Home Based Intervention Led by Nurse in Brazil

Not Applicable

Completed

• Conditions: Heart Failure
• Interventions: Behavioral: Home Based Education

• Registration Number: NCT01213862
• Lead Sponsor: Hospital de Clinicas de Porto Alegre

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.

Study Timeline

• Study Start: 2009-08
• Study First Submitted: 2009-11-09
• Study First Submitted QC: 2010-10-01
• Study First Posted: 2010-10-04
• Primary Completion: 2013-01
• Study Completion: 2013-01
• Status Verified: 2013-12
• Last Update Submitted: 2013-12-31
• Last Update Posted: 2014-01-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 200

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
intervention and control	Home Based Education	* 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.

Primary Outcome Measures

Name	Time	Method
Knowledge of the disease	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.	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	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 Outcome Measures

Name	Time	Method
Compliance score.	Home visits starting 7 days after discharge.	This secundary outcome will be measured at each visit and phone call, which will have different intervals, according to the research protocol.
Changes in functional class.	Home visits (HV) starting 7days after discharge.	This secundary outcome will be measured at each visit and phone call, which will have different intervals, according to the research protocol.
Presentation to emergency department	Home visits starting 7 days after discharge.	This secundary outcome will be measured at each visit and phone call, which will have different intervals, according to the research protocol.