Personalized Digital Remote Monitoring for Elderly Patients

NCT06845917 | Not Yet Recruiting

• 1 other identifier: EPOCA-CT-2024-001
• Study Type: interventional
• Target: 700
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Elderly Patients; Polypathology; Multiple Chronic Conditions

Keywords

Elderly; Hospitalization; Decompensation; Multiple chronic conditions; Remote monitoring

Outcome Measures

Primary Outcomes (1)

• Cumulative number of unplanned hospitalization days

  Over 12 months

Secondary Outcomes (4)

• Number of unplanned hospitalizations

  Over 12 months

• Change in quality of life from baseline using EQ-5D-5L scale

  Initial, 6 and 12 months

• Total number of days of hospitalizations for acute decompensation

  Over 12 months

• Survival and mortality proportion

  At 12 months

Other Outcomes (10)

• Number of hospitalizations

  At 30 days

• Number of emergency department visits

  At 1 and 12 months

• Number of patients referred to an EHPAD or USLD (long-term care facility)

  At 12 months

Study Arms (2)

Control arm: standard follow-up

NO INTERVENTION

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

Device: Remote Patient Monitoring system

Interventions

Remote Patient Monitoring system DEVICE

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 (PCP) will be defined. The nurse installs a telemonitoring kit for the patient and gives them instructions on how to use it. The PCP manager will be responsible for implementing and overseeing the patient care plan, including informing the relevant stakeholders. Patients will be monitored via regular data feedback from the connected devices, the physician and the PCP manager. The PCP manager will treat any identified anomalies or abnormalities and implement the necessary changes on the PCP.

Intervention arm: Patients followed by a Remote Monitoring System

Eligibility Criteria

• Age: 75 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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"

Sponsors & Collaborators

• EPOCA U&I: lead

MeSH Terms

Conditions

Multiple Chronic Conditions

Condition Hierarchy (Ancestors)

Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Elise CABANES, MD

CONTACT

+33; elise@epoca.health

Damien TESTA, Ph.D.

CONTACT

damien.testa@epoca.health

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Multicentric Randomized controlled trial with two arms (intervention vs. control) for remote monitoring system

Study Record Dates

• First Submitted: February 13, 2025
• First Posted: February 25, 2025
• Study Start: June 15, 2025
• Primary Completion (Estimated): June 1, 2027
• Study Completion (Estimated): October 1, 2027
• Last Updated: February 25, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will not share