Clinical trial NCT01213875: A Multifaceted Nurse-based Strategy Reduces HEart FaiLure Morbidity in PatiENts Admitted for Acute Decompensated Heart Failure in Brazil
Official title: A Multifaceted Nurse-based Strategy Reduces HEart FaiLure Morbidity in PatiENts Admitted for Acute Decompensated Heart Failure in Brazil
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Heart Failure
Keywords: heart failure
nursing
home based intervention
cost
efficacy
Lead sponsor: Hospital de Clinicas de Porto Alegre
Sponsor class: OTHER
Collaborators: name: Fundação de Amparo à Pesquisa do Estado do Rio Grande do Sul, Brazil
First posted: 2010-10-04
Enrollment: 252
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: 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.
timeFrame: Up to 36 months.
Secondary outcomes:
measure: Cost-effectiveness of visits to the emergency department and length of hospitalization.
timeFrame: up to 36 months
measure: The secondary outcomes were each individual end-points
timeFrame: 36 months
Other outcomes:
Locations:
city: Porto Alegre
country: Brazil
facility: Universidade Federal do Rio Grande do Sul - Post Graduated Program
state: Rio Grande do Sul
Study officials:
affiliation: HCPA and UFRGS
name: Eneida R Rabelo da Silva, RN, ScD
role: PRINCIPAL_INVESTIGATOR
References: