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

Seoul National University

Status: Completed

Conditions: Stroke

Treatments: Other: Early Supported discharge with home based Rehabilitation; Other: Conventional rehabilitation

Study type: Interventional

Funder types: Other

Identifiers

NCT04720820

B-2012-654-308

Details and patient eligibility

About

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.

Full 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.

Enrollment: 67 patients

Sex: All

Ages: 20+ years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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67 participants in 2 patient groups

Early Supported Discharge (ESD) Group

Experimental group

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.

Treatment:

Other: Early Supported discharge with home based Rehabilitation

Conventional Rehabilitation (CR) Group

Active Comparator group

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.

Treatment:

Other: Conventional rehabilitation