ArthritisNCT02822521
A Novel Mobile App & Population Management System to Manage Rheumatoid Arthritis Flares
A study testing Mobile Application and Population Management System in people with Arthritis and Rheumatoid Arthritis, run by Brigham and Women's Hospital at 1 site in United States.
Trial summary
The overall objective of this proposal is to implement a smart phone application (app) + population management system to monitor rheumatoid arthritis (RA) disease activity between scheduled physician office visits. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Arthritis, Rheumatoid Arthritis
- What is being tested?
- Mobile Application and Population Management System
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 190 participants
- Where
- 1 siteUnited States
- Study dates
- Nov 2016to Sep 2025
- Phase
- Interventional
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Diagnosis of RA by a board-certified rheumatologist
- Taking a DMARD (sulfasalazine, methotrexate, leflunomide, azathioprine, certolizumab, cyclosporine, adalimumab, etanercept, infliximab, golimumab, abatacept, tocilizumab, anakinra, tofacitinib, rituximab, hydroxychloroquine)
- Own a smart phone with either an Android or iPhone operating system
- Be English-speaking
Who cannot join
- Patients who do not plan on receiving follow-up care at the Brigham and Women's Hospital Arthritis Center
Trial locations and contacts
1 site in 1 country.
United States1 site
Brigham and Women's Hospital
Boston, Massachusetts, 02115
About this study
The overall objective of this proposal is to implement a smart phone application (app) + population management system to monitor rheumatoid arthritis (RA) disease activity between scheduled physician office visits. The population management system includes: 1) a web-based dashboard that consolidates incoming patient-reported data using pre-programmed algorithms to identify increases in disease activity, and 2) the population manager, a trained individual who monitors the web-based dashboard and connects patients with their healthcare providers (HCPs). The investigators central hypothesis is that the combined smart phone app + population management system will improve patient satisfaction and management of RA disease activity.
- Conditions
- Arthritis, Rheumatoid Arthritis
- Being tested
- Mobile Application, Population Management System
- Keywords
- Rheumatoid Arthritis, Mobile Health, Pain, Arthritis
- Medical subject headings
- Arthritis, Arthritis, Rheumatoid, Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mobile ApplicationOther
A mobile health application that asks daily questions about participants' pain, function, and disease activity.
Population Management SystemOther
Study staff will act as care managers behind a web-based dashboard to monitor participants' responses to the daily questions on the mobile application and connect them with their HCPs.
| Study group | Role | What they receive |
|---|---|---|
| Mobile Application + Population Manager | Experimental | This arm of the study will contain half the study population after randomization. The participants in this arm will receive the mobile application with daily questions after the first visit. A population manager will review patient-reported symptoms via a web-base dashboard and contact the subject based on pre-specified guidelines. Receives: Other: Mobile Application; Other: Population Management System |
| No Mobile Application | No intervention | This arm of the study will contain half the study population after randomization. The participants in this arm will not receive the mobile application after the first visit. Although participants will be provided with the contact information of a study staff member, there will be no active contact with the subject unless he/she initiates. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Treatment Satisfaction Questionnaire for Medication (TSQM)
Measured: 6 months
Clinical Disease Activity Index (CDAI)
Measured: 6 months
Perceived Efficacy in Patient-Physician Interactions Questionnaire (PEPPI)
Measured: 6 months
Secondary outcomes (2)
Patient Activity Scale-II (PAS-II)
Measured: 6 months
Flare Assessment in Rheumatoid Arthritis (FLARE) questionnaire
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jul 2016 (estimated)
- Study startNov 2016
- Primary completionSep 2025
- Study completionSep 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for ArthritisStudies of the same condition, open and under way.
- More trials run by Brigham and Women's HospitalThe sponsor's other registered studies.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 190 participants (actual)
Sponsor and investigators
- Lead sponsor
- Brigham and Women's Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Pfizer
- Responsible party
- Principal investigator, Daniel H. Solomon, M.D.,MPH, Brigham and Women's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02822521
- Sponsor's protocol ID
- 2014P002312
- Status last verified
- Sep 2025
- First submitted
- 22 Jun 2016
- Last updated
- 18 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
Lee YC, Lu F, Colls J, Luo D, Wang P, Dunlop DD, Muhammad LN, Song J, Michaud K, Solomon DH. Outcomes of a Mobile App to Monitor Patient-Reported Outcomes in Rheumatoid Arthritis: A Randomized Controlled Trial. Arthritis Rheumatol. 2021 Aug;73(8):1421-1429. doi: 10.1002/art.41686. Epub 2021 Jun 18.
PubMed 33559338Colls J, Lee YC, Xu C, Corrigan C, Lu F, Marquez-Grap G, Murray M, Suh DH, Solomon DH. Patient adherence with a smartphone app for patient-reported outcomes in rheumatoid arthritis. Rheumatology (Oxford). 2021 Jan 5;60(1):108-112. doi: 10.1093/rheumatology/keaa202.
