COMPASS: A Novel Transition Program to Reduce Disability After Stroke
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 185
- 试验地点
- 1
- 主要终点
- Reintegration to Normal Living Index (RNLI)
研究概览
简要总结
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.
详细描述
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
- 50 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
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 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.
研究组 & 干预措施
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.
干预措施: COMPASS (Behavioral)
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.
干预措施: Stroke education (Behavioral)
结局指标
主要结局
Reintegration to Normal Living Index (RNLI)
时间窗: 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.
次要结局
- Stroke Impact Scale (SIS) - Activities of Daily Living (ADL) Domain(Baseline and 12 months post-stroke)
- In-Home Occupational Performance Evaluation (I-HOPE) - Activity Score(Baseline and 12 months post-stroke)
- In-Home Occupational Performance Evaluation (I-HOPE) - Performance Score(Baseline and 12 months post-stroke)
- In-Home Occupational Performance Evaluation (I-HOPE) - Satisfaction Score(Baseline and 12-months post-stroke)
- In-Home Occupational Performance Evaluation (I-HOPE) - Barrier Severity Score(Baseline and 12-months post-stroke)