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Home Based Intervention Led by Nurse in Brazil (HFHELENI)

Primary Purpose

Heart Failure

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Home Based Education
Sponsored by
Hospital de Clinicas de Porto Alegre
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Heart Failure focused on measuring Home Based education, Knowledge of Disease, Self-Care Skills, Quality of Life, Heart Failure, Randomized Clinical Trial

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm Type

    Experimental

    Arm Label

    intervention and control

    Arm Description

    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.

    Outcomes

    Primary Outcome Measures

    Knowledge of the disease
    This primary outcome will be measured at each home visit, which will have different intervals, according to the research protocol.
    Self-care skills.
    This primary outcome will be measured at each home visit, which will have different intervals, according to the research protocol.
    Quality of Life
    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.
    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
    This secundary outcome will be measured at each visit and phone call, which will have different intervals, according to the research protocol.
    Compliance score.
    This secundary outcome will be measured at each visit and phone call, which will have different intervals, according to the research protocol.

    Full Information

    First Posted
    November 9, 2009
    Last Updated
    December 31, 2013
    Sponsor
    Hospital de Clinicas de Porto Alegre
    Collaborators
    Fundação de Amparo à Pesquisa do Estado do Rio Grande do Sul, Brazil
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    1. Study Identification

    Unique Protocol Identification Number
    NCT01213862
    Brief Title
    Home Based Intervention Led by Nurse in Brazil
    Acronym
    HFHELENI
    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

    2. Study Status

    Record Verification Date
    December 2013
    Overall Recruitment Status
    Completed
    Study Start Date
    August 2009 (undefined)
    Primary Completion Date
    January 2013 (Actual)
    Study Completion Date
    January 2013 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Hospital de Clinicas de Porto Alegre
    Collaborators
    Fundação de Amparo à Pesquisa do Estado do Rio Grande do Sul, Brazil

    4. Oversight

    Data Monitoring Committee
    Yes

    5. Study Description

    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Heart Failure
    Keywords
    Home Based education, Knowledge of Disease, Self-Care Skills, Quality of Life, Heart Failure, Randomized Clinical Trial

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    Outcomes Assessor
    Allocation
    Randomized
    Enrollment
    200 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    intervention and control
    Arm Type
    Experimental
    Arm Description
    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.
    Intervention Type
    Behavioral
    Intervention Name(s)
    Home Based Education
    Other Intervention Name(s)
    Education on Heart Failure, Home based intervention
    Intervention Description
    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.
    Primary Outcome Measure Information:
    Title
    Knowledge of the disease
    Description
    This primary outcome will be measured at each home visit, which will have different intervals, according to the research protocol.
    Time Frame
    Home visit 7 days after discharge
    Title
    Self-care skills.
    Description
    This primary outcome will be measured at each home visit, which will have different intervals, according to the research protocol.
    Time Frame
    Home visit 7 days after discharge.
    Title
    Quality of Life
    Description
    This primary outcome will be measured at each home visit, which will have different intervals, according to the research protocol.
    Time Frame
    Home visit 7 days after discharge
    Secondary Outcome Measure Information:
    Title
    Changes in functional class.
    Description
    This secundary outcome will be measured at each visit and phone call, which will have different intervals, according to the research protocol.
    Time Frame
    Home visits (HV) starting 7days after discharge.
    Title
    Presentation to emergency department
    Description
    This secundary outcome will be measured at each visit and phone call, which will have different intervals, according to the research protocol.
    Time Frame
    Home visits starting 7 days after discharge.
    Title
    Compliance score.
    Description
    This secundary outcome will be measured at each visit and phone call, which will have different intervals, according to the research protocol.
    Time Frame
    Home visits starting 7 days after discharge.

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    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.
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Eneida R Rabelo da Silva, RN, ScD
    Organizational Affiliation
    Federal University of Rio Grande do Sul
    Official's Role
    Principal Investigator
    First Name & Middle Initial & Last Name & Degree
    Eneida R Rabelo da Silva, RN, ScD
    Organizational Affiliation
    Universidade Federal do Rio do Sul
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Citations:
    PubMed Identifier
    23459887
    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.
    Results Reference
    derived

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    Home Based Intervention Led by Nurse in Brazil

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