Congratulations to Dr Nikolaus Mc Farland for his recent publication, “Enhancing Pandemic-Sensitive Recruitment Strategies for a Remote, Randomized Placebo-Controlled Trial for Fracture Prevention in Patients with Neurodegenerative Parkinsonisms (P1-1.Virtual)”. This article was published in the May issue of Neurology.
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.