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

NCT ID: NCT03389841

Last Updated: 2018-01-05

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

434 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-08-01

Study Completion Date

2016-04-10

Brief Summary

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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

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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.

Conditions

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Heart Failure

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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Intervention

Education of the caregiver

Group Type ACTIVE_COMPARATOR

Education

Intervention Type OTHER

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

No intervention

Usual care

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Education

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

Intervention Type OTHER

Eligibility Criteria

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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.
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Modena and Reggio Emilia

OTHER

Sponsor Role collaborator

Local Health Authority of Modena

UNKNOWN

Sponsor Role collaborator

Maria Stella Padula

OTHER

Sponsor Role lead

Responsible Party

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Maria Stella Padula

local manager of the province of Modena

Responsibility Role SPONSOR_INVESTIGATOR

References

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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.

Reference Type DERIVED
PMID: 30394960 (View on PubMed)

Other Identifiers

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MSP_01

Identifier Type: -

Identifier Source: org_study_id

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