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Postcards to Improve Remote Monitoring Adherence Among Veterans

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06068699
Enrollment
6351
Registered
2023-10-05
Start date
2020-05-01
Completion date
2022-02-28
Last updated
2023-10-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

ICD, Pacemaker DDD, Adherence, Patient

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.

Interventions

Participants received a postcard asking them to address non-adherence to remote monitoring.

Sponsors

US Department of Veterans Affairs
Lead SponsorFED

Study design

Allocation
RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
SINGLE (Investigator)

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.

Eligibility

Sex/Gender
ALL
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Remote monitoring transmission70 daysProportion of patients who sent a transmission within 70 days

Secondary

MeasureTime frameDescription
Transmission after first postcard70 daysProportion of patients who sent a transmission after the first postcard

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026