Ignite Creation Date:
2025-12-25 @ 3:07 AM
Ignite Modification Date:
2025-12-26 @ 1:46 AM
Study NCT ID:
NCT02361333
Status:
COMPLETED
Last Update Posted:
2018-01-17
First Post:
2015-01-20
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Barriers to Use of Remote Monitoring in Patients With Implantable Cardioverter Defibrillators
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 20}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2012-10'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-01', 'completionDateStruct': {'date': '2014-10', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-01-12', 'studyFirstSubmitDate': '2015-01-20', 'studyFirstSubmitQcDate': '2015-02-10', 'lastUpdatePostDateStruct': {'date': '2018-01-17', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2015-02-11', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-04', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of remote Transmissions of data using remote monitor made by patient', 'timeFrame': '6 months'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Cardiac Patients', 'Implantable Cardioverter Defibrillator']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to determine whether a teaching intervention can help increase the use of remote monitors in patients with implantable cardioverter defibrillators.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Received a Medtronic implantable cardioverter defibrillator (ICD) at Yale Electrophysiology, between January 2007 and June 2012\n* ICD is compatible with Carelink, Medtronic's remote monitoring system\n\nExclusion Criteria:\n\n* Less than 18 years of age\n* From a vulnerable population\n* Incompetent/suffers from dementia\n* Non-English speaking"}, 'identificationModule': {'nctId': 'NCT02361333', 'briefTitle': 'Barriers to Use of Remote Monitoring in Patients With Implantable Cardioverter Defibrillators', 'organization': {'class': 'OTHER', 'fullName': 'Yale University'}, 'officialTitle': 'Barriers to Use of Remote Monitoring in Patients With Implantable Cardioverter Defibrillators', 'orgStudyIdInfo': {'id': '1208010730'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Teaching Intervention', 'description': 'Patients will be taught how to install and use a remote monitor.', 'interventionNames': ['Behavioral: Teaching Intervention']}, {'type': 'NO_INTERVENTION', 'label': 'No Intervention', 'description': 'Patients will not be taught how to install and use a remote monitor'}], 'interventions': [{'name': 'Teaching Intervention', 'type': 'BEHAVIORAL', 'description': 'Patients will be taught how to install and use a remote monitor', 'armGroupLabels': ['Teaching Intervention']}]}, 'contactsLocationsModule': {'locations': [{'zip': '06511', 'city': 'New Haven', 'state': 'Connecticut', 'country': 'United States', 'facility': 'Yale Electrophysiology', 'geoPoint': {'lat': 41.30815, 'lon': -72.92816}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Yale University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}