Postcards to Improve Remote Monitoring Adherence Among Veterans

Sponsor

US Department of Veterans Affairs (U.S. Fed)

Overall Status

Completed

CT.gov ID

NCT06068699

Collaborator

(none)

6,351

Enrollment

Location

Arms

21.9

Actual Duration (Months)

289.4

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
ICD Pacemaker DDD Adherence, Patient	Other: Postcard	N/A

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 Design

Study Type:

Interventional

Actual Enrollment :

6351 participants

Allocation:

Randomized

Intervention Model:

Sequential Assignment

Intervention Model Description:

This was a stepped-wedge randomized controlled trial with two waves. 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 RM transmission within 1 month were mailed a second, identical postcard.This was a stepped-wedge randomized controlled trial with two waves. 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 RM transmission within 1 month were mailed a second, identical postcard.

Masking:

Single (Investigator)

Primary Purpose:

Health Services Research

Official Title:

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

Actual Study Start Date :

May 1, 2020

Actual Primary Completion Date :

Dec 31, 2021

Actual Study Completion Date :

Feb 28, 2022

Arms and Interventions

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).

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).

Outcome Measures

Primary Outcome Measures

Remote monitoring transmission [70 days]
Proportion of patients who sent a transmission within 70 days

Secondary Outcome Measures

Transmission after first postcard [70 days]
Proportion of patients who sent a transmission after the first postcard

Eligibility Criteria

Criteria

Ages Eligible for Study:

N/A and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	San Francisco VA Medical Center	San Francisco	California	United States	94121

Sponsors and Collaborators

US Department of Veterans Affairs

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Sanket Dhruva, MD, MHS, Staff Physician, San Francisco VA Health Care System

ClinicalTrials.gov Identifier:

NCT06068699

Other Study ID Numbers:

VANCDSP QUERI Postcards

First Posted:

Oct 5, 2023

Last Update Posted:

Oct 5, 2023

Last Verified:

Sep 1, 2023

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Study Results

No Results Posted as of Oct 5, 2023