NCT05603806

The ArthritisPower Wearable Study

Exploring Rheumatoid Arthritis Patients' Disease Activity Using Patient Reported Outcome Measures and Biometric Sensor Data (WEarables Activity in Patients With Rheumatoid Arthritis)

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 299 (actual)
• Sponsor: Global Healthy Living Foundation · Academic / Other
• Sex: All
• Age: 19 Years
• Healthy volunteers: Accepted

Summary

Rheumatoid arthritis patients being seen at one of the participating clinical sites in a U.S. network of community rheumatology practices who are starting treatment on adalimumab or upadacitinib will be enrolled into a 24-week study combining clinical data from physicians, self-reported patient outcomes from the ArthritisPower registry app, and activity and sleep data from a Fitbit wearable device. The primary objective of this study is: • Evaluate longitudinal associations between biometric sensor data (activity and sleep measures), physician-derived data (including clinical disease activity index (CDAI), Rheumatoid Factor (RF) lab results and other relevant biomarkers, current medications and disease duration), and patient-reported outcomes (PROs) (including PROMIS pain interference, physical function, fatigue, sleep disturbance, satisfaction with participation in discretionary social activities, and anxiety). The secondary objectives of this study are as follows: * Explore the reliability and predictive validity of biometric sensor data to classify changes in RA disease activity and associated symptoms, including PROs. * To assess adherence and predictors of adherence with use of biometric sensor * Assess/track changes in upadacitinib and adalimumab patients using combined physician, PRO and biosensor data.

Conditions

• Rheumatoid Arthritis

Timeline

• Start date: 2021-03-01
• Primary completion: 2023-12-31
• Completion: 2023-12-31
• First posted: 2022-11-03
• Last updated: 2024-09-26

Locations

1 site across 1 country: United States