Validation of Video Administration of a Modified UDSv3 Cognitive Battery

Scope of Work TITLE: Validation of Video Administration of a Modified UDSv3 Cognitive Battery ANTICIPATED PROJECT DATES: 9/2021-9/2026 WAKE FOREST PIs: Bonnie Sachs and Stephen Rapp (Wake Forest Co-I’s: Suzanne Craft, Mark Espeland, and Iris Leng) PARTICIPATING SITES: Wake Forest, University of Michigan, University of Pennsylvania, Massachusetts (MGH/Harvard), Emory University, Indiana University, University of Wisconsin, University of Washington, University of Kentucky, and Oregon Health Sciences University ADRC’s (UC Davis: pending) 1. Background This inter-ADRC project seeks to validate a Video-administered COGnitive (V-Cog) assessment for potential use by ADRCs whose in-person activities have been interrupted (e.g., during the pandemic). or are otherwise not feasible This battery, which incorporates a core set of the Uniform Data Set version 3 (UDSv3) measures plus select additional or slightly modified measures, could, if demonstrated to be reliable and valid, also be used in future ADRC initiatives in which travel to an ADRC site to complete cognitive assessments is infeasible due to disability, or transportation or financial challenges. The V- Cog protocol could also be used in the future to support recruitment and retention of historically underserved populations who are less likely to regularly travel to a metropolitan medical center for assessment. This proposed project is supported by pilot work completed at the Wake Forest Alzheimer’s Disease Research Center (WF ADRC) that shows the clear feasibility and strong acceptability of remotely-delivered (telephone and video) cognitive assessments in research participants with mild cognitive impairment, Alzheimer’s dementia, and normal cognition. 2. Scope This project seeks to recruit a total of 500 existing ADRC participants, across 10 sites, with a range of cognitive functioning (normal, MCI and early dementia) to complete a single remote in addition to their regularly scheduled annual in-person cognitive assessments, completed within approximately 3 weeks of each other. These visits will be scheduled in a counterbalanced fashion (remote then in-person, in-person then remote). Remote assessments will be completed either with the use of participant’s own electronic tablet or computer (if it meets certain specifications), or with a loaned tablet device enabled with cellular access (N=5 per site) provided to sites by the study coordinating center at Wake Forest. V-Cog assessments will be completed over a secure video-platform. The same 500 participants will be tested in identical fashion approximately 24 months after the first study assessment to assess the V-Cog battery’s sensitivity to change. 3. Site Objectives Each site will contribute to the overall collection of data by recruiting individuals from their existing clinical core to complete the video-administered cognitive assessment either 3 weeks before or 3 weeks after their scheduled annual follow-up cognitive exam. All components of the annually scheduled exam (cognitive and otherwise) will be completed in usual fashion. Sites will enroll approximately 50 participants over approximately 18 months from their existing Clinical Core, including participants previously adjudicated as having normal cognition (N=14), MCI (N=25), or mild dementia, suspected Alzheimer’s type (N=12). Enrollment targets for subgroups defined by education, race/ethnicity and rural/urban location will be provided by the coordinating center in collaboration with each site. Included in the V-Cog protocol will be a brief (5 minute) survey about participant’s experience with the remote versus in-person assessment, and cognitive assessors will provide several ratings of assessment experience. These same procedures will be completed in approximately 24 months following the first study exam. 4. Tasks Each site will be responsible for obtaining local IRB approval for this additional assessment, as well as successful recruitment of participants from their Clinical Core whose cognitive status matches that of the study recruitment aim. Sites will be responsible for maintaining logs of recruited participants to ensure sampling aims are met, initiation of participant contact, consenting, and successful recruitment. They will also be responsible for execution of study cognitive procedures utilizing WF designed protocols and forms provided by WF and the National Alzheimer’s Coordinating Center (NACC). This includes: coordination of mailing/shipping devices to participants, assisting participants with set-up of remote appointments and devices, standardized administration and scoring of cognitive protocols, sanitizing of devices using cleaning supplies (provided), and data entry. Data collected as part of the remote assessment will be entered into a WF-designed and maintained electronic data capture (EDC) system, with copies of paper files scanned monthly into a secure shared cloud storage system. Data collected as part of routine ADRC assessment protocols will be maintained per usual site fashion and also uploaded to NACC per usual protocol. These data will be provided to WF by NACC monthly, matched by de-identified PID. Compensation for each additional remote exam ($50/exam – budgeted to sites) will be managed by sites. Sub-contract will fund at each participating site a study manager/project coordinator (.20 FTE annually) a psychometrist (.15 FTE annually), a recruitment coordinator (0.05 FTE annually), and PI (.05 FTE annually). Sites will participate in monthly calls with WF PI’s to discuss study challenges and solutions. 5. Deliverables Site deliverables include number of participants successfully recruited and tested per protocol for each 18-month block ((1) initial assessment and (2) follow-up assessment), data entered and uploaded for the corresponding assessment, and data provided to NACC for their routine annual assessments. Participation in initial training on the manual of procedures (MOP), routine communication with the WF site, and PI participation in monthly calls is expected.