Impact of a digital platform and flare risk blood biomarker index on lupus: A study protocol design for evaluating self efficacy and disease management

We report the design of a pilot study employing clinic visits and a synergized digital, health coaching, and biomarker platform (aiSLE® MGMT [Management]) aimed at improving patient self-efficacy and patient-physician interactions to mitigate heightened disease activity, curtail clinical flares, and reduce potential long-term organ damage in systemic lupus erythematosus (SLE). This 12-month study will utilize a longitudinal cross-over design. Adult participants with confirmed SLE will be recruited and appropriately consented at five community-based US rheumatology clinics. Board certified rheumatologists will perform an exam, documenting the SLE Physician Global assessment (PGA) at Baseline, 3-, 6- and 9-month visits. Blood samples will be collected for completion of a newly developed and validated Lupus Flare Risk Index (L-FRI) that predicts the risk of developing a clinical flare in the next 12 weeks. The digital component of the study will be initiated following the 3-month visit. Participants will be given a mobile study app interfaced with a smartwatch to record activity, heart rate, and sleep quality. The app will be used to administer patient-reported outcome (PRO) surveys and health coaching. In the first three months participants and their rheumatologists will be blinded to L-FRI results; all L-FRI and digital results will be available starting in month four. This prospective pilot study will assess the impact of a comprehensive disease management platform employing a novel blood biomarker test, a mobile app interfaced with a smartwatch to collect biometric data, and app-based video health coaching on self-efficacy, clinical decisions, and outcomes in SLE disease management.