Development and Validation of a Protected Discharge Model Using Technology in Multimorbidity and Poly-treated Older Subjects. The PRO-HOME Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 60
- 试验地点
- 2
- 主要终点
- Length of hospital stay
研究概览
简要总结
The main goal of thi clinical trial is to evaluate if a protected discharge model can reduce the length of hospital stay in older participants aged over 65 years old who have been admitted to the hospital for an acute event and have been considered stable and dischargeable. Participants of the intervention group will be asked to transfer to a small apartment, inside the hospital setting, equipped by technological devices and to be involved in cognitive and physical activities during the stay. Researchers will compare this intervention group with a control group who receive normal clinical practice where older people remain in the hospital ward.
详细描述
Participants who fit the inclusion criteria are randomized in two arms (intervention or control groups). All of them are evaluated with a comprehensive geriatric assessment (Multidimensional Prognostic Index), a depression scale (Geriatric Depression Scale), quality of Life scale (Short-Form 12 items), and physical parameters (Hand Grip, Short Physical Performance Battery, gait speed). In the intervention group the following clinical parameters will be collected through technological devices: spontaneous physical performance, sleep monitoring, gait speed, quality of movements, heart rate, SpO2, and other vital parameters.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 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
- •participants aged 65 years or older;
- •admitted to the acute geriatric units for an acute event;
- •deemed stable and dischargeable from the hospital;
- •good personal autonomy in the Activities of Daily Living (ADL) (according to the Katz ADL scoring≥ 3/6);
- •normal cognition or mild cognitive impairment (Short Portable Mental Status Questionnaire (SPMSQ) ≤ 5/10);
- •signed informed consent
排除标准
- •participants aged less than 65 years old
- •not considerable stable and dischargeable
- •SPMSQ > 5/10
- •not signed informed consent
结局指标
主要结局
Length of hospital stay
时间窗: At 1 month after the baseline
Evaluate the efficacy of a protected discharge model in terms of length of hospital stay in multimorbid and poly-treated older subjects
次要结局
- Negative clinical outcome: re-hospitalization(1, 3 , 6 months after the baseline)
- Step mean through smartwatch(At baseline)
- Daily inactivity time through smartwatch(At baseline)
- Negative clinical outcome: mortality(1, 3 , 6 months after the baseline)
- Heart rate through smartwatch(At baseline)
- Gait speed through kinect Azure(At baseline)
- Negative clinical outcome: institutionalization(1, 3 , 6 months after the baseline)
- Distance covered through smartwatch(At Baseline)
- Trunk/head oscillation (body sway /lean in) through kinect Azure(At baseline)
研究者
Alberto Pilotto
Director of Department of Geriatric Care, Orthogeriatrics and Rehabilitation
Ente Ospedaliero Ospedali Galliera