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Completed

NCT Number: NCT01213862

Home Based Intervention Led by Nurse in Brazil

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.

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Key information

Conditions

Heart Failure Cardiovascular Diseases Heart Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Home based education

Behavioral

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

Primary outcomes

  1. 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.

  2. 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.

  3. 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

  1. Changes in functional class.

    Time frame: 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.

  2. Presentation to emergency department

    Time frame: 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.

  3. Compliance score.

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Hospital de Clinicas de Porto Alegre

Other

Collaborators

  • Fundação de Amparo à Pesquisa do Estado do Rio Grande do Sul, Brazil

Registry information

Official study title

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

Acronym: HFHELENI

Important dates

Study start
2009
Primary completion
2013
Study completion
2013
First posted
Oct 4, 2010
Registry last updated
Jan 3, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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