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The ArthritisPower Wearable Study

NCT05603806 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 299

Last updated 2024-09-26

No results posted yet for this study

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

Sponsors & Collaborators

  • University of Alabama at Birmingham

    collaborator OTHER

  • Illumination Health

    collaborator NETWORK

  • Global Healthy Living Foundation

    lead OTHER

Principal Investigators

  • Laura Stradford, MPH · Global Healthy Living Foundation

Eligibility

Min Age
19 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2021-03-01
Primary Completion
2023-12-31
Completion
2023-12-31

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05603806 on ClinicalTrials.gov