Objective: To assess the feasibility, reliability, and value of remote visits in a phase 3 trial of individuals with Parkinson’s disease (PD).

Background: Remote video-based clinical trial assessments can reduce costs and participant burden among those with neurodegenerative conditions, but rigorous studies of their use are lacking.

Method: We invited individuals enrolled in the phase 3 clinical trial STEADY-PD III (isradipine as a disease-modifying agent in PD) to enroll in a sub-study of remote video-based research visits. Participants completed 3 virtual visits over 1 year. These visits took place within 4 weeks of an in-person study visit. During the virtual visit, one of two central raters completed the same battery of motor and non-motor assessments performed at the in-person visit (by a separate investigator). We evaluated the ability to complete the remote assessments as scheduled; intra-class correlation coefficients (ICC) between remote and in-persons measures; and feedback from participants on the remote visits.

Results: We enrolled 40 participants (mean age 64.3, 29% women), and 38 (95%) completed all virtual visits. There was good to excellent correlation (ICC 0.57-0.87) between virtual and in-person non-motor assessments. There was moderate correlation (ICC 0.43-0.51) between virtual and in-person motor assessments. On average, virtual visits took less than 1/3 the time of in-person visits (44.2 vs 140.5 minutes). Participant satisfaction with virtual visits was positive, and 76% of participants indicated a higher likelihood of participating in future trials if some visits could be conducted virtually.

Conclusion: Remote video-based visits are feasible and reliable in a phase 3 clinical trial of individuals with PD. Lower correlations on motor assessments were likely due to a combination of inter-rater and inter-method (in-person vs remote) differences, with greater discordance between motor ratings among a subset of in-person raters. Satisfaction was high, and remote visits saved patients substantial travel and in-visit time. Survey results suggest the inclusion of remote visits to replace some in-person visits may improve recruitment and retention of individuals with PD in clinical trials.

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MDS Abstracts - https://www.mdsabstracts.org/abstract/remote-video-based-research-visits-in-a-phase-3-clinical-trial-in-parkinsons-disease/