Home Based Intervention Led by Nurse in Brazil

Study 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.

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

Conditions
-----------------
Heart Failure

Intervention / Treatment
-----------------
* Behavioral: Home Based Education


Participation Criteria
=================
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.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: intervention and control<br>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<br>* 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.<br>* Other names: 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. | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Home Based education, Knowledge of Disease, Self-Care Skills, Quality of Life, Heart Failure, Randomized Clinical Trial