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CompletedNCT05603806WEARUpdated Sep 26, 2024

The ArthritisPower Wearable Study

An observational study in Rheumatoid Arthritis, sponsored by Global Healthy Living Foundation. Completed at 1 site in United States. Open to participants aged 19 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-09-26.

Sponsored by Global Healthy Living Foundation · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
299
Ages
19 Years and older
Sex
All
01

Study 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.
02

Conditions studied

  • 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
03

In context

Arthritis

3,554 studies on the registry are indexed under Arthritis; 317 are open to participants now.

This study's enrollment of 299 is above the median of 155 across 1,057 observational studies indexed under Arthritis.

Browse Arthritis studies →

Lead sponsor

Global Healthy Living Foundation is the lead sponsor of 2 studies on the registry; 1 is open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
19 Years and older
Sexes eligible
All
Accepts healthy volunteers
Yes
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.

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
05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
299 participants (actual)
Patient registry
No

Groups and cohorts

  • RA new treatment starts

    Adult rheumatoid arthritis patients starting treatment on adalimumab or upadacitinib

06

What researchers measure

Primary outcomes

  1. 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

    Time frame: 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

  1. 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

    Time frame: CDAI is collected at baseline and then again at a follow up appointment from 2-6 months after baseline.

  2. Adherence to PRO measures

    Adherence\*: percent of days completing ePROs

    Time frame: PROs Data is collected daily for up to 6 months

  3. Adherence to wearing Fitbit

    Adherence\*: percent of days wearing Fitbit

    Time frame: Wearable Data is collected daily for up to 6 months

  4. 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.

    Time frame: PROs and Wearable Data is collected daily for up to 6 months

  5. 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

    Time frame: 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.

07

Study locations

1 site
  • Global Healthy Living Foundation
    Upper Nyack, New York 10960, United States
08

References and documents

Publications

  • 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. PubMed 31573949 ↗
  • 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. PubMed 30952391 ↗
  • 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. PubMed 30074946 ↗
  • 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. PubMed 30927515 ↗

Related links

Individual participant data

Plan to share: No

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 26, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05603806
Lead sponsor
Global Healthy Living Foundation
Collaborators
University of Alabama at Birmingham, Illumination Health
Responsible party
Sponsor
First posted
Nov 3, 2022
Start date
Mar 1, 2021
Primary completion
Dec 31, 2023
Completion
Dec 31, 2023
Last update
Sep 26, 2024

Study contacts

Laura Stradford, MPH
principal investigator · Global Healthy Living Foundation

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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