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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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Cumulative number of unplanned hospitalization days | Over 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| Number of unplanned hospitalizations | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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) |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Elise CABANES, MD | Contact | +33 | elise@epoca.health | |
| Damien TESTA, Ph.D. | Contact | damien.testa@epoca.health |
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| ID | Term |
|---|---|
| D000071069 | Multiple Chronic Conditions |
| ID | Term |
|---|---|
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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Multicentric Randomized controlled trial with two arms (intervention vs. control) for remote monitoring system
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| Initial, 6 and 12 months |
| Total number of days of hospitalizations for acute decompensation | Over 12 months |
| Survival and mortality proportion | At 12 months |
| At 12 months |
| Number of patients who require hospitalization at inclusion, including the days of hospitalization | 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." | 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. | 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 :
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. | At 12 months |
| Caregiver burnout, when present | Will be assessed using the Mini Zarit scale | 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 | 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" | At 12 months |