跳至主要内容
临床试验/NCT06445231
NCT06445231招募中不适用

Implementation and Effectiveness of Screening Echocardiography Performed in Nursing Home: ECHOGER

Nantes University Hospital2 个研究点 分布在 1 个国家目标入组 1,050 人开始时间: 2024年10月2日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
入组人数
1,050
试验地点
2
主要终点
Count of resident presenting a heart failure decompensation

研究概览

简要总结

The study seeks to explore the implementation characteristics (acceptability, appropriateness, feasibility, adoption, fidelity, penetration, implementation cost and sustainability) of systematic echocardiography in nursing homes and its impact on rates of heart failure flare-up and unscheduled hospitalization at 12 months among included nursing homes.

详细描述

Open-label cluster randomized type 1 hybrid trial, with 2 parallel arms: nursing homes will be randomized in the interventional (echocardiography by sonographer) or non-interventional arms (usual care). In the interventional arm echocardiography will be proposed to all residents of the nursing home at baseline. Clinical management will be adapted to the result of echocardiography by the general practitioner, in accordance with the cardiologist. The main objective is to assess the impact at 12 months of the initial performance of a systematic simplified echocardiography on the rate of nursing home residents presenting with heart failure episode or cardiovascular pathology. The Primary endpoint is the number of nursing home residents presenting a heart failure episode or an unscheduled hospitalization for heart failure or other cardiovascular pathologies at 12 months.

Thirty nursing homes and 1050 residents will be included overall

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Screening
盲法
None

盲法说明

Not relevant

入排标准

年龄范围
65 Years 至 —(Older Adult)
性别
All
接受健康志愿者

入选标准

  • 未提供

排除标准

  • 未提供

结局指标

主要结局

Count of resident presenting a heart failure decompensation

时间窗: 12 months

Number of residents with heart failure flare (worsening of at least 1 NYHA class) or unplanned hospitalization for heart failure

次要结局

  • Presence of a clinically significative change in medical management and care in the month following ultrasound(12 months)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

Loading locations...

相似试验