Ignite Creation Date:
2026-03-26 @ 3:19 PM
Ignite Modification Date:
2026-03-30 @ 2:26 AM
Study NCT ID:
NCT07464834
Status:
COMPLETED
Last Update Posted:
2026-03-11
First Post:
2026-03-05
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Postcards to Improve Remote Monitoring Connectivity Among Veterans With a Disconnected Monitor
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2026-03-25'}, 'conditionBrowseModule': {'meshes': [{'id': 'D010349', 'term': 'Patient Compliance'}], 'ancestors': [{'id': 'D010342', 'term': 'Patient Acceptance of Health Care'}, {'id': 'D000074822', 'term': 'Treatment Adherence and Compliance'}, {'id': 'D015438', 'term': 'Health Behavior'}, {'id': 'D001519', 'term': 'Behavior'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE', 'maskingDescription': 'Clinic staff was not informed as to which patients were sent postcards and which patients were not sent postcards. Only the study staff had access to randomization data and and the individuals mailing the postcards (who were not involved in patient-level remote monitoring adherence efforts) had access to mailing data.'}, 'primaryPurpose': 'HEALTH_SERVICES_RESEARCH', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 2726}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2024-08-05', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2026-03', 'completionDateStruct': {'date': '2025-07-29', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2026-03-09', 'studyFirstSubmitDate': '2026-03-05', 'studyFirstSubmitQcDate': '2026-03-09', 'lastUpdatePostDateStruct': {'date': '2026-03-11', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2026-03-11', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-07-29', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Median time to monitor reconnection', 'timeFrame': 'From intervention (mailing) to at least 100 days after intervention.', 'description': 'Time to reconnection using median survival time and assessing differences in each group through log-rank test. Assess relative difference across two groups through Cox proportional hazards regression.'}], 'secondaryOutcomes': [{'measure': 'Binary adherence to next scheduled transmission', 'timeFrame': 'From intervention (mailing) to at least 100 days after intervention.', 'description': 'Assesses whether a transmission received within 10 days of scheduled transmission assessed using logistic regression.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Remote Monitoring Adherence', 'cardiovascular implantable electronic devices'], 'conditions': ['ICD', 'Pacemaker', 'Implanted Loop Recorder', 'Remote Monitoring', 'Adherence, Patient']}, 'descriptionModule': {'briefSummary': 'We tested the effect of mailing informational postcards to patients with cardiovascular implantable electronic devices who have lost continuous RM connectivity because of a disconnected home monitor.', 'detailedDescription': "Objective: To determine the effect on remote monitoring (RM) connectivity of mailing informational postcards to patients with CIEDs who have lost continuous RM connectivity because of a disconnected monitor.\n\nDesign: Parallel prospective randomized controlled trial (RCT).\n\nSetting: Veterans Health Administration.\n\nParticipants: Randomized selection of all patients with CIEDs whose bedside or smartphone monitor had become disconnected for ≥16 but ≤40 days from the manufacturer's RM service.\n\nExposure: We developed postcards that notified patients about RM disconnection, described RM's clinical benefits, and provided the customer service number of their CIED manufacturer. Twice monthly, we randomized patients to either receive or not receive the postcard.\n\nMain Outcomes and Measures: Primary outcome was median time to reconnection."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients followed by the VA National Cardiac Device Surveillance Program for CIED remote monitoring care with a wireless-capable CIED (i.e., does not require manual transmission).\n* CIEDs: pacemakers, implantable cardioverter-defibrillators, and implantable loop recorders\n* Patients had a remote monitoring transmission received by VA National Cardiac Device Surveillance Program within past 100 days (representing standard 90-day interval plus additional 10-day buffer in case of travel)\n* Data from Abbott merlin.net, Biotronik Home Monitoring, Medtronic Carelink, or Boston Scientific Latitude indicating patient disconnected from remote monitoring for ≥16 days but ≤40 days\n\nExclusion Criteria:\n\n* Address outside of United States or Puerto Rico\n* Previously included in the present RCT or a complementary RCT (VANCDSP Disconnected CIED). Once a patient reconnects but then becomes disconnected again, cannot be included again'}, 'identificationModule': {'nctId': 'NCT07464834', 'briefTitle': 'Postcards to Improve Remote Monitoring Connectivity Among Veterans With a Disconnected Monitor', 'organization': {'class': 'FED', 'fullName': 'San Francisco VA Health Care System'}, 'officialTitle': 'Postcards to Improve Remote Monitoring Connectivity Among Patients With Cardiovascular Implantable Electronic Devices and Disconnected Monitors: A Randomized, Controlled Trial', 'orgStudyIdInfo': {'id': 'VANCDSP Disconnected Monitor'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Postcards', 'description': 'Participants who received tailored postcard', 'interventionNames': ['Other: Tailored Postcard']}, {'type': 'NO_INTERVENTION', 'label': 'Controls', 'description': 'Participants who did not receive a postcard (usual care)'}], 'interventions': [{'name': 'Tailored Postcard', 'type': 'OTHER', 'description': 'Participants received a postcard with a tailored notice that their home monitor was disconnected from remote monitoring with tips to reconnect and prompts to follow up with their CIED manufacturer or local VA clinic.', 'armGroupLabels': ['Postcards']}]}, 'contactsLocationsModule': {'locations': [{'zip': '94121', 'city': 'San Francisco', 'state': 'California', 'country': 'United States', 'facility': 'San Francisco VA Medical Center', 'geoPoint': {'lat': 37.77493, 'lon': -122.41942}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'San Francisco VA Health Care System', 'class': 'FED'}, 'collaborators': [{'name': 'US Department of Veterans Affairs', 'class': 'FED'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Staff Physician', 'investigatorFullName': 'Sanket Dhruva, MD, MHS', 'investigatorAffiliation': 'San Francisco VA Health Care System'}}}}