NCT06068699

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
6,351

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started May 2020

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2020

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2021

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

February 28, 2022

Completed
1.6 years until next milestone

First Submitted

Initial submission to the registry

September 21, 2023

Completed
14 days until next milestone

First Posted

Study publicly available on registry

October 5, 2023

Completed
Last Updated

October 5, 2023

Status Verified

September 1, 2023

Enrollment Period

1.7 years

First QC Date

September 21, 2023

Last Update Submit

October 4, 2023

Conditions

ICDPacemaker DDDAdherence, Patient

Outcome Measures

Primary Outcomes (1)

  • Remote monitoring transmission

    Proportion of patients who sent a transmission within 70 days

    70 days

Secondary Outcomes (1)

  • Transmission after first postcard

    70 days

Study Arms (2)

Postcards

EXPERIMENTAL

Participants who received a postcard.

Other: Postcard

Controls

NO INTERVENTION

Participants did not receive a postcard (usual care).

Interventions

PostcardOTHER

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

Postcards

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • 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)

You may not qualify if:

  • Veteran patients without a wireless RM-capable device
  • Had not sent a remote transmission in the past 2 years

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

San Francisco VA Medical Center

San Francisco, California, 94121, United States

Location

MeSH Terms

Conditions

Patient Compliance

Condition Hierarchy (Ancestors)

Patient Acceptance of Health CareTreatment Adherence and ComplianceHealth BehaviorBehavior

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
INVESTIGATOR
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
SEQUENTIAL
Model Details: 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.
Sponsor Type
FED
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Staff Physician

Study Record Dates

First Submitted

September 21, 2023

First Posted

October 5, 2023

Study Start

May 1, 2020

Primary Completion

December 31, 2021

Study Completion

February 28, 2022

Last Updated

October 5, 2023

Record last verified: 2023-09

Data Sharing

IPD Sharing
Will not share

Locations

US(1)