Design of a virtual longitudinal observational study in Parkinson’s disease (AT‐HOME PD)
| Autor: | Eric A. Macklin, Elizabeth Baloga, Catherine Kopil, Larsson Omberg, Caroline M. Tanner, Dan Novak, Shalini Anthwal, Elise Kayson, Alberto Ascherio, Alberto J. Espay, Joshua Gottesman, Jamie L Adams, Michael A. Schwarzschild, Lara M. Mangravite, James C. Beck, Margaret Daeschler, Phil Snyder, Tanya Simuni, Lauren Bataille, Ruth B. Schneider, Christopher G. Tarolli, Codrin Lungu, Sidney Duquette, Katherine F. Callahan, David Oakes, E. R. Dorsey, Taylor Myers, Ira Shoulson, Katherine Amodeo, Kevin Biglan |
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| Jazyk: | angličtina |
| Rok vydání: | 2021 |
| Předmět: |
0301 basic medicine
Research design Telemedicine medicine.medical_specialty Canada Clinical Neurology MEDLINE Neurosciences. Biological psychiatry. Neuropsychiatry 03 medical and health sciences 0302 clinical medicine Physical medicine and rehabilitation Informed consent Clinical endpoint Medicine Humans Longitudinal Studies Patient Reported Outcome Measures RC346-429 Research Articles Clinical Trials as Topic business.industry SARS-CoV-2 General Neuroscience COVID-19 Parkinson Disease Mobile Applications United States Clinical trial 030104 developmental biology Research Design Disease Progression Videoconferencing Observational study Neurology (clinical) Smartphone Neurology. Diseases of the nervous system business 030217 neurology & neurosurgery Cohort study Research Article Follow-Up Studies RC321-571 |
| Zdroj: | Annals of Clinical and Translational Neurology, Vol 8, Iss 2, Pp 308-320 (2021) Annals of Clinical and Translational Neurology |
| ISSN: | 2328-9503 |
| Popis: | 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. |
| Databáze: | OpenAIRE |
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