teleABLE: Adapting a Behavioral Activation-Based Intervention to Reduce Post-Stroke Sedentary Behavior Using Telehealth (Formative Phase)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 11
- 试验地点
- 1
- 主要终点
- Incidence of Treatment-Emergent Adverse Events
研究概览
简要总结
Adults with stroke-related disability spend more time sedentary than adults without stroke-related disability, which places them at risk for poor cardiovascular health outcomes. Few interventions are designed to reduce post-stroke sedentary time.
The purpose of this research is to test whether the teleABLE (Activating Behavior for Lasting Engagement) Intervention is feasible and acceptable to adults within the first 12 months post-stroke. The hypothesis is that teleABLE can be feasibly delivered using videoconferencing within the first 12 months post-stroke. 10 participants will complete assessments and activity monitoring (activPAL micro3) at 0 (baseline) and 8 (post-intervention)-weeks. Participants will complete 12 sessions of the teleABLE intervention.
Findings from this study will be used to guide the intervention protocol in the planned next phase of this research.
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 diagnosis ≤12 months prior to study enrollment
- •≥6 hours of sedentary behavior on a typical weekday (assessed by Sedentary Behavior Questionnaire)
- •Ambulatory with or without assistive device (assessed by Functional Independence Measure, mobility score ≥5)
- •Able to access an electronic device (smartphone, tablet, or computer) that is compatible with a videoconferencing application
- •Able to identify a support person with whom the participant has face-to-face interaction at least one time per week
- •Able and willing to participate fully in the study and provide informed consent
排除标准
- •Currently receiving care in an inpatient rehabilitation, transitional care unit, or skilled nursing facility
- •Severe cognitive or communication impairments (inability to respond accurately to complete study telephone screening or complete informed consent)
- •Comorbid neurodegenerative disorder (e.g. Parkinson's disease, multiple sclerosis, amyotrophic lateral sclerosis, myasthenia gravis, dementia, Alzheimer's disease, Huntington's disease, glioblastoma)
- •Comorbid cancer, currently undergoing chemotherapy or radiation treatment
- •Comorbid major depressive disorder (assessed by Patient Health Questionnaire-2, score ≥2)
- •Received inpatient treatment or hospitalized for psychiatric condition and/or alcohol or substance abuse within the past 12 months
- •Diagnosis of a terminal illness and/or in hospice care
- •History of skin sensitivity that precludes the use of medical tape necessary for adherence to activity monitor measure
- •Inability to speak, read, or understand English
- •Concurrent participation in another rehabilitation intervention research study
- •Investigator discretion for safety or adherence reasons
研究组 & 干预措施
teleABLE
Participants will complete 12 teleABLE sessions via videoconferencing, guided by an intervention therapist and participant workbook.
干预措施: teleABLE (Behavioral)
结局指标
主要结局
Incidence of Treatment-Emergent Adverse Events
时间窗: week 2 through week 7
The count of treatment-related serious (e.g. injurious) and non-serious (e.g. fall without injury) adverse events that occur during intervention delivery will be reported.
Participant Satisfaction
时间窗: week 8
Assessed by the Client Satisfaction Questionnaire-8. This is an 8-item questionnaire with each item ranked on an 1 to 4 Likert-type scale. We will compute the mean score across all items. The possible range is 1 to 4, with high scores indicating high satisfaction.
次要结局
- Change in Participation Restrictions(week 0 to week 8)
- Change in Health-Related Quality of Life(week 0 to week 8)
- Change in Sedentary Minutes(week 0 to week 8)