Efficacy and Safety of Early Supported Discharge for Post-Acute Stroke Patients in Korea (KOMPACT)
29. august 2022 opdateret af: Nam-Jong Paik, Seoul National University Bundang Hospital
A Pragmatic Multicenter Randomized Controlled Study on Early Supported Discharge: KOrean Model of Post-Acute Comprehensive rehabiliTation(KOMPACT)
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.
Studieoversigt
Status
Rekruttering
Betingelser
Intervention / Behandling
Detaljeret beskrivelse
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.
Undersøgelsestype
Interventionel
Tilmelding (Forventet)
90
Fase
- Ikke anvendelig
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiekontakt
- Navn: Wonkee Chang, MD
- Telefonnummer: 82-31-787-7739
- E-mail: wkchang@snubh.org
Studiesteder
-
-
Korea, Gyeonggi-do
-
Seongnam-si, Korea, Gyeonggi-do, Korea, Republikken, 463-707
- Rekruttering
- Department of Rehabilitation Medicine, Seoul National University College of Medicine, Seoul National University Bundang Hospital
-
Kontakt:
- Won Kee Chang, MD
- Telefonnummer: 82-031-787-7739
- E-mail: wonkee.chang@gmail.com
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Kontakt:
- Nam-Jong Paik, MD, PhD
- Telefonnummer: 82-031-787-7731
- E-mail: njpaik@snu.ac.kr
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Ledende efterforsker:
- Nam-jong Paik, MD, PhD
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Deltagelseskriterier
Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.
Berettigelseskriterier
Aldre berettiget til at studere
20 år og ældre (Voksen, Ældre voksen)
Tager imod sunde frivillige
Ingen
Køn, der er berettiget til at studere
Alle
Beskrivelse
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
Studieplan
Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Behandling
- Tildeling: Randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Enkelt
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
|---|---|
|
Eksperimentel: Early Supported Discharge (ESD) Group
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 by Physiotherapist and occupational therapist at least 30 minutes each, per week provided at home.
|
|
Aktiv komparator: Conventional Rehabilitation (CR) Group
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.
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Treatment will be provided according to current hospital's stroke rehabilitation program.
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Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
changes in Korean modified Barthel Index (K-MBI)
Tidsramme: 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.
|
Baseline, 1 month after discharge, 3 months after onset, changes from baseline
|
Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
modified Rankin Scale (mRS)
Tidsramme: 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.
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Baseline, 1 month after discharge, 3 months after onset
|
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Korean Instrumental Activities of Daily Living (K-IADL)
Tidsramme: 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.
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1 month after discharge, 3 months after onset
|
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Korean Reintegration to Normal Life Index (K-RNLI)
Tidsramme: 1 month after discharge, 3 months after onset
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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.
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1 month after discharge, 3 months after onset
|
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Patient Health Questionnaire-9 (PHQ-9)
Tidsramme: Baseline, 1 month after discharge, 3 months after onset
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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.
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Baseline, 1 month after discharge, 3 months after onset
|
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Korean Stroke Impact Scale ver 3.0 (K-SIS)
Tidsramme: 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.
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1 month after discharge, 3 months after onset
|
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European Quality of Life-5 Dimensions-5 Levels (EQ-5D-5L)
Tidsramme: 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.
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Baseline, 1 month after discharge, 3 months after onset
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Fall Experience
Tidsramme: 1 month after discharge, 3 months after onset
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Number of patients who experience fall within the period.
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1 month after discharge, 3 months after onset
|
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Mortality rate
Tidsramme: 1 month after discharge, 2 month after discharge(if needed), 3 months after onset
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Number of patients who died within the period.
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1 month after discharge, 2 month after discharge(if needed), 3 months after onset
|
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Readmission rate
Tidsramme: 1 month after discharge, 2 month after discharge(if needed), 3 months after onset
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Number of patients who were readmitted to the hospital within the period.
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1 month after discharge, 2 month after discharge(if needed), 3 months after onset
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Length of hospital stay
Tidsramme: 3 months after onset
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Number of days admitted to hospital for stroke treatment and post-stroke rehabilitation.
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3 months after onset
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Korean Zarit Burden Interview-22 (K-ZBI 22)
Tidsramme: 1 month after discharge, 3 months after onset
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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.
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1 month after discharge, 3 months after onset
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Direct costs related to rehabilitation
Tidsramme: 1 month after discharge, 2 month after discharge(if needed), 3 months after onset
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Direct costs includes expenses for medical and rehabilitation services.
It consists for inpatient cost, outpatient cost, home based rehabilitation cost.
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1 month after discharge, 2 month after discharge(if needed), 3 months after onset
|
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Indirect costs related to rehabilitation
Tidsramme: 1 month after discharge, 2 month after discharge(if needed), 3 months after onset
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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
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1 month after discharge, 2 month after discharge(if needed), 3 months after onset
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Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Publikationer og nyttige links
Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.
Datoer for undersøgelser
Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.
Studer store datoer
Studiestart (Faktiske)
1. marts 2021
Primær færdiggørelse (Forventet)
31. december 2022
Studieafslutning (Forventet)
30. juni 2023
Datoer for studieregistrering
Først indsendt
20. januar 2021
Først indsendt, der opfyldte QC-kriterier
20. januar 2021
Først opslået (Faktiske)
22. januar 2021
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
31. august 2022
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
29. august 2022
Sidst verificeret
1. august 2022
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- B-2012-654-308
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