The REACH Intervention for Caregivers of Veterans and Service Members With TBI: Efficacy and Implementation Planning Across the VA Polytrauma System of Care
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 160
- 试验地点
- 2
- 主要终点
- TBI-CareQOL Caregiver Strain - Short Form 6a
研究概览
简要总结
This randomized waitlist control trial will evaluate the effects of a psychoeducational intervention called Resources for Enhancing All Caregivers' Health - Traumatic Brain Injury (REACH TBI) to decrease caregiver strain (primary outcome) and improve caregiver self-efficacy, anxiety, depression, and health care frustrations (secondary outcomes). This study will modify and adapt an award-winning caregiver intervention, Resources for Enhancing All Caregivers Health in the Department of Veterans Affairs (REACH VA), to support the needs of Caregivers of Veterans and Service Members with TBI.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
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
- •To be eligible for the study, the participant must:
- •identify as a primary caregiver for a V/SM who sustained a TBI at least 6 months prior;
- •identify as a primary caregiver who has provided care for a V/SM with TBI for at least 6 months;
- •provide some level of daily supervision or assistance with either a physical, cognitive, or behavioral issue they think is likely related to TBI;
- •believe that at least half of their caregiving responsibilities are likely related to TBI rather than another health condition(s); and
- •endorse a score of at least high burden (a score of 8 or higher) on the Zarit Burden Inventory-4.
排除标准
- •no telephone;
- •current diagnosis of schizophrenia or other major mental illness;
- •auditory impairment that would make telephone use difficult; or
- •the caregiver believes that more than half of their caregiving for the V/SM is for issues related to another health condition(s) rather than TBI.
结局指标
主要结局
TBI-CareQOL Caregiver Strain - Short Form 6a
时间窗: Baseline; 3 months (post-intervention); 6 month follow-up
It assesses caregiver strain in caregivers of individuals with TBI. Values range from 6-30, with higher scores indicating greater strain/worse outcome.
次要结局
- Patient-Reported Outcomes Measurement Information System Emotional Distress - Depression - Short Form 4a(Baseline; 3 months (post-intervention); 6 month follow-up)
- Patient-Reported Outcomes Measurement Information System Emotional Distress - Anxiety - Short Form 4a(Baseline; 3 months (post-intervention); 6 month follow-up)
- TBI-CareQOL Health Care Frustration - Self - Short Form 6a(Baseline; 3 months (post-intervention); 6 month follow-up)
- Patient-Reported Outcomes Measurement Information System - General Self-Efficacy(Baseline; 3 months (post-intervention); 6 month follow-up)
研究者
Paul B. Perrin
Professor of Data Science and Psychology
University of Virginia