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

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

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.

Study Overview

• Status: Completed
• Conditions: Stroke
• Intervention / Treatment: Other: Early Supported discharge with home based Rehabilitation; Other: Conventional rehabilitation

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.

• Study Type: Interventional
• Enrollment (Actual): 67
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Korea, Republic of
  • Korea, Gyeonggi-do
    • Seongnam-si, Korea, Gyeonggi-do, Korea, Republic of, 463-707
      • Department of Rehabilitation Medicine, Seoul National University College of Medicine, Seoul National University Bundang Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Early Supported Discharge (ESD) Group; 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; Treatment by Physiotherapist and occupational therapist at least 30 minutes each, per week provided at home.
Active Comparator: Conventional Rehabilitation (CR) Group; 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; Treatment will be provided according to current hospital's stroke rehabilitation program.

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Seoul National University Bundang Hospital
• Collaborators: Pusan National University Yangsan Hospital; Chungnam National University Hospital

Publications and helpful links

General Publications

• Chang WK, Kim WS, Sohn MK, Jee S, Shin YI, Ko SH, Ock M, Kim HJ, Paik NJ. Korean Model for Post-acute Comprehensive rehabilitation (KOMPACT): The Study Protocol for a Pragmatic Multicenter Randomized Controlled Study on Early Supported Discharge. Front Neurol. 2021 Sep 8;12:710640. doi: 10.3389/fneur.2021.710640. eCollection 2021.

Study record dates

Study Major Dates

• Study Start (Actual): March 1, 2021
• Primary Completion (Actual): November 29, 2023
• Study Completion (Actual): November 29, 2023

Study Registration Dates

• First Submitted: January 20, 2021
• First Submitted That Met QC Criteria: January 20, 2021
• First Posted (Actual): January 22, 2021

Study Record Updates

• Last Update Posted (Actual): June 19, 2025
• Last Update Submitted That Met QC Criteria: June 16, 2025
• Last Verified: November 1, 2023

More Information

Terms related to this study

• Keywords: Early Supported Discharge; Acute stroke
• Additional Relevant MeSH Terms: Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Stroke
• Other Study ID Numbers: B-2012-654-308

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No