Study design
cSLE, CAN
MSU
This two-arm, international multi-site RCT will examine the feasibility and effect of a remotely delivered TEACH protocol in reducing symptoms in youth with cSLE. Six children’s hospitals (five in the United States [US], one in Canada [CAN]) plan to recruit participants. The anticipated participating sites expanded to this total number following the onset of the COVID-19 pandemic. All sites have established pediatric rheumatology programs with a substantial referral base. Two primary locations in the US (Michigan State University [MSU], led by NRC) and CAN (The Hospital for Sick Children, led by AMK) will coordinate study activities. Each primary location houses site PIs, interventionists, and research coordinators. MSU will receive referrals from the US-based sites: Helen DeVos Children’s Hospital, Seattle Children’s Hospital), Montefiore Medical Center/The Children’s Hospital at Montefiore), University of Alabama-Birmingham/Children’s of Alabama), and Cincinnati Children’s Hospital and Medical Center (see Fig. Referral, screening, and enrollment by referral site. Each rheumatology sites’ medical/research team will identify potentially eligible participants. US patients will be referred to research staff at MSU for consenting (if needed), screening, and enrollment. CAN patients will complete these study activities (e.g., consenting, screening, enrollment) with research staff at their home site, Toronto Hospital for Sick ChildrenEach referring site is anticipated to enroll between 5 and 20 participants, with an anticipated total of 75 participants. Across all sites, we expect a retention rate of 80% and a final sample size of 