Abstract Details

Title Clinical Prospective Research during COVID-19: Strategies to Mitigate the Impact of the Pandemic

Topic Aging, Dementia, and Behavioral Neurology

Presentation(s) P4 - Poster Session 4 (8:00 AM-9:00 AM)

Poster/Presentation
Number 3-004

Objective This analysis describes strategies to overcome challenges posed by the COVID-19 pandemic in a clinical study involving Mild Cognitive Impairment (MCI) patients.

Background

COVID-19 presents safety risks and technical difficulties for research involving in-person visits.

Design/Methods A prospective study investigating digital cognitive assessments in MCI patients was conducted in an outpatient memory clinic starting January 2020. In-person assessments were completed via tablet and paper. Recruitment paused during stay-at-home mandates for nonessential employees starting March 2020 and lasted six months. To optimize paused recruitment, study activities shifted to chart screening which also maintained grant supported study personnel. After resuming recruitment, precautions were applied, mitigating infection risk: protective glass, disinfection, temperature checks, six-foot distancing, surgical masks for patients, and respirators for staff. Participants were informed of precautions prior to scheduling a visit. Patient portal direct messaging, SMS appointment reminders, and increased compensation were implemented. Effects of masks on verbal response analysis by a speech recognition algorithm were assessed during a second, three-month pause starting January 2021.

Results

4569 medical charts were screened. 332 patients were eligible of which 190 patients declined participation with three citing COVID-19 as the reason. Four participants were enrolled prior to shutdown, 22 were analyzed for masking effects, and 62 were enrolled after the second pause (n=88, 74.9±6.8 years old, 46 female). Enrollment rates before and after portal messaging alongside increased compensation were 23.6% and 31.5%, respectively. Data suggested that masks had no effect on speech analysis. No COVID-19 cases were reported among research personnel or participants.

Conclusions The applied strategies allowed proper COVID-19 risk management without negatively affecting data quality. Rearranging study tasks mitigated the effect of recruitment pauses and transparent communication with patients regarding precautions helped instill confidence in their decision to participate, allowing for successful execution of the study. This work offers guidance for investigators faced with similar challenges.

Authors/Disclosures
Ryu P. Dorn (Dent Neurologic Institute) PRESENTER	Mr. Dorn has nothing to disclose.
Erica S. Westphal (Dent Neurologic Institute)	The institution of Ms. Westphal has received personal compensation in the range of $500-$4,999 for serving as a Consultant for McKesson Coorporation. The institution of Ms. Westphal has received research support from Dent Neurologic Institute.
	No disclosure on file
	No disclosure on file
Sarah Harlock, MBA (Dent Neurologic Group, LLP)	Ms. Harlock has nothing to disclose.
Bela Ajtai, MD	Dr. Ajtai has received personal compensation in the range of $10,000-$49,999 for serving on a Speakers Bureau for Biogen.
Nandor K. Pinter (Dent Neurologic Institute)	Nandor K. Pinter has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Hyperfine Inc. The institution of Nandor K. Pinter has received research support from Dent Family Foundation.

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