Discussion
cSLE, voice, lupus, autoimmune disease
LUPUS, RECRUITMENT, AUTOIMMUNE DISEASE
cSLE is a chronic, debilitating autoimmune disease associated with more severe symptoms as compared to adult-onset SLE and a 20-fold increased risk of mortality [While we have demonstrated feasibility of TEACH in a pilot investigation [COVID-19 impacted the study planning and recruitment plan. As such, COVID-related distress will now be measured and targeted. Furthermore, we expect enrollment rates to vary during different periods of the COVID-19 pandemic. We will examine these data carefully in the context of when it was collected.We anticipate minimal risk and maximal benefits to patients/families. The present trial allows for understanding of treatment effects. Lack of active treatment comparator and a modest sample size are limitations. In the future, we plan to test the Since cSLE is a complex condition disproportionately impacting females of color, it is important to test a treatment tailored to meet the needs of these individuals. Given the current trial focuses on cSLE, the results will be most applicable to this population. However, the learnings of this trial may provide insights into to developing and testing treatments for other conditions.This RCT was funded by the CARRA-AF organization, a network consisting of rheumatologists, other professionals, patients, and their caregivers who all take an interest in research. Aligned with the mission of CARRA, the investigative team partnered with patients with lupus and their caregivers to amplify their voice in the refinement of TEACH. In addition, several of the study investigators (NRC, TR, AMK) co-chair the mental health workgroup of CARRA. This is noteworthy as our CARRA mental health workgroup is finalizing guidance statements to assess and manage mental health concerns in pediatric rheumatology care. Given the synchrony of our CARRA grant-funded research and the larger body of work within the CARRA mental health workgroup, we anticipate continuing to leverage the organization and its partners for future research.