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
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
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
NCT ID
NCT01213862
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
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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