Ignite Creation Date:
2025-12-25 @ 2:38 AM
Ignite Modification Date:
2026-02-28 @ 6:54 AM
Study NCT ID:
NCT02498834
Status:
COMPLETED
Last Update Posted:
2019-01-16
First Post:
2015-06-24
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Using Question Prompt Lists During Pediatric Asthma Visits to Increase Adolescent Involvement
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001249', 'term': 'Asthma'}, {'id': 'D003142', 'term': 'Communication'}], 'ancestors': [{'id': 'D001982', 'term': 'Bronchial Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}, {'id': 'D008173', 'term': 'Lung Diseases, Obstructive'}, {'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D012130', 'term': 'Respiratory Hypersensitivity'}, {'id': 'D006969', 'term': 'Hypersensitivity, Immediate'}, {'id': 'D006967', 'term': 'Hypersensitivity'}, {'id': 'D007154', 'term': 'Immune System Diseases'}, {'id': 'D001519', 'term': 'Behavior'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'betsy_sleath@unc.edu', 'phone': '(919) 962-0079', 'title': 'Betsy Sleath, PhD', 'organization': 'University of North Carolina at Chapel Hill'}, 'certainAgreement': {'piSponsorEmployee': True, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'timeFrame': 'Up to approximately 1 year following enrollment', 'eventGroups': [{'id': 'EG000', 'title': 'Educational Video and Question Prompt List', 'description': '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.\n\nEducational Video and Question Prompt List: Educational Video and Question Prompt List', 'otherNumAtRisk': 185, 'deathsNumAtRisk': 185, 'otherNumAffected': 0, 'seriousNumAtRisk': 185, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Control Group', 'description': 'Standard of care will be used', 'otherNumAtRisk': 174, 'deathsNumAtRisk': 174, 'otherNumAffected': 0, 'seriousNumAtRisk': 174, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Number of Participants Achieving Asthma Control', 'denoms': [{'units': 'Participants', 'counts': [{'value': '174', 'groupId': 'OG000'}, {'value': '164', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Educational Video and Question Prompt List', 'description': '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.\n\nEducational Video and Question Prompt List: Educational Video and Question Prompt List'}, {'id': 'OG001', 'title': 'Control Group', 'description': 'Standard of care will be used'}], 'classes': [{'categories': [{'title': 'Controlled', 'measurements': [{'value': '121', 'groupId': 'OG000'}, {'value': '128', 'groupId': 'OG001'}]}, {'title': 'Not controlled', 'measurements': [{'value': '53', 'groupId': 'OG000'}, {'value': '36', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '12 month follow-up', 'description': '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".', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'One intervention group patient was excluded because they had to leave immediately after the final visit and did not complete the 12-month survey.'}, {'type': 'PRIMARY', 'title': 'Adolescent Asthma Management Self-efficacy Score', 'denoms': [{'units': 'Participants', 'counts': [{'value': '174', 'groupId': 'OG000'}, {'value': '164', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Educational Video and Question Prompt List', 'description': '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.\n\nEducational Video and Question Prompt List: Educational Video and Question Prompt List'}, {'id': 'OG001', 'title': 'Control Group', 'description': 'Standard of care will be used'}], 'classes': [{'categories': [{'measurements': [{'value': '58.9', 'spread': '8.6', 'groupId': 'OG000'}, {'value': '59.7', 'spread': '7.2', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '12 month follow-up', 'description': '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.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'One intervention group patient was excluded because they had to leave immediately after the final visit and did not complete the 12-month survey.'}, {'type': 'PRIMARY', 'title': 'Asthma Quality-of-life Score', 'denoms': [{'units': 'Participants', 'counts': [{'value': '174', 'groupId': 'OG000'}, {'value': '164', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Educational Video and Question Prompt List', 'description': '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.\n\nEducational Video and Question Prompt List: Educational Video and Question Prompt List'}, {'id': 'OG001', 'title': 'Control Group', 'description': 'Standard of care will be used'}], 'classes': [{'categories': [{'measurements': [{'value': '6.1', 'spread': '1.2', 'groupId': 'OG000'}, {'value': '6.2', 'spread': '0.98', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '12 month follow-up', 'description': '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.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'One intervention group patient was excluded because they had to leave immediately after the final visit and did not complete the 12-month survey.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Educational Video and Question Prompt List', 'description': '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.\n\nEducational Video and Question Prompt List: Educational Video and Question Prompt List'}, {'id': 'FG001', 'title': 'Control Group', 'description': 'Standard of care will be used'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '185'}, {'groupId': 'FG001', 'numSubjects': '174'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '175'}, {'groupId': 'FG001', 'numSubjects': '164'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '10'}, {'groupId': 'FG001', 'numSubjects': '10'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '185', 'groupId': 'BG000'}, {'value': '174', 'groupId': 'BG001'}, {'value': '359', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Educational Video and Question Prompt List', 'description': '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.