Association of Telemonitoring With Hospitalization Rates and Quality of Life in Patients With End-stage Heart Failure and Implanted Left Ventricular Cardiac Assist Devices
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Number of days spent in the hospital due to VAD-associated complications
研究概览
简要总结
The current study aims to investigate whether telemedical monitoring in patients with terminal heart failure and an implanted left ventricular assist device (LVAD) has an influence on LVAD-associated complications, hospitalization rates and quality of life. This is a prospective observational study. Patients with terminal heart failure and an implanted LVAD, where the indication for telemonitoring has already been stated by the attending physician are included in the study. Written informed consent is obtained from all patients. The telemedical monitoring is carried out by the West German Center for Applied Telemedicine (WZAT) and includes a standardized telephone interview every 3 days. In addition, all patients are equipped with an INR measuring device, a body scale and a clinical thermometer by WZAT. The data is documented in an electronic case file (medPower®). In the event of abnormalities, the West German Heart and Vascular Center (WHGZ) is contacted, and all necessary measures are initiated.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 99 Years(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age> 18 years
- •Indication for telemedicine
- •Permanently implanted left ventricular assist device (VAD)
排除标准
- •no possibility of telephone contact
- •patient does not speak german
- •incompliance
- •rejection or inability to give consent
结局指标
主要结局
Number of days spent in the hospital due to VAD-associated complications
时间窗: 6 months
VAD-associated complications are defined as * bleeding with the need for a transfusion * infection with the need for an antibiotic therapy * thrombosis with the need for a lysis therapy
次要结局
- Change in quality of life from baseline(6 months)
- Change in depression from baseline(6 months)
- Number of VAD-associated complications(6 months)
