Ignite Creation Date:
2025-12-24 @ 5:13 PM
Ignite Modification Date:
2025-12-29 @ 4:07 AM
Study NCT ID:
NCT04264650
Status:
COMPLETED
Last Update Posted:
2020-02-11
First Post:
2020-02-09
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effectiveness of an mHealth Intervention for Youth With Congenital Heart Disease
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006330', 'term': 'Heart Defects, Congenital'}, {'id': 'D000294', 'term': 'Adolescent Behavior'}], 'ancestors': [{'id': 'D018376', 'term': 'Cardiovascular Abnormalities'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D000013', 'term': 'Congenital Abnormalities'}, {'id': 'D009358', 'term': 'Congenital, Hereditary, and Neonatal Diseases and Abnormalities'}, {'id': 'D001519', 'term': 'Behavior'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'HEALTH_SERVICES_RESEARCH', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 143}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2016-06-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-02', 'completionDateStruct': {'date': '2018-02-28', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-02-09', 'studyFirstSubmitDate': '2020-02-09', 'studyFirstSubmitQcDate': '2020-02-09', 'lastUpdatePostDateStruct': {'date': '2020-02-11', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-02-11', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2018-02-28', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Cardiac disease knowledge', 'timeFrame': '12 months', 'description': 'measured by the Leuven Knowledge Questionnaire for CHD'}], 'secondaryOutcomes': [{'measure': 'Physical activity', 'timeFrame': '12 months', 'description': 'measured by the International Physical Activity Questionnaire-Taiwan Show-Card Version'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Congenital Heart Disease', 'Adolescent Behavior']}, 'referencesModule': {'references': [{'pmid': '34151444', 'type': 'DERIVED', 'citation': 'Lin PJ, Fanjiang YY, Wang JK, Lu CW, Lin KC, Cheong IM, Pan KY, Chen CW. Long-term effectiveness of an mHealth-tailored physical activity intervention in youth with congenital heart disease: A randomized controlled trial. J Adv Nurs. 2021 Aug;77(8):3494-3506. doi: 10.1111/jan.14924. Epub 2021 Jun 21.'}, {'pmid': '33112424', 'type': 'DERIVED', 'citation': 'Williams CA, Wadey C, Pieles G, Stuart G, Taylor RS, Long L. Physical activity interventions for people with congenital heart disease. Cochrane Database Syst Rev. 2020 Oct 28;10(10):CD013400. doi: 10.1002/14651858.CD013400.pub2.'}]}, 'descriptionModule': {'briefSummary': 'The aims of this study were to evaluate the long-term effectiveness of the Care \\& Organize Our Lifestyle (COOL) program, a self-regulation theory-based mHealth program, on improving disease knowledge and physical activity in youth with congenital heart disease (CHD). The COOL program is a 12-month randomized controlled trial that compared two active intervention groups to a standard-care control group (n = 47). Participants with simple and moderate CHD aged 15-24 years were recruited from pediatric or adult CHD outpatient departments. Participants in one active intervention group (n = 49) were provided with COOL Passport, a mobile healthcare application. Those in the other group (n = 47) were provided with access to the Health Promotion Cloud system and use of game-based interactive platforms along with COOL Passport. Outcomes were the Leuven Knowledge Questionnaire for CHD and the International Physical Activity Questionnaire-Taiwan Show-Card Version.', 'detailedDescription': 'Background: Mobile health initiatives may provide youth with congenital heart disease (CHD) relevant health information and a platform for managing the complex health care needs associated with undergoing transitional care.\n\nAims: To evaluate the long-term effectiveness of the Care \\& Organize Our Lifestyle (COOL) program, a self-regulation theory-based mHealth program, on improving disease knowledge and physical activity in youth with CHD.\n\nMethods: The COOL program is a 12-month randomized controlled trial that compared two active intervention groups to a standard-care control group (n = 47). Participants with simple and moderate CHD aged 15-24 years were recruited from pediatric or adult CHD outpatient departments. Participants in one active intervention group (n = 49) were provided with COOL Passport, a mobile healthcare application. Those in the other group (n = 47) were provided with access to the Health Promotion Cloud system and use of game-based interactive platforms along with COOL Passport. Outcomes were the Leuven Knowledge Questionnaire for CHD and the International Physical Activity Questionnaire-Taiwan Show-Card Version.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '24 Years', 'minimumAge': '15 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* being diagnosed with CHD by a pediatric cardiologist and qualifying as having simple or moderate CHD complexity according to the 2008 American College of Cardiology/American Heart Association guidelines;\n* having a regular pulse;\n* being 15-24 years of age;\n* being conversant in Mandarin and Taiwanese;\n* possessing a smartphone with Internet connection;\n* agreeing to wear an exercise-monitoring wristband to record physiological data;\n* agreeing to engage in exercises designed to test cardiopulmonary endurance;\n* agreeing to participate in the study and sign an informed consent form for a relevant interview. For participants under 20 years of age, guardian approval by signing a written consent form was required.\n\nExclusion Criteria:\n\n* having cognitive impairment to the extent of being noncommunicative;\n* having CHD complicated with other congenital abnormalities;\n* having undergone a cardiac catheter-related intervention or surgery within the past 6 months;\n* being pregnant'}, 'identificationModule': {'nctId': 'NCT04264650', 'briefTitle': 'Effectiveness of an mHealth Intervention for Youth With Congenital Heart Disease', 'organization': {'class': 'OTHER', 'fullName': 'National Yang Ming Chiao Tung University'}, 'officialTitle': 'Long-term Effectiveness of an mHealth Intervention for Improving the Disease Knowledge and Physical Activity of Youth With Congenital Heart Disease: A Randomized Controlled Trial', 'orgStudyIdInfo': {'id': '201603045RINA'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'NO_INTERVENTION', 'label': 'Control group', 'description': 'Standard care'}, {'type': 'EXPERIMENTAL', 'label': 'One active intervention group', 'description': 'provided with COOL Passport, a mobile healthcare application', 'interventionNames': ['Behavioral: an mHealth intervention']}, {'type': 'EXPERIMENTAL', 'label': 'The other active intervention group', 'description': 'provided with access to the Health Promotion Cloud system and use of game-based interactive platforms along with COOL Passport', 'interventionNames': ['Behavioral: an mHealth intervention']}], 'interventions': [{'name': 'an mHealth intervention', 'type': 'BEHAVIORAL', 'description': 'The Care \\& Organize Our Lifestyle (COOL) program, a self-regulation theory-based mHealth program', 'armGroupLabels': ['One active intervention group', 'The other active intervention group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '11221', 'city': 'Taipei', 'country': 'Taiwan', 'facility': 'National Yang-Ming University', 'geoPoint': {'lat': 25.05306, 'lon': 121.52639}}], 'overallOfficials': [{'name': 'Chi-Wen Chen, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'National Yang Ming Chiao Tung University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'National Yang Ming Chiao Tung University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'Chi-Wen Chen', 'investigatorAffiliation': 'National Yang Ming Chiao Tung University'}}}}