TY - JOUR
T1 - Feasibility, Reliability, and Value of Remote Video-Based Trial Visits in Parkinson's Disease
AU - Tarolli, Christopher G.
AU - Andrzejewski, Kelly
AU - Zimmerman, Grace A.
AU - Bull, Michael
AU - Goldenthal, Steven
AU - Auinger, Peggy
AU - O'Brien, Michael
AU - Dorsey, E. Ray
AU - Biglan, Kevin
AU - Simuni, Tanya
N1 - Publisher Copyright:
© 2020 - IOS Press and the authors. All rights reserved.
PY - 2020
Y1 - 2020
N2 - Background: There is rising interest in remote clinical trial assessments, particularly in the setting of the COVID-19 pandemic. Objective: To demonstrate the feasibility, reliability, and value of remote visits in a phase III clinical trial of individuals with Parkinson's disease. Methods: We invited individuals with Parkinson's disease enrolled in a phase III clinical trial (STEADY-PD III) to enroll in a sub-study of remote video-based visits. Participants completed three remote visits over one year within four weeks of an in-person visit and completed assessments performed during the remote visit. We evaluated the ability to complete scheduled assessments remotely; agreement between remote and in-person outcome measures; and opinions of remote visits. Results: We enrolled 40 participants (mean (SD) age 64.3 (10.4), 29% women), and 38 (95%) completed all remote visits. There was excellent correlation (ICC 0.81-0.87) between remote and in-person patient-reported outcomes, and moderate correlation (ICC 0.43-0.51) between remote and in-person motor assessments. On average, remote visits took around one quarter of the time of in-person visits (54 vs 190 minutes). Nearly all participants liked remote visits, and three-quarters said they would be more likely to participate in future trials if some visits could be conducted remotely. Conclusion: Remote visits are feasible and reliable in a phase III clinical trial of individuals with early, untreated Parkinson's disease. These visits are shorter, reduce participant burden, and enable safe conduct of research visits, which is especially important in the COVID-19 pandemic.
AB - Background: There is rising interest in remote clinical trial assessments, particularly in the setting of the COVID-19 pandemic. Objective: To demonstrate the feasibility, reliability, and value of remote visits in a phase III clinical trial of individuals with Parkinson's disease. Methods: We invited individuals with Parkinson's disease enrolled in a phase III clinical trial (STEADY-PD III) to enroll in a sub-study of remote video-based visits. Participants completed three remote visits over one year within four weeks of an in-person visit and completed assessments performed during the remote visit. We evaluated the ability to complete scheduled assessments remotely; agreement between remote and in-person outcome measures; and opinions of remote visits. Results: We enrolled 40 participants (mean (SD) age 64.3 (10.4), 29% women), and 38 (95%) completed all remote visits. There was excellent correlation (ICC 0.81-0.87) between remote and in-person patient-reported outcomes, and moderate correlation (ICC 0.43-0.51) between remote and in-person motor assessments. On average, remote visits took around one quarter of the time of in-person visits (54 vs 190 minutes). Nearly all participants liked remote visits, and three-quarters said they would be more likely to participate in future trials if some visits could be conducted remotely. Conclusion: Remote visits are feasible and reliable in a phase III clinical trial of individuals with early, untreated Parkinson's disease. These visits are shorter, reduce participant burden, and enable safe conduct of research visits, which is especially important in the COVID-19 pandemic.
KW - Clinical trial protocol
KW - Parkinson's disease
KW - phase III clinical trial
KW - technology
KW - telemedicine
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U2 - 10.3233/JPD-202163
DO - 10.3233/JPD-202163
M3 - Article
C2 - 32894251
AN - SCOPUS:85095461096
SN - 1877-7171
VL - 10
SP - 1779
EP - 1786
JO - Journal of Parkinson's Disease
JF - Journal of Parkinson's Disease
IS - 4
ER -