跳至主要内容
临床试验/NCT04703504
NCT04703504终止不适用

RAndomized Controlled Trial of a Multiple INtervention proGram to Decrease Heart Failure Rehospitalization

French Cardiology Society10 个研究点 分布在 1 个国家目标入组 25 人开始时间: 2022年7月15日最近更新:
适应症

试验速览

阶段
不适用
状态
终止
发起方
入组人数
25
试验地点
10
主要终点
Number of participants with a re-hospitalization due to heart decompensation

研究概览

简要总结

The prevalence of heart failure (HF) is constantly increasing in France due to the aging of the population, better management of etiological factors and improved treatments (drug / interventional). On the other hand, re-hospitalizations for heart failure continue to increase, exceeding reception capacities and constitute a real challenge for current public health systems. The PRADO system provides administrative support (through a health insurance advisor) in the management of patient appointments with their doctors as well as home visits by a nurse trained in heart failure. Other interventional medical and educational interventions performed during an out-of-hospital consultation guided by a computer platform would help to optimize the care and continuity of care.

详细描述

The aim of this study is to demonstrate the value of a multiple intervention program in reducing early readmissions for heat failure in patients hospitalized for cardiac decompensation.

This work will create an interventional assistance program to structure the exit consultation in order to optimize treatment, educate patients, ensure the continuity of hospital-city care and improve compliance (reminders) to reduce re-hospitalizations. This program will be carried out by using a computer platform allowing the systematization of output documents and the sending of messages (e-mail / SMS) for making appointments (medical consultations, biologicals sampling) and perfect therapeutic education.

研究设计

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

入排标准

年龄范围
18 Years 至 85 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Heart decompensation requiring hospitalization and the use of intravenous diuretic therapy
  • Left Ventricular Ejection Fraction ≤ 40%.

排除标准

  • Hospitalization for cardiac decompensation leading to an invasive procedure (valve, coronary, etc.).
  • Acute reversible cause of heart failure.
  • Incurable disease (other than heart failure) or estimated life expectancy of less than one year.
  • Patient transferred directly to another department or cardiac rehabilitation center.
  • Significant cognitive impairment.
  • Patient without cell phone or email.
  • Linguistic or psychic refusal or inability to sign the informed consent.
  • Current participation in a clinical tria

结局指标

主要结局

Number of participants with a re-hospitalization due to heart decompensation

时间窗: 3 months

Defined as occurence of the need for hospitalization for cardiac decompensation justifying the use of intravenous diuretic therapy.

次要结局

  • Number of participants with death(12 months)
  • Number of participants with a re-hospitalization due to heart decompensation(12 months)
  • Number of re-hospitalization due to heart decompensation per patient(12 months)
  • Delay between discharge and re-hospitalization due to heart decompensation(12 months)
  • Rate of pacemaker implantation(12 months)

研究者

发起方
French Cardiology Society
申办方类型
Other
责任方
Sponsor

研究点 (10)

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