Design of a virtual longitudinal observational study in Parkinson's disease (AT-HOME PD)

Ann Clin Transl Neurol. 2021 Feb;8(2):308-320. doi: 10.1002/acn3.51236. Epub 2020 Dec 22.


Objective: The expanding power and accessibility of personal technology provide an opportunity to reduce burdens and costs of traditional clinical site-centric therapeutic trials in Parkinson's disease and generate novel insights. The value of this approach has never been more evident than during the current COVID-19 pandemic. We sought to (1) establish and implement the infrastructure for longitudinal, virtual follow-up of clinical trial participants, (2) compare changes in smartphone-based assessments, online patient-reported outcomes, and remote expert assessments, and (3) explore novel digital markers of Parkinson's disease disability and progression.

Methods: Participants from two recently completed phase III clinical trials of inosine and isradipine enrolled in Assessing Tele-Health Outcomes in Multiyear Extensions of Parkinson's Disease trials (AT-HOME PD), a two-year virtual cohort study. After providing electronic informed consent, individuals complete annual video visits with a movement disorder specialist, smartphone-based assessments of motor function and socialization, and patient-reported outcomes online.

Results: From the two clinical trials, 226 individuals from 42 states in the United States and Canada enrolled. Of these, 181 (80%) have successfully downloaded the study's smartphone application and 161 (71%) have completed patient-reported outcomes on the online platform.

Interpretation: It is feasible to conduct a large-scale, international virtual observational study following the completion of participation in brick-and-mortar clinical trials in Parkinson's disease. This study, which brings research to participants, will compare established clinical endpoints with novel digital biomarkers and thereby inform the longitudinal follow-up of clinical trial participants and design of future clinical trials.

Publication types

  • Observational Study
  • Research Support, N.I.H., Extramural

MeSH terms

  • COVID-19
  • Canada
  • Clinical Trials as Topic
  • Disease Progression
  • Follow-Up Studies
  • Humans
  • Longitudinal Studies
  • Mobile Applications*
  • Parkinson Disease / physiopathology*
  • Patient Reported Outcome Measures*
  • Research Design*
  • SARS-CoV-2
  • Smartphone*
  • Telemedicine*
  • United States
  • Videoconferencing*