Evaluating the Effectiveness of Remote Patient Monitoring (Satelia® Cardio) for Patients With Heart Failure (TELESAT-HF Study)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Satelia
- 入组人数
- 20,000
- 试验地点
- 1
- 主要终点
- Number of All Causes Deaths
研究概览
简要总结
The goal of this multicenter observational longitudinal cohort study is to evaluate the ability of a Remote Patient Monitoring (RPM) program to prevent cardiac decompensation by detecting weak signals of decompensation early in patients with chronic heart failure in France.
The main question it aims to answer is whether an RPM solution can provide the improvement in overall patient survival
Participants will answer to questionnaires provided by the RPM solution for the follow-up of their condition.
Researchers will compare the following cohorts to see if RPM can improve their condition:
- Cohort 1: using RPM for follow-ups.
- Cohort 2: conventional care and not using any devices and solutions for the follow-ups.
详细描述
TELESAT study is a national-scale observational prospective cohort study conducted in France from August 2018 to December 2022.
The study was conducted using the French national health data system known as the Système National des Données de Santé (SNDS) which covers approximately 99% of the French population.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Retrospective
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
- •residing in France
- •having heart failure
- •adults over the age of 18 years
- •New York Heart Association (NYHA) score≥2 and Brain Natriuretic Peptid (BNP)>100 pg/ml or N-terminal pro BNP>1000 pg/ml OR prior hospitalization for heart failure
排除标准
- •physician's assessment deemed patient not be physically or mentally able to be remotely monitored
- •had chronic dialysis
- •severe liver failure
- •the presence of any other medical condition resulting in a less than one-year life expectancy,
- •an estimated low adherence to treatment
- •lack of a stable place of residence
- •refusing to participate in the program ineligible.
结局指标
主要结局
Number of All Causes Deaths
时间窗: August 2018 to December 2021
Number of deaths for any cause
次要结局
- Number of All Causes Deaths in elderly patients(August 2018 to December 2021)
- Number of unplanned hospitalization for heart failure in elderly patients(August 2018 to December 2021)
- Number of unplanned heart failure Hospitalization(August 2018 to December 2021)