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

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

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.

Study Overview

• Status: Completed
• Conditions: Heart Failure
• Intervention / Treatment: Other: Education

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 Type: Interventional
• Enrollment (Actual): 434
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: ADULT; OLDER_ADULT; CHILD
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: PREVENTION
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
ACTIVE_COMPARATOR: Intervention; Education of the caregiver	Other: Education; Education of the caregiver about early symptoms and signs of heart failure
NO_INTERVENTION: No intervention; Usual care

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Hospital admissions for any cause	Hospital admissions for any cause	Twelve months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Hospital admissions for cardiovascular causes	Hospital admissions for cardiovascular causes	Twelve months
Mortality for general or cardiovascular causes	Mortality for general or cardiovascular causes	Twelve months

Collaborators and Investigators

• Sponsor: Maria Stella Padula
• Collaborators: University of Modena and Reggio Emilia; Local Health Authority of Modena

Publications and helpful links

General Publications

• Padula MS, D'Ambrosio GG, Tocci M, D'Amico R, Banchelli F, Angeli L, Scarpa M, Capelli O, Cricelli C, Boriani G. Home care for heart failure: can caregiver education prevent hospital admissions? A randomized trial in primary care. J Cardiovasc Med (Hagerstown). 2019 Jan;20(1):30-38. doi: 10.2459/JCM.0000000000000722.

Study record dates

Study Major Dates

• Study Start (ACTUAL): August 1, 2013
• Primary Completion (ACTUAL): April 10, 2016
• Study Completion (ACTUAL): April 10, 2016

Study Registration Dates

• First Submitted: December 27, 2017
• First Submitted That Met QC Criteria: December 27, 2017
• First Posted (ACTUAL): January 4, 2018

Study Record Updates

• Last Update Posted (ACTUAL): January 5, 2018
• Last Update Submitted That Met QC Criteria: January 3, 2018
• Last Verified: January 1, 2018

More Information

Terms related to this study

• Keywords: heart failure; caregivers; health education; comorbidity; home care services; patient admission
• Additional Relevant MeSH Terms: Heart Diseases; Cardiovascular Diseases; Heart Failure
• Other Study ID Numbers: MSP_01

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: all Individual Participant Data that underlie results in a publication
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF; CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No