New Care Pathways for Supporting TRANSitional CARE From Hospital to Home Using AI and Personalized Digital Assistance
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 210
- 试验地点
- 3
- 主要终点
- 30-Day Re-hospitalization Rate
研究概览
简要总结
The objective of the TRANSCARE study is to evaluate the use of a digital remote monitoring system to reduce the risk of 30-day readmission in multimorbid elderly patients. The pilot study is multicenter, and the trial will be conducted across 3 sites: Italy, Romania, and Norway. The overall goal of the TRANSCARE project is to create a digital monitoring ecosystem capable of identifying and preventing the risk of readmission. Two hundred and ten older adults aged over 65, who meet the inclusion and exclusion criteria, will be enrolled in the study. They will be randomized into two groups and allocated to an intervention group or a control group.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Health Services Research
- 盲法
- None
入排标准
- 年龄范围
- 65 Years 至 —（Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Able to stand and walk even with support;
- •Mini Mental State Examination (MMSE) ≥ 18;
- •Clinical Frailty Scale (CFS) score 2-7;
排除标准
- •Allergy to nichel components;
- •Concomitant participation in other studies;
- •Severe dementia condition
- •Mild to moderate dementia condition in the absence of the caregiver
- •Terminal chronic renal failure with the need for dialysis
- •Inability or unwillingness to sign written informed consent;
- •Pacemaker or implantable cardioverter defibrillator;
- •Metastatic cancer or immunosuppressive therapy;
- •Significant visual or hearing impairment;
- •Severe systemic diseases with life expectancy < 6 year;
- •Move to nursing home after discharge
结局指标
主要结局
30-Day Re-hospitalization Rate
时间窗: 30 days post-discharge
Percentage of participants re-admitted to the hospital for any all-cause unplanned readmission within 30 days following discharge.
次要结局
- Re-hospitalization Rate at 60 days(60 days post-discharge)
- Re-hospitalization Rate at 90 Days(90 days post-discharge)
- Change in Physical Performance(Baseline, 30 days, 60 days, and 90 days post-discharge.)
- Platform Usability(30 days, 60 days, and 90 days post-discharge)
- Psychosocial Impact of Technology(30 days, 60 days, and 90 days post-discharge)
- Change in Digital Health Literacy(Baseline and 90 days post-discharge)