此页面是自动翻译的,不保证翻译的准确性。请参阅 英文版 对于源文本。

减少中风后残疾的新型过渡计划 (COMPASS)

2026年11月2日 更新者:Washington University School of Medicine

COMPASS:一种减少中风后残疾的新型过渡计划

This study evaluates a program designed to help individuals transition home from inpatient rehabilitation following an ischemic or hemorrhagic stroke. Half of the participants will receive a stroke education program while the other half will receive an environmental modifications program.

研究概览

详细说明

A gap in care exists at the point of transition from inpatient rehabilitation (IR) to home, when survivors encounter new environmental barriers due to the cognitive and sensorimotor sequelae of stroke. Resolving these barriers and improving independence in the community have potential to significantly improve stroke survivors' long-term morbidity. The proposed study investigates the efficacy and safety of a novel enhanced rehabilitation-transition program to reduce environmental barriers and improve daily activity performance and community participation.

研究类型

介入性

注册 (实际的)

185

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。

学习地点

    • Missouri
      • St Louis、Missouri、美国、63108
        • Washington University School of Medicine

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

50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:

  • aged ≥50 years
  • acute ischemic or hemorrhagic stroke diagnosis
  • independent ADLs prior to stroke (premorbid Modified Rankin Scale Score ≤2)
  • plan to discharge to home

Exclusion Criteria:

  • severe terminal systemic disease that limits life expectancy to < 6 months
  • previous disorder (e.g. dementia) that makes interpretation of the self-rated scales difficult or Short Blessed Test (SBT) score of 10 or less (indicating significant cognitive impairment)
  • moderate to severe Aphasia as determined by the NIHSS Best Language rating of 2 or more
  • reside in congregate living facility.

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:COMPASS

COMPASS is a complex intervention that combines 2 evidence-based treatment strategies at a new point of care (transition from inpatient rehabilitation). The objective of home visits by an occupational therapy (OT) practitioner is to remediate barriers in the home and community that influence daily activities and community participation. The treatment will include a set of 1 predischarge and four 75-minute postdischarge visits. The intervention is followed by 2 booster sessions.

The data from the baseline assessment will be used to develop an environmental modification intervention plan. Environmental modifications will be installed before discharge if possible. Problem areas addressed are participant specific (tailored), but the process to identify and address the target area is systematic. All participants will receive identical intervention components. The standardized components include assessment, identification of problematic activities (and environmental barriers), identification of three solutions (for each problem), implementation of solution set selected by the participant, training, and active practice of daily activities in one's own home and community.

假比较器:Education program

An OT practitioner will deliver the program in accordance with "Evidence-Based Educational Guidelines for Stroke Survivors after Discharge Home." Topic order is determined by participants. Four 75-minute sessions will be provided. Topics may include stroke symptoms, risk factors and preventing stroke recurrence, nutrition, managing emotions, sleep, pain. Written materials from the National Stroke Association and the American Stroke Association are provided.

The control group will experience the same effects of time and attention in the home but no effect on the outcome of interest.

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
Reintegration to Normal Living Index (RNLI)
大体时间:Baseline and 12 months post-stroke

The RNLI is a disability-related quality-of life-instrument used to measure participants' satisfaction with their home and community participation and has been validated on a population of community-dwelling individuals with chronic conditions. It uses an 11-item, 10 point scale, with higher scores indicating greater reintegration to normal living. The sum score is divided by 110 and then multiplied by 100 to obtain an adjusted score. Adjusted scores range from 0 to 100, with higher scores indicating greater reintegration to normal living.

Baseline and 12 months post-stroke

次要结果测量

结果测量
措施说明
大体时间
Stroke Impact Scale (SIS) - Activities of Daily Living (ADL) Domain
大体时间:Baseline and 12 months post-stroke

The SIS is a health-related quality of life (HRQoL) measure that quantifies the impact of stroke on a client's life, via questionnaire. The Activities of Daily Living (ADL) domain was used to measure daily activity performance. The scale ranges from 0 to 100, with higher scores indicating less difficulty.

Baseline and 12 months post-stroke
In-Home Occupational Performance Evaluation (I-HOPE) - Activity Score
大体时间:Baseline and 12 months post-stroke

The In-Home Occupational Performance Evaluation (I-HOPE) activity score measures current activity patterns of participants across 44 activities. The score ranges from 0 to 1.0, with a higher score indicating fewer problematic activities for the participant.

Baseline and 12 months post-stroke
In-Home Occupational Performance Evaluation (I-HOPE) - Performance Score
大体时间:Baseline and 12 months post-stroke

The In-Home Occupational Performance Evaluation (I-HOPE) performance score is a mean rating of up to 10 participant-prioritized activities on a scale from 1 (unable to perform the activity at all) to 5 (able to perform the activity without difficulty). Higher mean scores indicate better functional ability to perform tasks without difficulty.

Baseline and 12 months post-stroke
In-Home Occupational Performance Evaluation (I-HOPE) - Satisfaction Score
大体时间:Baseline and 12-months post-stroke

The In-Home Occupational Performance Evaluation (I-HOPE) satisfaction score is a mean rating of up to 10 participant-prioritized activities on a scale of 1 (not satisfied at all with their performance of the activity) to 5 (very satisfied with their performance of the activity). Higher mean scores indicate more satisfaction with self-rated activity performance.

Baseline and 12-months post-stroke
In-Home Occupational Performance Evaluation (I-HOPE) - Barrier Severity Score
大体时间:Baseline and 12-months post-stroke

The In-Home Occupational Performance Evaluation (I-HOPE) barrier severity score is a total sum of barrier ratings (0=independent with/without a device, 1=stand-by assistance needed, 2=minimum assistance needed, 3=moderate assistance needed, 4=maximum assistance needed, 5=no activity ) for all identified barriers across up to 10 prioritized activities. Multiple barriers could be identified for each prioritized activity. Higher sum scores indicate a greater need for assistance/less independence for completion of functional activities. There is no maximum score.

Baseline and 12-months post-stroke

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。

调查人员

  • 首席研究员:Susan Stark, PhD、Washington University School of Medicine

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。

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)

2018年1月9日

初级完成 (实际的)

2023年12月20日

研究完成 (实际的)

2024年2月28日

研究注册日期

首次提交

2018年3月26日

首先提交符合 QC 标准的

2018年3月26日

首次发布 (实际的)

2018年4月2日

研究记录更新

最后更新发布 (实际的)

2026年11月4日

上次提交的符合 QC 标准的更新

2026年11月2日

最后验证

2026年10月1日

更多信息

与本研究相关的术语

其他研究编号

  • 201705047
  • 1R01HD092398-01 (美国 NIH 拨款/合同)

计划个人参与者数据 (IPD)

计划共享个人参与者数据 (IPD)?

不

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.

订阅