Postcards to Improve Remote Monitoring Adherence Among Veterans

Not Applicable

Completed

• Conditions: Adherence, Patient; ICD; Pacemaker DDD
• Interventions: Other: Postcard

• Registration Number: NCT06068699
• Lead Sponsor: US Department of Veterans Affairs

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.

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 Timeline

• Study Start: 2020-05-01
• Primary Completion: 2021-12-31
• Study Completion: 2022-02-28
• Status Verified: 2023-09
• Study First Submitted: 2023-09-21
• Study First Submitted QC: 2023-10-04
• Last Update Submitted: 2023-10-04
• Study First Posted: 2023-10-05
• Last Update Posted: 2023-10-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 6351

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SEQUENTIAL

Arm && Interventions

Group	Intervention	Description
Postcards	Postcard	Participants who received a postcard.

Primary Outcome Measures

Name	Time	Method
Remote monitoring transmission	70 days	Proportion of patients who sent a transmission within 70 days

Secondary Outcome Measures

Name	Time	Method
Transmission after first postcard	70 days	Proportion of patients who sent a transmission after the first postcard

Trial Locations

Locations (1)

San Francisco VA Medical Center; 🇺🇸 San Francisco, California, United States