The ArthritisPower Wearable Study

NCT ID: NCT05603806

Last Updated: 2024-09-26

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 299 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2021-03-01
• Study Completion Date: 2023-12-31

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.

Conditions

Rheumatoid Arthritis

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

RA new treatment starts

Adult rheumatoid arthritis patients starting treatment on adalimumab or upadacitinib

No interventions assigned to this group

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

• Minimum Eligible Age: 19 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

University of Alabama at Birmingham

OTHER

Sponsor Role: collaborator

Illumination Health

NETWORK

Sponsor Role: collaborator

Global Healthy Living Foundation

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Laura Stradford, MPH

Role: PRINCIPAL_INVESTIGATOR

Global Healthy Living Foundation

Locations

Global Healthy Living Foundation

Upper Nyack, New York, United States

Countries

United States

References

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.

Reference Type: BACKGROUND

PMID: 31573949 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 30952391 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 30074946 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 30927515 (View on PubMed)

Related Links

http://arthritispower.org

ArthritisPower

Other Identifiers

Pro00047954

Identifier Type: -

Identifier Source: org_study_id