Personalized Digital Remote Monitoring for Elderly Patients

Официальное название

Personalized Digital Remote Monitoring for Elderly Patients: Multicentric RCT Study

Обзор

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.

Вмешательства

• Устройство 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 (P

Первичные конечные точки

• Cumulative number of unplanned hospitalization days [Срок оценки: Over 12 months]

Вторичные конечные точки (4)

• Number of unplanned hospitalizations [Срок оценки: Over 12 months]
• Change in quality of life from baseline using EQ-5D-5L scale [Срок оценки: Initial, 6 and 12 months]
• Total number of days of hospitalizations for acute decompensation [Срок оценки: Over 12 months]
• Survival and mortality proportion [Срок оценки: At 12 months]

Критерии участия

Критерии включения

• 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.

Критерии исключения

• 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"

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Другое

Центры проведения

Список центров уточняется — проверьте первичный протокол.

Идентификаторы

NCT: NCT06845917 · EPOCA-CT-2024-001

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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