Improving Outcomes for Care Partners of Persons with Traumatic Brain Injury

摘要 中度至重度创伤性脑损伤（TBI）患者的护理伙伴通常需要承担 照顾者角色，承担主要责任，在身体，精神，经济和心理方面帮助TBI患者， 休闲活动。由于这些新的责任，这些护理伙伴通常会 报告身体、心理和社会健康问题，以及与健康相关的生活质量受损 （HRQOL）。考虑到护理伙伴的福祉和功能既影响他们自己的个人健康， 结果，以及TBI患者的功能和康复结果，迫切需要 制定新的健康管理干预措施，以确保两个成员更好的健康结果， 创伤性脑损伤护理合伙人。因此，我们的长期目标是改善这些护理人员的健康和福祉 他们的伴侣，以及他们为所爱的人提供照顾的能力。因此，拟议的随机对照试验 将检查及时适应性干预（JITAI）或个性化自我管理的有效性 使用客观的移动的传感器数据反馈的干预，以改善体力活动、睡眠和HRQOL， 240名TBI患者的护理伙伴。我们的主要目的是：1）评估这种新的疗效 个性化自我管理干预（即，JITAI）用于预防不良症状的发展 (e.g.,移动性、睡眠、差的HRQOL）;以及2）使用从可穿戴设备收集的数据（即，Fitbit Charge®）和 HRQOL的实时评估，以确定负性身体和 精神HRQOL结果，以及他们处于最大风险时的时间。我们期待合作伙伴 随机接受JITAI的患者将证明HRQOL、体力活动和睡眠改善 相对于对照。我们还假设，客观的，数据来源的移动的表型可以预测 不良照顾者HRQOL。拟议研究的科学前提是基于我们的多学科 具有护理人员研究专业知识的团队，使用患者报告的结果评估HRQOL，临床试验 实施，在HRQOL的真实的时间评估的专业知识，以及在高， 维度统计和机器学习。此外，创新的基础是审查一个 实时、真实、个性化和可扩展的JITAI，旨在改善护理伙伴的HRQOL。 最终，这项研究将使我们能够识别出最有可能出现负面身心健康的护理伙伴。 健康结果，并将提供重要的疗效数据，以支持低成本，低负担的临床效用 自我管理干预，以改善TBI患者的护理伙伴的HRQOL。

Abstract Care partners of persons with moderate to severe traumatic brain injury (TBI) are often required to assume a caregiver role, bearing primary responsibility for assisting the person with TBI in physical, mental, financial, and leisure activities. As a result of these new caregiving responsibilities, it is common for these care partners to report problems with physical, mental, and social health, as well as compromised health-related quality of life (HRQOL). Given that care partners’ well-being and functioning affects both their own personal health outcomes, as well as the functional and rehabilitation outcomes of the person with TBI, there is a critical need to develop novel health management interventions to ensure better health outcomes for both members of the TBI care partnership dyad. Therefore, our long-term goal is to improve the health and well-being of these care partners, as well as their ability to provide care to their loved one. Thus, the proposed randomized control trial will examine the efficacy of a just-in-time adaptive intervention (JITAI), or personalized self-management intervention that uses objective mobile sensor data feedback to improve physical activity, sleep, and HRQOL in 240 care partners of persons with TBI. Our primary objectives are to: 1) assess the efficacy of this novel personalized self-management intervention (i.e., JITAI) for preventing the development of adverse symptoms (e.g., mobility, sleep, poor HRQOL); and 2) use data collected from wearables (i.e., the Fitbit Charge®) and real-time assessments of HRQOL to identify care partners with the greatest risk for negative physical and mental HRQOL outcomes, as well as the timing for when they are at greatest risk. We expect care partners that are randomized to receive the JITAI will demonstrate improvements in HRQOL, physical activity and sleep relative to controls. We also hypothesize is that objective, data-derived mobile phenotypes can predict risk for adverse caregiver HRQOL. The scientific premise for the proposed research is based on our multidisciplinary team with expertise in caregiver research, evaluation of HRQOL using patient-reported outcomes, clinical trials implementation, expertise in real time assessment of HRQOL, as well as the statistical expertise in high- dimensional statistics and machine learning. Furthermore, the innovation is grounded in the examination of a real-time, real-world, personalized and scalable JITAI designed to improve HRQOL in care partners. Ultimately, this study will allow us to identify care partners at the greatest risk for negative physical and mental health outcomes, and will provide important efficacy data to support the clinical utility of a low cost, low burden self-management intervention to improve HRQOL for care partners of persons with TBI.