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Completed

NCT Number: NCT04720820

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

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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Key information

Age range

20 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Department of Rehabilitation Medicine, Seoul National University College of Medicine, Seoul National University Bundang Hospital

Seongnam-si, Korea, Gyeonggi-do, 463-707, South Korea

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Early Supported discharge with home based Rehabilitation

Other

Treatment by Physiotherapist and occupational therapist at least 30 minutes each, per week provided at home.

conventional rehabilitation

Other

Treatment will be provided according to current hospital's stroke rehabilitation program.

Primary outcomes

  1. changes in Korean modified Barthel Index (K-MBI)

    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.

Secondary outcomes

  1. modified Rankin Scale (mRS)

    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.

  2. Korean Instrumental Activities of Daily Living (K-IADL)

    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.

  3. Korean Reintegration to Normal Life Index (K-RNLI)

    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.

  4. Patient Health Questionnaire-9 (PHQ-9)

    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.

  5. Korean Stroke Impact Scale ver 3.0 (K-SIS)

    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.

  6. European Quality of Life-5 Dimensions-5 Levels (EQ-5D-5L)

    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.

  7. Fall Experience

    Time frame: 1 month after discharge, 3 months after onset

    Number of patients who experience fall within the period.

  8. Mortality rate

    Time frame: 1 month after discharge, 2 month after discharge(if needed), 3 months after onset

    Number of patients who died within the period.

  9. Readmission rate

    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.

  10. Length of hospital stay

    Time frame: 3 months after onset

    Number of days admitted to hospital for stroke treatment and post-stroke rehabilitation.

  11. Korean Zarit Burden Interview-22 (K-ZBI 22)

    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.

  12. Direct costs related to rehabilitation

    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.

  13. Indirect costs related to rehabilitation

    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

Sponsors and collaborators

Lead sponsor

Seoul National University Bundang Hospital

Other

Collaborators

  • Chungnam National University Hospital
  • Pusan National University Yangsan Hospital

Registry information

Official study title

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

Acronym: KOMPACT

Important dates

Study start
2021
Primary completion
2023
Study completion
2023
First posted
Jan 22, 2021
Registry last updated
Jun 19, 2025

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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