Ignite Creation Date:
2025-12-24 @ 7:02 PM
Ignite Modification Date:
2026-02-06 @ 11:31 AM
Study NCT ID:
NCT02668757
Status:
COMPLETED
Last Update Posted:
2018-02-28
First Post:
2016-01-27
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
HeartHab, Can a Patient-tailored Application Support Coronary Artery Disease Patients During Rehabilitation?
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'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 30}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2016-03', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-02', 'completionDateStruct': {'date': '2017-12-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-02-26', 'studyFirstSubmitDate': '2016-01-27', 'studyFirstSubmitQcDate': '2016-01-27', 'lastUpdatePostDateStruct': {'date': '2018-02-28', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2016-01-29', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2017-12-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Impact on motivation', 'timeFrame': 'week 6', 'description': "By means of a questionnaire and an interview, questions are asked about participants' motivation for a tour"}], 'secondaryOutcomes': [{'measure': 'Usability of the HeartHab application', 'timeFrame': 'week 6', 'description': 'By means of a questionnaire and an interview, the participants are asked about the usability of the application. This information will give insights in parts of the application that could be improved considering the usability'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Coronary Artery Disease']}, 'descriptionModule': {'briefSummary': 'The HeartHab study is a pilot trial in which coronary artery disease patients (n = 15-30) are given the HeartHab application. The HeartHab application is a smarthphone based mobile application that serves as a secondary prevention tool, to support cardiac patients after their phase II cardiac rehabilitation program. During study period (4-6 weeks), participating patients will be asked to use the application. HeartHab includes a module devoted to therapy compliance, one to exercise training prescription and one to risk factor control. HeartHab aims to motivate the patient to improve his/her self-management skills and hence decrease cardiovascular morbidity (and mortality).\n\nMotivational aspects and usability data will be collected during study period by means of app logs and/or questionnaires/interviews.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients with coronary artery disease for which they received a percutaneous coronary intervention, coronary artery bypass grafting or drugs only.\n* Patients that have completed the standard cardiac rehabilitation program\n* Patients who have access to a computer and a WiFi internet connection\n* Patients that are able to go to the rehabilitation centre ReGo of Jessa Hospital\n* Patients who signed the informed consent document\n\nExclusion Criteria:\n\n* Patients with a history of VF, sustained VT and/or supraventricular tachycardia during the last 6 months before enrollment.\n* Patients who due to cognitive, neurological and/or musculoskeletal constraints are unable to ride a bicycle.\n* Patients with a pacemaker or defibrillator.\n* Non-Dutch speaking patients\n* Patients who simultaneously participate in another study'}, 'identificationModule': {'nctId': 'NCT02668757', 'acronym': 'HeartHab', 'briefTitle': 'HeartHab, Can a Patient-tailored Application Support Coronary Artery Disease Patients During Rehabilitation?', 'organization': {'class': 'OTHER', 'fullName': 'Hasselt University'}, 'officialTitle': 'Pilot Study, How the HeartHab Application Can Support Coronary Artery Disease Patients in Their Rehabilitation Program?', 'orgStudyIdInfo': {'id': 'HeartHab-001'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'HeartHab application arm', 'description': 'Patients in the HeartHab application arm will receive the mobile application during study period.', 'interventionNames': ['Behavioral: HeartHab application intervention']}], 'interventions': [{'name': 'HeartHab application intervention', 'type': 'BEHAVIORAL', 'description': 'The intervention patients will use the HeartHab application on a smartphone. During the study, the patients will use the HeartHab application for 4-6 weeks.', 'armGroupLabels': ['HeartHab application arm']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Hasselt', 'country': 'Belgium', 'facility': 'Jessa Ziekenhuis', 'geoPoint': {'lat': 50.93106, 'lon': 5.33781}}], 'overallOfficials': [{'name': 'Paul Dendale, Prof. dr.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'paul.dendale@jessazh.be'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Hasselt University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'prof. dr.', 'investigatorFullName': 'prof. dr. Paul Dendale', 'investigatorAffiliation': 'Hasselt University'}}}}