High-Impact Trials Center: Techniques Development Component

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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.