可穿戴活动追踪器研究：利用患者报告的结果指标、临床指标和生物传感器数据探索类风湿性关节炎患者的疾病活动（穿戴研究）

IF 1.4 Q4 MEDICINE, RESEARCH & EXPERIMENTAL

Contemporary Clinical Trials Communications Pub Date : 2024-02-27 DOI:10.1016/j.conctc.2024.101272

Laura Stradford , Jeffrey R. Curtis , Patrick Zueger , Fenglong Xie , David Curtis , Kelly Gavigan , Cassie Clinton , Shilpa Venkatachalam , Esteban Rivera , W. Benjamin Nowell

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引用次数: 0

摘要

背景数字健康研究使用患者电子报告结果（ePRO）、可穿戴设备和临床数据来提供更全面的患者健康状况。方法将从风湿病卓越网络（ENRGY）基于实践的研究网络的社区环境中招募接受达帕替尼或阿达木单抗治疗的新发RA患者。在三到六个月的时间里，将收集三个数据流（1）可链接的医生数据；（2）通过 ArthritisPower 注册应用程序自我报告的每日和每周 ePRO；以及（3）通过可穿戴设备被动收集的生物传感器数据。本研究的结果将为新开始接受 RA 治疗的患者提供有关医生数据、可穿戴设备数据和 ePRO 之间关系的宝贵信息，并证明了数字数据采集用于风湿病患者远程患者监测的可行性。

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查看原文本刊更多论文

Wearable activity tracker study exploring rheumatoid arthritis patients’ disease activity using patient-reported outcome measures, clinical measures, and biometric sensor data (the wear study)

Background

Digital health studies using electronic patient reported outcomes (ePROs), wearables, and clinical data to provide a more comprehensive picture of patient health.

Methods

Newly initiated patients on upadacitinib or adalimumab for RA will be recruited from community settings in the Excellence NEtwork in RheumatoloGY (ENRGY) practice-based research network. Over the period of three to six months, three streams of data will be collected (1) linkable physician-derived data; (2) self-reported daily and weekly ePROs through the ArthritisPower registry app; and (3) biometric sensor data passively collected via wearable. These data will be analyzed to evaluate correlations among the three types of data and patient improvement on the newly initiated medication.

Conclusions

Results from this study will provide valuable information regarding the relationships between physician data, wearable data, and ePROs in patients newly initiating an RA treatment, and demonstrate the feasibility of digital data capture for Remote Patient Monitoring of patients with rheumatic disease.

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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.