ArticleContemporary clinical trials communications2025
Impact of a digital platform and flare risk blood biomarker index on lupus: A study protocol design for evaluating self efficacy and disease management.
Article in Contemporary clinical trials communications, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 2 papers.
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The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.
Who cites it
2 citing papers in PubMed.
- From pathogenesis to precision medicine in systemic lupus erythematosus: Emerging biomarkers and targeted interventions.iScience · 2026Review
- Criteria and Protocol: Assessing Generative AI Efficacy in Perceiving EULAR 2019 Lupus Classification.Diagnostics (Basel, Switzerland) · 2025Article
Corrections and comments
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Authors and funding
13 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
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.
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Registered trials
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