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Assessment Validation

Award Information
Agency: Department of Health and Human Services
Branch: National Institutes of Health
Contract: 1R43AG082615-01A1
Agency Tracking Number: R43AG082615
Amount: $266,035.00
Phase: Phase I
Program: SBIR
Solicitation Topic Code: NIA
Solicitation Number: PAS22-196
Timeline
Solicitation Year: 2022
Award Year: 2023
Award Start Date (Proposal Award Date): 2023-09-30
Award End Date (Contract End Date): 2025-08-31
Small Business Information
2299 Via Puerta
Laguna Woods, CA 92637
United States
DUNS: 031270205
HUBZone Owned: No
Woman Owned: No
Socially and Economically Disadvantaged: No
Principal Investigator
 JAMES OHALLORAN
 (949) 246-2238
 johalloran@neurocomp.com
Business Contact
 JAMES OHALLORAN
Phone: (949) 246-2238
Email: johalloran@neurocomp.com
Research Institution
N/A
Abstract

Numerous exploratory research studies over the past decade have demonstrated good to excellent agreement of remote neurocognitive assessment (rNCA) compared to paper-based Face-to-Face (p-FTF) by both televideo and telephonic modalities. Studies in samples of elderly subjects with Alzheimer’s disease and related dementias reported similar results. Rationale for rNCA include addressing the needs of underserved populations, reducing risk of exposure to infective disorders such as COVID-19 and variants, rapid care access, and minimizing travel burden to clinical centers. Currently, televideo-based rNCA is implemented using conferencing devices and services with a “remote” examiner entering patient responses onto paper forms. Tests requiring graphical entry pose complications. Telephonically-based rNCA enables in-home assessment and longitudinal tracking and follow up but is similarly dependent on paper-based data capture and associated manual processing.
A purpose-designed Computerized Assessment by Remote Examiner System (CARES) is proposed that will enable unified, end-to-end rNCA assessment and management based on an enterprise-level, next-generation hybrid REACT NATIVE (hRN) architecture. CARES will host computerized versions of reference standard neurocognitive and behavioral tests widely applied in the clinical identification and assessment of MCI and Alzheimer’s disease and for controlled trials and wide-ranging research. Televideo-based assessments will be performed by a remote “Virtual Examiner” approach, enabling administration as if seated adjacent to a patient or research participant. At the start of a session and between tests, a Remote Examiner (R-Ex) and a participant will be able to see and converse with each other in full screen mode, establishing and maintaining rapport. At a participant-hosting site, the system will be comprised of a Windows 10-11 PC and an ultrathin 15.6” touch-sensitive secondary monitor (e.g., ViewSonic TD1655) enabling graphical stylus entry for commonly applied tests such as Clock Drawing and Trail Making. CARES has been designed to accommodate the elderly and those with cognitive impairments by closely integrating the R-Ex who will be able to 1) control the mouse and keyboard on the site’s PC, entering responses, 2) control session pace, 3) repeat and supplement digitized (human voice) instructions, and 4) immediately score responses (e.g., verbal report), and 5) pause or terminate a test. These capabilities will be enabled by integrated, application-specific Remote Desktop Control (RDC) operability and screen sharing. Application-integrated web connectivity will be implemented by a proprietary peer-to-peer WebRTC communication layer. The multiplatform CARES will support assessment across televideo, telephonic, and (computerized) in-person modalities and across operating systems (Windows, iOS, Android). In Phase I, the system will be evaluated at two established Alzheimer’s centers to estimate concurrent validity, reliability, and acceptability of CARES computerized versions vs. p-FTF versions in a set of neurocognitive tests commonly applied in the evaluation of Alzheimer’s disease and related dementias. CARES represents a fundamental advance in operationalizing rNCA.

* Information listed above is at the time of submission. *

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