An innovative protocol for the artificial speech-directed, contactless administration of laboratory-based comprehensive cognitive assessments: PAAD-2 trial management during the COVID-19 pandemic

The COVID-19 pandemic resulted in suspending in-person human subject research across most institutions in the US. Our extensive cognitive assessment for a phase-2 clinical trial, Physical Activity and Alzheimer's Disease–2 (PAAD-2), was also paused in March 2020. It was important to identify strategies to mitigate the risk of COVID-19 transmission during our testing, which initially required substantial human speech and close person-to-person contact for test directions and instant feedback on paper/pencil tests. Given current understanding of the COVID-19 transmission, we dramatically adjusted the testing protocol to minimize the production of speech droplets and allow social distancing while maintaining the integrity of testing. We adopted state-of-the-art speech synthesis and computerization techniques to create an avatar to speak on behalf of the experimenter for all verbal instructions/feedback, used a document camera to observe the paper/pencil tests from the required distances, and automated the testing sequence and timing. This paper aims 1) to describe an innovative laboratory-based cognitive testing protocol for a completely contact-free, computer-speaking, and semi-automated administration; and 2) to evaluate the integrity of the modified protocol (n = 37) compared with the original protocol (n = 32). We have successfully operated the modified protocol since July 2020 with no evidence of COVID-19 transmission during testing, and data support that the modified protocol is robust and captures data identical to the original protocol. This transition of data collection methods has been critical during the pandemic and will be useful in future studies to mitigate the risk of contagious disease transmission and standardize laboratory-based psychological tests. Trial registration: ClinicalTrials.gov NCT03876314. Registered March 15, 2019