Efficacy and Safety of Early Supported Discharge for Post-Acute Stroke Patients in Korea

Study Overview
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Brief Summary
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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
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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.

Official Title
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A Pragmatic Multicenter Randomized Controlled Study on Early Supported Discharge: KOrean Model of Post-Acute Comprehensive rehabiliTation(KOMPACT)

Conditions
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Stroke

Intervention / Treatment
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* Other: Early Supported discharge with home based Rehabilitation
* Other: Conventional rehabilitation


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Exclusion Criteria: 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

Ages Eligible for Study
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Minimum Age: 20 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: The trial consists of two arms; An Early Supported Discharge group and Conventional Rehabilitation group
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Early Supported Discharge (ESD) Group<br>Patients in the ESD group will be discharged to home as soon as the acute medical treatment is finished. The patients will follow a pre-planned ESD program which consists of home-based rehabilitation (at least 30 minutes of physical therapy and 30 minutes of occupational therapy per week) offered by therapists. The ESD team will also provide social/medical services as needed. The ESD program will be provided till 1 months after discharge point. | Other: Early Supported discharge with home based Rehabilitation<br>* Treatment by Physiotherapist and occupational therapist at least 30 minutes each, per week provided at home.<br>|
| Active Comparator: Conventional Rehabilitation (CR) Group<br>The patients in CR group will be provided with inpatient rehabilitation after the acute medical treatment is finished. The length of inpatient rehabilitation may depend on the hospital's current program. Patients will be provided with outpatient based rehabilitation program if needed after discharge. | Other: Conventional rehabilitation<br>* Treatment will be provided according to current hospital's stroke rehabilitation program.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| changes in Korean modified Barthel Index (K-MBI) | 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. | Baseline, 1 month after discharge, 3 months after onset, changes from baseline | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| modified Rankin Scale (mRS) | 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. | Baseline, 1 month after discharge, 3 months after onset | 
| Korean Instrumental Activities of Daily Living (K-IADL) | 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. | 1 month after discharge, 3 months after onset | 
| Korean Reintegration to Normal Life Index (K-RNLI) | 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. | 1 month after discharge, 3 months after onset | 
| Patient Health Questionnaire-9 (PHQ-9) | 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. | Baseline, 1 month after discharge, 3 months after onset | 
| Korean Stroke Impact Scale ver 3.0 (K-SIS) | 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. | 1 month after discharge, 3 months after onset | 
| European Quality of Life-5 Dimensions-5 Levels (EQ-5D-5L) | EQ-5D-5L evaluates the quality of life. The scale ranges from -0.066 to 0.904, lower value means worse quality of life. | Baseline, 1 month after discharge, 3 months after onset | 
| Fall Experience | Number of patients who experience fall within the period. | 1 month after discharge, 3 months after onset | 
| Mortality rate | Number of patients who died within the period. | 1 month after discharge, 2 month after discharge(if needed), 3 months after onset | 
| Readmission rate | Number of patients who were readmitted to the hospital within the period. | 1 month after discharge, 2 month after discharge(if needed), 3 months after onset | 
| Length of hospital stay | Number of days admitted to hospital for stroke treatment and post-stroke rehabilitation. | 3 months after onset | 
| Korean Zarit Burden Interview-22 (K-ZBI 22) | 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. | 1 month after discharge, 3 months after onset | 
| Direct costs related to rehabilitation | Direct costs includes expenses for medical and rehabilitation services. It consists for inpatient cost, outpatient cost, home based rehabilitation cost. | 1 month after discharge, 2 month after discharge(if needed), 3 months after onset | 
| Indirect costs related to rehabilitation | 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 | 1 month after discharge, 2 month after discharge(if needed), 3 months after onset | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Early Supported Discharge, Acute stroke