Objective: To describe the design and initiation of a remote, long-term observational Parkinson’s disease (PD) study – Tele-Health Outcomes in Multiyear Extensions of Parkinson’s Disease Trials-2 (AT-HOME PD2).

Background: Remote, decentralized research studies can enable the participation of geographically dispersed individuals, using digital tools to objectively assess PD symptoms and self-report to monitor real-world function. Such an approach is particularly apt for mid-stage PD, given the increasing risk of falls, motor complications, and cognitive impairment that can limit in-person research participation.

Method: AT-HOME PD2 leverages the well-characterized AT-HOME PD cohort, comprised of now mid-stage PD clinical trial participants from two phase III clinical trials (STEADY-PD III and SURE-PD3), to 1) evaluate the extent to which digital tools and remote participant reporting improve the prediction of falls and cognitive impairment compared with traditional models, 2) quantify longitudinal change in physical activity in the real-world using digital tools, and 3) explore the relationship between physical activity and disease progression. AT-HOME PD2 participants complete up to 36 months of follow-up and undergo comprehensive clinical characterization through annual investigator-led video visits, quarterly smartphone-based motor and cognitive tasks using a PD-specific application (mPower 2.0), and monthly use of two wrist-worn accelerometers. On a quarterly basis, participants also complete online surveys through Fox Insight, which includes the PD – Patient Report of Problems (PD-PROP), a tool that captures participant report of bothersome symptoms. Study data will be transferred to the Sage Bionetworks Synapse repository and made available to researchers via the Parkinson’s Disease Biomarkers Program’s Data Management Resource.

Results: Recruitment initiated September 15, 2023 and as of March 6, 2024, 84 individuals have completed a screening visit and 40 have completed an enrollment visit. To date, 79 weeks of accelerometer wear have been completed and 36 out of 40 enrolled participants have completed at least one set of motor tasks using mPower 2.0.

Conclusion: AT-HOME PD2 has been successfully initiated. Upon completion, it will yield up to ten years of continuous data on progression from de novo to mid-stage PD and provide insights into the prediction of important clinical milestones.

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MDS Abstracts - https://www.mdsabstracts.org/abstract/initiation-of-at-home-pd2-a-remote-observational-study-of-parkinsons-disease-clinical-trial-participants/