Personalized digital remote monitoring for older patients: multicentric RCT study protocol–EPOCARE

Population ageing combined with the growing prevalence of multimorbidity is placing increasing pressure on healthcare systems, contributing to frequent emergency department (ED) visits and unplanned hospitalizations among older adults. Remote patient monitoring (RPM) has emerged as a promising care model to support the follow-up of complex older patients through early detection of clinical deterioration and proactive care coordination. However, evidence from randomized control trials (RCTs) evaluating multidimensional and integrated RPM interventions in geriatric care remains limited. This paper presents the protocol of the EPOCARE trial, which aims to evaluate the effectiveness of the EPOCA Remote Monitoring System (RMS) a novel RPM intervention for older adults with multimorbidity at high risk of hospitalization. EPOCARE is a multicenter, prospective, parallel-group RCT with individual 1:1 randomization, designed within a superiority framework. The trial will assess whether the EPOCA RMS reduces unplanned hospital utilization compared with usual care over a 12-month follow-up period. Eligible participants are adults aged 75 years or older with at least three chronic conditions, at least one hospitalization or fall in the previous year, and recently discharged from the ED. A total of 700 participants (350 per arm) will be randomized to either the EPOCA RMS or usual care. The primary outcome is the total number of unplanned hospitalizations days over 12 months. Secondary outcomes include number of unplanned hospitalizations, total hospital days for acute decompensation, quality of life, patient experience, and all-cause mortality. A budget impact analysis and a qualitative process evaluation will also be conducted to estimate healthcare resource use and associated costs in both arms, and to examine the implementation and management of personalized care pathways within EPOCA RMS. The EPOCARE trial will provide rigorous evidence on the effectiveness of EPOCA RMS, an integrated telemonitoring intervention combining automated monitoring, alert prioritization, and human clinical oversight via Nurse Navigators, in managing care for complex older adults. If effective, the finding of this trial will inform healthcare decision-makers the design, implementation and scaling of RPM care model for complex chronic care pathways. NCT06845917. Registered 20 February 2025.