Clinical trial NCT04720820: Efficacy and Safety of Early Supported Discharge for Post-Acute Stroke Patients in Korea
Official title: A Pragmatic Multicenter Randomized Controlled Study on Early Supported Discharge: KOrean Model of Post-Acute Comprehensive rehabiliTation(KOMPACT)
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Stroke
Keywords: Early Supported Discharge
Acute stroke
Lead sponsor: Seoul National University Bundang Hospital
Sponsor class: OTHER
Collaborators: name: Chungnam National University Hospital
name: Pusan National University Yangsan Hospital
First posted: 2021-01-22
Enrollment: 90
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: The trial consists of two arms; An Early Supported Discharge group and Conventional Rehabilitation group
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: changes in Korean modified Barthel Index (K-MBI)
timeFrame: Baseline, 1 month after discharge, 3 months after onset, changes from baseline
Secondary outcomes:
measure: modified Rankin Scale (mRS)
timeFrame: Baseline, 1 month after discharge, 3 months after onset
measure: Korean Instrumental Activities of Daily Living (K-IADL)
timeFrame: 1 month after discharge, 3 months after onset
measure: Korean Reintegration to Normal Life Index (K-RNLI)
timeFrame: 1 month after discharge, 3 months after onset
measure: Patient Health Questionnaire-9 (PHQ-9)
timeFrame: Baseline, 1 month after discharge, 3 months after onset
measure: Korean Stroke Impact Scale ver 3.0 (K-SIS)
timeFrame: 1 month after discharge, 3 months after onset
measure: European Quality of Life-5 Dimensions-5 Levels (EQ-5D-5L)
timeFrame: Baseline, 1 month after discharge, 3 months after onset
measure: Fall Experience
timeFrame: 1 month after discharge, 3 months after onset
measure: Mortality rate
timeFrame: 1 month after discharge, 2 month after discharge(if needed), 3 months after onset
measure: Readmission rate
timeFrame: 1 month after discharge, 2 month after discharge(if needed), 3 months after onset
measure: Length of hospital stay
timeFrame: 3 months after onset
measure: Korean Zarit Burden Interview-22 (K-ZBI 22)
timeFrame: 1 month after discharge, 3 months after onset
measure: Direct costs related to rehabilitation
timeFrame: 1 month after discharge, 2 month after discharge(if needed), 3 months after onset
measure: Indirect costs related to rehabilitation
timeFrame: 1 month after discharge, 2 month after discharge(if needed), 3 months after onset
Other outcomes:
Locations:
city: Seongnam-si
country: Korea, Republic of
facility: Department of Rehabilitation Medicine, Seoul National University College of Medicine, Seoul National University Bundang Hospital
state: Korea, Gyeonggi-do
Study officials:
References:
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.