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NCT05603806 · ClinicalTrials.gov registry record
The ArthritisPower Wearable Study
A clinical trial, sponsored by Global Healthy Living Foundation.
- Completed
- Registry status
- 299
- Enrollment target
NCT05603806: Completed study, sponsored by Global Healthy Living Foundation.
NCT05603806 is a clinical trial that has completed, run by Global Healthy Living Foundation. The registered enrollment target is 299 participants. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05603806 has completed, sponsored by Global Healthy Living Foundation.
- COMPLETED
- Registry status
- 299 participants
- Enrollment target
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.
Primary Outcome
Pearson correlation coefficient between patient reported outcomes, wearable data, and physician derived data PROs include:Daily- Pain NRS 0-10; Fatigue NRS 0-10; Duration of Morning Joint Stiffness Weekly- Rheumatoid Arthritis Disease Activity Index-5 (RADAI-5); Patient Global Assessment; PROMIS Pain Interference CAT; PROMIS Physical Function CAT; PROMIS Fatigue CAT; PROMIS Sleep Disturbance CAT Monthly- PROMIS Satisfaction with Participation in Discretionary Social Activities; PROMIS Anxiety We
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 299 participants |
| Start Date | 2021-03-01 |
| Est. Completion | 2023-12-31 |
What the finished NCT05603806 record still lists
NCT05603806 is an observational study that tracks outcomes without assigning an intervention. The registered 299 participants enrollment target is mid-sized for trials with a published cap.
The record links to 0 conditions, and to 0 interventions.
NCT05603806 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT05603806 about?
NCT05603806 is a clinical study titled "The ArthritisPower Wearable Study". 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 outc...
What is the current status of trial NCT05603806?
This trial is currently completed. The enrollment target is 299 participants. The study started on 2021-03-01. Estimated completion is 2023-12-31.
Who is sponsoring clinical trial NCT05603806?
This trial is sponsored by Global Healthy Living Foundation, which has 2 total clinical trials registered on ClinicalTrials.gov.
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