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

IF 1.4 Q4 MEDICINE, RESEARCH & EXPERIMENTAL

Contemporary Clinical Trials Communications Pub Date : 2025-03-15 DOI:10.1016/j.conctc.2025.101471

Eldon R. Jupe , Mohan Purushothaman , Bruce Wang , Gerald Lushington , Sandeep Nair , Vijay R. Nadipelli , Bernard Rubin , Melissa E. Munroe , Jessica Crawley , Sneha Nair , Georg Armstrong , Arif Sorathia , Brett Adelman

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引用次数: 0

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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数字平台和耀斑风险血液生物标志物指数对狼疮的影响：评估自我效能和疾病管理的研究方案设计

我们报告了一项试点研究的设计，该研究采用临床就诊和协同数字、健康指导和生物标志物平台（aiSLE®MGMT[管理]），旨在提高患者自我效能和医患互动，以减轻疾病活动加剧，减少临床发作，并减少系统性红斑狼疮（SLE）的潜在长期器官损害。这项为期12个月的研究将采用纵向交叉设计。确认SLE的成年参与者将在美国5个社区风湿病诊所招募并适当同意。委员会认证的风湿病学家将执行检查，记录基线、3个月、6个月和9个月的SLE医师总体评估（PGA）。将采集血液样本，以完成新开发和验证的狼疮发作风险指数（L-FRI），预测未来12周内发生临床发作的风险。该研究的数字部分将在3个月的访问后开始。参与者将获得一个与智能手表连接的移动学习应用程序，以记录活动、心率和睡眠质量。该应用程序将用于管理患者报告结果（PRO）调查和健康指导。在前三个月，受试者及其风湿病医生将对L-FRI结果不知情；所有L-FRI和数字结果将从第四个月开始提供。这项前瞻性试点研究将评估综合疾病管理平台的影响，该平台采用一种新型血液生物标志物测试，与智能手表接口的移动应用程序收集生物特征数据，以及基于应用程序的视频健康指导，对SLE疾病管理中自我效能感、临床决策和结果的影响。

本文章由计算机程序翻译，如有差异，请以英文原文为准。

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来源期刊

Contemporary Clinical Trials Communications Pharmacology, Toxicology and Pharmaceutics-Pharmacology

CiteScore

2.70

自引率

6.70%

发文量

146

审稿时长

20 weeks

期刊介绍： Contemporary Clinical Trials Communications is an international peer reviewed open access journal that publishes articles pertaining to all aspects of clinical trials, including, but not limited to, design, conduct, analysis, regulation and ethics. Manuscripts submitted should appeal to a readership drawn from a wide range of disciplines including medicine, life science, pharmaceutical science, biostatistics, epidemiology, computer science, management science, behavioral science, and bioethics. Contemporary Clinical Trials Communications is unique in that it is outside the confines of disease specifications, and it strives to increase the transparency of medical research and reduce publication bias by publishing scientifically valid original research findings irrespective of their perceived importance, significance or impact. Both randomized and non-randomized trials are within the scope of the Journal. Some common topics include trial design rationale and methods, operational methodologies and challenges, and positive and negative trial results. In addition to original research, the Journal also welcomes other types of communications including, but are not limited to, methodology reviews, perspectives and discussions. Through timely dissemination of advances in clinical trials, the goal of Contemporary Clinical Trials Communications is to serve as a platform to enhance the communication and collaboration within the global clinical trials community that ultimately advances this field of research for the benefit of patients.