High-Impact Trials Center: Techniques Development Component

高影响力试验中心：技术开发部分

• 批准号: 9040717
• 负责人: GERALD MCGWIN
• 金额: $ 14.55万
• 依托单位: UNIVERSITY OF ALABAMA AT BIRMINGHAM
• 依托单位国家: 美国
• 资助国家: 美国
• 起止时间: 至
• 项目状态: 未结题
• 来源: https://reporter.nih.gov/project-details/9040717
• 关键词: Abbreviations; Adult; Age; Biomedical Research; Biosensor; Cellular Phone; Child; Chronic; Clinical Research; Clinical Trials; Collaborations; Collection; Communities; Core Facility; Data; Data Collection; Data Set; Development; Devices; Dietary intake; Disabled Persons; Evaluation; Exercise; Expenditure; Goals; Health; Heart Rate; Home environment; Housing; Human; Individual; Intervention; Intervention Studies; Laboratories; Marketing; Measures; Medicine; Monitor; Movement; Needs Assessment; Neuromechanics; Outcome; Pattern; Physiologic Monitoring; Physiological; Pilot Projects; Publishing; Rehabilitation Research; Rehabilitation therapy; Relative (related person); Research; Research Personnel; Resources; Services; Site; Skin Temperature; Societies; Surveys; Technology; Testing; Time; Transportation; Validation; Validity and Reliability; Work; base; body position; college; empowered; experience; industry partner; interest; mHealth; meetings; neuromuscular function; novel; respiratory; response; technique development; tool; validation studies

PROJECT SUMMARY Recent technological advances have initiated a booming new field of biosensors, wearable devices, and smartphone apps for monitoring physiological responses, movement patterns, step counts, caloric expenditure, dietary intake calorie counts, and personal health information. Usage of these tools – in many cases for goal- setting (e.g., “10,000 steps per day”) – is growing at a rapid pace among children and adults of all ages. In parallel, there is an ever-heightening interest in applying these technologies to biomedical research. A particularly attractive research application for medical rehabilitation researchers is the potential for more rigorous home-based or community-based interventional research; enabling the collection of physiological or other useful data with relative ease. Such technologies would empower researchers conducting T2-T3 research, and provide underserved persons with disabilities or chronic conditions more opportunities to participate in clinical trials or other home-based interventional studies. However, a major problem facing the medical rehabilitation field is a lack of validity and reliability testing of these devices. Therefore, the central goal of the Techniques Development Component (Tech-C) of the P2C National Resource Center for High- Impact Clinical Trials in Medical Rehabilitation is to fill a major gap in the field that will catalyze more rigorous, home-based medical rehabilitation clinical trials. We will achieve this goal by providing a HITC Validation Laboratory to the national community of medical rehabilitation researchers to evaluate the validity and reliability of novel and existing tools and technology used for remote data collection in clinical trials. Building on our own experiences, the HITC Validation Laboratory will provide the resources and expertise to assist researchers in their pursuit of useful, home-based monitoring and intervention technologies. Our central goal will be achieved via the following specific aims: Aim 1. We will conduct a nationwide needs assessment in collaboration with the CCIT and Promo-C. Aim 2. By surveying the national user base of medical rehabilitation researchers (again in collaboration with the CCIT and Promo-C), we will work with investigators to obtain currently available, de-identified datasets for analysis, and to help guide (via consultative services in collaboration with Collab-C) the development of short-term, multi-site pilot studies that would generate new datasets for validation by the HITC Validation Laboratory. Aim 3. In collaboration with industry partners, other P2C resource centers, and investigators across the national HITC user base, we will conduct in-house validation studies of the most common, commercially available wearable and biosensor devices. By achieving these aims, the HITC Validation Laboratory will meet a significant and growing need for the medical rehabilitation research community.

项目摘要 最近的技术进步启动了一个蓬勃发展的生物传感器，可穿戴设备和 用于监视身体响应，运动模式，步骤计数，热量支出的智能手机应用程序， 饮食摄入量卡路里计数和个人健康信息。使用这些工具 - 在许多情况下用于目标 - 设置（例如，“每天10,000步”） - 各个年龄段的儿童和成年人都在迅速增长。 相关地，将这些技术应用于生物医学研究一直存在着浓厚的兴趣。一个 特别有吸引力的医疗康复研究申请研究人员有可能获得更多 严格的家庭或基于社区的介入研究；能够收集生理或 其他有用的数据相对轻松。这样的技术将赋予进行T2-T3的研究人员的能力 研究，并为服务不足的残疾人或慢性病提供了更多机会 参加临床试验或其他基于家庭的介入研究。但是，面临的一个主要问题 医疗康复领域缺乏这些设备的有效性和可靠性测试。因此，中央 P2C国家高级资源中心的技术开发组件（Tech-C）的目标 在医疗康复中的影响临床试验是填补该领域的主要空白，该空白将使更严格， 家庭医疗康复临床试验。我们将通过提供HITC验证来实现这一目标 国家医疗康复研究人员的实验室，以评估有效性和 在临床试验中用于远程数据收集的新颖和现有工具和技术的可靠性。建立 我们自己的经验，HITC验证实验室将提供资源和专业知识以协助 研究人员追求有用的，基于家庭的监测和干预技术。我们的中心目标 将通过以下特定目标来实现：目标1。我们将在全国范围内进行需求评估 与CCIT和Promo-C合作。目标2。通过调查国家康复的国家用户群 研究人员（再次与CCIT和COMO-C合作），我们将与研究人员合作以获取 目前可用的，取消识别的数据集进行分析，并帮助指导（通过咨询服务 与COMPARIT-C）合作，开发短期，多站点的试点研究，该研究将产生新的 HITC验证实验室验证的数据集。目标3。与行业合作伙伴合作，其他 P2C资源中心和全国HITC用户群的调查人员，我们将在内部进行 对最常见的，可享用的可穿戴设备和生物传感器设备的验证研究。通过实现 这些目的，HITC验证实验室将满足对医疗的巨大需求 康复研究社区。