Effects of COVID-19 Related Stressors on an Effectiveness Trial of an E-Health Intervention: Administrative Supplement

Despite clear evidence of diabetes-related health disparities among African American youth with T1D, almost no clinical trials have focused on testing behavioral interventions to improve diabetes management for this population. The lack of research to develop effective interventions to improve health outcomes among minority youth with T1D is even more concerning in light of the coronavirus 2019 (COVID-19) pandemic. African American adults and children are likely to be at disproportionate risk to acquire COVID-19 and may be more likely to suffer from psychosocial and economic burdens of the pandemic. The parent clinical trial upon which the supplement will build has successfully recruited a large and representative sample of urban, African American youth with T1D (N=155). The occurrence of the COVID-19 pandemic in the midst of our clinical trial interjects variance that, if unmeasured, could affect study outcomes in ways that are unknown. Therefore, we propose to directly measure the effects of three COVID-19 related social/behavioral stressors (psychological distress, reduced health care utilization and loss of financial resources) on our two primary trial outcomes: diabetes management and glycemic control. We will obtain data on the impact of the pandemic via three new data collections obtained for all trial participants over a period of six months. The supplement will also allow us to evaluate the impact of the novel coronavirus pandemic on the overall health of minority youth with T1D. Our study is ideally posed to conduct this critical work, which is vital to understanding which social/behavioral factors associated with the pandemic are affecting health outcomes in this high-risk population. In turn, such data can inform the development of interventions to mitigate the effects of COVID-19 in the future.