Korean Stroke Cohort for Functioning and Rehabilitation

• Conditions: Function; Rehabilitation; Burden; Stroke; Disability

• Registration Number: NCT03402451
• Lead Sponsor: Samsung Medical Center

Brief Summary

Korean Stroke Cohort for functioning and rehabilitation (KOSCO) 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. The main objectives of this study are to identify the factors that influence residual disability and long-term quality of life. The secondary objectives of this study are to determine the risk of mortality and recurrent vascular events in patients with acute first-ever stroke. 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.

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design

Study Timeline

• Study Start: 2012-08-01
• Study First Submitted: 2018-01-01
• Study First Submitted QC: 2018-01-17
• Study First Posted: 2018-01-18
• Status Verified: 2021-07
• Last Update Submitted: 2021-07-16
• Last Update Posted: 2021-07-19
• Primary Completion: 2021-12-31
• Study Completion: 2021-12-31

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 7858

Inclusion Criteria

1. 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.
2. Age ≥ 19 years at onset of stroke.
3. Onset of symptoms within seven days prior to inclusion.

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Exclusion Criteria

1. Transient ischemic attack.
2. History of stroke.
3. Traumatic intracerebral hemorrhage.
4. Not Korean.

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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 cognitive function
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
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 Euro Quality of Life-5 Dimensions	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
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
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.
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
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
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 Fugl-Meyer Assessment	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 motor function