Home Based Intervention Led by Nurse in Brazil (HFHELENI)

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

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.

Study Overview

• Status: Completed
• Conditions: Heart Failure
• Intervention / Treatment: Behavioral: Home Based Education

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 Type: Interventional
• Enrollment (Actual): 200
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: intervention and control; 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.

Behavioral: Home Based Education; There will provided education about what is heart failure, its causes, how to recognize signs and symptoms, monitoring of weight and blood pressure, the importance of compliance to treatment. Patients will be instructed about the medications; a guide to rest and exercise, sexual activity, vaccines, travel and diet will be provided. The involvement of the family will be encouraged; the contact with the team should be done when: patient observes an increase of 1 or 2 kg of weight in 2-3 days, worsening of dyspnea on effort, edema in legs / abdomen, worsening of cough, persistent vomiting, syncope, sputum with blood, fever, persistent tachycardia. In phone calls made between home visits, the compliance to treatment will be evaluated and reinforced.; Other Names: Education on Heart Failure; Home based intervention

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Knowledge of the disease	This primary outcome will be measured at each home visit, which will have different intervals, according to the research protocol.	Home visit 7 days after discharge
Self-care skills.	This primary outcome will be measured at each home visit, which will have different intervals, according to the research protocol.	Home visit 7 days after discharge.
Quality of Life	This primary outcome will be measured at each home visit, which will have different intervals, according to the research protocol.	Home visit 7 days after discharge

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Hospital de Clinicas de Porto Alegre
• Collaborators: Fundação de Amparo à Pesquisa do Estado do Rio Grande do Sul, Brazil
• Investigators: Principal Investigator: Eneida R Rabelo da Silva, RN, ScD, Federal University of Rio Grande do Sul; Principal Investigator: Eneida R Rabelo da Silva, RN, ScD, Universidade Federal do Rio do Sul

Publications and helpful links

General Publications

• Mussi CM, Ruschel K, de Souza EN, Lopes AN, Trojahn MM, Paraboni CC, Rabelo ER. Home visit improves knowledge, self-care and adhesion in heart failure: Randomized Clinical Trial HELEN-I. Rev Lat Am Enfermagem. 2013 Jan-Feb;21 Spec No:20-8. doi: 10.1590/s0104-11692013000700004. English, Portuguese.

Study record dates

Study Major Dates

• Study Start: August 1, 2009
• Primary Completion (Actual): January 1, 2013
• Study Completion (Actual): January 1, 2013

Study Registration Dates

• First Submitted: November 9, 2009
• First Submitted That Met QC Criteria: October 1, 2010
• First Posted (Estimate): October 4, 2010

Study Record Updates

• Last Update Posted (Estimate): January 3, 2014
• Last Update Submitted That Met QC Criteria: December 31, 2013
• Last Verified: December 1, 2013

More Information

Terms related to this study

• Keywords: Heart Failure; Quality of Life; Randomized Clinical Trial; Home Based education; Knowledge of Disease; Self-Care Skills
• Additional Relevant MeSH Terms: Heart Diseases; Cardiovascular Diseases; Heart Failure
• Other Study ID Numbers: UFRGS and HCPA 09111