Ignite Creation Date:
2025-12-24 @ 1:35 PM
Ignite Modification Date:
2025-12-31 @ 2:10 AM
Study NCT ID:
NCT06011395
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-10-18
First Post:
2023-08-21
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Smart Wearable Insights to Prevent Exacerbations and Recurrence - Rehabilitation Study: SWIPER-REHAB
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D002318', 'term': 'Cardiovascular Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 1800}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2025-01-30', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-10', 'completionDateStruct': {'date': '2026-03-02', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-10-16', 'studyFirstSubmitDate': '2023-08-21', 'studyFirstSubmitQcDate': '2023-08-21', 'lastUpdatePostDateStruct': {'date': '2024-10-18', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-08-25', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-03-02', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Uptake of cardiac rehabilitation', 'timeFrame': '12 months', 'description': 'Percentage uptake of cardiac rehabilitation programme (of those that are eligible)'}], 'secondaryOutcomes': [{'measure': 'Quality of life assessment (EQ-5D-5L)', 'timeFrame': '12 months', 'description': 'Patient quality of life as measured by the EQ-5D-5L instrument'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Cardiac rehabilitation', 'Prevention', 'Digital health', 'Smart wearables', 'Remote patient monitoring'], 'conditions': ['Cardiovascular Diseases']}, 'descriptionModule': {'briefSummary': "Aims of the study:\n\n* To measure the rate of completion of a digital cardiac rehabilitation programme at Imperial College Healthcare NHS Trust (ICHNT)\n* To measure the health economic impact of a digital cardiac rehabilitation programme at ICHNT\n\nAny adult patient eligible for ICHNT cardiac rehabilitation (CR) programmes is eligible to participate. Participants will receive a commercially available smart watch and be asked to wear the device as much as possible. In addition, they will be asked to download a smartphone application called 'Imperial Healthy Hearts', which displays movement and information on heart rate, breathing and oxygen levels to both the participant and the research team (digital data). The Healthy Hearts app also allows the direct care team to provide educational materials to patients as part of their routine care.\n\nThe clinical content and structure of the CR programme is determined by the clinical CR team, and does not deviate from established local and national standards and practices.\n\nResearchers will capture physiological data such as heart rate, respiratory rate, blood pressure (where available) and oxygen saturation (where available) via the Healthy Hearts platform. Researchers will also capture clinical information from the electronic health record, and will compare CR programme uptake and completion rates with historical data and national targets."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients at Imperial College Healthcare NHS Trust eligible for cardiac rehabilition', 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age 18 years or above\n* Able to give informed consent\n* Eligible for Cardiac Rehabilitation programme\n\nExclusion Criteria:\n\n* Any wrist wound, skin pathology or other feature that would prohibit the wearing of a smartwatch\n* Any visual impairment preventing the use of the Fitbit or smartphone application.'}, 'identificationModule': {'nctId': 'NCT06011395', 'acronym': 'SWIPER-REHAB', 'briefTitle': 'Smart Wearable Insights to Prevent Exacerbations and Recurrence - Rehabilitation Study: SWIPER-REHAB', 'organization': {'class': 'OTHER', 'fullName': 'Imperial College London'}, 'officialTitle': 'Smart Watch Insights to Prevent Exacerbations and Recurrence - Rehabilitation Study: SWIPER-REHAB', 'orgStudyIdInfo': {'id': '22HH7635'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Smartwatch', 'type': 'DEVICE', 'description': 'Activity tracker (step count, calories burned), heart rate monitor'}, {'name': 'Imperial Healthy Hearts app', 'type': 'DEVICE', 'description': 'Digital cardiac rehabilitation smartphone application. Represents smart watch data and source of educational materials for cardiac rehabilitiation programme.'}]}, 'contactsLocationsModule': {'locations': [{'city': 'London', 'country': 'United Kingdom', 'facility': 'Imperial College Healthcare NHS Trust', 'geoPoint': {'lat': 51.50853, 'lon': -0.12574}}], 'centralContacts': [{'name': 'Mihir Kelshiker, MD', 'role': 'CONTACT', 'email': 'mihir.kelshiker10@imperial.ac.uk', 'phone': '+447590673758'}], 'overallOfficials': [{'name': 'Nicholas S Peters, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Imperial College London'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Imperial College London', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}