Stroke
Conditions
Keywords
Early Supported Discharge, Acute stroke
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.
Interventions
OTHEREarly Supported discharge with home based Rehabilitation
Treatment by Physiotherapist and occupational therapist at least 30 minutes each, per week provided at home.
OTHERConventional rehabilitation
Treatment will be provided according to current hospital's stroke rehabilitation program.
Sponsors
Chungnam National University Hospital
Pusan National University Yangsan Hospital
Seoul National University Bundang Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Masking description
The assessors are blinded to the patients' group
Intervention model description
The trial consists of two arms; An Early Supported Discharge group and Conventional Rehabilitation group
Eligibility
Sex/Gender
ALL
Age
20 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| changes in Korean modified Barthel Index (K-MBI) | Baseline, 1 month after discharge, 3 months after onset, changes from baseline | 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
| Measure | Time frame | Description |
|---|---|---|
| Korean Instrumental Activities of Daily Living (K-IADL) | 1 month after discharge, 3 months after onset | 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) | 1 month after discharge, 3 months after onset | 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) | Baseline, 1 month after discharge, 3 months after onset | 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) | 1 month after discharge, 3 months after onset | 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) | Baseline, 1 month after discharge, 3 months after onset | 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 | 1 month after discharge, 3 months after onset | Number of patients who experience fall within the period. |
| modified Rankin Scale (mRS) | Baseline, 1 month after discharge, 3 months after onset | 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. |
| Readmission rate | 1 month after discharge, 2 month after discharge(if needed), 3 months after onset | Number of patients who were readmitted to the hospital within the period. |
| Length of hospital stay | 3 months after onset | Number of days admitted to hospital for stroke treatment and post-stroke rehabilitation. |
| Korean Zarit Burden Interview-22 (K-ZBI 22) | 1 month after discharge, 3 months after onset | 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 | 1 month after discharge, 2 month after discharge(if needed), 3 months after onset | 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 | 1 month after discharge, 2 month after discharge(if needed), 3 months after onset | 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 |
| Mortality rate | 1 month after discharge, 2 month after discharge(if needed), 3 months after onset | Number of patients who died within the period. |
Countries
South Korea
Outcome results
None listed