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临床试验/NCT06068699
NCT06068699已完成不适用

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

US Department of Veterans Affairs2 个研究点 分布在 1 个国家目标入组 6,351 人开始时间: 2020年5月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
6,351
试验地点
2
主要终点
Remote monitoring transmission

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Sequential
主要目的
Health Services Research
盲法
Single (Investigator)

入排标准

性别
All
接受健康志愿者

入选标准

  • 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)

排除标准

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

结局指标

主要结局

Remote monitoring transmission

时间窗: 70 days

Proportion of patients who sent a transmission within 70 days

次要结局

  • Transmission after first postcard(70 days)

研究者

申办方类型
Fed
责任方
Principal Investigator
主要研究者

Sanket Dhruva, MD, MHS

Staff Physician

San Francisco VA Health Care System

研究点 (2)

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