Effectiveness of video monitoring in transition of care for patients with heart failure (EVIT-HF): a study protocol for a randomized clinical trial

Abstract

Abstract Background Real data on the impact on prognosis of video monitoring in patients with heart failure (HF) are limited and inconclusive. This article aim to describe a randomized clinical trial protocol designed to assess the efficacy of a video monitoring and educational strategy delivered to patients with heart failure with reduced ejection fraction (HFrEF). Methods This is a randomized, parallel trial with blinded outcome assessment. During hospitalization patients who meet the inclusion criteria will be invited to participate. Sociodemographic data, clinical variables, results of laboratory tests, current medications and cardiovascular physical examination will be collected. Additionally, Clinical congestion score, European HF self-care, HF knowledge, HF treatment adherence, HF quality of life and cardiorespiratory fitness will be collected by specific, validated instruments. The control group (CG) will receive the usual care after hospital discharge. In the intervention group (IG), the clinical discharge summary will be shared with the nurse of the primary health care unit in order to discuss the transition care. IG participants will receive specialized cardiovascular nursing appointments through video monitoring (at 7 days, 30 days, 60 days, and 180 days). The primary outcome consists of the self-care score. Secondary outcomes will be quality of life scores, HF knowledge scores, HF treatment adherence scores and cardiorespiratory fitness scores, death rates and hospital readmissions. Discussion Unlike strategies based on mobile devices or voice telemonitoring, the video monitoring, hypothetically is a strategy able to generate greater bond and trust between patients and health professionals, leading to improvements in the outcomes measured. Trial registration: https://ensaiosclinicos.gov.br/rg/RBR-9fkncwv