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Responding to the need to investigate potential treatments of COVID-19, a research team employed a telehealth platform to determine whether niclosamide, an oral anthelmintic drug that had shown antiviral activity, reduced SARS-CoV-2 shedding and duration of symptoms in patients with mild-to-moderate symptoms of COVID-19. To encourage compliance with patient self-quarantine, this randomized placebo-controlled clinical trial was conducted utilizing a remote telehealth design to complete all study visits, monitor symptoms, and coordinate participant self-collected specimens.
Methods:
A mixed methods approach employing surveys and interviews of trial participants and interviews of research team members was used to collect their experiences with and perspectives on the acceptability of the remote clinical trial design and delivery.
Results:
Of the 67 eligible trial participants invited to take part in a study to evaluate the telehealth platform, 46% (n = 31) completed a post-participation survey. While 97% (n = 30) of respondents had not previously participated in a clinical trial, 77% (n = 24) reported they would consider taking part in a future remote research study. The majority of respondents were moderately or very comfortable (93%) with using the technology.
Conclusions:
The COVID-19 crisis was a call to action to expand understanding of the conduct of remote clinical trials, including the experiences of research participants. Our findings showed that this approach can be both effective for the conduct of research and positive for participants. Further research on the use of telehealth research platforms seems warranted in rural, underserved populations, and remote trials of prevention, screening, and treatment.
The validated long Research Participant Perception Survey (RPPS-Long) elicits valuable data at modest response rates.
Methods
To address this limitation, we developed shorter RPPS-Ultrashort and RPPS-Short versions, fielded them with the RPPS-Long to a random sample of a national research volunteer registry, and assessed response and completion rates, test/retest reliability, and demographics.
Results
In total, 2228 eligible registry members received survey links. Response rates were 64% (RPPS-Ultrashort), 63% (RPPS-Short), and 51% (RPPS-Long), respectively (p<0.001). Completion rates were 63%, 54%, and 37%, respectively (p<0.001). All surveys were reliable with Cronbach α=0.81, 0.84, and 0.87, respectively. Retest reliability was highest for RPPS-short (κ=0.85). Provision of compensation increased RPPS-short completion rate from 54% to 71% (p<0.001). Compensated respondents were younger (p<0.001), with greater minority representation (p=0.03).
Conclusions
Shorter surveys were reliable and produced higher response and completion rates then long surveys. Compensation further increased completion rates and shifted sample age and race profiles.
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