Home Care for the Patient With Heart Failure: Can Caregiver Education Prevent Hospital Admissions?

Not Applicable

Completed

• Conditions: Heart Failure
• Interventions: Other: Education

• Registration Number: NCT03389841
• Lead Sponsor: Maria Stella Padula

Brief Summary

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.

Detailed Description

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.

Study Timeline

• Study Start: 2013-08-01
• Primary Completion: 2016-04-10
• Study Completion: 2016-04-10
• Study First Submitted: 2017-12-27
• Study First Submitted QC: 2017-12-27
• Status Verified: 2018-01
• Last Update Submitted: 2018-01-03
• Study First Posted: 2018-01-04
• Last Update Posted: 2018-01-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 434

Inclusion Criteria

• 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.

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Intervention	Education	Education of the caregiver

Primary Outcome Measures

Name	Time	Method
Hospital admissions for any cause	Twelve months	Hospital admissions for any cause

Secondary Outcome Measures

Name	Time	Method
Hospital admissions for cardiovascular causes	Twelve months	Hospital admissions for cardiovascular causes
Mortality for general or cardiovascular causes	Twelve months	Mortality for general or cardiovascular causes