Feasibility of a Novel Intervention to Improve Participation After Stroke
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 15
- 试验地点
- 1
- 主要终点
- Rate and Severity of Falls (Calculated With an Algorithm)
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 45 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •≥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
排除标准
- •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
研究组 & 干预措施
Education Group
Participants in the Education group receive five 90 minute tailored stroke education sessions in the home.
干预措施: Education Group (Behavioral)
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.
干预措施: Home Modifications Group (Behavioral)
结局指标
主要结局
Rate and Severity of Falls (Calculated With an Algorithm)
时间窗: 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.
次要结局
- Intervention Dose, Number of Treatment Sessions(2 months)
- Health Care Utilization, Number of Emergency Department Visits(12 months)
- Intervention Dose (Minutes)(2 months)
- Health Care Utilization, Days of Hospitalization(12 months)
研究者
Susan Stark
Assisstant Professor of Neurology and Occupational Therapy
Washington University School of Medicine