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)

• 批准号: 10418791
• 负责人: Helene Joy Moriarty
• 金额: $ 61.78万
• 依托单位: VILLANOVA UNIVERSITY
• 依托单位国家: 美国
• 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
• 来源: https://reporter.nih.gov/project-details/10418791
• 关键词: Acute; Address; Aftercare; Age; Behavioral Symptoms; Caregiver Burden; Caregivers; Caring; Chronic; Chronic Phase; Clinic; Cognitive; Communities; Eligibility Determination; Emotional; Enrollment; Environment; Epidemic; Family; Family Caregiver; Family member; Funding; Goals; Guidelines; Heterogeneity; Home; Home environment; Individual; Injury; Intervention; Interview; Knowledge; Left; Maintenance; Medical; Memory Loss; Mental Depression; Methodology; Military Personnel; Neurobehavioral Manifestations; Occupational Therapist; Occupational Therapy; Outcome; Patients; Persons; Phase; Physical environment; Physiological; Protocols documentation; Public Health; Quality of life; Randomized Controlled Trials; Recovery; Rehabilitation therapy; Research; Role; Sample Size; Sampling; Schools; Self Management; Services; Severities; Social Environment; Standardization; Subgroup; Symptoms; Testing; Time; Traumatic Brain Injury; Underserved Population; United States National Institutes of Health; Veterans; Work; acceptability and feasibility; attentional control; base; care giving burden; community reintegration; daily functioning; depressive symptoms; design; disability; emotional symptom; experience; family management; improved; indexing; innovation; intervention effect; physical symptom; primary outcome; programs; rehabilitation strategy; restoration; sex; social; symptom management; treatment effect; trial design

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面临的主要公共健康问题