ABSTRACT
Purpose of Study Prior to the COVID-19 pandemic, we initiated a randomized clinical trial for childhood obesity. The trial consented 131 and randomized 104;6-12 year old patients who reside in rural regions in 4 member states (DE, NE, SC, and WV) of the ECHO IDeA States Pediatric Clinical Trials Network (ISPCTN) Approximately 6 weeks into the 10-week recruitment period, the trial was forced to pause all study activity due to the COVID-19 pandemic. This pause necessitated a substantial revision in recruitment and study methods to using virtual procedures. This descriptive paper outlines ways to recruit and manage clinical trial participants using technology to obtain informed consent, obtain height and weight measurements by video, and maintain participant engagement throughout the duration of the trial. Methods Used We reviewed multiple data sources to describe the transition to virtual study procedures. These include research electronic data capture (REDCap) surveys conducted both during the pause and at the completion of the study to identify readiness for each site to conduct virtual recruitment and other study procedures as well as at the end of the study to identify issues that each site encountered during the virtual phase of the project. We also reviewed meeting notes and study enrollment figures. Summary of Results The IRB approved study changes allowed for variability between clinical sites in terms of virtual communication platforms and methods for participant consent and height/weight assessment. Identified advantages of the study included ability to conduct visits during all times of the day or evening, and reduced travel requirements. Challenges included poor Internet reliability in some rural areas;additional participant contacts for consent and eligibility screening;shipping delays of materials;reliance on family to perform height and weight measures;increased costs for materials and shipping. Despite the added challenges, all sites were able to meet the study enrollment objectives. Flexibility was key in implementation of virtual procedures given the variations in site resources. Conclusions While each study site had certain challenges unique to their location during the pandemic, we also identified several common issues with the transition to remote procedures. Lessons learned from this study can assist other study groups in navigating challenges, especially when recruiting and implementing studies with a difficult to reach rural and underserved populations or during challenging events like the pandemic.