Personalized Digital Remote Monitoring for Elderly Patients
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Remote Patient Monitoring system.
- Who it may be relevant to
- Registry conditions: Elderly Patients, Polypathology, Multiple Chronic Conditions. Basic parameters: from 75 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Center list to be confirmed — check the primary protocol.
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Personalized Digital Remote Monitoring for Elderly Patients: Multicentric RCT Study
Overview
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.
Interventions
- 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 (P
Primary outcome measures
- Cumulative number of unplanned hospitalization days [Time frame: Over 12 months]
Secondary outcome measures (4)
- Number of unplanned hospitalizations [Time frame: Over 12 months]
- Change in quality of life from baseline using EQ-5D-5L scale [Time frame: Initial, 6 and 12 months]
- Total number of days of hospitalizations for acute decompensation [Time frame: Over 12 months]
- Survival and mortality proportion [Time frame: At 12 months]
Eligibility criteria
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"
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Other
Study locations
Center list to be confirmed — check the primary protocol.
Identifiers
NCT: NCT06845917 · EPOCA-CT-2024-001