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

N/ACompletedNCT04720820

Seoul National University Bundang Hospital67 enrolled

Overview

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.

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

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Enrollment

Conditions

Stroke

Interventions

Early Supported discharge with home based RehabilitationOTHER

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

Conventional rehabilitationOTHER

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

Eligibility

Sex: ALLMin age: 20 Years

Medical Language ↔ Plain English

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

Locations (1)

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

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

Outcomes

Primary Outcomes

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.

Time frame: Baseline, 1 month after discharge, 3 months after onset, changes from baseline

Secondary Outcomes

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.

Time frame: 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.

Time frame: 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.

Time frame: 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.

Time frame: 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.

Data from ClinicalTrials.gov

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