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

NCT ID: NCT01213875

Last Updated: 2014-01-03

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 252 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2009-08-31
• Study Completion Date: 2013-12-31

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.

Detailed Description

The epidemiological picture of cardiovascular disease in which the IC sets itself as the leading cause of readmissions in the National Health System and that has not changed over the years, undertake the management of the limited resources of the public health system. Moreover, the IC contributes to significant loss of quality of life of patients, many in socially productive ages resulting in absenteeism and early retirement. This study aims to evaluate the impact of home monitoring, intercalated with telephone contact by the nursing staff at the HF patients, after hospital discharge in relation to the rate of hospital readmissions, compliance and cost-effectiveness this intervention, compared to conventional monitoring of patients within 6 months without this intervention, as well as building a structure that allows the use computerized forms of assessment in nursing in cardiology by mobile technology, assess the knowledge of the disease and the skills to self-care; assess compliance, assess the quality of life, linking the sociodemographic characteristics and clinical with adherence to treatment and rates of readmission in both groups, and check the cost of home monitoring. For this purpose, a randomized clinical trial was designed in two centers, blinded to outcomes and costs of readmission.

Summary of the study:

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.

Detailed description: The epidemiological picture of cardiovascular disease in which the IC sets itself as the leading cause of readmissions in the National Health System and that has not changed over the years, undertake the management of the limited resources of the public health system. Moreover, the IC contributes to significant loss of quality of life of patients, many in socially productive ages resulting in absenteeism and early retirement. This study aims to evaluate the impact of home monitoring, intercalated with telephone contact by the nursing staff at the HF patients, after hospital discharge in relation to the rate of hospital readmissions, compliance and cost-effectiveness this intervention, compared to conventional monitoring of patients within 6 months without this intervention, as well as building a structure that allows the use computerized forms of assessment in nursing in cardiology by mobile technology, assess the knowledge of the disease and the skills to self-care; assess compliance, assess the quality of life, linking the sociodemographic characteristics and clinical with adherence to treatment and rates of readmission in both groups, and check the cost of home monitoring. For this purpose, a randomized clinical trial was designed in two centers, blinded to outcomes and costs of readmission.

Intervention: 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 they are using. A guide to rest and exercise, sexual activity, vaccines, travel and diet (water and salt restriction) will be provided. The involvement of the family will be encouraged and reinforced at every home visit. 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, motor deficit / paralysis and / or unexplained chest pain. In phone calls made between home visits, the compliance to treatment will be evaluated and reinforced.

Conditions

Heart Failure

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Experimental: Intervention and control

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.

Group Type: EXPERIMENTAL

Home based education

Intervention Type: 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.

Control

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

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.

Intervention Type: BEHAVIORAL

Other Intervention Names

Education on Heart Failure; Home Intervention

Eligibility Criteria

Inclusion Criteria

• 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.

Exclusion Criteria

• 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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Fundação de Amparo à Pesquisa do Estado do Rio Grande do Sul, Brazil

OTHER

Sponsor Role: collaborator

Hospital de Clinicas de Porto Alegre

OTHER

Sponsor Role: lead

Responsible Party

Eneida Rejane Rabelo da Silva

Professor; PhD.

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Eneida R Rabelo da Silva, RN, ScD

Role: PRINCIPAL_INVESTIGATOR

HCPA and UFRGS

Locations

Universidade Federal do Rio Grande do Sul - Post Graduated Program

Porto Alegre, Rio Grande do Sul, Brazil

Countries

Brazil

Other Identifiers

UFRGS and HCPA 09112

Identifier Type: -

Identifier Source: org_study_id