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Korean Stroke Cohort for Functioning and Rehabilitation

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03402451
Recruitment Status : Active, not recruiting
First Posted : January 18, 2018
Last Update Posted : September 20, 2019
Sponsor:
Collaborator:
Korean Center for Disease Control and Prevention
Information provided by (Responsible Party):
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.

Condition or disease
Stroke Disability Function Rehabilitation Burden

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Study Type : Observational
Actual Enrollment : 7858 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Korean Stroke Cohort for Functioning and Rehabilitation
Actual Study Start Date : August 1, 2012
Estimated Primary Completion Date : December 31, 2021
Estimated Study Completion Date : December 31, 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Rehabilitation




Primary Outcome Measures :
  1. Change in Korean modified Barthel Index [ Time Frame: 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

  2. Change in Euro Quality of Life-5 Dimensions [ Time Frame: 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

  3. Change in Functional Independence Measurement [ Time Frame: 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

  4. Change in Korean Mini-Mental State Examination [ Time Frame: 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

  5. Change in Korean Version of Frenchay Aphasia Screening Test [ Time Frame: 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

  6. Change in modified Rankin Scale [ Time Frame: 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

  7. Change in American Speech-Language-Hearing Association National Outcome Measurement System Swallowing Scale [ Time Frame: 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.

  8. Change in Geriatric depression scale-short form [ Time Frame: 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.

  9. Change in Fugl-Meyer Assessment [ Time Frame: 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

  10. Change in Functional Ambulatory Category [ Time Frame: 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



Information from the National Library of Medicine

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Ages Eligible for Study:   19 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
All consecutive patients with an acute first-ever stroke, admitted to the representative hospitals in the nine distinct areas of Korea, will be asked to participate in the study. Participating study centres are Samsung Medical Center, Seoul; Severance Hospital, Seoul; Konkuk University Hospital, Seoul; Chungnam National University Hospital, Daejeon; Chonnam National University Hospital, Gwangu; Pusan National University Yangsan Hospital, Yangsan; Kyungpook National University Hospital, Deagu; Wonkwang University Hospital, Iksan; and Jeju National University Hospital, Jeju.
Criteria

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.

Exclusion Criteria:

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

Other Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Samsung Medical Center
ClinicalTrials.gov Identifier: NCT03402451    
Other Study ID Numbers: 2012-06-016-001
First Posted: January 18, 2018    Key Record Dates
Last Update Posted: September 20, 2019
Last Verified: September 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Stroke
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases