AT-HOME-PD (Tele-Health Extension for Phase 3 Parkinson's Disease Trial Cohorts)

Project: Research project

Project Details

Description

1. To establish and implement infrastructure for longitudinal remote follow up of phase 3 trial cohorts:
a. Transition from site-based to a centralized coordination center to manage all subject activity in virtual extensions of STEADY-PD3 and SURE-PD3, with projected enrollment of ≥70% of final trial cohorts, and core data collection in accordance with PDBP schedule of activities.
b. To conduct an annual telemedicine research visit (tele-visit) program, and to establish the feasibility and cross-sectional reliability of tele-visit versus in-person visit assessments
c. Implement a smartphone data collection system based on the mPower platform and tailored to a clinical trial cohort as preliminarily characterized in the Smart4SURE sub-study of SURE-PD3.
2. To compare smartphone (patient-driven) vs tele-visit (clinician-driven) outcomes by:
a. Correlating these platforms’ component and composite features, and their changes over years
b. Comparing their abilities to i) measure PD progression; ii) distinguish rapid vs slow progressors based on baseline MDS-UPDRS scores, DAT deficit (in SURE) or serum urate levels (in STEADY); iii) demonstrate persistence of any effects of isradipine or inosine in their trials.
3. To explore novel smartphone-based real-life mobility biomarkers of PD disability and its progression that are normally inaccessible with traditional office measures. We will investigate the ability of passively collected smartphone data, on ambulation and location, to enable assessments of physical activity and socialization that meaningfully integrate motor and non-motor functions.
StatusActive
Effective start/end date7/1/184/30/23

Funding

  • Massachusetts General Hospital (232297//5U01NS107009-03)
  • National Institute of Neurological Disorders and Stroke (232297//5U01NS107009-03)

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