Running an active gaming-based randomized controlled trial during the COVID-19 pandemic: Challenges, solutions and lessons learned

Abstract

Objectives: The COVID-19 pandemic has created significant obstacles for clinical trials and human subject research. This paper discusses the challenges our study team encountered while implementing an eHealth intervention during the pandemic, including: increased dropout, cancellation and rescheduling rates, increased mailing returns and delays, social distancing impediments, COVID-19 positive team members, and restricted training access. Study design: This is a short paper on research protocol for a six-month randomized controlled single-blind trial. Methods: N/A. Results: In response to these challenges, we changed the study protocol. We included multimodal communication models, amplified recruitment efforts, expanded our population's age range, increasingly utilized tracking labels, utilized external space for extra participants, and transitioned to a virtual RA training format. Conclusions: Sharing our experience and the adaptations required to run a clinical trial during the pandemic should provide useful and practical knowledge for institutions, funding agencies, and researchers. We believe that the lessons learned here would be applicable to future clinical trial research after the pandemic as well.

Keywords

• COVID-19
• Clinical trial
• Research protocol
• Human subject study