Ignite Creation Date:
2025-12-25 @ 4:18 AM
Ignite Modification Date:
2025-12-26 @ 3:18 AM
Study NCT ID:
NCT05697120
Status:
COMPLETED
Last Update Posted:
2023-09-11
First Post:
2022-11-03
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Long-term Effects of Individualized Follow-up With an App for One Year
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003324', 'term': 'Coronary Artery Disease'}], 'ancestors': [{'id': 'D003327', 'term': 'Coronary Disease'}, {'id': 'D017202', 'term': 'Myocardial Ischemia'}, {'id': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D001161', 'term': 'Arteriosclerosis'}, {'id': 'D001157', 'term': 'Arterial Occlusive Diseases'}, {'id': 'D014652', 'term': 'Vascular Diseases'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2023-08-28', 'size': 133177, 'label': 'Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'SAP_000.pdf', 'typeAbbrev': 'SAP', 'uploadDate': '2023-08-28T04:23', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 102}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2023-02-07', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-10', 'completionDateStruct': {'date': '2023-09-07', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-09-08', 'studyFirstSubmitDate': '2022-11-03', 'studyFirstSubmitQcDate': '2023-01-16', 'lastUpdatePostDateStruct': {'date': '2023-09-11', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-01-25', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-09-07', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Peak oxygen uptake', 'timeFrame': '5 year post rehab', 'description': 'Relative VO2peak (ml/kg/min)'}], 'secondaryOutcomes': [{'measure': 'Time to exhaustion', 'timeFrame': '5 year post rehab', 'description': 'Time on treadmill measured in seconds'}, {'measure': 'Peak incline', 'timeFrame': '5 year post rehab', 'description': 'Incline (%) at treadmill in the end of the test'}, {'measure': 'Peak velocity', 'timeFrame': '5 year post rehab', 'description': 'Kilometer per hour in the end of the test'}, {'measure': 'Bodyweight', 'timeFrame': '5 year post rehab', 'description': 'Kilograms'}, {'measure': 'LDL cholesterol', 'timeFrame': '5 year post rehab', 'description': 'Blood sample'}, {'measure': 'HDL cholesterol', 'timeFrame': '5 year post rehab', 'description': 'Blood sample'}, {'measure': 'Total cholesterol', 'timeFrame': '5 year post rehab', 'description': 'Blood sample'}, {'measure': 'Exercise habits', 'timeFrame': '5 year post rehab', 'description': 'Mean number of exercise sessions each week for the last year'}, {'measure': 'Health related quality of life', 'timeFrame': '5 year post rehab', 'description': 'HeartQoL'}, {'measure': 'Health status', 'timeFrame': '5 year post rehab', 'description': 'EQ5D'}, {'measure': 'Cardiovascular events', 'timeFrame': '5 year post rehab', 'description': 'Number of new cardiovascular events in the last five years'}, {'measure': 'Dietary habits', 'timeFrame': '5 year post rehab', 'description': '"Hva spiser du" - a norwegian questionnaire developed to assess nutrional habits'}, {'measure': 'Triglycerides', 'timeFrame': '5 year post rehab', 'description': 'Bloodsample'}, {'measure': 'Physical activity', 'timeFrame': '5 year post rehab', 'description': 'IPAQ'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Cardiac rehabilitation', 'mHealth', 'mobile phone app', 'Lifestyle', 'Smartphone'], 'conditions': ['Coronary Artery Disease']}, 'referencesModule': {'references': [{'pmid': '39946716', 'type': 'DERIVED', 'citation': 'Lunde P, Bye A, Grimsmo J, Pripp AH, Ritschel V, Jarstad E, Nilsson BB. Effects of Individualized Follow-Up With an App Postcardiac Rehabilitation: Five-Year Follow-Up of a Randomized Controlled Trial. J Med Internet Res. 2025 Feb 13;27:e60256. doi: 10.2196/60256.'}]}, 'descriptionModule': {'briefSummary': 'The aim of this study is to examine the long-term (3-5 year post intervention) effects post individualized follow-up with an app for one year, compared to a control group that received usual care on factors related to healthy behaviour in patients post-CR.', 'detailedDescription': 'Recently, our research group demonstrated that individualized follow-up with an app for one year post-Cardiac Rehabilitation (post-CR) significantly improved exercise capacity, exercise habits and self-perceived goal achievement compared to a control group receiving usual care. To prepare for real-world implementation of an app to promote healthy behaviour post-CR, we will investigate the long-term effects (3-5 year post intervention). The aim of this study is to examine the long-term (3-5 year post intervention) effects post individualized follow-up with an app for one year, compared to a control group that received usual care on factors related to healthy behaviour in patients post-CR. We hypothesize that patients allocated to the intervention group post-CR have internalized healthy behaviour and therefore have significantly higher exercise capacity and lower bodyweight compared to the control group, 3-5year post intervention.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '41 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients participating in cardiac rehabilitation. The sample in this study will be the same as in the RCT of which this study is built on (ClinicalTrials.gov NCT03174106)', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Included in the RCT of which this study is built on'}, 'identificationModule': {'nctId': 'NCT05697120', 'briefTitle': 'Long-term Effects of Individualized Follow-up With an App for One Year', 'organization': {'class': 'OTHER', 'fullName': 'Oslo Metropolitan University'}, 'officialTitle': 'Effect of Using a Smartphone Application to Promote Adherence to Healthy Behaviour Post-cardiac Rehabilitation: Five Year Follow-up of a Randomized Controlled Trial', 'orgStudyIdInfo': {'id': 'OsloMetU'}}, 'contactsLocationsModule': {'locations': [{'city': 'Oslo', 'country': 'Norway', 'facility': 'Oslo Metropolitan University', 'geoPoint': {'lat': 59.91273, 'lon': 10.74609}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Oslo Metropolitan University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}