Not Yet RecruitingNot Applicable

Personalized Digital Remote Monitoring for Elderly Patients

700 participantsStarted 2025-06-15

Plain-language 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.

Who can participate

Age range

75 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Age ≥ 75 years, * Three or more chronic pathologies (e.g., diabetes, heart disease, depression, cancer, respiratory failure, renal failure, dementia), * Hospitalization or fall at least once in the previous year (Y-1), * Recently discharged from the emergency department (within 24 hours), * Patients, with or without caregivers, who accepted to participate and provided informed consent. Exclusion Criteria: * Patients discharged to or having been institutionalized in nursing homes (EHPAD), * Patients enrolled in another clinical trial * Suicidal or hetero-aggressive risk in a patient alone at home, * Homeless patients, * Patients protected by the following French legal measure: "sauvegarde de justice"

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Cumulative number of unplanned hospitalization days

Timeframe: Over 12 months

Trial details

NCT IDNCT06845917

SponsorEPOCA U&I

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2027-06

Contact for this trial

Elise CABANES, MD

+33 elise@epoca.health

View on ClinicalTrials.gov More Elderly Patients trials