Design of a virtual longitudinal observational study in Parkinson’s disease (AT‐HOME PD)
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 d...
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Format: | Article |
Language: | English |
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Wiley
2021-02-01
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Series: | Annals of Clinical and Translational Neurology |
Online Access: | https://doi.org/10.1002/acn3.51236 |
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record_format |
Article |
collection |
DOAJ |
language |
English |
format |
Article |
sources |
DOAJ |
author |
Ruth B. Schneider Larsson Omberg Eric A. Macklin Margaret Daeschler Lauren Bataille Shalini Anthwal Taylor L. Myers Elizabeth Baloga Sidney Duquette Phil Snyder Katherine Amodeo Christopher G Tarolli Jamie L. Adams Katherine F Callahan Joshua Gottesman Catherine M. Kopil Codrin Lungu Alberto Ascherio James C. Beck Kevin Biglan Alberto J. Espay Caroline Tanner David Oakes Ira Shoulson Dan Novak Elise Kayson Earl Ray Dorsey Lara Mangravite Michael A. Schwarzschild Tanya Simuni the Parkinson Study Group AT‐HOME PD Investigators |
spellingShingle |
Ruth B. Schneider Larsson Omberg Eric A. Macklin Margaret Daeschler Lauren Bataille Shalini Anthwal Taylor L. Myers Elizabeth Baloga Sidney Duquette Phil Snyder Katherine Amodeo Christopher G Tarolli Jamie L. Adams Katherine F Callahan Joshua Gottesman Catherine M. Kopil Codrin Lungu Alberto Ascherio James C. Beck Kevin Biglan Alberto J. Espay Caroline Tanner David Oakes Ira Shoulson Dan Novak Elise Kayson Earl Ray Dorsey Lara Mangravite Michael A. Schwarzschild Tanya Simuni the Parkinson Study Group AT‐HOME PD Investigators Design of a virtual longitudinal observational study in Parkinson’s disease (AT‐HOME PD) Annals of Clinical and Translational Neurology |
author_facet |
Ruth B. Schneider Larsson Omberg Eric A. Macklin Margaret Daeschler Lauren Bataille Shalini Anthwal Taylor L. Myers Elizabeth Baloga Sidney Duquette Phil Snyder Katherine Amodeo Christopher G Tarolli Jamie L. Adams Katherine F Callahan Joshua Gottesman Catherine M. Kopil Codrin Lungu Alberto Ascherio James C. Beck Kevin Biglan Alberto J. Espay Caroline Tanner David Oakes Ira Shoulson Dan Novak Elise Kayson Earl Ray Dorsey Lara Mangravite Michael A. Schwarzschild Tanya Simuni the Parkinson Study Group AT‐HOME PD Investigators |
author_sort |
Ruth B. Schneider |
title |
Design of a virtual longitudinal observational study in Parkinson’s disease (AT‐HOME PD) |
title_short |
Design of a virtual longitudinal observational study in Parkinson’s disease (AT‐HOME PD) |
title_full |
Design of a virtual longitudinal observational study in Parkinson’s disease (AT‐HOME PD) |
title_fullStr |
Design of a virtual longitudinal observational study in Parkinson’s disease (AT‐HOME PD) |
title_full_unstemmed |
Design of a virtual longitudinal observational study in Parkinson’s disease (AT‐HOME PD) |
title_sort |
design of a virtual longitudinal observational study in parkinson’s disease (at‐home pd) |
publisher |
Wiley |
series |
Annals of Clinical and Translational Neurology |
issn |
2328-9503 |
publishDate |
2021-02-01 |
description |
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. |
url |
https://doi.org/10.1002/acn3.51236 |
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doaj-7feb687f3d094d1c9e817ead9428641d2021-05-02T19:23:20ZengWileyAnnals of Clinical and Translational Neurology2328-95032021-02-018230832010.1002/acn3.51236Design of a virtual longitudinal observational study in Parkinson’s disease (AT‐HOME PD)Ruth B. Schneider0Larsson Omberg1Eric A. Macklin2Margaret Daeschler3Lauren Bataille4Shalini Anthwal5Taylor L. Myers6Elizabeth Baloga7Sidney Duquette8Phil Snyder9Katherine Amodeo10Christopher G Tarolli11Jamie L. Adams12Katherine F Callahan13Joshua Gottesman14Catherine M. Kopil15Codrin Lungu16Alberto Ascherio17James C. Beck18Kevin Biglan19Alberto J. Espay20Caroline Tanner21David Oakes22Ira Shoulson23Dan Novak24Elise Kayson25Earl Ray Dorsey26Lara Mangravite27Michael A. Schwarzschild28Tanya Simuni29the Parkinson Study Group AT‐HOME PD InvestigatorsDepartment of Neurology University of Rochester Medical Center Rochester New YorkUSASage Bionetworks Seattle WashingtonUSABiostatistics Center Massachusetts General Hospital Boston MassachusettsUSAThe Michael J. Fox Foundation for Parkinson’s Research New York New YorkUSAThe Michael J. Fox Foundation for Parkinson’s Research New York New YorkUSACenter for Health + Technology University of Rochester Medical Center Rochester New YorkUSACenter for Health + Technology University of Rochester Medical Center Rochester New YorkUSACenter for Health + Technology University of Rochester Medical Center Rochester New YorkUSACenter for Health + Technology University of Rochester Medical Center Rochester New YorkUSASage Bionetworks Seattle WashingtonUSADepartment of Neurology University of Rochester Medical Center Rochester New YorkUSADepartment of Neurology University of Rochester Medical Center Rochester New YorkUSADepartment of Neurology University of Rochester Medical Center Rochester New YorkUSADepartment of Neurology Massachusetts General Hospital Boston MassachusettsUSAThe Michael J. Fox Foundation for Parkinson’s Research New York New YorkUSAThe Michael J. Fox Foundation for Parkinson’s Research New York New YorkUSADivision of Clinical Research National Institute of Neurological Disorders and Stroke Bethesda MarylandUSADepartment of Nutrition Harvard T.H. Chan School of Public Health Boston MassachusettsUSAParkinson’s Foundation New York New YorkUSADepartment of Neurology University of Rochester Medical Center Rochester New YorkUSADepartment of Neurology University of Cincinnati Cincinnati OhioUSADepartment of Neurology Weill Institute for Neurosciences University of CaliforniaSan Francisco Veterans Affairs Health Care System San Francisco CaliforniaUSADepartment of Biostatistics University of Rochester Medical Center Rochester New YorkUSADepartment of Neurology University of Rochester Medical Center Rochester New YorkUSAParkinson’s Foundation New York New YorkUSADepartment of Neurology University of Rochester Medical Center Rochester New YorkUSADepartment of Neurology University of Rochester Medical Center Rochester New YorkUSASage Bionetworks Seattle WashingtonUSADepartment of Neurology Massachusetts General Hospital Boston MassachusettsUSADepartment of Neurology Northwestern University Feinberg School of Medicine Chicago IllinoisUSAAbstract 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.https://doi.org/10.1002/acn3.51236 |