Compass 3: A Novel Transition Program to Reduce Disability After a Stroke
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 520
- 试验地点
- 3
- 主要终点
- Admission to SNF (skilled nursing facility)
研究概览
简要总结
This study evaluates a program designed to help individuals transition from inpatient rehabilitation to home 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.
Investigators will conduct a randomized, controlled multi-center trial (RCT) and concurrent implementation evaluation and review of process data to examine therapeutic efficacy, cost-effectiveness and implementation potential of a compensatory intervention (COMPASS) designed to improve daily activity performance and participation outcomes in persons transitioning home from inpatient rehabilitation (IR) following a 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
- 55 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Aged ≥55 years at the time of screening
- •Acute stroke diagnosis (IS or ICH) verified by the stroke team or medical record
- •Independent in activities of daily living (ADLs) prior to stroke (premorbid Modified Rankin Scale score ≤2)
- •Plan to discharge to home from an IR
- •Capable of giving informed consent which includes compliance with the requirements and duration of participation as listed in the Informed Consent Form (ICF).
排除标准
- •Life expectancy <6 months
- •Cognitive impairment that the participant's stroke team or a research team member believes impairs their ability to provide informed consent or make reasoned choice including the interpretation of the self-rated scales
- •Any communication problem that would prevent study completion
- •Residence in a congregate living facility
- •Not eligible for a therapeutic pass
- •Residence outside of the designated catchment area (specific catchment distance to be determined by each site)
- •Site investigator's judgment that the participant would not be able to complete research procedures or interventions
- •Participation in another research study that in the site investigator's judgment could interfere or conflict with this research study's assessments or interventions
研究组 & 干预措施
COMPASS intervention
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.
干预措施: COMPASS (Behavioral)
Education Program
A research team member will deliver the program in accordance with "Evidence-Based Educational Guidelines for Stroke Survivors after Discharge Home." Topics may include stroke symptoms, risk factors and preventing stroke recurrence.
干预措施: Education Program (Behavioral)
结局指标
主要结局
Admission to SNF (skilled nursing facility)
时间窗: From enrollment to 12 months post-discharge from inpatient rehabilitation facility
Date and days of admission to a skilled nursing facility
次要结局
未报告次要终点