Improving Outcomes for Care Partners of Persons With Traumatic Brain Injury
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 257
- 试验地点
- 4
- 主要终点
- Change From Baseline in Self-reported Caregiver Strain as Measured by Traumatic Brain Injury Caregiver Quality of Life (TBI-CareQOL) Caregiver Strain
研究概览
简要总结
Care partners of persons with traumatic brain injury (TBI) are often faced with considerable physical and emotional stress resulting from their caregiver role. The researchers hypothesize that the care partners who receive the intervention will show improvements in caregiver strain and mental health.
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
- 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
- 是
入选标准
- •Be caring for an adult (age 18 or above) with a medically documented TBI that is ≥1-year post-injury and meets the TBI Model Systems (TBIMS) criteria for complicated mild, moderate or severe TBI and who sustained their TBI at age 16 or older
- •Provide emotional, physical, and/or financial support/assistance to the individual with the TBI, indicating a response ≥1 to the following question: "On a scale of 0-10, where 0 is "no assistance" and 10 is "assistance with all activities", how much assistance does the person you care for require from you to complete activities of daily living due to problems resulting from his/her TBI? Activities could consist of personal hygiene, dressing and undressing, housework, taking medications, managing money, running errands, shopping for groceries or clothing, transportation, meal preparation and cleanup, remembering things, etc."
- •Have access to necessary resources for participating in a technology-based intervention (smartphone/tablet and internet access) and be willing to use their personal equipment/internet for this study, including downloading the study app and the Fitbit® app on their mobile device
- •Is able and willing to complete all study assessments for the duration of their study participation (approximately 375 days)
排除标准
- •Is a professional, paid caregiver (e.g., home health aide)
- •Anything that would preclude safe or meaningful participation in the study
结局指标
主要结局
Change From Baseline in Self-reported Caregiver Strain as Measured by Traumatic Brain Injury Caregiver Quality of Life (TBI-CareQOL) Caregiver Strain
时间窗: Baseline, Day 180 of intervention
TBI-CareQOL Caregiver Strain assesses perceived feelings of feeling overwhelmed, stressed and "beat-down" related to the care partner role. Self-reported responses are on a Likert scale. The measure is scored on a T metric with a mean of 50 and a standard deviation of 10. Higher scores indicate more strain.
次要结局
- Change From Baseline in Self-reported Anxiety Score as Measured by Patient-Reported Outcomes Measurement Information System (PROMIS) Anxiety(Baseline, Day 180 of intervention)
- Change From Baseline in Self-reported Depression Score as Measured by Patient-Reported Outcomes Measurement Information System (PROMIS) Depression(Baseline, Day 180 of intervention)
研究者
Noelle E Carlozzi
Associate Professor of Physical Medicine and Rehabilitation
University of Michigan