NCT06845917

Personalized Digital Remote Monitoring for Elderly Patients

Personalized Digital Remote Monitoring for Elderly Patients: Multicentric RCT Study

• Status: Not Yet Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 700 (estimated)
• Sponsor: EPOCA U&I · Industry
• Sex: All
• Age: 75 Years
• Healthy volunteers: Not accepted

Summary

Objective This clinical investigation aims to evaluate whether the EPOCA Remote Monitoring System (RMS) enhances care for elderly patients with multiple chronic conditions and reduces unplanned hospitalizations. Key Research Questions This study will assess: * Unplanned Hospitalizations: Does EPOCA RMS reduce the total number of unplanned hospital days over 12 months? * Quality of Life \& Costs: What is the impact of EPOCA RMS on patients' quality of life and overall healthcare costs? * Survival Rates: Does EPOCA RMS improve survival rates compared to standard care? Participant Criteria Participants must: * Be 75 years or older with at least three chronic conditions. * Have experienced a hospitalization or fall in the past year. * Be randomly assigned to either the EPOCA RMS group or a control group receiving standard care. * Be monitored for 12 months, with data collected at multiple time points. Study Design * Type: Multicenter, randomized controlled trial (RCT). * Sites: Conducted across 8 hospitals in France. * Duration: 12-month follow-up. * Sample Size: 700 participants (350 per group). * Intervention Group: Remote monitoring through the EPOCA RMS, integrating connected devices and medical coordination. * Control Group: Standard care follow-up. Expected Outcomes * Reduced unplanned hospital stays and emergency visits. * Improved quality of life and patient satisfaction. * Comprehensive cost-effectiveness analysis and economic impact assessment.

Conditions

• Elderly Patients
• Polypathology
• Multiple Chronic Conditions

Interventions

Type	Name	Description
DEVICE	Remote Patient Monitoring system	RMS consists of an initial assessment visit and system installation: A nurse trained by the EPOCA team will conduct a comprehensive assessment of the patient's needs during a home visit within 48 hours of enrollment. This includes collecting biometric measurements, socio-economic profile, and completing a questionnaire with the patient. The initial visit also includes a consultation with a physician. All the information is transmitted to a digital platform accordingly a personalized care plan (PCP) will be defined. The nurse installs a telemonitoring kit for the patient and gives them instructions on how to use it. The PCP manager will be responsible for implementing and overseeing the patient care plan, including informing the relevant stakeholders. Patients will be monitored via regular data feedback from the connected devices, the physician and the PCP manager. The PCP manager will treat any identified anomalies or abnormalities and implement the necessary changes on the PCP.

Timeline

• Start date: 2025-06-15
• Primary completion: 2027-06-01
• Completion: 2027-10-01
• First posted: 2025-02-25
• Last updated: 2025-02-25