Personalized Digital Remote Monitoring for Elderly Patients
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age75+
SponsorEPOCA U&I
About this trial
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.
Eligibility criteria
Qualifiers
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),
Disqualifiers
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,
Trial design
Treatments tested in this trial
- Remote Patient Monitoring system
Treatment groups
700 Participants
are divided into 2 treatment groupsLocations
Sponsors and collaborators
Source ClinicalTrials.gov