A Multifaceted Nurse-based Strategy Reduces HEart FaiLure Morbidity in PatiENts Admitted for Acute Decompensated Heart Failure in Brazil

NCT01213875 | Completed

• 1 other identifier: UFRGS and HCPA 09112
• Study Type: interventional
• Target: 252
• Locations: 1 country
• Sites: 1

Brief Summary

The home based intervention is a multidisciplinary approach that has shown benefit in the follow-up of patients with Heart Failure (HF). It is considered one of the most effective approaches and humanized by education and care for the patient in his environment of routine. In this study the monitoring of HF patients in the home after hospital discharge will include the reinforcement, monitoring and reassessment of previously provided guidance on the disease and self-care, compliance to prescribed medications and especially the early recognition of signs and symptoms of decompensation by patients and their caregivers.

Conditions

Heart Failure

Keywords

heart failure; nursing; home based intervention; cost; efficacy

Outcome Measures

Primary Outcomes (1)

• The primary outcome was a composite end-point of a first visit to the emergency department (lasting less than 24 hours), or a first hospital readmission (> 24h) or all-cause death, assessed during the first 6 months of follow-up.

  This primary outcomes will be measured at each visit, which will have different intervals, according to the research protocol, with a final evaluation after the last home visit. Home visits (HV): 7 days after discharge, 15 days after 1st phone call (PC), 30 days after 2nd PC, 30 days after 3rd PC. Phone calls (PC): 7-10 days after 1st HV, 30 days after 2nd HV, 30 days after 3rd HV, 15 days after 4th HV. All patients come to Hospital evaluation after the 4th phone call.

  Up to 36 months.

Secondary Outcomes (2)

• Cost-effectiveness of visits to the emergency department and length of hospitalization.

  up to 36 months

• The secondary outcomes were each individual end-points

  36 months

Study Arms (2)

Experimental: Intervention and control

EXPERIMENTAL

I: Experimental Routine monitoring by health team in the reference institution, four home visits and four telephone contacts with trained nurses. II: Control Routine monitoring by health team in the reference institution.

Behavioral: Home based education

Control

NO INTERVENTION

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 Intervention

Experimental: 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, aged 18 years or above, with a diagnosis of heart failure with systolic dysfunction (ejection fraction ≤ 45%), hospitalized for decompensation of HF
• Who agree to participate in the study by signing the Informed Consent.

You may not qualify if:

• Patients with communication disabilities and people with degenerative neurological diseases.
• Are also excluded patients who presented acute coronary syndrome (ACS) in the last 6 months before randomization
• Patients with renal, hepatic, pulmonary or systemic disease that may confuse the interpretation of the findings or result in limited life expectancy
• Surgical plan or therapeutic that might influence the follow-up
• Pregnancy, diagnosis of acute heart failure secondary to:
• sepsis
• myocarditis
• myocardial infarction
• acute peripartum and other cause
• Have no interest in receiving home visits
• Living at a distance greater than 10 km from the hospital of origin
• Not be able to contact by telephone.

Sponsors & Collaborators

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

Study Sites (1)

Universidade Federal do Rio Grande do Sul - Post Graduated Program

Porto Alegre, Rio Grande do Sul, 90035003, Brazil

Location

MeSH Terms

Conditions

Heart Failure

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases

Study Officials

• Eneida R Rabelo da Silva, RN, ScD

  HCPA and UFRGS

  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: December 1, 2013
• Study Completion: December 1, 2013
• Last Updated: January 3, 2014

Record last verified: 2014-01

Locations

BR (1)