Personalized Digital Remote Monitoring for Elderly Patients

NCT ID: NCT06845917

Last Updated: 2025-02-25

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 700 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-06-15
• Study Completion Date: 2027-10-31

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

Control arm: standard follow-up

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.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Intervention arm: Patients followed by a Remote Monitoring System

Group Type: EXPERIMENTAL

Remote Patient Monitoring system

Intervention Type: 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.

Interventions

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 (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 Type: DEVICE

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"

• Minimum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

EPOCA U&I

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Central Contacts

Elise CABANES, MD

Role: CONTACT

elise@epoca.health

+33

Damien TESTA, Ph.D.

Role: CONTACT

damien.testa@epoca.health

Other Identifiers

EPOCA-CT-2024-001

Identifier Type: -

Identifier Source: org_study_id