中风后社区参与的转变 (COMPASS)
提高中风后参与度的新型干预措施的可行性
Stroke is one of the most serious, disabling health conditions in the United States. Patients who undergo rehabilitation treatment for stroke have a high rate of disability. Poor outcomes for many persons with stroke may be low because of incomplete treatment. The investigators will conduct a randomized controlled trial and a process evaluation to examine the feasibility, safety, and preliminary efficacy of an enhanced rehabilitation transition program, Community Participation Transition after Stroke (COMPASS), designed to bridge inpatient rehabilitation and the home to support the performance of everyday activities.
研究概览
详细说明
We propose an enhanced rehabilitation transition program: Community Participation Transition after Stroke (COMPASS) is a compensatory intervention consisting of one pre-discharge and five post-discharge home visits by an occupational therapist to supplement usual care. This intervention is focused on resolving barriers to independence in daily activities and participation using environmental support and active practice of daily activities in an individual's real home (versus an idealized clinical setting). This is a new combination of evidence-based compensatory treatments delivered in a novel treatment setting (transition to home). Our long-term goal is the development of an effective intervention for a transition home designed to prevent excess disability for people living with stroke that could have an immediate effect and high public health significance.16
We will recruit 40 patients currently undergoing inpatient rehabilitation (IR) for ischemic stroke from longitudinal studies of stroke at Washington University School of Medicine (WUSM) and randomize them to receive six additional sessions of the enhanced rehabilitation transition program or attention control. Exploratory participation outcomes will be assessed by blinded evaluators at baseline, 6 months, 9 months, and 12 months after stroke.
We will test the central hypothesis that COMPASS will be acceptable, feasible, and superior to attention control on measures of participation and daily activity performance at 6 months after stroke.
研究类型
注册 (实际的)
阶段
- 不适用
联系人和位置
学习地点
-
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Missouri
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St Louis、Missouri、美国、63110
- Washington University School of Medicine
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参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
描述
Inclusion Criteria:
- ≥45 years old
- acute ischemic stroke, verified by a neurologist
- baseline National Institutes of Health Stroke Scale (NIHSS) ≥8
- independent in activities of daily living prior to stroke (premorbid Rankin score of ≤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 a Short Blessed Test (SBT) score of ≥9 (indicating significant cognitive impairment)
- moderate to severe aphasia, as determined by the NIHSS Best Language rating of ≥2
- residence in a congregate living facility
- not eligible for a therapeutic pass
学习计划
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 |
|---|---|
|
有源比较器：Education Group
Participants in the Education group receive five 90 minute tailored stroke education sessions in the home. |
Attention will be provided to the control group to ensure they experience the same effects of time and attention but no effect on the outcome of interest. |
|
实验性的：Home Modifications Group
Participants in the treatment group receive a home assessment and home modifications tailored to functional abilities (pre discharge) and then five 90 minute occupational therapy treatment sessions at home (post discharge) to improve functional abilities and community participation. |
The standardized components include assessment, identification of five problematic activities (and environmental barriers), identification of three solutions (for each problem), implementation of a solution set selected by the participant, training, and active practice of daily activities in one's own home and community. |
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 |
|---|---|---|
|
Rate and Severity of Falls (Calculated With an Algorithm)
大体时间：12 months
|
We will explore the safety of the intervention by determining the rate and severity of falls (calculated with an algorithm). Scores are as follows: 0, those with no falls, 1, those with one fall without serious injury, 2, those with at least two falls without serious injury, and 3, those with one or more falls causing serious injury. Maximum score of three indicates an increased severity of fall. We will compare the difference in scores between groups using t-tests. |
12 months
|
次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Intervention Dose (Minutes)
大体时间：2 months
|
The does of the intervention as measured in minutes received by both groups. The number of minutes reported is the average of the total for each participant in each group. |
2 months
|
|
Health Care Utilization, Number of Emergency Department Visits
大体时间：12 months
|
We analyzed health care utilization by examining the number of emergency department visits, outpatient physical and occupational therapy visits, and doctor visits. The total number of each was calculated for each participant and the average is reported here. |
12 months
|
|
Intervention Dose, Number of Treatment Sessions
大体时间：2 months
|
The does of the intervention as measured by amount of treatment minutes received by both groups. The total number of treatment sessions was calculated for each participant and the average is reported here. |
2 months
|
|
Health Care Utilization, Days of Hospitalization
大体时间：12 months
|
We analyzed health care utilization by examining the number of days participants in each group spent in the hospital. The total number of days was calculated for participants in each group and the average is reported here. |
12 months
|
其他结果措施
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Intervention Adherence
大体时间：9 months
|
Adherence to the intervention will be measured by examine the number of recommendations implemented per recommendations suggested. Long-term adherence will be calculated as the number of recommendations used at 9 months per recommendations suggested. |
9 months
|
合作者和调查者
调查人员
- 首席研究员：Susan L Stark, PhD、Washington University School of Medicine, Program in Occupational Therapy
研究记录日期
研究主要日期
学习开始 (实际的)
初级完成 (实际的)
研究完成 (实际的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (估计的)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
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