\n\nEducational Video and Question Prompt List: Educational Video and Question Prompt List'}, {'id': 'BG001', 'title': 'Control Group', 'description': 'Standard of care will be used'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '13.2', 'spread': '1.9', 'groupId': 'BG000'}, {'value': '13.2', 'spread': '1.9', 'groupId': 'BG001'}, {'value': '13.2', 'spread': '1.9', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '76', 'groupId': 'BG000'}, {'value': '78', 'groupId': 'BG001'}, {'value': '154', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '109', 'groupId': 'BG000'}, {'value': '96', 'groupId': 'BG001'}, {'value': '205', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '26', 'groupId': 'BG000'}, {'value': '19', 'groupId': 'BG001'}, {'value': '45', 'groupId': 'BG002'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '159', 'groupId': 'BG000'}, {'value': '155', 'groupId': 'BG001'}, {'value': '314', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '24', 'groupId': 'BG000'}, {'value': '17', 'groupId': 'BG001'}, {'value': '41', 'groupId': 'BG002'}]}, {'title': 'Asian', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '4', 'groupId': 'BG002'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Black or African American', 'measurements': [{'value': '71', 'groupId': 'BG000'}, {'value': '63', 'groupId': 'BG001'}, {'value': '134', 'groupId': 'BG002'}]}, {'title': 'White', 'measurements': [{'value': '60', 'groupId': 'BG000'}, {'value': '70', 'groupId': 'BG001'}, {'value': '130', 'groupId': 'BG002'}]}, {'title': 'More than one race', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '30', 'groupId': 'BG000'}, {'value': '20', 'groupId': 'BG001'}, {'value': '50', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '185', 'groupId': 'BG000'}, {'value': '174', 'groupId': 'BG001'}, {'value': '359', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Number of Participants Achieving Asthma Control', 'classes': [{'categories': [{'title': 'Controlled', 'measurements': [{'value': '101', 'groupId': 'BG000'}, {'value': '105', 'groupId': 'BG001'}, {'value': '206', 'groupId': 'BG002'}]}, {'title': 'Not controlled', 'measurements': [{'value': '84', 'groupId': 'BG000'}, {'value': '69', 'groupId': 'BG001'}, {'value': '153', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'description': '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".', 'unitOfMeasure': 'Participants'}, {'title': 'Adolescent asthma management self-efficacy score', 'classes': [{'categories': [{'measurements': [{'value': '55.9', 'spread': '8.0', 'groupId': 'BG000'}, {'value': '56.0', 'spread': '8.2', 'groupId': 'BG001'}, {'value': '55.9', 'spread': '8.1', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'description': '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.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Asthma quality-of-life score', 'classes': [{'categories': [{'measurements': [{'value': '5.7', 'spread': '1.2', 'groupId': 'BG000'}, {'value': '5.8', 'spread': '1.2', 'groupId': 'BG001'}, {'value': '5.7', 'spread': '1.2', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'description': '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.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'STANDARD_DEVIATION'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2015-04-27', 'size': 384241, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2018-07-25T13:31', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 359}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2015-07'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-07', 'completionDateStruct': {'date': '2017-11', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-07-26', 'studyFirstSubmitDate': '2015-06-24', 'resultsFirstSubmitDate': '2018-07-23', 'studyFirstSubmitQcDate': '2015-07-14', 'lastUpdatePostDateStruct': {'date': '2019-01-16', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2018-07-26', 'studyFirstPostDateStruct': {'date': '2015-07-15', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2019-01-16', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2017-11', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of Participants Achieving Asthma Control', 'timeFrame': '12 month follow-up', 'description': '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".'}, {'measure': 'Adolescent Asthma Management Self-efficacy Score', 'timeFrame': '12 month follow-up', 'description': '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.'}, {'measure': 'Asthma Quality-of-life Score', 'timeFrame': '12 month follow-up', 'description': '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.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Communication', 'provider', 'caregiver', 'adolescent'], 'conditions': ['Asthma']}, 'descriptionModule': {'briefSummary': '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.\n\nThe 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.', 'detailedDescription': '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.\n\nAll 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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '17 Years', 'minimumAge': '11 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* ages 11 to 17 years;\n* speak and read English or Spanish;\n* have persistent asthma;\n* are present for an acute or follow-up asthma visit or a well-child visit;\n* and have previously visited the clinic at least once for asthma.\n\nAdolescents' 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.\n\nExclusion Criteria:\n\n* present for gastrointestinal complaints or other non-asthma related acute illness."}, 'identificationModule': {'nctId': 'NCT02498834', 'briefTitle': 'Using Question Prompt Lists During Pediatric Asthma Visits to Increase Adolescent Involvement', 'organization': {'class': 'OTHER', 'fullName': 'University of North Carolina, Chapel Hill'}, 'officialTitle': 'Using Question Prompt Lists During Pediatric Asthma Visits to Increase Adolescent Involvement', 'orgStudyIdInfo': {'id': '14-2628'}, 'secondaryIdInfos': [{'id': 'CDR-1402-09777', 'type': 'OTHER', 'domain': 'PCORI'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Educational Video and Question Prompt List', 'description': '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.', 'interventionNames': ['Behavioral: Educational Video and Question Prompt List']}, {'type': 'NO_INTERVENTION', 'label': 'Control group', 'description': 'Standard of care will be used'}], 'interventions': [{'name': 'Educational Video and Question Prompt List', 'type': 'BEHAVIORAL', 'description': 'Educational Video and Question Prompt List', 'armGroupLabels': ['Educational Video and Question Prompt List']}]}, 'contactsLocationsModule': {'locations': [{'zip': '27599', 'city': 'Chapel Hill', 'state': 'North Carolina', 'country': 'United States', 'facility': 'University of North Carolin at Chapel Hill', 'geoPoint': {'lat': 35.9132, 'lon': -79.05584}}], 'overallOfficials': [{'name': 'Betsy L Sleath, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of North Carolina, Chapel Hill'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of North Carolina, Chapel Hill', 'class': 'OTHER'}, 'collaborators': [{'name': 'Patient-Centered Outcomes Research Institute', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}