This supplement proposal is in response to PA-18-591 with NOT-AG-20-022, NIA Availability of Administrative Supplements and Revision Supplements on Coronavirus Disease 2019 (COVID-19). The parent R03 study (AG063328) is to conduct a pilot, systematic investigation to scrutinize multi-system risk factors (MRFs) for AD/ADRD outcomes among older adults aged 65 ? 89 years. The study includes cross-sectional (Aim 1, N= 150) and prospective (Aim 2, N= 50) aims.
For Aim 2, a prospective investigation of 50 older individuals with and without mild cognitive impairment will be performed at two time points about 10 - 12 months apart. COVID-19 pandemic and the statewide quarantine order have had and are having a significant impact on the ongoing project such that all in-person project-related activities had been suspended since the first week of March, and active enrollment and in-person data collection had been halted. Currently, many eligible study participants, referred by the UCSD memory clinic with available neuropsychological test data (?outcomes?), cannot undergo an in-person assessment of the MRFs (?risk factors?). Furthermore, the duration of suspended on-site testing of human subjects is currently unclear, especially when abundant caution should be taken for elderly participants with pre-existing conditions (e.g., hypertension, diabetes, etc.) that increase the morbidity and mortality risk of COVID-19. Recruitment and formal enrollment into a 10 - 12 month prospective study without definitive projected testing timeline is far from effective for high potential for drop-out and loss of interest. Thus, we request supplement funds to initiate remote data collection of MRFs as well as COVID-19-related factors that are hypothesized to affect many MRFs and the study outcomes as timely as we are able. We propose to collect guided participant-reported and participant-collected data of MRFs through online, mail and phone methods during a ?tele-study-visit?. All five MRF domain measurements will be collected remotely except for more sophisticated hemodynamics measures. A number of basic hemodynamic data will be collected by self or a household/family member using a study-provided BP and O2 monitors while instructions provided over the phone or video. The majority of psychosocial and some daily functioning variables will be measured via online when possible and/or mailed forms. This will enable timely enrollment of identified eligible participants and assessment of MRFs in their associations with (Aim 1) and predictability (Aim 2) for available cognition/ADRD data. The effects of COVID-19-related isolation stress/loneliness and PTSD symptoms on cognitive functioning and AD/ADRD risk as well as key MRFs are critical to consider as covariates, which will be also achieved through this timely supplement. The primary purpose of this supplement is to adapt to the COVID-19-related state of human subject testing procedures, and the aims of this supplement are not to change but to ensure the successful achievement of the original aims.
Given the complex disease processes of AD/ADRD, systematic investigations to scrutinize multi-system risk factors (MRFs) for AD/ADRD outcomes among older adults are needed. The ongoing parent study aims to investigate the associations and predictability of MRFs with AD/ADRD outcomes, but COVID-19 pandemic and the statewide quarantine order resulted in suspension of the in-person data collection. The primary purpose of this supplement is to adapt to the COVID-19-related state of human subject testing procedures by implementing remote data collection, using diverse methods including online or mailed survey and guided self- measurements during a ?tele-study-visit?.
