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

November 9, 2009
December 31, 2013
August 2009
January 2013   (final data collection date for primary outcome measure)
  • 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.
Same as current
Complete list of historical versions of study NCT01213862 on ClinicalTrials.gov Archive Site
  • 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.
Same as current
Not Provided
Not Provided
 
Home Based Intervention Led by Nurse in Brazil
Home Visit Impact on Knowledge of Disease, Self-Care Skills and Quality of Life of Heart Failure Patients: Randomized Clinical Trial

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.

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.

Interventional
Not Provided
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Heart Failure
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
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.
Intervention: Behavioral: Home Based Education
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. English, Portuguese.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
200
January 2013
January 2013   (final data collection date for primary outcome measure)

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.
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Not Provided
 
NCT01213862
UFRGS and HCPA 09111
Yes
Eneida Rejane Rabelo da Silva, Hospital de Clinicas de Porto Alegre
Hospital de Clinicas de Porto Alegre
Fundação de Amparo à Pesquisa do Estado do Rio Grande do Sul, Brazil
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
Hospital de Clinicas de Porto Alegre
December 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP