NCT05603806Completed
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)
Source: ClinicalTrials.gov · Last updated 26 Sept 2024
Brief summary (registry, in English)
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.
- Status (registry)
- Completed
- Study type
- Observational
- Enrollment
- 299 (actual)
- First submitted
- 22 Sept 2022
- Start date
- 1 Mar 2021
- Primary completion date
- 31 Dec 2023
- Lead sponsor
- Global Healthy Living Foundation
- Diseases
- Rheumatoid arthritis
- NCT number
- NCT05603806
What you commit to
- Study type: Observational
- Participants enrolled: 299
- From 1 Mar 2021 to the primary completion date, 31 Dec 2023
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Who the study is looking for
- Age 19 and above who are adults (i.e., the age of majority where they reside)
- Diagnosis of RA by a physician (as indicated by survey screening questions)
- Currently being seen by a U.S. rheumatologist
- Starting on the day of enrollment (with no prior use ever) or soon-to-initiate (i.e. in the next 28 days) upadacitinib or adalimumab for RA
- Ability to walk without the use of assistive devices;
- Have access to a computer or smartphone to take health assessments and a survey;
- Already own a smartphone (iPhone or Android); iPhone 4S and later or Android 4.3 and later
- Are willing to join the ArthritisPower patient registry;
- Are willing to download the ArthritisPower app;
- Are willing to contribute daily and weekly ePROs for at least at 89 days, and health activity tracker data for at least 84 days (lead-in period minimum of 5 days plus main study period 84 days). Some participants may contribute data more than 89 days if there was a lag in receiving their medication and hence later medication start date;
- Are willing to wear the smartwatch while sleeping;
- Are willing to complete the 7-day run-in requirements (i.e. completing daily PRO assessments for at least 5 of 7 days);
- Have started their medication within 30 days of enrolling in the study (i.e. enrolling in ArthritisPower)
- Will not be out of internet access (wifi and/or mobile data) for 4 or more consecutive days during the study; and
- Willing to be contacted by e-mail/text message and/or phone by the study coordinator if participants fail to adhere to the study Protocol or for any study related assistance as required.
- Clinician must collect a CDAI (including the raw scores for the four components - patient global, physician global and tender and swollen joint count) on day of enrollment.
- CDAI must be \>10
- Must have rheumatoid and CCP antibody lab results available, or collect those labs (as part of standard of care during the enrollment visit) if not available
Age in the registry: 19 years to - · Sex: All · Accepts healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Global Healthy Living Foundation Coordinator of this site? Confirm its status | Upper Nyack | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.