Quality of Life and Device Acceptance in Patients With Implantable Cardioverter-defibrillators Undergoing Remote ICD Follow-up
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 182
- 试验地点
- 4
- 主要终点
- Influence of ICD remote monitoring on Quality of Life, measured by the EQ5D questionnaire
研究概览
简要总结
This study investigates whether an additional remote follow-up of patients with implantable cardioverter-defibrillators (ICDs) has beneficial effects on Quality of life (QoL), levels of anxiety and depression and device acceptance. Patients are randomized to either conventional in-office FU only or additional remote surveillance, follow-up duration is 12 months. The influence of other variables (age, sex,..) is evaluated regarding their influence on study endpoints.
详细描述
The rising number of implantable cardiac devices leads to an increasing amount of device-related workload, e.g. regular in-office follow-ups (FU). New means of ICD FU strategies are necessary to handle the increasing burden. ICD remote monitoring promises a time- and cost efficient alternative to conventional in-office FU strategies. Many studies have already shown benefits on FU burden reduction, on saving of costs and time, and recently on total mortality. The impact of remote ICD FU on Quality of life, anxiety and depression levels and device acceptance is still under discussion. The aim of this trial is to investigate the influence of additional remote ICD surveillance on the primary endpoint health related quality of life (HRQoL), further on levels of anxiety and depression and on device acceptance.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients willing to participate
- •Patients with new-implantation of an ICD or device replacement due to battery depletion between May 2011 and April 2013
- •Sufficient knowledge of the German language
- •Expectancy of life >1 years at good clinical status
- •Written informed consent
排除标准
- •Age <18 years
- •Subjects not able to give written informed consent
- •Subjects without sufficient German language skills
研究组 & 干预措施
ICD remote monitoring
Active Comparator: ICD remote monitoring additionally to regular in-office visits/FU 1,3,6 and 12 months post implantation of an ICD or post ICD replacement
干预措施: ICD remote monitoring (Procedure)
Control group
Regular in-office visits/FU 1,3,6 and 12 months post implantation of an ICD or post ICD replacement w/o remote FU
干预措施: Control group (Other)
结局指标
主要结局
Influence of ICD remote monitoring on Quality of Life, measured by the EQ5D questionnaire
时间窗: 12 months
次要结局
- Influence of ICD remote monitoring on device acceptance, measured by the Florida Patient acceptance scale (FPAS)(12 months)
- Influence of ICD remote monitoring on levels of anxiety and depression, measured by the HADS questionnaire (Hospital Anxiety and Depression scale)(12 months)
研究者
Johannes Siebermair, MD
Johannes Siebermair, MD
LMU Klinikum