The ArthritisPower Wearable Study

Rheumatoid Arthritis Clinical Trial

— WEAR  

Official title:

Exploring Rheumatoid Arthritis Patients' Disease Activity Using Patient Reported Outcome Measures and Biometric Sensor Data (WEarables Activity in Patients With Rheumatoid Arthritis)

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05603806
• Other study ID #: Pro00047954
• Status: Recruiting
• Start date: March 1, 2021
• Est. completion date: December 31, 2023

Study information

• Verified date: October 2022
• Source: Global Healthy Living Foundation
• Contact: Ben Nowell, PhD
• Phone: (845) 348 0400
• Email: bnowell[@]ghlf.org
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 160
• Est. completion date: December 31, 2023
• Est. primary completion date: December 31, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 19 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Arthritis
• Arthritis, Rheumatoid
• Rheumatoid Arthritis

Locations

Country	Name	City	State
United States	Global Healthy Living Foundation	Upper Nyack	New York

Sponsors (3)

Lead Sponsor	Collaborator
Global Healthy Living Foundation	Illumination Health, University of Alabama at Birmingham

Country where clinical trial is conducted

United States, 

References & Publications (4)

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. Review. — View 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:S16-S21. doi: 10.1097/MLR.0000000000000814. — View 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Correlations between patient reported outcomes (PROs), wearable data, and physician derived data	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 Wearable Data include:Activity- steps, distance, energy expenditure, metabolic equivalents, time walking per day, time in activity intensity per day, active time, aerobic time Heart rate-beats per minute, time in heart rate zones; Sleep-time asleep/restless/awake, and derived variables.; Physician derived outcomes include:Clinical Disease Activity Index (CDAI); RA Clinical Labs (Rheumatoid Factor lab results); Current prescription medications for RA; Years since RA diagnosis	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	Changes in RA disease activity and associated symptoms	Changes in RA will be measured using change in Clinical Disease Activity Index (CDAI) between baseline and follow up visits	CDAI is collected at baseline and then again at a follow up appointment from 2-6 months after baseline.
Secondary	Adherence to PRO measures	Adherence*: percent of days completing ePROs	PROs Data is collected daily for up to 6 months
Secondary	Adherence to wearing Fitbit	Adherence*: percent of days wearing Fitbit	Wearable Data is collected daily for up to 6 months
Secondary	Predictors of adherence	Using Patient Reported Outcomes and wearable data to predict who is adherent to study protocol; 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 Wearable Data include:Activity- steps, distance, energy expenditure, metabolic equivalents, time walking per day, time in activity intensity per day, active time, aerobic time Heart rate-beats per minute, time in heart rate zones; Sleep-time asleep/restless/awake, and derived variables.	PROs and Wearable Data is collected daily for up to 6 months
Secondary	Changes in upadacitinib and adalimumab patients using combined physician, PRO and biosensor data.	Changes will be measured using numerical scales for PROs.; 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 Wearable Data include:Activity- steps, distance, energy expenditure, metabolic equivalents, time walking per day, time in activity intensity per day, active time, aerobic time Heart rate-beats per minute, time in heart rate zones; Sleep-time asleep/restless/awake, and derived variables.; Physician derived outcomes include:Clinical Disease Activity Index (CDAI); RA Clinical Labs (Rheumatoid Factor lab results); Current prescription medications for RA; Years since RA diagnosis	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.

External Links

•   ArthritisPower