Home Based Intervention Led by Nurse in Brazil (HFHELENI)

This study has been completed.
Sponsor:
Collaborator:
Fundação de Amparo à Pesquisa do Estado do Rio Grande do Sul, Brazil
Information provided by (Responsible Party):
Eneida Rejane Rabelo da Silva, Hospital de Clinicas de Porto Alegre
ClinicalTrials.gov Identifier:
NCT01213862
First received: November 9, 2009
Last updated: December 31, 2013
Last verified: December 2013
  Purpose

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.


Condition Intervention
Heart Failure
Behavioral: Home Based Education

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Home Visit Impact on Knowledge of Disease, Self-Care Skills and Quality of Life of Heart Failure Patients: Randomized Clinical Trial

Resource links provided by NLM:


Further study details as provided by Hospital de Clinicas de Porto Alegre:

Primary Outcome Measures:
  • Knowledge of the disease [ Time Frame: Home visit 7 days after discharge ] [ Designated as safety issue: No ]
    This primary outcome will be measured at each home visit, which will have different intervals, according to the research protocol.

  • Self-care skills. [ Time Frame: Home visit 7 days after discharge. ] [ Designated as safety issue: No ]
    This primary outcome will be measured at each home visit, which will have different intervals, according to the research protocol.

  • Quality of Life [ Time Frame: Home visit 7 days after discharge ] [ Designated as safety issue: No ]
    This primary outcome will be measured at each home visit, which will have different intervals, according to the research protocol.


Secondary Outcome Measures:
  • Changes in functional class. [ Time Frame: Home visits (HV) starting 7days after discharge. ] [ Designated as safety issue: No ]
    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 [ Time Frame: Home visits starting 7 days after discharge. ] [ Designated as safety issue: No ]
    This secundary outcome will be measured at each visit and phone call, which will have different intervals, according to the research protocol.

  • Compliance score. [ Time Frame: Home visits starting 7 days after discharge. ] [ Designated as safety issue: No ]
    This secundary outcome will be measured at each visit and phone call, which will have different intervals, according to the research protocol.


Enrollment: 200
Study Start Date: August 2009
Study Completion Date: January 2013
Primary Completion Date: January 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01213862

Sponsors and Collaborators
Hospital de Clinicas de Porto Alegre
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
  More Information

No publications provided by Hospital de Clinicas de Porto Alegre

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Eneida Rejane Rabelo da Silva, Professor, PhD., Hospital de Clinicas de Porto Alegre
ClinicalTrials.gov Identifier: NCT01213862     History of Changes
Other Study ID Numbers: UFRGS and HCPA 09111
Study First Received: November 9, 2009
Last Updated: December 31, 2013
Health Authority: Brazil: National Committee of Ethics in Research

Keywords provided by Hospital de Clinicas de Porto Alegre:
Home Based education
Knowledge of Disease
Self-Care Skills
Quality of Life
Heart Failure
Randomized Clinical Trial

Additional relevant MeSH terms:
Heart Failure
Cardiovascular Diseases
Heart Diseases

ClinicalTrials.gov processed this record on October 29, 2014