Feasibility, Reliability, and Value of Remote Video-Based Trial Visits in Parkinson's Disease.
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.
['Tarolli|Christopher G|CG|', 'Andrzejewski|Kelly|K|', 'Zimmerman|Grace A|GA|', 'Bull|Michael|M|', 'Goldenthal|Steven|S|', 'Auinger|Peggy|P|', "O'Brien|Michael|M|", 'Dorsey|E Ray|ER|', 'Biglan|Kevin|K|', 'Simuni|Tanya|T|']
D000368:Aged D000086382:COVID-19 D018352:Coronavirus Infections D005240:Feasibility Studies D005260:Female D006801:Humans D008297:Male D008875:Middle Aged D058873:Pandemics D010300:Parkinson Disease D011024:Pneumonia, Viral D015203:Reproducibility of Results D012107:Research Design D017216:Telemedicine
phase III clinical trial Clinical trial protocol Parkinson’s disease technology telemedicine