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临床试验/NCT04613401
NCT04613401Unknown不适用

Association of Telemonitoring With Hospitalization Rates and Quality of Life in Patients With End-stage Heart Failure and Implanted Left Ventricular Cardiac Assist Devices

University Hospital, Essen1 个研究点 分布在 1 个国家目标入组 50 人开始时间: 2020年7月1日最近更新:
适应症

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

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)

研究者

发起方
University Hospital, Essen
申办方类型
Other
责任方
Sponsor

研究点 (1)

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