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

2022年8月29日 更新者：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.

研究概览

地位

招聘中

条件

干预/治疗

详细说明

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.

研究类型

介入性

注册 (预期的)

90

阶段

  • 不适用

联系人和位置

本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。

学习联系方式

学习地点

  • 大韩民国
    • Korea, Gyeonggi-do
      • Seongnam-si、Korea, Gyeonggi-do、大韩民国、463-707
        • 招聘中
        • Department of Rehabilitation Medicine, Seoul National University College of Medicine, Seoul National University Bundang Hospital
        • 接触：
        • 接触：
          • Nam-Jong Paik, MD, PhD
          • 电话号码：82-031-787-7731
          • 邮箱：njpaik@snu.ac.kr
        • 首席研究员：
          • Nam-jong Paik, MD, PhD

参与标准

研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

20年 及以上 (成人、年长者)

接受健康志愿者

不

有资格学习的性别

全部

描述

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

学习计划

本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。

研究是如何设计的？

设计细节

  • 主要用途：治疗
  • 分配：随机化
  • 介入模型：并行分配
  • 屏蔽：单身的

武器和干预

参与者组/臂
干预/治疗
实验性的：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.
其他：Early Supported discharge with home based Rehabilitation
Treatment by Physiotherapist and occupational therapist at least 30 minutes each, per week provided at home.
有源比较器：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.
其他：Conventional rehabilitation
Treatment will be provided according to current hospital's stroke rehabilitation program.

研究衡量的是什么？

主要结果指标

结果测量
措施说明
大体时间
changes in Korean modified Barthel Index (K-MBI)
大体时间：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

次要结果测量

结果测量
措施说明
大体时间
modified Rankin Scale (mRS)
大体时间：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.
Baseline, 1 month after discharge, 3 months after onset
Korean Instrumental Activities of Daily Living (K-IADL)
大体时间：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.
1 month after discharge, 3 months after onset
Korean Reintegration to Normal Life Index (K-RNLI)
大体时间：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.
1 month after discharge, 3 months after onset
Patient Health Questionnaire-9 (PHQ-9)
大体时间：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.
Baseline, 1 month after discharge, 3 months after onset
Korean Stroke Impact Scale ver 3.0 (K-SIS)
大体时间：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.
1 month after discharge, 3 months after onset
European Quality of Life-5 Dimensions-5 Levels (EQ-5D-5L)
大体时间：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.
Baseline, 1 month after discharge, 3 months after onset
Fall Experience
大体时间：1 month after discharge, 3 months after onset
Number of patients who experience fall within the period.
1 month after discharge, 3 months after onset
Mortality rate
大体时间：1 month after discharge, 2 month after discharge(if needed), 3 months after onset
Number of patients who died within the period.
1 month after discharge, 2 month after discharge(if needed), 3 months after onset
Readmission rate
大体时间：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.
1 month after discharge, 2 month after discharge(if needed), 3 months after onset
Length of hospital stay
大体时间：3 months after onset
Number of days admitted to hospital for stroke treatment and post-stroke rehabilitation.
3 months after onset
Korean Zarit Burden Interview-22 (K-ZBI 22)
大体时间：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.
1 month after discharge, 3 months after onset
Direct costs related to rehabilitation
大体时间：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.
1 month after discharge, 2 month after discharge(if needed), 3 months after onset
Indirect costs related to rehabilitation
大体时间：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
1 month after discharge, 2 month after discharge(if needed), 3 months after onset

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

赞助

Seoul National University Bundang Hospital

合作者

Pusan National University Yangsan Hospital
Chungnam National University Hospital

出版物和有用的链接

负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。

一般刊物

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始 (实际的)

2021年3月1日

初级完成 (预期的)

2022年12月31日

研究完成 (预期的)

2023年6月30日

研究注册日期

首次提交

2021年1月20日

首先提交符合 QC 标准的

2021年1月20日

首次发布 (实际的)

2021年1月22日

研究记录更新

最后更新发布 (实际的)

2022年8月31日

上次提交的符合 QC 标准的更新

2022年8月29日

最后验证

2022年8月1日

更多信息

与本研究相关的术语

关键字

其他相关的 MeSH 术语

其他研究编号

  • B-2012-654-308

计划个人参与者数据 (IPD)

计划共享个人参与者数据 (IPD)？

未定

药物和器械信息、研究文件

研究美国 FDA 监管的药品

不

研究美国 FDA 监管的设备产品

不

此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.

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赞助者和合作者

医疗条件

药物干预

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条件

罕见疾病

药物干预

膳食补充剂

赞助者/合作者

地点

3
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