Objective: To collect evidence to support the use of a digital solution to improve health outcomes in PD through remote, timely and appropriate drug adjustments, higher levels of compliance, patient engagement and satisfaction. 1. To assess the effectiveness of the digital solution for moderate to advanced Parkinson’s disease management. 2. To study the impact of the solution to health outcomes and on healthcare utilization.

Background: The use of user friendly, digital health solutions has shown to improve health outcomes in adult populations with chronic diseases such as major depression and type 2 DM. Despite advances and growing awareness of technology solutions, scales and traditional patient-reported outcomes continue to be the primary assessment tools in both clinical care and research in PD.

Methods: The digital solution combines objective measures of motor function and an advanced diary for disease monitoring delivered through a tablet. The trial will target a sample size of 60 moderate/advanced Parkinson’s disease subjects with a history of motor fluctuations that demonstrate efficient use of the digital solution during training (5 US sites). Following consent, subjects that meet I/E criteria will be randomized into 2 arms: Arm 1 will use the solution for the full duration of the 12-month study. Arm 1 subjects will complete a minimum of 2 site visits. Arm 2 will receive standard of care treatment for 6 months. After 6 months subjects will be trained to use the solution and continue for an additional 6 months. Arm 2 subjects will complete a minimum of 3 site visits.

Results: The digital solution will generate periodic, aggregate reports summarizing patient’s motor function. Reports will be used for medical decision support and could trigger on-time treatment modifications by study investigators. The study’s primary endpoint will be the reduction in OFF time as measured by the digital solution. Other endpoints will include tablet-based objective measures, PDQ-39, patient and clinician satisfaction levels, MOCA and global clinical impression of change. A variety of health economic variables will also be assessed.

Conclusions: The design of this innovative and “first-of-its-kind” study is expected to generate data that could position qualified digital solutions as key components for PD monitoring and management in both clinical trials and everyday care.

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MDS Abstracts - https://www.mdsabstracts.org/abstract/a-12-month-2-arm-2-period-randomized-controlled-trial-of-a-digital-solution-for-the-management-of-parkinsons-disease-pd-rationale-and-study-design/