Efficacy of the Improving Participation After Stroke Self-Management-Rehabilitation (IPASS-R) Program in Sub-acute Stroke
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 100
- 试验地点
- 2
- 主要终点
- Canadian Occupational Performance Measure (COPM) Performance
研究概览
简要总结
The overall goal of this proposed study is to evaluate the efficacy of a small-group, stroke-specific, self-management program delivered via telehealth to improve self-efficacy, activity performance, and quality of life in individuals with sub-acute 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)
盲法说明
All outcomes assessors will be blinded to participant study group assignment.
入排标准
- 年龄范围
- 45 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •less than 6 months post-stroke
- •age 45-85 years
- •completed inpatient rehabilitation services (if recommended)
- •living in the community with or without caregiver support (i.e., not living in a skilled nursing facility)
- •ability to read, write, and speak English
- •diagnosis of mild or moderate stroke (National Institutes of Health stroke score <16)
- •able to use videoconferencing independently or with caregiver support
排除标准
- •severe depressive symptoms as indicated by a score ≥21 on the Patient Health Questionnaire
- •dementia symptoms as indicated by a score of <23 on the Montreal Cognitive Assessment
- •additional neurological diagnoses (e.g., brain malignancy, previous severe stroke)
- •(4) moderate or severe aphasia as indicated by a National Institutes of Health Stroke Scale aphasia score of ≥ 2
- •inability to provide informed consent
- •any other condition not otherwise specified that the PI determines would render participation in this study as unsafe for the participant
研究组 & 干预措施
Improving Participation after Stroke Self-Management Program (IPASS)
The IPASS-R intervention consists of 6 weekly 90-minute sessions delivered by an occupational therapist and stroke survivor peer facilitator. All sessions will be delivered remotely via videoconferencing.
干预措施: Improving Participation after Stroke Self-Management Program (IPASS) (Behavioral)
Chronic Disease Self-Management Program (CDSMP)
The CDSMP will consist of 6, weekly 90-minute sessions. All sessions will be delivered remotely via videoconferencing.
干预措施: Chronic Disease Self-Management Program (CDSMP) (Behavioral)
结局指标
主要结局
Canadian Occupational Performance Measure (COPM) Performance
时间窗: Pre-intervention (week 0), post-intervention (week 6), and 6-month follow-up (week 32)
Self-report measure of activity performance. Minimum = 1, Maximum = 10. Higher scores mean better performance.
Canadian Occupational Performance Measure (COPM) Satisfaction
时间窗: Pre-intervention (week 0), post-intervention (week 6), and 6-month follow-up (week 32)
Self-report measure of activity performance. Minimum = 1, Maximum = 10. Higher scores mean higher satisfaction.
Participation Strategies Self-Efficacy Scale (PS-SES)
时间窗: Pre-intervention (week 0), post-intervention (week 6), and 6-month follow-up (week 32)
Self-report measure of self-efficacy in using participation strategies. The subject rates confidence across 35 items within six subscales: (1) managing home participation, (2) staying organized, (3) planning and managing community participation, (4) managing work and productivity), (5) managing communication, and (6) advocating for resources. Range of scores from 35-350. Higher scores indicate greater self-efficacy.
次要结局
- In home activity level as measured by sensor system(Duration of study (from baseline assessment (week 0) to 6-month follow-up assessment))
- Community engagement as measured by sensor system(Duration of study (from baseline assessment (week 0) to 6-month follow-up assessment))
- Stroke Impact Scale participation domain(Pre-intervention (week 0), post-intervention (week 6), and 6-month follow-up (week 32))
- Assessment of Life Habits (LIFE-H)(Pre-intervention (week 0), post-intervention (week 6), and 6-month follow-up (week 32))
研究者
Anna Boone
Assistant Professor of Occupational Therapy
University of Missouri-Columbia