跳至主要内容
临床试验/NCT05782075
NCT05782075进行中(未招募)不适用

Biological Monitoring by a Nurse of Post-hospital Heart Failure Patients.

Hôpital NOVO1 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2023年2月23日最近更新:
适应症

试验速览

阶段
不适用
状态
进行中(未招募)
发起方
入组人数
100
试验地点
1
主要终点
Assessment of the concordance, appropriateness and safety of nursing decisions in post-hospitalization heart failure

研究概览

简要总结

The aim of this study is to evaluate the feasibility and safety of delegating remote biological monitoring in post-hospitalization for cardiac decompensation by a heart failure nurse.

详细描述

Chronic heart failure is a major public health issue in France. It is the leading cause of hospitalisation in people over 65 years of age and results in many costly and potentially avoidable hospital stays. One third of patients are readmitted to hospital within 3 months of discharge.

A remote monitoring programme and natriuretic peptide monitoring during this vulnerable period can help improve patient management, reducing rehospitalisation rates, emergency room visits and mortality.

Given the increasing pressure on already limited healthcare resources, it is important to examine the delegation of care to specialist nurses, as well as their safety.

This study aims to evaluate the feasibility and safety of delegating remote biological monitoring in post-hospitalization for cardiac decompensation by a heart failure nurse.

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 —(Adult, Older Adult)
性别
All
接受健康志愿者
否

入选标准

  • •Patient ≥18 years old,
  • •Patient hospitalised for heart failure and discharged,
  • •Glomerular filtration rate at discharge > 20ml/min/1.73m²,
  • •Patient informed and agree to participate,
  • •Patient able to carry out the follow-up proposed by the cardiology department.

排除标准

  • •Cognitive disorders with Codex test category C and D,
  • •Barrier of the language,
  • •Psychiatric disorder that may interfere with treatment,
  • •Major surgery scheduled within 3 months,
  • •Excessive alcohol or drug use with no desire to withdraw
  • •Cardiac amyloidosis,
  • •Terminal heart failure,
  • •Patient discharged to specialised Care and Rehabilitation department,
  • •Any disease other than cardiac with a life expectancy of less than 1 year according to the investigator,
  • •Patient under guardianship,

结局指标

主要结局

Assessment of the concordance, appropriateness and safety of nursing decisions in post-hospitalization heart failure

时间窗: At the end of the patient's follow-up, an average of 3 month

The relevance and safety of IDE decisions will be determined by the concordance rate between the decisions made by the cardiologist and the IDE following the biological results at each check-up and after blind review by a second cardiologist

次要结局

  • Assessment of the risk of death in the study population between discharge and M3(At the end of the patient's follow-up, an average of 3 month)
  • Impact of the organisation on patient outcomes at M3 (Brain natriuretic peptide)(At the end of the patient's follow-up, an average of 3 month)
  • Assessment of the risk of rehospitalisation in the study population between discharge and M3(At the end of the patient's follow-up, an average of 3 month)
  • Impact of the organisation on patient outcomes at M3 (New York Heart Association (NYHA))(At the end of the patient's follow-up, an average of 3 month)
  • Assessment of the feasibility of the patient monitoring system(At the end of the patient's follow-up, an average of 3 month)

研究者

发起方
Hôpital NOVO
申办方类型
Other
责任方
Sponsor

研究点 (1)

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