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OpenTrials
Completed

NCT Number: NCT07464834

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

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.

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Key information

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

San Francisco VA Medical Center

San Francisco, California, 94121, United States

About this study

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.

Design: Parallel prospective randomized controlled trial (RCT).

Setting: Veterans Health Administration.

Participants: 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.

Exposure: 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.

Main Outcomes and Measures: Primary outcome was median time to reconnection.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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 CIED). Once a patient reconnects but then becomes disconnected again, cannot be included again

Treatment and study plan

Tailored Postcard

Other

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.

Primary outcomes

  1. Median time to monitor 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.

Secondary outcomes

  1. 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.

Sponsors and collaborators

Lead sponsor

San Francisco VA Health Care System

Fed

Collaborators

  • US Department of Veterans Affairs

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Mar 11, 2026
Registry last updated
Mar 11, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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