Home Based Intervention Led by Nurse in Brazil

NCT01213862 | Completed DMC

• 1 other identifier: UFRGS and HCPA 09111
• Study Type: interventional
• Target: 200
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Heart Failure

Keywords

Home Based education; Knowledge of Disease; Self-Care Skills; Quality of Life; Heart Failure; Randomized Clinical Trial

Outcome Measures

Primary Outcomes (3)

• Knowledge of the disease

  This primary outcome will be measured at each home visit, which will have different intervals, according to the research protocol.

  Home visit 7 days after discharge

• Self-care skills.

  This primary outcome will be measured at each home visit, which will have different intervals, according to the research protocol.

  Home visit 7 days after discharge.

• Quality of Life

  This primary outcome will be measured at each home visit, which will have different intervals, according to the research protocol.

  Home visit 7 days after discharge

Secondary Outcomes (3)

• Changes in functional class.

  Home visits (HV) starting 7days after discharge.

• Presentation to emergency department

  Home visits starting 7 days after discharge.

• Compliance score.

  Home visits starting 7 days after discharge.

Study Arms (1)

intervention and control

EXPERIMENTAL

* 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

Interventions

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.

Also known as: Education on Heart Failure, Home based intervention

intervention and control

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Hospital de Clinicas de Porto Alegre: lead
• Fundação de Amparo à Pesquisa do Estado do Rio Grande do Sul, Brazil: collaborator

Related Publications (1)

• 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.

  PMID: 23459887 DERIVED

MeSH Terms

Conditions

Heart Failure

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases

Study Officials

• 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

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor, PhD.

Study Record Dates

• First Submitted: November 9, 2009
• First Posted: October 4, 2010
• Study Start: August 1, 2009
• Primary Completion: January 1, 2013
• Study Completion: January 1, 2013
• Last Updated: January 3, 2014

Record last verified: 2013-12