Personalized Digital Remote Monitoring for Elderly Patients (EPOCARE)

EPOCA U&I

Status: Not yet enrolling

Conditions: Polypathology; Multiple Chronic Conditions; Elderly Patients

Treatments: Device: Remote Patient Monitoring system

Study type: Interventional

Funder types: Industry

Identifiers

NCT06845917

EPOCA-CT-2024-001

Details and patient eligibility

About

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.

Enrollment: 700 estimated patients

Sex: All

Ages: 75+ years old

Volunteers: No Healthy Volunteers

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"

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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700 participants in 2 patient groups

Control arm: standard follow-up

No Intervention group

Description:

Patients in the control group will receive standard medical care from their general practitioner or their geriatrician. In addition to the standard follow-up, they will be contacted for data collection purposes.

Intervention arm: Patients followed by a Remote Monitoring System

Experimental group

Treatment:

Device: Remote Patient Monitoring system