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

March 13, 2026 updated by: Sanket Dhruva, MD, MHS, San Francisco VA Health Care System

Postcards to Improve Remote Monitoring Connectivity Among Patients With Disconnected Cardiovascular Implantable Electronic Devices: A Randomized, Controlled Trial

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

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 their home monitor had become disconnected from their CIED. Design: Parallel prospective randomized controlled trial (RCT). Setting: Veterans Health Administration. Participants: Randomized selection of all patients with CIEDs that had become disconnected from their home monitor for ≥16 but ≤40 days from the manufacturer's RM service. Exposure: The investigators 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, the investigators randomized patients to either receive or not receive the postcard. Main Outcomes and Measures: Primary outcome was median time to reconnection.

Study Type

Interventional

Enrollment (Actual)

1312

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • San Francisco, California, United States, 94121
        • San Francisco VA Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Health Services Research
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Postcards
Participants who received tailored postcard
Other: Tailored Postcards
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.
No Intervention: Controls
Participants who did not receive a postcard (usual care)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Median time to CIED reconnection
Time Frame: From intervention (mailing) to at least 100 days after intervention.
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Binary adherence to next scheduled transmission
Time Frame: From intervention (mailing) to at least 100 days after intervention.
Assesses whether a transmission received within 10 days of scheduled transmission assessed using logistic regression.
From intervention (mailing) to at least 100 days after intervention.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

San Francisco VA Health Care System

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 5, 2024

Primary Completion (Actual)

August 21, 2025

Study Completion (Actual)

August 21, 2025

Study Registration Dates

First Submitted

March 9, 2026

First Submitted That Met QC Criteria

March 13, 2026

First Posted (Actual)

March 17, 2026

Study Record Updates

Last Update Posted (Actual)

March 17, 2026

Last Update Submitted That Met QC Criteria

March 13, 2026

Last Verified

March 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • VANCDSP Disconnected CIED

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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