Virtual research visits in individuals with Parkinson disease enrolled in a clinical trial: REACT-PD Study (P3.038)

Objective: To demonstrate the feasibility, reliability, and value of conducting virtual research visits in individuals with Parkinson disease (PD). Background: Increasing interest has focused on the use of 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 retention through improved accessibility and convenience of trial participation. Design/Methods: We are conducting an add-on study of 40 individuals with PD enrolled in the phase 3 clinical trial STEADY-PD III. Enrolled participants complete 3 virtual visits over 1 year using a smartphone equipped with telehealth software from AMC Health. Visits occur within four weeks of in-person trial visits. All trial assessments performed at the preceding in-person visit are performed remotely. 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. The study will also evaluate the ability of virtual visits to detect change in outcome measures over time. Results: 40 participants were enrolled, and 38 participants remain active in the study. To date, 95 televisits have been completed, with 91% completed in window. All active participants have completed at least 2 visits, and 19 (50%) have completed study participation. The last virtual visit is expected in March, 2018. Intraclass correlation coefficient (ICC) for the UPDRS part 3 was 0.37. ICCs for the Montreal Cognitive Assessment, MDS-UPDRS part IA, and part IB were 0.78, 0.61, and 0.82, respectively. ICC of the MDS-UPDRS part 3 was 0.59. Conclusions: Preliminary results indicate that virtual research visits are feasible in individuals with PD. The low ICC for motor outcomes is likely driven by poor inter-rater reliability, as a single in-person rater accounts for the greatest outlier data points. Study Supported by: AMC Health, National Institute of Neurological Disorders and Stroke (P20 NS092529) Disclosure: Dr Tarolli has nothing to disclose. Dr. Andrzejewski has received personal compensation for consulting, serving on a scientific advisory board, speaking, or other activities with US Worldmeds; Teva. Dr. Zimmerman has nothing to disclose. Dr. Bull has nothing to disclose. Dr. Goldenthal has nothing to disclose. Dr. O9Brien has received personal compensation for consulting, serving on a scientific advisory board, speaking, or other activities with AMC Health. Dr. O9Brien has received compensation for serving on the Board of Directors of AMC Health. Dr. Simuni has received personal compensation for consulting, serving on a scientific advisory board, speaking, or other activities with Acadia Abbvie Anavex Allergan Avid Civitas Accorda GE Medical Eli Lilly Cynapsus Ibsen IMPAX Merz Inc National Parkinson Foundation Navidea Sanofi Pfizer Sunovion TEVA UCB Pharma Voyager US World Meds. Dr. Simuni has received research support from Civitas, Acorda, Biogen, Roche Neuroderm. Dr. Biglan has received personal compensation for consulting, serving on a scientific advisory board, speaking, or other activities with Eli Lilly, Company. Dr. Dorsey has received personal compensation for consulting, serving on a scientific advisory board, speaking, or other activities with AbbVie and MC10. Dr. Dorsey has received research support from Great Lakes Neurotechnologies.