How much did it cost to develop and implement an eHealth intervention for a minority children population that overlapped with the COVID-19 pandemic?

BACKGROUND: eHealth interventions using active video games (AVGs) offer an alternative method to help children exercise, especially during a pandemic where options are limited. There is limited data on costs associated with developing and implementing such interventions. OBJECTIVES: We quantified the costs of delivering an eHealth RCT intervention among minority children during COVID-19. METHODS: We categorized the total trial cost into five subcategories: intervention material development, advertising and recruitment, intervention delivery, personnel salaries, and COVID-19-related equipment costs. RESULTS: The total RCT cost was $1,927,807 (Direct: $1,227,903; Indirect: $699,904) with three visits required for each participant. The average cost per participant completing the RCT (79 participants/237 visits) was $24,403 (Direct: $15,543; Indirect: $8860). Due to no-shows and cancellations (198 visits) and dropouts before study completion (61 visits; 56 participants), 496 visits had to be scheduled to ensure complete data collection on 79 participants. If all 496 visits were from participants completing the three-visit protocol, that would correspond to 165 participants, bringing the average cost per participant down to $11,684 (Direct: $7442; Indirect: $4242). Of the subcategories, intervention material development accounted for the largest portion, followed by personnel salaries. While the direct COVID-19-specific cost constituted <1% of the entire budget, the indirect effects were much larger and significantly impacted the trial. CONCLUSION: RCTs typically involve significant resources, even more so during a pandemic. Future eHealth intervention investigators should budget and plan accordingly to prepare for unexpected costs such as recruitment challenges to increase flexibility while maximizing the intervention efficacy.

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

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.