Clinical trial NCT01213862: Home Based Intervention Led by Nurse in Brazil
Official title: Home Visit Impact on Knowledge of Disease, Self-Care Skills and Quality of Life of Heart Failure Patients: Randomized Clinical Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Heart Failure
Keywords: Home Based education
Knowledge of Disease
Self-Care Skills
Quality of Life
Heart Failure
Randomized Clinical Trial
Lead sponsor: Hospital de Clinicas de Porto Alegre
Sponsor class: OTHER
Collaborators: name: Fundação de Amparo à Pesquisa do Estado do Rio Grande do Sul, Brazil
First posted: 2010-10-04
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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:

  * 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.

Primary outcomes:
measure: Knowledge of the disease
timeFrame: Home visit 7 days after discharge
measure: Self-care skills.
timeFrame: Home visit 7 days after discharge.
measure: Quality of Life
timeFrame: Home visit 7 days after discharge
Secondary outcomes:
measure: Changes in functional class.
timeFrame: Home visits (HV) starting 7days after discharge.
measure: Presentation to emergency department
timeFrame: Home visits starting 7 days after discharge.
measure: Compliance score.
timeFrame: Home visits starting 7 days after discharge.
Other outcomes:
Locations:
Study officials:
affiliation: Federal University of Rio Grande do Sul
name: Eneida R Rabelo da Silva, RN, ScD
role: PRINCIPAL_INVESTIGATOR
affiliation: Universidade Federal do Rio do Sul
name: Eneida R Rabelo da Silva, RN, ScD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.