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

August 29, 2022 updated by: Nam-Jong Paik, Seoul National University Bundang Hospital

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

Recruiting

Conditions

Intervention / Treatment

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 (Anticipated)

90

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Korea, Republic of
    • Korea, Gyeonggi-do
      • Seongnam-si, Korea, Gyeonggi-do, Korea, Republic of, 463-707
        • Recruiting
        • Department of Rehabilitation Medicine, Seoul National University College of Medicine, Seoul National University Bundang Hospital
        • Contact:
        • Contact:
        • Principal Investigator:
          • Nam-jong Paik, MD, PhD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

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)
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.
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)
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.
Baseline, 1 month after discharge, 3 months after onset
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.
1 month after discharge, 3 months after onset
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.
1 month after discharge, 3 months after onset
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.
Baseline, 1 month after discharge, 3 months after onset
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.
1 month after discharge, 3 months after onset
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.
Baseline, 1 month after discharge, 3 months after onset
Fall Experience
Time Frame: 1 month after discharge, 3 months after onset
Number of patients who experience fall within the period.
1 month after discharge, 3 months after onset
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.
1 month after discharge, 2 month after discharge(if needed), 3 months after onset
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.
1 month after discharge, 2 month after discharge(if needed), 3 months after onset
Length of hospital stay
Time Frame: 3 months after onset
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)
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.
1 month after discharge, 3 months after onset
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.
1 month after discharge, 2 month after discharge(if needed), 3 months after onset
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
1 month after discharge, 2 month after discharge(if needed), 3 months after onset

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Seoul National University Bundang Hospital

Collaborators

Pusan National University Yangsan Hospital
Chungnam National University Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 1, 2021

Primary Completion (Anticipated)

December 31, 2022

Study Completion (Anticipated)

June 30, 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)

August 31, 2022

Last Update Submitted That Met QC Criteria

August 29, 2022

Last Verified

August 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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