NCT05603806Befejeződött
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)
Forrás: ClinicalTrials.gov · Utoljára frissítve: 2024. szept. 26.
Rövid összefoglaló (regiszter, angolul)
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.
- Állapot (regiszter)
- Befejeződött
- Vizsgálattípus
- Megfigyeléses
- Résztvevők száma
- 299 (tényleges)
- Első benyújtás
- 2022. szept. 22.
- Kezdés
- 2021. márc. 1.
- Elsődleges befejezés
- 2023. dec. 31.
- Fő szponzor
- Global Healthy Living Foundation
- Betegségek
- Rheumatoid arthritis
- NCT-szám
- NCT05603806
Mit vállalsz
- Vizsgálat típusa: Megfigyeléses
- Bevont résztvevők: 299
- 2021. márc. 1. és az elsődleges befejezés (2023. dec. 31.) között
- 1 helyszín, 1 országban
- Vizitek és vizsgálatok: kérdezd a vizsgálat csapatát, a regiszter nem sorolja fel őket
A(z) ClinicalTrials.gov regisztermezőiből összeállítva. A vizsgálat felépítését írja le.
Ki nem vehet részt
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Kiket keres a vizsgálat
- 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
Életkor a regiszterben: 19 év – - · Nem: nők és férfiak · Egészséges önkénteseket is fogad
Helyszínek (1)
Helyszínek a regiszter sorrendjében. Ha a profilodba mented a városodat, távolság szerint rendeződnek.
| Helyszín | Város | Ország | Helyszín állapota |
|---|---|---|---|
| Global Healthy Living Foundation | Upper Nyack | Egyesült Államok | Ismeretlen állapot |
Ez az oldal tájékoztatás, nem orvosi tanács. Bármely vizsgálatról az orvosoddal beszélj.