An interventional study of Remote Patient Monitoring system in Elderly Patients, Polypathology and Multiple Chronic Conditions, sponsored by EPOCA U&I. Not yet recruiting. Open to participants aged 75 Years and older. Per ClinicalTrials.gov, last updated 2025-02-25.
Sponsored by EPOCA U&I · Not applicable, Interventional, and Other
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:
Participant Criteria
Participants must:
Study Design
Expected Outcomes
89 studies on the registry are indexed under Multiple Chronic Conditions; 16 are open to participants now.
This study's planned enrollment of 700 is above the median of 128 across 71 interventional studies indexed under Multiple Chronic Conditions.
Browse Multiple Chronic Conditions studies →This is the only study on the registry with EPOCA U&I as lead sponsor.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
Device: 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.
Cumulative number of unplanned hospitalization days
Time frame: Over 12 months
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
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
The level of satisfaction with follow-ups using in-house specific survey
The satisfaction of patients regarding their care pathway will be evaluated through the administration of a questionnaire developed by the research team. The survey will include questions pertaining to the patients' satisfaction with the telehealth experience, any equipment-related issues, concerns about privacy, the perceived impact of the telehealth intervention on their overall health, ability to stay healthier, and their understanding of their illness. Patients will be requested to provide a rating of their care on a Likert scale, with 10 representing the highest satisfaction rating and scores. The control group will complete the identical survey, substituting the term "telehealth" with "usual home care services."
Time frame: At 12 months
Patient experience and perceived quality of care using Patient Assessment of Chronic Illness Care (PACIC) survey
Patient experience will be assessed at two time points (6 and 12 months) using the Patient Assessment of Chronic Illness Care (PACIC) survey. The PACIC tool consists of a 20-item patient report instrument that assesses a patient's receipt of clinical services and actions consistent with the Chronic Care Model (CCM). Respondents rate how often they experience the content described in each item during the past six months. Each item is scored on a five-point scale, ranging from one (no or never) to five (yes or always). Patients rate the care received from their primary health care team (not just their personal physician) for the chronic illness that they identified as most impacting their life.
Time frame: At 6 months and 12 months
Health services utilization - Economic evaluation through Budget Impact Analysis
The economic evaluation will be a Budget Impact Analysis (BIA) of the intervention from both perspectives, societal and the NHI ("Assurance Maladie"). Endpoints are : * Number of hospitalizations, length of stay and reason of admissions * Emergency room (ER) admissions * The number of consultations with the attending physician * Supportive care (physiotherapist, psychologist, sophrologist, etc.) * Home care visits * Transport services (taxi, VSL, ambulance, SAMU) * Nursing home care visits. For each questionnaire, the number of times the resource was consumed within the follow-up time was collected. For each patient, the total RU for 1 year will be estimated and expressed as yearly frequencies. RU will be valued by applying unit costs to RU in both arms and the difference between them will be estimated for all endpoints. Total cost per patient will be estimated for a 12-month duration of study.
Time frame: At 12 months
Caregiver burnout, when present
Will be assessed using the Mini Zarit scale
Time frame: At inclusion and 12 months
Costs per patient
Will be calculated by applying unit costs to resource use, estimating the average costs per patient over a 12-month period from societal and payer ("Assurance maladie") perspectives
Time frame: At 12 months
Level of personalization based on GERS-model for care personnalisation
The level of personalization will be described according to the care personnalisation model (GERS) - "Managing Singularity on a Large-Scale"
Time frame: At 12 months
No study locations are listed for this record.
Plan to share: No
No publications or documents are linked to this record.
Start is estimated for Jun 2025; primary completion for Jun 2027, 24 months later.
Of 59 interventional studies with no phase under Multiple Chronic Conditions, half reached primary completion within 20 months of starting (the median), counting those still running; a quarter within 11 and three quarters within 37. This study's planned 24 months is above that.
Multiple Chronic Conditions covers many different conditions, not one, so the studies compared here vary widely. Read these figures as a rough guide.
How these figures are worked out, and which studies are left out of them.
This study is not yet recruiting, as verified in Feb 2025. You cannot join it, but the record below documents what was studied.
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