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NCT06068699 Clinical Trial

Postcards to Improve Remote Monitoring Adherence Among Veterans

Adherence, Patient Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT06068699
Other study ID # VANCDSP QUERI Postcards
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date May 1, 2020
Est. completion date February 28, 2022

Study information
Verified date September 2023
Source San Francisco VA Health Care System
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility
Status Completed
Enrollment 6351
Est. completion date February 28, 2022
Est. primary completion date December 31, 2021
Accepts healthy volunteers No
Gender All
Age group N/A and older
Eligibility 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

Related Conditions & MeSH terms

Intervention

Other:
• Postcard
Participants received a postcard asking them to address non-adherence to remote monitoring.

Locations
Country Name City State
United States San Francisco VA Medical Center San Francisco California

Sponsors (1)
Lead Sponsor Collaborator
US Department of Veterans Affairs

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary Remote monitoring transmission Proportion of patients who sent a transmission within 70 days 70 days
Secondary Transmission after first postcard Proportion of patients who sent a transmission after the first postcard 70 days
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