| ID | Type | Description | Link |
|---|---|---|---|
| CDR-1402-09777 | Other Identifier | PCORI |
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| Name | Class |
|---|---|
| Patient-Centered Outcomes Research Institute | OTHER |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Educational Video and Question Prompt List | 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. |
|
| Control group | No Intervention | Standard of care will be used |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Educational Video and Question Prompt List | Behavioral | Educational Video and Question Prompt List |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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". | 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. | 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. | 12 month follow-up |
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Inclusion Criteria:
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:
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| Name | Affiliation | Role |
|---|---|---|
| Betsy L Sleath, PhD | University of North Carolina, Chapel Hill | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of North Carolin at Chapel Hill | Chapel Hill | North Carolina | 27599 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | 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 |
| FG001 | Control Group | Standard of care will be used |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | 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 |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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". | One intervention group patient was excluded because they had to leave immediately after the final visit and did not complete the 12-month survey. | Posted | Count of Participants | Participants | 12 month follow-up |
|
Up to approximately 1 year following enrollment
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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 |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Betsy Sleath, PhD | University of North Carolina at Chapel Hill | (919) 962-0079 | betsy_sleath@unc.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Apr 27, 2015 | Jul 25, 2018 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D001249 | Asthma |
| D003142 | Communication |
| ID | Term |
|---|---|
| D001982 | Bronchial Diseases |
| D012140 | Respiratory Tract Diseases |
| D008173 | Lung Diseases, Obstructive |
| D008171 | Lung Diseases |
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| BG001 | Control Group | Standard of care will be used |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Count of Participants | Participants |
|
| 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". | Count of Participants | Participants |
|
| 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. | Mean | Standard Deviation | score on a scale |
|
| 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. | Mean | Standard Deviation | score on a scale |
|
| OG001 | Control Group | Standard of care will be used |
|
|
| 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. | One intervention group patient was excluded because they had to leave immediately after the final visit and did not complete the 12-month survey. | Posted | Mean | Standard Deviation | score on a scale | 12 month follow-up |
|
|
|
| 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. | One intervention group patient was excluded because they had to leave immediately after the final visit and did not complete the 12-month survey. | Posted | Mean | Standard Deviation | score on a scale | 12 month follow-up |
|
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|
| 0 |
| 185 |
| 0 |
| 185 |
| 0 |
| 185 |
| EG001 | Control Group | Standard of care will be used | 0 | 174 | 0 | 174 | 0 | 174 |
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| D012130 |
| Respiratory Hypersensitivity |
| D006969 | Hypersensitivity, Immediate |
| D006967 | Hypersensitivity |
| D007154 | Immune System Diseases |
| D001519 | Behavior |