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

Stroke Clinical Trial

— KOMPACT  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04720820
• Other study ID #: B-2012-654-308
• Status: Recruiting
• Phase: N/A
• Start date: March 1, 2021
• Est. completion date: June 30, 2023

Study information

• Verified date: August 2022
• Source: Seoul National University Bundang Hospital
• Contact: Wonkee Chang, MD
• Phone: 82-31-787-7739
• Email: wkchang[@]snubh.org
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 90
• Est. completion date: June 30, 2023
• Est. primary completion date: December 31, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Stroke

Intervention

Other:
• Early Supported discharge with home based Rehabilitation
Treatment by Physiotherapist and occupational therapist at least 30 minutes each, per week provided at home.
• Conventional rehabilitation
Treatment will be provided according to current hospital's stroke rehabilitation program.

Locations

Country	Name	City	State
Korea, Republic of	Department of Rehabilitation Medicine, Seoul National University College of Medicine, Seoul National University Bundang Hospital	Seongnam-si	Korea, Gyeonggi-do

Sponsors (3)

Lead Sponsor	Collaborator
Seoul National University Bundang Hospital	Chungnam National University Hospital, Pusan National University Yangsan Hospital

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	Fall Experience	Number of patients who experience fall within the period.	1 month after discharge, 3 months after onset
Secondary	Mortality rate	Number of patients who died within the period.	1 month after discharge, 2 month after discharge(if needed), 3 months after onset
Secondary	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
Secondary	Length of hospital stay	Number of days admitted to hospital for stroke treatment and post-stroke rehabilitation.	3 months after onset
Secondary	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
Secondary	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
Secondary	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