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Clinical Trials/NCT01213862
NCT01213862
Completed
Not Applicable

Home Visit Impact on Knowledge of Disease, Self-Care Skills and Quality of Life of Heart Failure Patients: Randomized Clinical Trial

Hospital de Clinicas de Porto Alegre0 sites200 target enrollmentAugust 2009
ConditionsHeart Failure

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Heart Failure
Sponsor
Hospital de Clinicas de Porto Alegre
Enrollment
200
Primary Endpoint
Knowledge of the disease
Status
Completed
Last Updated
12 years ago

Overview

Brief Summary

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.

Detailed 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.

Registry
clinicaltrials.gov
Start Date
August 2009
End Date
January 2013
Last Updated
12 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Eneida Rejane Rabelo da Silva

Professor, PhD.

Hospital de Clinicas de Porto Alegre

Eligibility Criteria

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:
  • myocarditis
  • acute myocardial infarction
  • peripartum cardiomyopathy and other acute cause
  • No interest in receiving home visits

Outcomes

Primary Outcomes

Knowledge of the disease

Time Frame: Home visit 7 days after discharge

This primary outcome will be measured at each home visit, which will have different intervals, according to the research protocol.

Self-care skills.

Time Frame: Home visit 7 days after discharge.

This primary outcome will be measured at each home visit, which will have different intervals, according to the research protocol.

Quality of Life

Time Frame: Home visit 7 days after discharge

This primary outcome will be measured at each home visit, which will have different intervals, according to the research protocol.

Secondary Outcomes

  • Compliance score.(Home visits starting 7 days after discharge.)
  • Changes in functional class.(Home visits (HV) starting 7days after discharge.)
  • Presentation to emergency department(Home visits starting 7 days after discharge.)

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