NCT06845917尚未招募不适用
Personalized Digital Remote Monitoring for Elderly Patients: Multicentric RCT Study
EPOCA U&I0 个研究点目标入组 700 人开始时间: 2025年6月15日最近更新:
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 700
- 主要终点
- Cumulative number of unplanned hospitalization days
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 75 Years 至 —（Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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"
研究组 & 干预措施
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
干预措施: Remote Patient Monitoring system (Device)
结局指标
主要结局
Cumulative number of unplanned hospitalization days
时间窗: Over 12 months
次要结局
- Number of unplanned hospitalizations(Over 12 months)
- Change in quality of life from baseline using EQ-5D-5L scale(Initial, 6 and 12 months)
- Total number of days of hospitalizations for acute decompensation(Over 12 months)
- Survival and mortality proportion(At 12 months)
研究者
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