Remote Monitoring of Heart Failure Patients With Cardiovascular Implantable Electronic Device: The Patient Perspective
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- UMC Utrecht
- 入组人数
- 600
- 试验地点
- 1
- 主要终点
- Patient-reported health status
研究概览
简要总结
A relatively new and promising development in the area of cardiovascular implantable electronic device therapy is remote patient monitoring (RPM). RPM systems can interrogate the device automatically and send the data from the patients' home to the physician, thereby reducing in-clinic follow-ups.
The purpose of this study is to evaluate the effect of RPM + in-clinic follow-up versus in-clinic follow-up only on patient-reported health status and device-acceptance after implantation with an implantable cardioverter defibrillator (ICD) or cardiac resynchronization defibrillator (CRT-D).
Secondary objectives are (1) to identify subgroups of patients who prefer RPM over in-clinic visits or vice versa due to specific clinical and psychological factors and (2) To investigate the cost-effectiveness of RPM + in-clinic follow-up compared to in-clinic follow-up only.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •first time ICD/CRT-D implanted at one of the participating centers
- •left ventricular ejection fraction <35%
- •NYHA functional class II or III symptoms
- •ICD/CRT-D device compatible with the LATITUDE(r) RPM system from Boston Scientific
排除标准
- •On the waiting list for heart transplantation
- •History of psychiatric illness others than affective/anxiety disorders
- •Cognitive impairments
- •Insufficient knowledge of the language to fill in the questionnaires
结局指标
主要结局
Patient-reported health status
时间窗: 24 months
23-item Kansas City Cardiomyopathy Questionnaire (KCCQ)
Patient-reported device acceptance
时间窗: 24 months
12-item Florida Patient Acceptance Scale (FPAS)
次要结局
- Cost-effectiveness(24 months)
- Patient-reported satisfaction with care(24 months)