Personalized Digital Remote Monitoring for Elderly Patients

ConditionsElderly Patients Polypathology Multiple Chronic Conditions

Trial statusNot yet recruiting

Trial phaseNot applicable

Trial typeInterventional

Biological sexAll

Age75+

SponsorEPOCA U&I

About this trial

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

This trial does not accept healthy volunteers

Qualifiers

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),

Disqualifiers

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,

Trial design

Design model

Parallel

Treatments tested in this trial

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.

Treatment groups

700 Participants

are divided into 2 treatment groups

Group A: Control arm: standard follow-upNo intervention 0 interventions

Group B: Intervention arm: Patients followed by a Remote Monitoring SystemExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

Cumulative number of unplanned hospitalization days

Time frame

Over 12 months

Secondary outcomes

Number of unplanned hospitalizations

Time frame

Over 12 months

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

The instrument utilized was the EQ-5D-5L questionnaire, which comprises a self-reported health state description and a visual analogue scale (VAS). The EQ-5D-5L descriptive system comprises five dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension has 5 levels: no problem, slight problems, moderate problems, severe problems, and extreme problems. Index scores range from -0.59 to 1; where 1 is the best possible health state. Negative values represent health states perceived as worse than dead, which is equal to 0.

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

Other outcomes

Number of hospitalizations

Time frame

At 30 days

Number of emergency department visits

Time frame

At 1 and 12 months

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

Time frame

At 12 months

Number of patients who require hospitalization at inclusion, including the days of hospitalization

Time frame

At inclusion

Locations

This trial has no locations.

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

EPOCA U&I

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: