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Design of a virtual longitudinal observational study in Parkinsons disease (AT-HOME PD) Open Access (recommended)

Schneider RB, Omberg L, Macklin EA, Daeschler M, Bataille L, Anthwal S, Myers TL, Baloga E, Duquette S, Snyder P, Amodeo K, Tarolli CG, Adams JL, Callahan KF, Gottesman J, Kopil CM, Lungu C, Ascherio A, Beck JC, Biglan K, Espay AJ, Tanner C, Oakes D, Shoulson I, Novak D, Kayson E, Dorsey ER, Mangravite L, Schwarzschild MA, Simuni T, Parkinson Study Grp ATHPDI. Design of a virtual longitudinal observational study in Parkinson's disease (AT-HOME PD). Annals of Clinical and Translational Neurology. 2021;8(2):308-320.

Descriptions

Resource type(s)
Article
Keyword
COVID-19
Rights
Attribution-NonCommercial-NoDerivs 3.0 United States

Creator
Schneider, Ruth B.
Omberg, Larsson
Macklin, Eric A.
Daeschler, Margaret
Bataille, Lauren
Anthwal, Shalini
Myers, Taylor L.
Baloga, Elizabeth
Duquette, Sidney
Snyder, Phil
Amodeo, Katherine
Tarolli, Christopher G.
Adams, Jamie L.
Callahan, Katherine F.
Gottesman, Joshua
Kopil, Catherine M.
Lungu, Codrin
Ascherio, Alberto
Beck, James C.
Biglan, Kevin
Espay, Alberto J.
Tanner, Caroline
Oakes, David
Shoulson, Ira
Novak, Dan
Kayson, Elise
Dorsey, Earl Ray
Mangravite, Lara
Schwarzschild, Michael A.
Simuni, Tanya
Parkinson Study Grp AT-HOME PD Inv
Abstract
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.
Related URL
Publisher
WILEY
Date Created
2021-02
Original Identifier
(PMID) 33350601
Grants and funding
PDBP of the National Institute of Neurological Disorders and Stroke of the National Institutes of Health [U01NS107009]
DOI
10.1002/acn3.51236

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