Clinical trial NCT06068699: Postcards to Improve Remote Monitoring Adherence Among Veterans
Official title: Informational Postcards to Improve Remote Monitoring Among Veterans With Pacemakers and Implantable Cardioverter-Defibrillators
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: ICD
Pacemaker DDD
Adherence, Patient
Lead sponsor: San Francisco VA Health Care System
Sponsor class: FED
First posted: 2023-10-05
Enrollment: 6351
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SEQUENTIAL
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.
Primary purpose: HEALTH_SERVICES_RESEARCH

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.

Eligibility criteria: 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

Primary outcomes:
measure: Remote monitoring transmission
timeFrame: 70 days
Secondary outcomes:
measure: Transmission after first postcard
timeFrame: 70 days
Other outcomes:
Locations:
city: San Francisco
country: United States
facility: San Francisco VA Medical Center
state: California
Study officials:
References: