Objective: To demonstrate the feasibility, reliability, and value of conducting web-based clinical trial assessments in individuals with Parkinson disease (PD).

Background: Increasing interest has been focused on the use of web-based clinical trial assessments (virtual research visits) given the rising cost and difficulties with recruitment and retention in clinical trials. Virtual research visits have the potential to reduce infrastructure costs, expedite recruitment, and improve participant retention through improved accessibility and convenience of trial participation.

Methods: We are conducting an add-on study of 40 individuals with PD enrolled in the phase 3, double-blind, placebo-controlled trial STEADY-PD III (Safety, Tolerability, and Efficacy Assessment of Isradipine for Parkinson Disease). Enrolled participants complete virtual research visits using a smart phone device equipped with telehealth software from AMC Health. Each participant will complete two to four virtual visits over 12 months, occurring within four weeks of their scheduled in-person research visits. All clinical trial assessments performed at the preceding in-person visit are performed remotely during the virtual research visit. Study outcomes include (1) feasibility determined by the ability to conduct remote assessments; (2) reliability of remote assessments compared to in-person assessments; (3) value of virtual visits measured by patient and provider preference of remote versus in-person visits.

Results: To date, 40 participants have been enrolled and consented. 33 participants have successfully completed their first visit and all participants are scheduled to complete at least one visit by March, 2017. 88% (28/33) of virtual research visits have been completed as scheduled, and all virtual research visits have been completed. The study will be completed in March, 2018.

Conclusions: This study assesses the feasibility and comparability of remote assessments to in-person assessments in an ongoing PD clinical trial. Preliminary results suggest the intervention is feasible. Further results will determine if virtual research visits are a reliable and valuable method of conducting clinical trials, and may serve as a model for increasing access, recruitment, and retention in PD clinical trials.

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MDS Abstracts - https://www.mdsabstracts.org/abstract/virtual-research-visits-in-individuals-with-parkinson-disease-enrolled-in-a-clinical-trial-react-pd-study-interim-analysis/