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

Primary Purpose

Stroke

Status
Recruiting
Phase
Not Applicable
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Early Supported discharge with home based Rehabilitation
Conventional rehabilitation
Sponsored by
Seoul National University Bundang Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Stroke focused on measuring Early Supported Discharge, Acute stroke

Eligibility Criteria

20 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Department of Rehabilitation Medicine, Seoul National University College of Medicine, Seoul National University Bundang HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Early Supported Discharge (ESD) Group

Conventional Rehabilitation (CR) Group

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.
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.
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.
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.
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.
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.
Fall Experience
Number of patients who experience fall within the period.
Mortality rate
Number of patients who died within the period.
Readmission rate
Number of patients who were readmitted to the hospital within the period.
Length of hospital stay
Number of days admitted to hospital for stroke treatment and post-stroke rehabilitation.
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.
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.
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

Full Information

First Posted
January 20, 2021
Last Updated
August 29, 2022
Sponsor
Seoul National University Bundang Hospital
Collaborators
Chungnam National University Hospital, Pusan National University Yangsan Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT04720820
Brief Title
Efficacy and Safety of Early Supported Discharge for Post-Acute Stroke Patients in Korea
Acronym
KOMPACT
Official Title
A Pragmatic Multicenter Randomized Controlled Study on Early Supported Discharge: KOrean Model of Post-Acute Comprehensive rehabiliTation(KOMPACT)
Study Type
Interventional

2. Study Status

Record Verification Date
August 2022
Overall Recruitment Status
Recruiting
Study Start Date
March 1, 2021 (Actual)
Primary Completion Date
December 31, 2022 (Anticipated)
Study Completion Date
June 30, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Seoul National University Bundang Hospital
Collaborators
Chungnam National University Hospital, Pusan National University Yangsan Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stroke
Keywords
Early Supported Discharge, Acute stroke

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
The trial consists of two arms; An Early Supported Discharge group and Conventional Rehabilitation group
Masking
Outcomes Assessor
Masking Description
The assessors are blinded to the patients' group
Allocation
Randomized
Enrollment
90 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Early Supported Discharge (ESD) Group
Arm Type
Experimental
Arm Description
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.
Arm Title
Conventional Rehabilitation (CR) Group
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
Early Supported discharge with home based Rehabilitation
Intervention Description
Treatment by Physiotherapist and occupational therapist at least 30 minutes each, per week provided at home.
Intervention Type
Other
Intervention Name(s)
Conventional rehabilitation
Intervention Description
Treatment will be provided according to current hospital's stroke rehabilitation program.
Primary Outcome Measure Information:
Title
changes in Korean modified Barthel Index (K-MBI)
Description
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.
Time Frame
Baseline, 1 month after discharge, 3 months after onset, changes from baseline
Secondary Outcome Measure Information:
Title
modified Rankin Scale (mRS)
Description
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.
Time Frame
Baseline, 1 month after discharge, 3 months after onset
Title
Korean Instrumental Activities of Daily Living (K-IADL)
Description
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.
Time Frame
1 month after discharge, 3 months after onset
Title
Korean Reintegration to Normal Life Index (K-RNLI)
Description
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.
Time Frame
1 month after discharge, 3 months after onset
Title
Patient Health Questionnaire-9 (PHQ-9)
Description
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.
Time Frame
Baseline, 1 month after discharge, 3 months after onset
Title
Korean Stroke Impact Scale ver 3.0 (K-SIS)
Description
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.
Time Frame
1 month after discharge, 3 months after onset
Title
European Quality of Life-5 Dimensions-5 Levels (EQ-5D-5L)
Description
EQ-5D-5L evaluates the quality of life. The scale ranges from -0.066 to 0.904, lower value means worse quality of life.
Time Frame
Baseline, 1 month after discharge, 3 months after onset
Title
Fall Experience
Description
Number of patients who experience fall within the period.
Time Frame
1 month after discharge, 3 months after onset
Title
Mortality rate
Description
Number of patients who died within the period.
Time Frame
1 month after discharge, 2 month after discharge(if needed), 3 months after onset
Title
Readmission rate
Description
Number of patients who were readmitted to the hospital within the period.
Time Frame
1 month after discharge, 2 month after discharge(if needed), 3 months after onset
Title
Length of hospital stay
Description
Number of days admitted to hospital for stroke treatment and post-stroke rehabilitation.
Time Frame
3 months after onset
Title
Korean Zarit Burden Interview-22 (K-ZBI 22)
Description
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.
Time Frame
1 month after discharge, 3 months after onset
Title
Direct costs related to rehabilitation
Description
Direct costs includes expenses for medical and rehabilitation services. It consists for inpatient cost, outpatient cost, home based rehabilitation cost.
Time Frame
1 month after discharge, 2 month after discharge(if needed), 3 months after onset
Title
Indirect costs related to rehabilitation
Description
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
Time Frame
1 month after discharge, 2 month after discharge(if needed), 3 months after onset

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Wonkee Chang, MD
Phone
82-31-787-7739
Email
wkchang@snubh.org
Facility Information:
Facility Name
Department of Rehabilitation Medicine, Seoul National University College of Medicine, Seoul National University Bundang Hospital
City
Seongnam-si
State/Province
Korea, Gyeonggi-do
ZIP/Postal Code
463-707
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Nam-Jong Paik, MD, PhD
Phone
82-031-787-7731
Email
njpaik@snu.ac.kr
First Name & Middle Initial & Last Name & Degree
Won Kee Chang, MD
Phone
82-031-787-7739
Email
wonkee.chang@gmail.com
First Name & Middle Initial & Last Name & Degree
Nam-jong Paik, MD, PhD

12. IPD Sharing Statement

Plan to Share IPD
Undecided
Citations:
PubMed Identifier
34566853
Citation
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.
Results Reference
derived

Learn more about this trial

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

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