Clinical trial NCT05603806: The ArthritisPower Wearable Study
Official title: Exploring Rheumatoid Arthritis Patients' Disease Activity Using Patient Reported Outcome Measures and Biometric Sensor Data (WEarables Activity in Patients With Rheumatoid Arthritis)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Rheumatoid Arthritis
Keywords: patient-reported outcomes
rheumatoid arthritis
real world evidence
wearable digital technology
real world data
rheumatology
patients
patient-generated health data
mobile technology
Lead sponsor: Global Healthy Living Foundation
Sponsor class: OTHER
Collaborators: name: University of Alabama at Birmingham
name: Illumination Health
First posted: 2022-11-03
Enrollment: 299
Sex: ALL
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: The investigators will recruit patients from non-academic clinical settings and the American Arthritis and Rheumatology Associates (AARA) physician network, Bendcare. All patients seen and treated by Bendcare AARA clinicians may participate in this study should they fit the eligibility criteria. Physicians at these sites will identify patients for their coordinators to enroll. All participants must be or must become ArthritisPower members in order to be eligible for this study consistent with Investigator previously approved studies.

Brief 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.


Eligibility criteria: Inclusion Criteria:

* 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

Primary outcomes:
measure: Correlations between patient reported outcomes (PROs), wearable data, and physician derived data
timeFrame: PROs and Wearable Data is collected daily. Physician Derived outcomes are collected at baseline and at follow up appointment at 2-6 months post baseline.
Secondary outcomes:
measure: Changes in RA disease activity and associated symptoms
timeFrame: CDAI is collected at baseline and then again at a follow up appointment from 2-6 months after baseline.
measure: Adherence to PRO measures
timeFrame: PROs Data is collected daily for up to 6 months
measure: Adherence to wearing Fitbit
timeFrame: Wearable Data is collected daily for up to 6 months
measure: Predictors of adherence
timeFrame: PROs and Wearable Data is collected daily for up to 6 months
measure: Changes in upadacitinib and adalimumab patients using combined physician, PRO and biosensor data.
timeFrame: PROs Data is collected daily from baseline physician appointment until follow up appointment. Physician derived outcomes are collected at baseline and then again at a follow up appointment from 2-6 months after baseline.
Other outcomes:
Locations:
city: Upper Nyack
country: United States
facility: Global Healthy Living Foundation
state: New York
Study officials:
affiliation: Global Healthy Living Foundation
name: Laura Stradford, MPH
role: PRINCIPAL_INVESTIGATOR
References:
citation: Nowell WB, Curtis JR, Nolot SK, Curtis D, Venkatachalam S, Owensby JK, Poon JL, Calvin AB, Kannowski CL, Faries DE, Gavigan K, Haynes VS. Digital Tracking of Rheumatoid Arthritis Longitudinally (DIGITAL) Using Biosensor and Patient-Reported Outcome Data: Protocol for a Real-World Study. JMIR Res Protoc. 2019 Sep 26;8(9):e14665. doi: 10.2196/14665.
citation: Nowell WB, Curtis D, Thai M, Wiedmeyer C, Gavigan K, Venkatachalam S, Ginsberg S, Curtis JR. Digital Interventions to Build a Patient Registry for Rheumatology Research. Rheum Dis Clin North Am. 2019 May;45(2):173-186. doi: 10.1016/j.rdc.2019.01.009.
citation: Nowell WB, Curtis JR, Crow-Hercher R. Patient Governance in a Patient-Powered Research Network for Adult Rheumatologic Conditions. Med Care. 2018 Oct;56 Suppl 10 Suppl 1(10 Suppl 1):S16-S21. doi: 10.1097/MLR.0000000000000814.
citation: Yun H, Nowell WB, Curtis D, H Willig J, Yang S, Auriemma M, Chen L, Filby C, Curtis JR. Assessing Rheumatoid Arthritis Disease Activity With Patient-Reported Outcomes Measurement Information System Measures Using Digital Technology. Arthritis Care Res (Hoboken). 2020 Apr;72(4):553-560. doi: 10.1002/acr.23888.