Home Based Intervention Led by Nurse in Brazil (HFHELENI)

Hospital de Clinicas de Porto Alegre

Status: Completed

Conditions: Heart Failure

Treatments: Behavioral: Home Based Education

Study type: Interventional

Funder types: Other

Identifiers

NCT01213862

UFRGS and HCPA 09111

Details and patient eligibility

About

Home visits (HV) are one of the multidisciplinary approaches that has already shown to benefit the follow-up of Heart Failure (HF) patients. It is considered to be one of the most effective and humane approaches as it educates and takes care of the patient in his/her routine environment. In this study, the follow-up of HF patients in a home setting after being discharged from hospital will include the reinforcement, monitoring and re-evaluation of guidelines previously provided about the disease and self-care, compliance to prescribed medicines and, specially, the early recognition of decompensation signs and symptoms by patients and their caregivers.

Full description

The epidemiological overview of cardiovascular diseases in which HF turns out to be the main cause of re-hospitalizations in the Unified Health System, which has not changed over the years, impairs the management of the limited resources of the public health system. Additionally, HF leads to substantial damage to the quality of life of patients, many of them at a socially productive age, resulting in early retirements and absences. In this study, the objective is to evaluate the impact of the follow-up of heart failure patients at home, interspersed with telephone contacts, by the nursing team, after hospital discharge, regarding knowledge of the disease, self-care skills and quality of life improvement, compared with the conventional follow-up of patients in a 6-month period without this intervention, as well as to build a mobile-technology computer structure to make the use of cardiology nursing evaluation forms viable; correlate sociodemographic and clinical characteristics with treatment compliance and re-hospitalization rates in both; and ascertain home follow-up costs.

With this purpose, a two-center randomized clinical trial, blinded for the endpoints re-hospitalization and costs, was designed.

Enrollment: 200 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Patients of both sexes
• Age equal to or above 18 years
• Diagnosis of heart failure with systolic dysfunction (ejection fraction ≤ 45%)
• Hospitalized for heart failure decompensation and who agree to participate in the study by signing a Free Informed Consent Form.

Exclusion criteria

• Patients presenting with communication barriers and suffering from degenerative neurological diseases.

• Patients who had Acute Coronary Syndrome (ACS) in the past 6 months before randomization

• Patients with renal/hepatic/pulmonary or systemic disease who may confuse the interpretation of findings or result in limited life expectancy

• Surgical or therapeutic treatment that may influence the follow-up

• Pregnancy

• Diagnosis of Heart Failure secondary to:

  • sepsis
  • myocarditis
  • acute myocardial infarction
  • peripartum cardiomyopathy and other acute cause

• No interest in receiving home visits

• Living more than 10 km away for the original hospital

• No possibility of telephone contact.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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200 participants in 1 patient group

intervention and control

Experimental group

Description:

* Group I - Intervention: Routine follow-up in a reference health institution with four home visits and four telephone contacts with specialist nurses. * Group II - Control: Routine follow-up with the health team in the reference institution.

Treatment:

Behavioral: Home Based Education