Effect of the National Taiwan University Hospital Elder Life Program
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 377
- 试验地点
- 2
- 主要终点
- Frailty rates and transition between frailty states
研究概览
简要总结
The aim is to replicate, develop, and pilot test a model of care for the prevention and management of functional decline of older patients during hospitalization.
详细描述
to develop an intervention protocol that achieves clinical development objectives in a scientifically rigorous and time efficient manner.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
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
- •Age 65 year and older
- •Length of Stay is over 6 days
- •Able to communicate verbally or in writing
排除标准
- •Mechanism ventilation
- •Aphasia, if communication ability is severely impaired
- •Terminal condition with comfort care only, death imminent
- •Combative or dangerous behavior
- •Severe psychotic disorder that prevents patient from participating in interventions
- •Severe dementia (e.g. unable to communicate; MMSE=0). For patients with severe impairment (e.g. MMSE<10), decision to enroll will be made on a case-by-case basis depending on their ability to participate in intervention.
- •Respiratory isolation (e.g. tuberculosis). Patients on contact isolation (e.g. vancomycin-resistant enterococcus) or droplet precautions will be enrolled.
- •Discharge firmly anticipated within 6 days of admission. Enroll if discharge date unsure
- •Refusal by patient or family member.
- •Others. Reason to be well documented.
研究组 & 干预措施
Usual Care Group
Usual care consists of standard hospital services provided by physicians, nurses, and support staff (e.g., physical therapist, dietitian) in the general surgery units.
Experimental Group
The intervention consisted of a daily inpatient care protocol on three core intervention protocols on top of hospital routine care.
干预措施: a modified NTU-HELP (Behavioral)
结局指标
主要结局
Frailty rates and transition between frailty states
时间窗: through study completion, an average of 3 months
Changes from Baseline Frailty rates at 6 weeks after discharge
Postoperative delirium incidence rate [Confusion Assessment Method (CAM)]
时间窗: through study completion, an average of 3 months
Record the incidence of postoperative delirium developing during hospitalization after surgery
Functional status:Barthel Index.
时间窗: through study completion, an average of 3 months
Changes from Baseline Barthel Index (BI) scores at 6 weeks after discharge
Mini-Nutritional Assessment scores (MNA)
时间窗: through study completion, an average of 3 months
Changes from Baseline Mini-Nutritional Assessment (MNA) scores at 6 weeks after discharge
Mini Mental State Examination scores (MMSE)
时间窗: through study completion, an average of 3 months
Changes from Baseline Mini Mental State Examination (MMSE) scores at 6 weeks after discharge
Postoperative bowel dysmotility
时间窗: through study completion, an average of 3 months
Record the incidence of postoperative bowel dysmotility developing during hospitalization after surgery
次要结局
- Body weight(through study completion, an average of 3 months)
- Grip strength(through study completion, an average of 3 months)
- Length of Hospital Stay (LOS)(through study completion, an average of 3 months)
- Oral health(through study completion, an average of 3 months)
- Executive function(through study completion, an average of 3 months)
- Geriatric Depressive Scale scores (GDS)(through study completion, an average of 3 months)