High-Impact Trials Center: Techniques Development Component

高影响力试验中心：技术开发部分

• 批准号: 9312146
• 负责人: Robert Wayne Motl
• 金额: $ 19.15万
• 依托单位: UNIVERSITY OF ALABAMA AT BIRMINGHAM
• 依托单位国家: 美国
• 财政年份: 2017
• 资助国家: 美国
• 起止时间: 2017-07-01 至 2020-06-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/9312146
• 关键词: Abbreviations; Adult Acute Lymphocytic Leukemia; Age; Biomedical Research; Biosensor; Calories; Cellular Phone; Child; Chronic; Clinical Research; Clinical Trials; Collaborations; Collection; Communities; Consultations; Core Facility; Data; Data Collection; Data Set; Development; Devices; Dietary intake; Disabled Persons; Evaluation; Exercise; Expenditure; Goals; Health; Heart Rate; Home environment; Human; Individual; Industrialization; Intervention; Intervention Studies; Laboratories; Measures; Medicine; Monitor; Movement; Needs Assessment; Neuromechanics; Outcome; Pattern; Physiologic Monitoring; Physiological; Pilot Projects; Professional Organizations; Publishing; Rehabilitation Research; Rehabilitation therapy; Research; Research Personnel; Resources; Services; Site; Skin Temperature; Surveys; Technology; Testing; Text; Time; Transportation; Validation; Validity and Reliability; Work; base; body position; college; exercise rehabilitation; experience; industry partner; interest; mHealth; 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.

项目概要 最近的技术进步催生了生物传感器、可穿戴设备和生物传感器等新兴领域的蓬勃发展。 用于监测生理反应、运动模式、步数、热量消耗的智能手机应用程序， 饮食摄入热量计数和个人健康信息——在许多情况下是为了目标—— 设定（例如“每天 10,000 步”）——在各个年龄段的儿童和成人中正在快速增长。 与此同时，人们对将这些技术应用于生物医学研究的兴趣日益浓厚。 对于医疗康复研究人员来说特别有吸引力的研究应用是更多的潜力 严格的以家庭或社区为基础的介入研究； 相对而言，其他有用的数据将有助于研究人员进行 T2-T3。 研究，并为服务不足的残疾人或慢性病患者提供更多机会 然而，参与临床试验或其他以家庭为基础的介入研究面临的一个主要问题。 因此，医疗康复领域缺乏对这些设备的有效性和可靠性测试。 P2C 国家高技术资源中心技术开发组件 (Tech-C) 的目标 医疗康复领域的影响临床试验将填补该领域的一项重大空白，这将促进更严格、 我们将通过提供 HITC 验证来实现这一目标。 实验室向全国医疗康复界研究人员评估其有效性和 用于临床试验中远程数据收集的新颖和现有工具和技术的可靠性。 根据我们自己的经验，HITC 验证实验室将提供资源和专业知识来协助 研究人员追求有用的、基于家庭的监测和干预技术。 将通过以下具体目标来实现： 目标 1. 我们将在全国范围内开展需求评估 与 CCIT 和 Promo-C 合作 目标 2. 通过调查全国医疗康复用户群。 研究人员（再次与 CCIT 和 Promo-C 合作），我们将与研究人员合作以获得 目前可用的、去识别化的数据集用于分析，并帮助指导（通过咨询服务） 与 Collab-C 合作）开展短期、多地点试点研究，以产生新的 目标 3. 与行业合作伙伴合作，其他。 P2C 资源中心以及全国 HITC 用户群的调查员，我们将在内部进行 对最常见的市售可穿戴设备和生物传感器设备进行验证研究。 这些目标，HITC 验证实验室将满足医疗领域日益增长的重大需求。 康复研究团体。