Ruth B Schneider1,2, Larsson Omberg3, Eric A Macklin4,5, Margaret Daeschler6, Lauren Bataille6, Shalini Anthwal2, Taylor L Myers2, Elizabeth Baloga2, Sidney Duquette2, Phil Snyder3, Katherine Amodeo1, Christopher G Tarolli1,2, Jamie L Adams1,2, Katherine F Callahan7, Joshua Gottesman6, Catherine M Kopil6, Codrin Lungu8, Alberto Ascherio9, James C Beck10, Kevin Biglan1,11, Alberto J Espay12, Caroline Tanner13, David Oakes14, Ira Shoulson1,2,15, Dan Novak10, Elise Kayson1,2, Earl Ray Dorsey1,2, Lara Mangravite3, Michael A Schwarzschild7, Tanya Simuni16. 1. Department of Neurology, University of Rochester Medical Center, Rochester, New York, USA. 2. Center for Health + Technology, University of Rochester Medical Center, Rochester, New York, USA. 3. Sage Bionetworks, Seattle, Washington, USA. 4. Biostatistics Center, Massachusetts General Hospital, Boston, Massachusetts, USA. 5. Harvard Medical School, Boston, Massachusetts, USA. 6. The Michael J. Fox Foundation for Parkinson's Research, New York, New York, USA. 7. Department of Neurology, Massachusetts General Hospital, Boston, Massachusetts, USA. 8. Division of Clinical Research, National Institute of Neurological Disorders and Stroke, Bethesda, Maryland, USA. 9. Department of Nutrition, Harvard T.H. Chan School of Public Health, Boston, Massachusetts, USA. 10. Parkinson's Foundation, New York, New York, USA. 11. Eli Lilly and Company, Indianapolis, Indiana, USA. 12. Department of Neurology, University of Cincinnati, Cincinnati, Ohio, USA. 13. Department of Neurology, Weill Institute for Neurosciences, University of California, San Francisco Veterans Affairs Health Care System, San Francisco, California, USA. 14. Department of Biostatistics, University of Rochester Medical Center, Rochester, New York, USA. 15. Grey Matter Technologies, Sarasota, Florida, USA. 16. Department of Neurology, Northwestern University Feinberg School of Medicine, Chicago, Illinois, USA.
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.
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.
Authors: Taylor L Myers; Erika F Augustine; Elizabeth Baloga; Margaret Daeschler; Paul Cannon; Helen Rowbotham; Eli Chanoff; Stella Jensen-Roberts; Julia Soto; Robert G Holloway; Connie Marras; Caroline M Tanner; E Ray Dorsey; Ruth B Schneider Journal: J Parkinsons Dis Date: 2022 Impact factor: 5.568
Authors: Rachel L Nosheny; Rebecca Amariglio; Sietske A M Sikkes; Carol Van Hulle; Maria Aparecida Camargos Bicalho; N Maritza Dowling; Sonia Maria Dozzi Brucki; Zahinoor Ismail; Kensaku Kasuga; Elizabeth Kuhn; Katya Numbers; Anna Aaronson; Davide Vito Moretti; Arturo X Pereiro; Gonzalo Sánchez-Benavides; Allis F Sellek Rodríguez; Prabitha Urwyler; Kristina Zawaly Journal: Alzheimers Dement (N Y) Date: 2022-10-04