Efficacy of the programa educativo para o autocuidado na insuficiência cardíaca: controlled randomized clinical trial

• Grant number: 20/15834-8
• Support Opportunities: Regular Research Grants
• Duration: August 01, 2021 - July 31, 2023
• Field of knowledge: Health Sciences - Nursing - Medical-Surgical Nursing
• Principal Investigator: Diná de Almeida Lopes Monteiro da Cruz
• Grantee: Diná de Almeida Lopes Monteiro da Cruz
• Host Institution: Escola de Enfermagem (EE). Universidade de São Paulo (USP). São Paulo , SP, Brazil

Abstract

Heart failure (HF) is a chronic syndrome with negative impacts on quality of life of people who lives with the syndrome. Self-care, including behaviors to maintain health, monitor and handle illness symptoms, is needed to control the syndrome progression. Although self-care has positive effects patients' outcomes, it is still inadequate among people with HF in the world. Interventions to promote HF self-care are recommended to improve health outcomes of people with HF. The Programa Educativo para o Autocuidado na Insuficiência Cardíaca - PEAC-IC was created to promote positive outcomes for people with HF. The feasibility and acceptability of the PEAC-IC were evaluated in a pilot study with favorable results. Main objective: to compare the PEAC-IC effect with usual care on HF self-care, knowledge on HF, health-related quality of life, hospitalization and visits to emergency services. Methods: This is a randomized controlled clinical trial, blinded for outcomes evaluation and for statistical analyses. It will be conducted at the Unidade Clínica Cardiológica with 42 beds in the Instituto Dante Pazzanese de Cardiologia (IDPC), and at the ambulatory care service of the same institution. IDPC is an academic, public hospital, specialized in cardiovascular diseases. The sample size, calculated with data from the pilot study, is 56 participants in total. Participants (adults and old patients hospitalized or in HF treatment in the ambulatory setting) will be randomized in intervention group (n=28) and control group (n=28). Intervention group will receive usual treatment and PEAC-IC, delivered in one face-to-face session and five weekly telephone structured contacts. Control group will receive only usual care: hospitalized patients receive discharge orientation and a written discharge plan; outpatients are followed by physicians and nurses' consultations. Nursing consults are delivered according to medical referrals; not all patients receive nursing consults. Both groups, control and intervention, will have outcome variables evaluated in the baseline, seventh week, third and sixth month after participants allocation. Data will be analyzed by repeated measurement data analyses. The study will only begin after a favorable statement from the Comitê de Ética em Pesquisa and authorization of the IDPC. (AU)