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. 2024 Feb 27:38:101272.
doi: 10.1016/j.conctc.2024.101272. eCollection 2024 Apr.

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

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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)

Laura Stradford et al. Contemp Clin Trials Commun. .

Abstract

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.

Keywords: Mobile technology; Patient-generated health data; Patient-reported outcomes; Patients; Real world data; Real world evidence; Rheumatoid arthritis; Wearable digital technology.

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Conflict of interest statement

The authors declare that they have no known competing financial interests or personal relationships that could have appeared to influence the work reported in this paper. Global Healthy Living Foundation receives grants, sponsorships and contracts from pharmaceutical manufacturers and private foundations. A full list of GHLF funders is publicly available here: https://www.ghlf.org/our-partners/ PZ is employed by 10.13039/100006483AbbVie. JRC receives grants from 10.13039/100000960ACR, 10.13039/100006483AbbVie, 10.13039/100002429Amgen, ArthritisPower, Aqtual, Bendcare, 10.13039/100002491BMS, CorEvitas, FASTER, 10.13039/100004330GSK, IlluminationHealth, Janssen, Labcorp, 10.13039/100004312Lilly, 10.13039/100016939Myriad, 10.13039/100008272Novartis, 10.13039/100004319Pfizer, 10.13039/100004339Sanofi, Scipher, Setpoint, 10.13039/100006978UCB, United Rheumatology. He has received honorariums from 10.13039/100000960ACR, 10.13039/100006483Abbvie, 10.13039/100002429Amgen, ArthritisPower, Aqtual, Bendcare, BMS, CorEvitas, FASTER, GSK, IlluminationHealth, Janssen, Labcorp, 10.13039/100004312Lilly Myriad, 10.13039/100004336Novartis, Revero, 10.13039/100004319Pfizer, 10.13039/100004339Sanofi, Scipher, Setpoint, TNacity, Blue Ocean, 10.13039/100006978UCB.

Figures

Fig. 1
Fig. 1
Overall study design.

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