Postcards to Improve Remote Monitoring Connectivity Among Veterans With a Disconnected CIED

NCT07477964 | Completed

• 1 other identifier: VANCDSP Disconnected CIED
• Study Type: interventional
• Target: 1,312
• Locations: 1 country
• Sites: 1

Brief Summary

The investigators tested the effect of mailing informational postcards to patients with cardiovascular implantable electronic devices (CIED) who have lost continuous RM connectivity because their home monitor had become disconnected from their CIED.

Conditions

ICD; Pacemaker; Implanted Loop Recorder; Remote Monitoring; Adherence, Patient

Keywords

Remote Monitoring Adherence; cardiovascular implantable electronic devices

Outcome Measures

Primary Outcomes (1)

• Median time to CIED reconnection

  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.

  From intervention (mailing) to at least 100 days after intervention.

Secondary Outcomes (1)

• Binary adherence to next scheduled transmission

  From intervention (mailing) to at least 100 days after intervention.

Study Arms (2)

Postcards

EXPERIMENTAL

Participants who received tailored postcard

Other: Tailored Postcards

Controls

NO INTERVENTION

Participants who did not receive a postcard (usual care)

Interventions

Tailored Postcards OTHER

Participants received a postcard with a tailored notice that their CIED was disconnected from remote monitoring with tips to reconnect and prompts to follow up with their CIED manufacturer or local VA clinic.

Postcards

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).
• CIEDs: pacemakers, implantable cardioverter-defibrillators, and implantable loop recorders
• 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)
• 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

You may not qualify if:

• Address outside of United States or Puerto Rico
• Previously included in the present RCT or a complementary RCT (VANCDSP Disconnected Monitor). Once a patient reconnects but then becomes disconnected again, cannot be included again

Sponsors & Collaborators

• San Francisco VA Health Care System: lead

Study Sites (1)

San Francisco VA Medical Center

San Francisco, California, 94121, United States

Location

MeSH Terms

Conditions

Patient Compliance

Condition Hierarchy (Ancestors)

Patient Acceptance of Health Care; Treatment Adherence and Compliance; Health Behavior; Behavior

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: 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.
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: FED
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Staff Physician

Study Record Dates

• First Submitted: March 9, 2026
• First Posted: March 17, 2026
• Study Start: August 5, 2024
• Primary Completion: August 21, 2025
• Study Completion: August 21, 2025
• Last Updated: March 17, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)