Rheumatoid ArthritisWEARNCT05603806
The ArthritisPower Wearable Study
An observational study of Rheumatoid Arthritis, run by Global Healthy Living Foundation at 1 site in United States.
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… Read more about this study
- Who is it for?
- Ages 19 years and olderHealthy volunteers can take part
- Conditions the study is for
- Rheumatoid Arthritis
- How many people
- 299 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Mar 2021to 31 Dec 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
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.
Who may be able to join
- 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;
Show all 18Show fewer
- 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
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
United States1 site
Global Healthy Living Foundation
Upper Nyack, New York, 10960
About this 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)
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:
Read more
- 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
- Keywords
- patient-reported outcomes, rheumatoid arthritis, real world evidence, wearable digital technology, real world data, rheumatology, patients, patient-generated health data, mobile technology
- Medical subject headings
- Arthritis, Rheumatoid
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| RA new treatment starts | Adult rheumatoid arthritis patients starting treatment on adalimumab or upadacitinib |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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 (5)
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
Measured: CDAI is collected at baseline and then again at a follow up appointment from 2-6 months after baseline.
Adherence to PRO measures
Adherence*: percent of days completing ePROs
Measured: PROs Data is collected daily for up to 6 months
Adherence to wearing Fitbit
Adherence*: percent of days wearing Fitbit
Measured: Wearable Data is collected daily for up to 6 months
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.
Measured: PROs and Wearable Data is collected daily for up to 6 months
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
Measured: 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.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Nov 2022
- Study start1 Mar 2021
- Primary completion31 Dec 2023
- Study completion31 Dec 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Rheumatoid ArthritisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 299 participants (actual)
Sponsor and investigators
- Lead sponsor
- Global Healthy Living Foundation
- Sponsor type
- University, hospital or other
- Collaborators
- University of Alabama at Birmingham, Illumination Health
- Responsible party
- Sponsor
- Investigators
- Laura Stradford, MPH, Principal investigator, Global Healthy Living Foundation
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05603806
- Sponsor's protocol ID
- Pro00047954
- Acronym
- WEAR
- Status last verified
- Sep 2024
- First submitted
- 22 Sep 2022
- Last updated
- 26 Sep 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
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 31573949Nowell 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 30952391Nowell 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 30074946Yun 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
Study at a glance
From the registry record, last updated by the sponsor on 26 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Exploring Rheumatoid Arthritis Patients' Disease Activity Using Patient Reported Outcome Measures and Biometric Sensor Data (WEarables Activity in Patients With Rheumatoid Arthritis)
- ClinicalTrials.gov ID
- NCT05603806
- Acronym / sponsor ID
- WEAR / Pro00047954
- Conditions
- Rheumatoid Arthritis
- Keywords
- patient-reported outcomes, rheumatoid arthritis, real world evidence, wearable digital technology, real world data, rheumatology, patients, patient-generated health data
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 299 participants (actual)
- Lead sponsor
- Global Healthy Living FoundationUniversity, hospital or other
- Collaborators
- University of Alabama at Birmingham, Illumination Health
- Study start
- 1 Mar 2021 (actual)
- Primary completion
- 31 Dec 2023 (actual)
- Study completion
- 31 Dec 2023 (actual)
- First posted
- 3 Nov 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| RA new treatment starts | – | –Adult rheumatoid arthritis patients starting treatment on adalimumab or upadacitinib |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (18 listed)
- 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;
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Correlations between patient reported outcomes (PROs), wearable data, and physician derived data
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.
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
5 secondary outcomes
Changes in RA disease activity and associated symptoms
Time frame: CDAI is collected at baseline and then again at a follow up appointment from 2-6 months after baseline.
Adherence to PRO measures
Time frame: PROs Data is collected daily for up to 6 months
Adherence to wearing Fitbit
Time frame: Wearable Data is collected daily for up to 6 months
Predictors of adherence
Time frame: PROs and Wearable Data is collected daily for up to 6 months
Changes in upadacitinib and adalimumab patients using combined physician, PRO and biosensor data.
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Sep 2024.
- Background: PubMed 31573949Nowell 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.
- Background: PubMed 30952391Nowell 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.
- Background: PubMed 30074946Nowell 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.
- Background: PubMed 30927515Yun 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.
- ArthritisPowerLink provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Laura Stradford, MPH principal investigator
Global Healthy Living Foundation
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Rheumatoid Arthritis, run by Global Healthy Living Foundation at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 18 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 Sep 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Correlations between patient reported outcomes (PROs), wearable data, and physician derived data (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.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05603806, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Sep 2024.