ABSTRACT
Objective: To describe changes in daily activity measured by wearable sensors in participants with Parkinson's disease (PD) following the COVID-19 pandemic. Background: Digital tools provide objective, frequent and sensitive data collection in real-world settings. In a natural history study of PD, participants used wearable sensors before and after COVID-19 shutdowns. Design/Methods: At research visits throughout this two-year study at the University of Rochester Medical Center, participants wore sensors with accelerometer and gyroscopic capabilities and completed questionnaires. Following each visit, participants wore sensors remotely for 7 days during waking hours. Participant position and activity from days 1-6 of wear was classified from sensor data. Results: Prior to March 14 2020, when COVID-19 shutdowns began in Monroe County, NY, 17 participants with PD (70.4 (6.3) years) and 13 controls (61.1 (13.5) years) completed a baseline visit. All 30 later completed a month 12 visit after COVID-19 shutdowns. Sensor wear was comparable at baseline (13.9 (1.4) hours/day) and month 12 (13.74 (2.1) hours/day). At month 12, PD participants walked an average of 1709 (1457) steps/day, approximately 17% less than at baseline (2048 (1416) steps/day), with considerable individual variation. PD participants spent approximately 20% more time lying while awake at month 12 (112.7 (149.9) min) than at baseline (93.6 (103.1) min). Daytime sleep did not increase from baseline (39.6 (39.3) min) to month 12 (39.2 (32.8) min). PD and control participants reported greater anxiety and depression at month 12. From baseline to month 12, controls had similar activity trends as participants with PD, but walked more, spent less time lying, had less daytime sleep, and reported less depression and anxiety at both time points. Conclusions: Following the emergence of COVID-19, participants with PD walked less and spent more time resting. These data provide an objective measure of the pandemic's impact on a small cohort of individuals with PD.
ABSTRACT
Objective: To develop a diversified recruitment model for the ongoing Trial of Parkinson's and Zoledronic Acid (TOPAZ) during the COVID-19 pandemic. Background: TOPAZ is a home-based trial examining the efficacy of zoledronate in preventing fractures in people with neurodegenerative parkinsonisms, who have up to 4-fold increased fracture risk. Design/Methods: Consent is obtained online (https://www.topazstudy.org). After eligibility is determined by movement disorders specialists using medical records and/or telemedicine, study drug is infused by research nurses at home. Fractures are ascertained by email or telephone. The 2/2020 onset of recruitment coincided with COVID-19 restrictions, with a nearly 7 months pause. To randomize 3,500 participants by 12/2023, we developed multiple methods to recruit potential participants via: 1) 46 Parkinson Study Group (PSG) sites, 2) 11 health care systems with integrated research networks, 3) community outreach organizations (i.e. support groups, social media, newsletters, etc.), 4) outreach by the Parkinson's Foundation (PF), 5) Fox Trial Finder (FTF), and 6) the 23andMe Parkinson's disease research program. Results: By 10/1/2021, 2002 had registered on the website, 1333 consented, 992 were eligible per expert diagnostic confirmation, and 632 were randomized, exceeding our goal of 600 for 9/30/21. Registered participants came from the multiple sources: 1) 609 (27.7%) from PSG sites, 2) 529 (24%) from health care systems with integrated research networks, 3) 213 (9.7%) from community outreach, 4) 34 (1.5%) from PF, 5) 16 (0.7%) from FTF and 6) 601 (27.3%) from 23andMe. The largest source of recruitment was PSG. A single study invitation emailed from 23andMe to its 19,733 PD research participants led to nearly the same number of referrals as PSG but in only a few weeks'time. Conclusions: Using diverse referral sources to the TOPAZ study website, we are succeeding in achieving enrollment targets for a Parkinson's trial amidst the challenges of the COVID-19 pandemic.