KOSCO-II: Korean Stroke Cohort for Functioning and Rehabilitation-II
Study Details
Study Description
Brief Summary
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
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Study Design
Outcome Measures
Primary Outcome Measures
- Change in Korean modified Barthel Index [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 [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 [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 [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 [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 [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 [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 [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 [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.
Eligibility Criteria
Criteria
Inclusion Criteria:
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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.
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Age ≥ 19 years at onset of stroke.
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Onset of symptoms within seven days prior to inclusion.
Exclusion Criteria:
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Transient ischemic attack.
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History of stroke.
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Traumatic intracerebral hemorrhage.
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Not Korean.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Samsung Medical Center | Seoul | Korea, Republic of | 135-710 |
Sponsors and Collaborators
- Samsung Medical Center
Investigators
- Principal Investigator: Yun-Hee Kim, MD.,PhD., Samsung Medical Center
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- 2019-11-095