Korean Stroke Cohort for Functioning and Rehabilitation-II

Stroke Clinical Trial

— KOSCO-II  

Official title:

Korean Stroke Cohort for Functioning and Rehabilitation-II

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04976894
• Other study ID #: 2019-11-095
• Status: Active, not recruiting
• Start date: January 1, 2020
• Est. completion date: December 31, 2030

Study information

• Verified date: March 2024
• Source: Samsung Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 2431
• Est. completion date: December 31, 2030
• Est. primary completion date: December 31, 2030
• Gender: All
• Age group: 19 Years and older

Eligibility

Inclusion Criteria:

• 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.

Exclusion Criteria:

• Transient ischemic attack.
• History of stroke.
• Traumatic intracerebral hemorrhage.
• Not Korean.

Related Conditions & MeSH terms

• Stroke

Intervention

Other:
• open
open

Locations

Country	Name	City	State
Korea, Republic of	Samsung Medical Center	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Samsung Medical Center

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in Korean modified Barthel Index	measurement for activities of daily living Minimum: 0, Maximum: 100 Higher scores means a better.	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.
Primary	Change in Euro Quality of Life-5 Dimensions measurement for quality of life	measurement for quality of life Minimum: 0, Maximum: 1 Higher scores means a better.	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.
Primary	Change in Functional Independence Measurement	measurement for activities of daily living Minimum: 0, Maximum: 126 Higher scores means a better.	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.
Primary	Change in Korean Mini-Mental State Examination	measurement for language function Minimum: 0, Maximum: 30 Higher scores means a better.	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.
Primary	Change in Korean Version of Frenchay Aphasia Screening Test	measurement for language function Minimum: 0, Maximum: 30 Higher scores means a better.	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.
Primary	Change in modified Rankin Scale	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	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
Primary	Change in American Speech-Language-Hearing Association National Outcome Measurement System Swallowing Scale	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.	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
Primary	Change in Geriatric depression scale-short form	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.	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
Primary	Change in Functional Ambulatory Category	measurement for gait function Minimum: 0, Maximum: 5 Higher scores means a better.	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