Efficacy and Safety of Early Supported Discharge for Post-Acute Stroke Patients in Korea
- Conditions
- Stroke
- Registration Number
- NCT04720820
- Lead Sponsor
- Seoul National University Bundang Hospital
- Brief Summary
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.
- Detailed Description
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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 67
- Patient who is over 20 years old
- Patient who had acute stroke and admitted to hospital (excludes TIA)
- Patient who will be discharged to home within 30 days after onset
- Patient who has indwelling caregiver and is able to support in ESD program
- Patient who's initial mRS is 1-3
- Patient who's initial FAC is 3 or above
- Patient who's initial K-NIHSS consciousness scores (1a,1b,1c) are all 0
- Patient who had Transient Ischemic Attack
- Patient who is medically unstable requiring intense treatment
- Patient who has indwelling urinary catheter
- Patient who is unable to intake food by mouth
- Patient who is initial MMSE is below 15
- Patient who has uncontrolled pain
- Patient who has psychobehavioral problems
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method changes in Korean modified Barthel Index (K-MBI) 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.
- Secondary Outcome Measures
Name Time Method Mortality rate 1 month after discharge, 2 month after discharge(if needed), 3 months after onset Number of patients who died within the period.
Direct costs related to rehabilitation 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.
Korean Instrumental Activities of Daily Living (K-IADL) 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.
Korean Zarit Burden Interview-22 (K-ZBI 22) 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.
modified Rankin Scale (mRS) 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.
Korean Stroke Impact Scale ver 3.0 (K-SIS) 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.
European Quality of Life-5 Dimensions-5 Levels (EQ-5D-5L) 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.
Fall Experience 1 month after discharge, 3 months after onset Number of patients who experience fall within the period.
Readmission rate 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.
Korean Reintegration to Normal Life Index (K-RNLI) 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.
Patient Health Questionnaire-9 (PHQ-9) 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.
Indirect costs related to rehabilitation 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
Length of hospital stay 3 months after onset Number of days admitted to hospital for stroke treatment and post-stroke rehabilitation.
Trial Locations
- Locations (1)
Department of Rehabilitation Medicine, Seoul National University College of Medicine, Seoul National University Bundang Hospital
🇰🇷Seongnam-si, Korea, Gyeonggi-do, Korea, Republic of
Department of Rehabilitation Medicine, Seoul National University College of Medicine, Seoul National University Bundang Hospital🇰🇷Seongnam-si, Korea, Gyeonggi-do, Korea, Republic of