Elderly PatientsEPOCARENCT06845917
Personalized Digital Remote Monitoring for Elderly Patients
A study testing Remote Patient Monitoring system in people with Elderly Patients and Polypathology, run by EPOCA U&I.
Trial 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. Read more about this study
- Who is it for?
- Ages 75 years and older
- Conditions the study is for
- Elderly Patients, Polypathology, Multiple Chronic Conditions
- What is being tested?
- Remote Patient Monitoring system
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 700 participants
- Where
- No sites listed yet
- Study dates
- 15 Jun 2025to Oct 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 75 years and older
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- 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.
Who cannot join
- 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 locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
Damien TESTA, Ph.D. contact
About this study
Official title: Personalized Digital Remote Monitoring for Elderly Patients: Multicentric RCT Study
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
Read more
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
- Being tested
- Remote Patient Monitoring system
- Keywords
- Elderly, Hospitalization, Decompensation, Multiple chronic conditions, Remote monitoring
- Medical subject headings
- Multiple Chronic Conditions
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Remote Patient Monitoring systemDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| 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 | Not described Receives: Device: Remote Patient Monitoring system |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cumulative number of unplanned hospitalization days
Measured: Over 12 months
Secondary outcomes (4)
Number of unplanned hospitalizations
Measured: 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.
Measured: Initial, 6 and 12 months
Total number of days of hospitalizations for acute decompensation
Measured: Over 12 months
Survival and mortality proportion
Measured: At 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Feb 2025
- Study start15 Jun 2025 (estimated)
- Primary completionJun 2027 (estimated)
- Study completionOct 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Elderly PatientsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Multicentric Randomized controlled trial with two arms (intervention vs. control) for remote monitoring system
- Masking
- None (open label)
- Enrolment
- 700 participants (estimated)
Sponsor and investigators
- Lead sponsor
- EPOCA U&I
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06845917
- Sponsor's protocol ID
- EPOCA-CT-2024-001
- Acronym
- EPOCARE
- Status last verified
- Feb 2025
- First submitted
- 13 Feb 2025
- Last updated
- 25 Feb 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Personalized Digital Remote Monitoring for Elderly Patients: Multicentric RCT Study
- ClinicalTrials.gov ID
- NCT06845917
- Acronym / sponsor ID
- EPOCARE / EPOCA-CT-2024-001
- Conditions
- Elderly Patients, Polypathology, Multiple Chronic Conditions
- Keywords
- Elderly, Hospitalization, Decompensation, Multiple chronic conditions, Remote monitoring
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 700 participants (estimated)
- Lead sponsor
- EPOCA U&IIndustry (pharma, biotech, devices)
- Study start
- 15 Jun 2025 (estimated)
- Primary completion
- Jun 2027 (estimated)
- Study completion
- Oct 2027 (estimated)
- First posted
- 25 Feb 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Multicentric Randomized controlled trial with two arms (intervention vs. control) for remote monitoring system
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- 75 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (5 listed)
- 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"
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Remote Patient Monitoring systemRMS 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. | Device | Intervention arm: Patients followed by a Remote Monitoring System |
Primary outcome
Cumulative number of unplanned hospitalization days
Time frame: Over 12 months
4 secondary outcomes
Number of unplanned hospitalizations
Time frame: Over 12 months
Change in quality of life from baseline using EQ-5D-5L scale
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Feb 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Damien TESTA, Ph.D. contact
Questions about this trial
What is this clinical trial studying?
A study testing Remote Patient Monitoring system in people with Elderly Patients and Polypathology, run by EPOCA U&I.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 25 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Elise CABANES, MD (+33, elise@epoca.health), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cumulative number of unplanned hospitalization days (time frame: Over 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Feb 2025.