Department of Rehabilitation Medicine, Seoul National University College of Medicine, Seoul National University Bundang Hospital
Seongnam-si, Korea, Gyeonggi-do, 463-707, South Korea
NCT Number: NCT04720820
The study aims to examine the effect of early supported discharge (ESD) service on the functional outcomes and quality of life of acute stroke patients with mild to moderate disability in Korea.
The study is a double-armed prospective multi-centered, assessor-blinded randomized controlled trial comparing the effect of ESD program with conventional rehabilitation program.
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Notify Me20 year and older
All sexes
Interventional
Not applicable
Seongnam-si, Korea, Gyeonggi-do, 463-707, South Korea
Early Supported Discharge (ESD) is a form of medical service applicable to acute stroke patients with mild to moderate disabilities. ESD service was developed to facilitate patient to their daily livings at home, reduce the length of stay in the hospital with possibly better or equivalent outcomes for patients and caregivers.
ESD service has been proven to be non-inferior in the functional and quality of life measures as well as cost-effective, compared to the conventional rehabilitation service in many countries, however the effectiveness of ESD service may differ among countries and medical, economical circumstances. This study aims to examine the effect of ESD service on the acute stroke patients with mild to moderate disabilities in Korea and demonstrate its feasibility as an alternative medical service option to those patients.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Treatment by Physiotherapist and occupational therapist at least 30 minutes each, per week provided at home.
Treatment will be provided according to current hospital's stroke rehabilitation program.
Time frame: Baseline, 1 month after discharge, 3 months after onset, changes from baseline
K-MBI is an ordinal scale used to measure performance in activities of daily living(ADL). score ranges from 0 to 100, higher score meaning better ADL function.
Time frame: Baseline, 1 month after discharge, 3 months after onset
mRS is a scale used for measuring the degree of disability or dependence in the daily activities of people with stroke. Scale ranges from 0-6, with 0 meaning no symptoms and 6 meaning dead.
Time frame: 1 month after discharge, 3 months after onset
K-IADL assesses a person's ability to perform tasks such as using a telephone, doing laundry, and handling finances. The scale ranges from 0 to 100, higher score meaning better IADL function.
Time frame: 1 month after discharge, 3 months after onset
K-RNLI assesses the degree of individuals who have experienced stroke achieve reintegration into normal social activities. The scale ranges from 0-100 with higher score meaning better reintegration to normal life.
Time frame: Baseline, 1 month after discharge, 3 months after onset
PHQ-9 is a instrument for screening, diagnosing and measuring the severity of depression. The scale ranges from 0-27 with higher score indicating severer depression.
Time frame: 1 month after discharge, 3 months after onset
K-SIS evaluates disability and health-related quality of life after stroke. It consists of 8 domains each score ranges from 0-100 with higher score meaning better quality of life.
Time frame: Baseline, 1 month after discharge, 3 months after onset
EQ-5D-5L evaluates the quality of life. The scale ranges from -0.066 to 0.904, lower value means worse quality of life.
Time frame: 1 month after discharge, 3 months after onset
Number of patients who experience fall within the period.
Time frame: 1 month after discharge, 2 month after discharge(if needed), 3 months after onset
Number of patients who died within the period.
Time frame: 1 month after discharge, 2 month after discharge(if needed), 3 months after onset
Number of patients who were readmitted to the hospital within the period.
Time frame: 3 months after onset
Number of days admitted to hospital for stroke treatment and post-stroke rehabilitation.
Time frame: 1 month after discharge, 3 months after onset
K-ZBI 22 assesses caregiver perceptions of burden in health, personal, social or financial domains. The scale ranges from 0-88 with higher score indicating higher burden.
Time frame: 1 month after discharge, 2 month after discharge(if needed), 3 months after onset
Direct costs includes expenses for medical and rehabilitation services. It consists for inpatient cost, outpatient cost, home based rehabilitation cost.
Time frame: 1 month after discharge, 2 month after discharge(if needed), 3 months after onset
Indirect costs means expenses needed for treatment and rehabilitation of the patients other tahn medical and rehabilitation services. Indirect costs include transportation expense and caregiver expense and productivity loss
Seoul National University Bundang Hospital
Other
A Pragmatic Multicenter Randomized Controlled Study on Early Supported Discharge: KOrean Model of Post-Acute Comprehensive rehabiliTation(KOMPACT)
Acronym: KOMPACT
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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