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临床试验/NCT03389841
NCT03389841已完成不适用

Home Care for the Patient With Heart Failure: Can Caregiver Education Prevent Hospital Admissions? A Clinical Randomized Trial.

Maria Stella Padula0 个研究点目标入组 434 人开始时间: 2013年8月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
434
主要终点
Hospital admissions for any cause

研究概览

简要总结

The study is aimed to evaluate if the education of the caregiver is able to reduce hospital admissions of patients with heart failure assisted at home.

详细描述

The primary objective of the study is to assess whether an educational intervention aimed at increasing the caregiver's skills is able to reduce hospital admissions for any cause in patients with heart failure assisted at home.

The General Practitioners who agree to participate are randomized in two groups: a) intervention group, whose patients are assisted in accordance with the procedures established by the project; b) control group, whose patients continue to be assisted in the usual modality.

The intervention consists of an educational session for each caregiver aimed at improving his ability to recognize early symptoms and signs of heart failure.

研究设计

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

入排标准

性别
All
接受健康志愿者
否

入选标准

  • •adults of any age and gender in NYHA (New York Heart Association) classes II, III, IV, assisted exclusively at home;
  • •willingness and ability to sign a written informed consent;
  • •presence of a person who cared for the patient in a prevalent and regular way;
  • •willingness of the caregiver to attend a training meeting.

排除标准

  • 未提供

研究组 & 干预措施

No intervention

No Intervention

Usual care

Intervention

Active Comparator

Education of the caregiver

干预措施: Education (Other)

结局指标

主要结局

Hospital admissions for any cause

时间窗: Twelve months

Hospital admissions for any cause

次要结局

  • Hospital admissions for cardiovascular causes(Twelve months)
  • Mortality for general or cardiovascular causes(Twelve months)

研究者

发起方
Maria Stella Padula
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Maria Stella Padula

local manager of the province of Modena

Italian College of General Practitioners

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