A Pragmatic Multicenter Randomized Controlled Study on Early Supported Discharge: KOrean Model of Post-Acute Comprehensive rehabiliTation(KOMPACT)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 67
- 试验地点
- 2
- 主要终点
- changes in Korean modified Barthel Index (K-MBI)
研究概览
简要总结
The study aims to examine the effect of early supported discharge (ESD) service on the functional outcomes and quality of life of acute stroke patients with mild to moderate disability in Korea.
The study is a double-armed prospective multi-centered, assessor-blinded randomized controlled trial comparing the effect of ESD program with conventional rehabilitation program.
详细描述
Early Supported Discharge (ESD) is a form of medical service applicable to acute stroke patients with mild to moderate disabilities. ESD service was developed to facilitate patient to their daily livings at home, reduce the length of stay in the hospital with possibly better or equivalent outcomes for patients and caregivers.
ESD service has been proven to be non-inferior in the functional and quality of life measures as well as cost-effective, compared to the conventional rehabilitation service in many countries, however the effectiveness of ESD service may differ among countries and medical, economical circumstances. This study aims to examine the effect of ESD service on the acute stroke patients with mild to moderate disabilities in Korea and demonstrate its feasibility as an alternative medical service option to those patients.
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
- Single (Outcomes Assessor)
盲法说明
The assessors are blinded to the patients' group
入排标准
- 年龄范围
- 20 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patient who is over 20 years old
- •Patient who had acute stroke and admitted to hospital (excludes TIA)
- •Patient who will be discharged to home within 30 days after onset
- •Patient who has indwelling caregiver and is able to support in ESD program
- •Patient who's initial mRS is 1-3
- •Patient who's initial FAC is 3 or above
- •Patient who's initial K-NIHSS consciousness scores (1a,1b,1c) are all 0
排除标准
- •Patient who had Transient Ischemic Attack
- •Patient who is medically unstable requiring intense treatment
- •Patient who has indwelling urinary catheter
- •Patient who is unable to intake food by mouth
- •Patient who is initial MMSE is below 15
- •Patient who has uncontrolled pain
- •Patient who has psychobehavioral problems
结局指标
主要结局
changes in Korean modified Barthel Index (K-MBI)
时间窗: Baseline, 1 month after discharge, 3 months after onset, changes from baseline
K-MBI is an ordinal scale used to measure performance in activities of daily living(ADL). score ranges from 0 to 100, higher score meaning better ADL function.
次要结局
- Mortality rate(1 month after discharge, 2 month after discharge(if needed), 3 months after onset)
- Direct costs related to rehabilitation(1 month after discharge, 2 month after discharge(if needed), 3 months after onset)
- Korean Instrumental Activities of Daily Living (K-IADL)(1 month after discharge, 3 months after onset)
- Korean Zarit Burden Interview-22 (K-ZBI 22)(1 month after discharge, 3 months after onset)
- modified Rankin Scale (mRS)(Baseline, 1 month after discharge, 3 months after onset)
- Korean Stroke Impact Scale ver 3.0 (K-SIS)(1 month after discharge, 3 months after onset)
- European Quality of Life-5 Dimensions-5 Levels (EQ-5D-5L)(Baseline, 1 month after discharge, 3 months after onset)
- Fall Experience(1 month after discharge, 3 months after onset)
- Readmission rate(1 month after discharge, 2 month after discharge(if needed), 3 months after onset)
- Korean Reintegration to Normal Life Index (K-RNLI)(1 month after discharge, 3 months after onset)
- Patient Health Questionnaire-9 (PHQ-9)(Baseline, 1 month after discharge, 3 months after onset)
- Indirect costs related to rehabilitation(1 month after discharge, 2 month after discharge(if needed), 3 months after onset)
- Length of hospital stay(3 months after onset)
研究者
Nam-Jong Paik
Professor
Seoul National University Bundang Hospital