Korean Stroke Cohort for Functioning and Rehabilitation-II
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 2,431
- 试验地点
- 2
- 主要终点
- Change in Korean modified Barthel Index
研究概览
简要总结
Korean Stroke Cohort for functioning and rehabilitation (KOSCO)-II is a large, multi-centre prospective cohort study for all acute first-ever stroke patients admitted to participating hospitals in nine distinct areas of Korea. This study is designed as a 10-year, longitudinal follow-up investigating the residual disabilities, activity limitations, and quality of life issues arising in patients suffering from first-ever stroke as previous similar stroke cohort with KOSCO. The main objectives of this study are to identify and compare the factors that influence residual disability and long-term quality of life in first-ever acute stroke patients with KOSCO. The secondary objectives of this study are to determine and compare the risk of mortality and recurrent vascular events in first-ever acute stroke patients with KOSCO. Investigators will investigate longitudinal health behaviors and patterns of healthcare utilization, including stroke rehabilitation care. Investigators will also investigate the long-term health status, mood, and quality of life in stroke patient caregivers. In addition, investigators will identify baseline and ongoing characteristics that are associated with secondary outcomes.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 19 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •First-ever acute stroke (ischemic stroke or intracerebral hemorrhage) with corresponding lesion and/or evidence of acute arterial occlusion on CT (A)- or MRI/A-scan.
- •Age ≥ 19 years at onset of stroke.
- •Onset of symptoms within seven days prior to inclusion.
排除标准
- •Transient ischemic attack.
- •History of stroke.
- •Traumatic intracerebral hemorrhage.
- •Not Korean.
结局指标
主要结局
Change in Korean modified Barthel Index
时间窗: 3 months, 6 months, 12 months, 18 months, 24 months, 36 months, 48 months, 60 months, 72 months, 84 months, 96 months, 108 months after stroke onset.
measurement for activities of daily living Minimum: 0, Maximum: 100 Higher scores means a better.
Change in Euro Quality of Life-5 Dimensions measurement for quality of life
时间窗: 3 months, 6 months, 12 months, 18 months, 24 months, 36 months, 48 months, 60 months, 72 months, 84 months, 96 months, 108 months after stroke onset.
measurement for quality of life Minimum: 0, Maximum: 1 Higher scores means a better.
Change in Functional Independence Measurement
时间窗: 3 months, 6 months, 12 months, 18 months, 24 months, 36 months, 48 months, 60 months, 72 months, 84 months, 96 months, 108 months after stroke onset.
measurement for activities of daily living Minimum: 0, Maximum: 126 Higher scores means a better.
Change in Korean Mini-Mental State Examination
时间窗: 7 days, 3 months, 6 months, 12 months, 18 months, 24 months, 36 months, 48 months, 60 months, 72 months, 84 months, 96 months, 108 months after stroke onset.
measurement for language function Minimum: 0, Maximum: 30 Higher scores means a better.
Change in Korean Version of Frenchay Aphasia Screening Test
时间窗: 7 days, 3 months, 6 months, 12 months, 18 months, 24 months, 36 months, 48 months, 60 months, 72 months, 84 months, 96 months, 108 months after stroke onset.
measurement for language function Minimum: 0, Maximum: 30 Higher scores means a better.
Change in modified Rankin Scale
时间窗: 7 days, 3 months, 6 months, 12 months, 18 months, 24 months, 36 months, 48 months, 60 months, 72 months, 84 months, 96 months, 108 months after stroke onset
Measurement for disability. Range of total score 0 to 6. 0 is no disability at all and 6 is death. Therefore, greater value means worse functional status
Change in American Speech-Language-Hearing Association National Outcome Measurement System Swallowing Scale
时间窗: 7 days, 3 months, 6 months, 12 months, 18 months, 24 months, 36 months, 48 months, 60 months, 72 months, 84 months, 96 months, 108 months after stroke onset
Measurement for swallowing function. Range of scale is 0 to 7, and greater value means better function. For example, 7 means no swallowing difficulty at all.
Change in Geriatric depression scale-short form
时间窗: 3 months, 6 months, 12 months, 18 months, 24 months, 36 months, 48 months, 60 months, 72 months, 84 months, 96 months, 108 months after stroke onset
measurement for depression. The scale is 0 to 15. 0 is normal whereas 15 indicates severe depression. Minimum: 0, Maximum: 15. Lower scores means a better.
Change in Functional Ambulatory Category
时间窗: 7 days, 3 months, 6 months, 12 months, 18 months, 24 months, 36 months, 48 months, 60 months, 72 months, 84 months, 96 months, 108 months after stroke onset
measurement for gait function Minimum: 0, Maximum: 5 Higher scores means a better.
次要结局
未报告次要终点
研究者
Yun-Hee Kim
Professor
Samsung Medical Center