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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)

针对 TBI 患者及其家人的创新家庭康复计划的随机对照试验：家庭职业治疗和环境管理 (HOME for Us)

基本信息

批准号：
10627900
负责人：
Helene Joy Moriarty
金额：
$ 61.53万
依托单位：
VILLANOVA UNIVERSITY
依托单位国家：
美国
项目类别：
财政年份：
2020
资助国家：
美国
起止时间：
2020-09-15 至 2025-06-30
项目状态：
未结题

项目摘要

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.

创伤性脑损伤被认为是平民和军人的主要公共卫生问题 (脑损伤)会产生广泛的认知、情绪、行为和身体症状。这些症状阻碍重新融入社区(参与家庭、工作、学校、有意义的活动)，并减少生活质量(QOL)。TBI对家庭照顾者也有深远的影响，他们经常与抑郁症作斗争，护理需求带来的高负担，以及许多未得到满足的需求。创伤性脑损伤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，在受伤多年后，许多人仍有慢性创伤性脑损伤症状，往往只能靠自己来应对。此外，标准的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临床为基础的，很少有家庭参与，尽管他们在康复中发挥了关键作用。建议的随机对照试验(RCT)将评估一种创新的康复方法有慢性脑外伤相关症状的人(&gt；受伤后1年)及其家人。基于这个人- 适合环境的框架，家庭(以家庭为基础的职业治疗和环境管理) 对于我们来说，是由职业治疗师在家中提供的为期4个月、8个疗程的干预，旨在提高社区重新融入、管理自我确定的TBI相关问题的能力，以及患有脑外伤的人。Home以家庭环境(物理和社会环境)为目标，以重新调整环境对个人优势和不足的要求。Home让患有脑外伤的人和家庭照顾者参与管理慢性脑外伤症状的策略。它教育家庭成员加强和保持干预战略，也满足家庭需求。我们早期对患有脑外伤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与TBI相关的问题的能力。家庭成员与对照组相比，经历了较低的抑郁症状和照顾者负担，并且该计划是双方都高度接受。这些调查结果证明有必要进一步扩大该项目的范围：包括平民对于脑外伤和退伍军人；使用注意力控制条件；在6个月后测试维护效果完成治疗，探索对新问题或新情况的概括。A两组随机将对220名社区居住的平民和患有慢性脑外伤相关的退伍军人进行对照试验症状(受伤后1年)及其家庭照顾者。脑外伤患者的结果将是社区重返社会、生活质量和管理患者识别的脑外伤相关问题的能力。家庭照顾者结果将是负担、抑郁症状和满足家庭需求。治疗效果将与控制在4个月，维护和推广效果将在10个月进行评估。这项研究解决慢性脑损伤症状患者及其家人在服务和研究方面的严重差距。