A randomized controlled trial of an innovative in-home rehabilitation program for persons with TBI and their families: Home-based Occupational-therapy and Management of the Environment (HOME for Us)

创伤性脑损伤被认为是平民和军人的一个主要公共卫生问题， (TBI)产生广泛的认知、情绪、行为和身体症状。这些症状 阻碍重返社区（参与家庭、工作、学校、有意义的活动）， 生活质量（QoL）。TBI也对家庭照顾者产生了深远的影响，他们经常与抑郁症作斗争， 需求激增造成的沉重负担以及许多未得到满足的需求。TBI护理的标准方法 通常为近期受伤（受伤后1年内）提供急性后康复。然而，受伤多年后， 许多人仍然经历慢性TBI症状，并且经常被留给他们自己处理这些症状。 此外，标准康复主要侧重于医疗恢复，以减少赤字，而不是 症状管理是以诊所为基础的，很少让家庭参与，尽管他们在康复中发挥着关键作用。 拟议的随机对照试验（RCT）将评估一种创新的康复方法， 有慢性创伤性脑损伤相关症状的人（伤后> 1年）及其家人。基于这个人- 环境适应框架，家庭（以家庭为基础的职业治疗和环境管理） 为我们是一个4个月，8个会议的干预提供的职业治疗师在家里，旨在 改善社区重新融合、管理自我确定的创伤性脑损伤相关问题的能力以及 TBI患者。HOME针对家庭环境（物理和社会）重新调整环境 对个人优势和缺陷的要求。HOME让TBI患者和家庭护理人员参与， 管理慢性TBI症状的策略。它教育家庭成员加强和保持干预 战略，并解决家庭的需要。 我们早期对患有TBI的退伍军人的研究证明了这种方法在改善 重新融入社区和管理自我确定的TBI相关问题的能力。家庭成员 经历了较低的抑郁症状和照顾者的负担，与对照组相比，该计划是 双方都高度接受。这些调查结果证明有必要继续扩大该项目，办法是： TBI以及退伍军人;使用注意力控制条件;测试6个月后的维持效果 治疗完成和探索推广到新的问题或情况。2组随机化 将对220名社区居民和退伍军人进行对照试验， 症状（受伤后> 1年）及其家人照顾者。TBI患者的结局将是社区 再融合、生活质量和管理患者识别的TBI相关问题的能力。Family caregiver 结果将是负担，抑郁症状，并满足家庭需求。治疗效果将与 在4个月时进行对照，并在10个月时评价维持和泛化效果。研究 解决了慢性创伤性脑损伤症状患者及其家人在服务和研究方面的关键差距。

Recognized as a major public health problem for civilian and military populations, traumatic brain injury (TBI) produces a broad range of cognitive, emotional, behavioral, and physical symptoms. These symptoms impede community reintegration (participation in family, work, school, meaningful activities) and decrease quality of life (QoL). TBI also has a profound impact on family caregivers, who often struggle with depression, high levels of burden from caregiving demands, and many unmet needs. Standard approaches to TBI care typically provide post-acute rehabilitation for recent injuries (within 1 year post injury). Yet, years after injury, many persons still experience chronic TBI symptoms and are often left to manage these on their own. Furthermore, standard rehabilitation focuses primarily on medical restoration to reduce deficits rather than on symptom management, is clinic based, and rarely engages families, despite their critical role in rehabilitation. The proposed randomized controlled trial (RCT) will evaluate an innovative rehabilitation approach for persons with chronic TBI-related symptoms (> 1 year post injury) and their families. Based on the person- environment fit framework, HOME (Home-based Occupational-therapy and Management of the Environment) for Us is a 4-month, 8-session intervention delivered by occupational therapists in the home, designed to improve community reintegration, ability to manage self-identified TBI-related problems, and quality of life in persons with TBI. HOME targets the home environment (physical and social) to realign environmental demands to individual strengths and deficits. HOME engages persons with TBI and family caregivers in strategies to manage chronic TBI symptoms. It educates family members to reinforce and maintain intervention strategies, and also addresses family needs. Our earlier research with veterans with TBI demonstrated the efficacy of this approach in improving community reintegration and ability to manage self-identified TBI-related problems. Family members experienced lower depressive symptoms and caregiver burden, compared to controls, and the program was highly acceptable to both. These findings warrant moving forward to extend the project by: including civilians with TBI as well as veterans; using an attention-control condition; testing maintenance effects at 6 months after treatment completion and exploring generalization to new problems or situations. A 2-group randomized controlled trial will be conducted with 220 community-dwelling civilians and veterans with chronic TBI-related symptoms (> 1 year post injury) and their family caregivers. Outcomes for persons with TBI will be community reintegration, quality of life, and ability to manage patient-identified TBI-related problems. Family caregiver outcomes will be burden, depressive symptoms, and met family needs. Treatment effects will be compared to controls at 4 months, and maintenance and generalization effects will be evaluated at 10 months. The study addresses a critical gap in services and research for persons with chronic TBI symptoms and their families.