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Completed

NCT Number: NCT03389841

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

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.

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Key information

Conditions

Heart Failure Adherence Interventions Behavior Cardiovascular Diseases Health Behavior Health Education Heart Diseases Medication Adherence Patient Acceptance of Health Care Patient Compliance Treatment Adherence and Compliance

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Education

Other

Education of the caregiver about early symptoms and signs of heart failure

Primary outcomes

  1. Hospital admissions for any cause

    Time frame: Twelve months

    Hospital admissions for any cause

Secondary outcomes

  1. Hospital admissions for cardiovascular causes

    Time frame: Twelve months

    Hospital admissions for cardiovascular causes

  2. Mortality for general or cardiovascular causes

    Time frame: Twelve months

    Mortality for general or cardiovascular causes

Sponsors and collaborators

Lead sponsor

Maria Stella Padula

Other

Collaborators

  • Local Health Authority of Modena
  • University of Modena and Reggio Emilia

Registry information

Official study title

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

Important dates

Study start
2013
Primary completion
2016
Study completion
2016
First posted
Jan 4, 2018
Registry last updated
Jan 5, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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