duoABLE for People With Stroke and Their Caregivers (Feasibility)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 16
- 试验地点
- 1
- 主要终点
- Participant satisfaction
研究概览
简要总结
The goal of this intervention study is to test whether a behavioral program that involves people with stroke and their caregivers is acceptable, safe, and can promote physically active lifestyles using enjoyable activities. Participant duos (person with stroke and their caregiver) will be asked to complete assessments at 2 timepoints, wear an activity tracker, participate in 12 sessions with an occupational therapist, and complete an interview.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •(Stroke Participants):
- •Stroke diagnosed more than 6 months ago
- •Are 18 years of age or older
- •Report ≥6 hours of sedentary behavior on a typical day OR report engagement in ≤90 minutes of moderate-to-vigorous physical activity in the past week
- •Reside in a community-based setting
- •Are mobile within their home, with or without an assistive device and without physical assistance
- •Are able to identify an eligible caregiver who will engage in assessments and intervention.
- •Inclusion Criteria (Caregiver Participants):
- •Are 18 years of age or older
- •Report ≥6 hours of sedentary behavior on a typical day OR report engagement in ≤90 minutes of moderate-to-vigorous physical activity in the past week
- •Reside in a community-based setting
- •Are mobile within their home, with or without an assistive device and without physical assistance
排除标准
- •(Stroke Participants):
- •Severe aphasia
- •Are currently receiving chemotherapy or radiation treatments for cancer
- •Have a medical diagnosis of neurodegenerative disorder (i.e., dementia, Parkinson's disease, multiple sclerosis, amyotrophic lateral sclerosis, glioblastoma)
- •Received inpatient treatment for substance use disorder or psychiatric condition within the past 12 months
- •Have a history of skin sensitivity related to adhesives
- •Are pregnant or expecting to become pregnant in the next 2 months
- •Reside in an institutional setting
- •Are currently incarcerated
- •Exclusion Criteria (Caregiver Participants):
- •Have a history of skin sensitivity related to adhesives
- •Are currently receiving chemotherapy or radiation treatments for cancer
- •Have a medical diagnosis of neurodegenerative disorder (i.e., dementia, Parkinson's disease, multiple sclerosis, amyotrophic lateral sclerosis, glioblastoma)
- •Received inpatient treatment for substance use disorder or psychiatric condition within the past 12 months
- •Are pregnant or expecting to become pregnant in the next 2 months
- •Reside in an institutional setting
- •Are currently incarcerated
研究组 & 干预措施
duoABLE
Stroke participant-caregiver duos (dyads) will meet with an occupational therapist 12 times (2x/week for 6 weeks, approximately 30 minutes/session) to apply activity monitoring, activity scheduling, collaborative problem solving, self-assessment, and social interdependence to self-selected activities that aim to increase both dyad members' physical activity levels
干预措施: duoABLE (Behavioral)
结局指标
主要结局
Participant satisfaction
时间窗: Score at week 8
Measured using the Client Satisfaction Questionnaire-8 (CSQ-8)
次要结局
- Change in sedentary minutes per day(Baseline to 8 weeks)
- Change in daily step count(Baseline to 8 weeks)
- Adverse event count(Count of adverse events at week 8)
- Change in activity restrictions(Baseline to 8 weeks)
- Change in Health-related quality of life(Baseline to 8 weeks)