Postcards to Improve Remote Monitoring Adherence Among Veterans

October 4, 2023 updated by: Sanket Dhruva, MD, MHS, US Department of Veterans Affairs

Informational Postcards to Improve Remote Monitoring Among Veterans With Pacemakers and Implantable Cardioverter-Defibrillators

We tested the effect of informational postcards on improving remote monitoring adherence among Veterans with pacemakers and implantable cardioverter-defibrillators in a stepped-wedge randomized controlled trial.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Objective: To test the effect of informational postcards on remote monitoring adherence among Veterans with pacemakers and implantable cardioverter-defibrillators (ICDs).

Design/Patients: Stepped-wedge randomized controlled trial among Veterans with pacemakers and ICDs.

Intervention: In wave 1, Veterans who had sent at least 1 transmission within the past 2 years but had become non-adherent were randomly assigned to receive a postcard or no postcard. Those receiving postcards were randomized to 1 of 2 messages: 1) a "warning" postcard describing risks of non-adherence or 2) an "encouraging" postcard describing benefits of adherence. In wave 2, Veterans who had either not received a postcard in wave 1 or had since become non-adherent were mailed a postcard (again, randomized to 1 of 2 messages). Patients who did not send a remote monitoring transmission within 1 month were mailed a second, identical postcard.

Main Measures: Proportion of patients who sent a transmission within 70 days.

Study Type

Interventional

Enrollment (Actual)

6351

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:

  • Veteran patients with wireless RM-capable pacemakers and ICDs followed by the VA National Cardiac Device Surveillance Program (VANCDSP)
  • Sent at least 1 remote transmission within the past 2 years but had become non-adherent (defined as missing their last scheduled transmission by at least 10 days)

Exclusion Criteria:

  • Veteran patients without a wireless RM-capable device
  • Had not sent a remote transmission in the past 2 years

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: Sequential Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Postcards
Participants who received a postcard.
Other: Postcard
Participants received a postcard asking them to address non-adherence to remote monitoring.
No Intervention: Controls
Participants did not receive a postcard (usual care).

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Remote monitoring transmission
Time Frame: 70 days
Proportion of patients who sent a transmission within 70 days
70 days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Transmission after first postcard
Time Frame: 70 days
Proportion of patients who sent a transmission after the first postcard
70 days

Collaborators and Investigators

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

Sponsor

US Department of Veterans Affairs

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)

May 1, 2020

Primary Completion (Actual)

December 31, 2021

Study Completion (Actual)

February 28, 2022

Study Registration Dates

First Submitted

September 21, 2023

First Submitted That Met QC Criteria

October 4, 2023

First Posted (Actual)

October 5, 2023

Study Record Updates

Last Update Posted (Actual)

October 5, 2023

Last Update Submitted That Met QC Criteria

October 4, 2023

Last Verified

September 1, 2023

More Information

Terms related to this study

Other Study ID Numbers

  • VANCDSP QUERI Postcards

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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