Clinical trial NCT06845917: Personalized Digital Remote Monitoring for Elderly Patients
Official title: Personalized Digital Remote Monitoring for Elderly Patients: Multicentric RCT Study
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Elderly Patients
Polypathology
Multiple Chronic Conditions
Keywords: Elderly
Hospitalization
Decompensation
Multiple chronic conditions
Remote monitoring
Lead sponsor: EPOCA U&I
Sponsor class: INDUSTRY
First posted: 2025-02-25
Enrollment: 700
Sex: ALL
Minimum age (years): 75
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Multicentric Randomized controlled trial with two arms (intervention vs. control) for remote monitoring system
Primary purpose: OTHER

Brief 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.


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"

Primary outcomes:
measure: Cumulative number of unplanned hospitalization days
timeFrame: Over 12 months
Secondary outcomes:
measure: Number of unplanned hospitalizations
timeFrame: Over 12 months
measure: Change in quality of life from baseline using EQ-5D-5L scale
timeFrame: Initial, 6 and 12 months
measure: Total number of days of hospitalizations for acute decompensation
timeFrame: Over 12 months
measure: Survival and mortality proportion
timeFrame: At 12 months
Other outcomes:
measure: Number of hospitalizations
timeFrame: At 30 days
measure: Number of emergency department visits
timeFrame: At 1 and 12 months
measure: Number of patients referred to an EHPAD or USLD (long-term care facility)
timeFrame: At 12 months
measure: Number of patients who require hospitalization at inclusion, including the days of hospitalization
timeFrame: At inclusion
measure: The level of satisfaction with follow-ups using in-house specific survey
timeFrame: At 12 months
measure: Patient experience and perceived quality of care using Patient Assessment of Chronic Illness Care (PACIC) survey
timeFrame: At 6 months and 12 months
measure: Health services utilization - Economic evaluation through Budget Impact Analysis
timeFrame: At 12 months
measure: Caregiver burnout, when present
timeFrame: At inclusion and 12 months
measure: Costs per patient
timeFrame: At 12 months
measure: Level of personalization based on GERS-model for care personnalisation
timeFrame: At 12 months
Locations:
Study officials:
References: