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Wearable Activity Tracker Study Exploring Rheumatoid Arthritis Patients’ Disease Activity Using Patient-Reported Outcome Measures, Clinical Measures, and Biometric Sensor Data (the Wear Study)

Contemporary clinical trials communications(2024)

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摘要
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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关键词
Real world evidence,Real world data,Patients,Rheumatoid arthritis,Patient-reported outcomes,Patient-generated health data,Mobile technology,Wearable digital technology
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