PubMed 32572490Wang P, Luo D, Lu F, Elias JS, Landman AB, Michaud KD, Lee YC. A Novel Mobile App and Population Management System to Manage Rheumatoid Arthritis Flares: Protocol for a Randomized Controlled Trial. JMIR Res Protoc. 2018 Apr 11;7(4):e84. doi: 10.2196/resprot.8771.
PubMed 29643053
Study at a glance
From the registry record, last updated by the sponsor on 18 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Novel Mobile App & Population Management System to Manage Rheumatoid Arthritis Flares
- ClinicalTrials.gov ID
- NCT02822521
- Acronym / sponsor ID
- 2014P002312
- Conditions
- Arthritis, Rheumatoid Arthritis
- Keywords
- Rheumatoid Arthritis, Mobile Health, Pain, Arthritis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 190 participants (actual)
- Lead sponsor
- Brigham and Women's HospitalUniversity, hospital or other
- Collaborators
- Pfizer
- Study start
- Nov 2016
- Primary completion
- Sep 2025 (actual)
- Study completion
- Sep 2025 (actual)
- First posted
- 4 Jul 2016 (estimated)
- 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.
The overall objective of this proposal is to implement a smart phone application (app) + population management system to monitor rheumatoid arthritis (RA) disease activity between scheduled physician office visits. The population management system includes: 1) a web-based dashboard that consolidates incoming patient-reported data using pre-programmed algorithms to identify increases in disease activity, and 2) the population manager, a trained individual who monitors the web-based dashboard and connects patients with their healthcare providers (HCPs). The investigators central hypothesis is that the combined smart phone app + population management system will improve patient satisfaction and management of RA disease activity.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Mobile Application + Population Manager | Experimental | Other: Mobile Application, Other: Population Management SystemThis arm of the study will contain half the study population after randomization. The participants in this arm will receive the mobile application with daily questions after the first visit. A population manager will review patient-reported symptoms via a web-base dashboard and contact the subject based on pre-specified guidelines. |
| No Mobile Application | No intervention | –This arm of the study will contain half the study population after randomization. The participants in this arm will not receive the mobile application after the first visit. Although participants will be provided with the contact information of a study staff member, there will be no active contact with the subject unless he/she initiates. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Diagnosis of RA by a board-certified rheumatologist
- Taking a DMARD (sulfasalazine, methotrexate, leflunomide, azathioprine, certolizumab, cyclosporine, adalimumab, etanercept, infliximab, golimumab, abatacept, tocilizumab, anakinra, tofacitinib, rituximab, hydroxychloroquine)
- Own a smart phone with either an Android or iPhone operating system
- Be English-speaking
Key exclusion criteria (1 listed)
- Patients who do not plan on receiving follow-up care at the Brigham and Women's Hospital Arthritis Center
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Mobile ApplicationA mobile health application that asks daily questions about participants' pain, function, and disease activity. | Other | Mobile Application + Population Manager |
| Population Management SystemStudy staff will act as care managers behind a web-based dashboard to monitor participants' responses to the daily questions on the mobile application and connect them with their HCPs. | Other | Mobile Application + Population Manager |
Primary outcome
Treatment Satisfaction Questionnaire for Medication (TSQM)
Time frame: 6 months
Clinical Disease Activity Index (CDAI)
Time frame: 6 months
Perceived Efficacy in Patient-Physician Interactions Questionnaire (PEPPI)
Time frame: 6 months
2 secondary outcomes
Patient Activity Scale-II (PAS-II)
Time frame: 6 months
Flare Assessment in Rheumatoid Arthritis (FLARE) questionnaire
Time frame: 6 months
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 18 Sep 2025.
- Derived from this study: PubMed 33559338Lee YC, Lu F, Colls J, Luo D, Wang P, Dunlop DD, Muhammad LN, Song J, Michaud K, Solomon DH. Outcomes of a Mobile App to Monitor Patient-Reported Outcomes in Rheumatoid Arthritis: A Randomized Controlled Trial. Arthritis Rheumatol. 2021 Aug;73(8):1421-1429. doi: 10.1002/art.41686. Epub 2021 Jun 18.
- Derived from this study: PubMed 32572490Colls J, Lee YC, Xu C, Corrigan C, Lu F, Marquez-Grap G, Murray M, Suh DH, Solomon DH. Patient adherence with a smartphone app for patient-reported outcomes in rheumatoid arthritis. Rheumatology (Oxford). 2021 Jan 5;60(1):108-112. doi: 10.1093/rheumatology/keaa202.
- Derived from this study: PubMed 29643053Wang P, Luo D, Lu F, Elias JS, Landman AB, Michaud KD, Lee YC. A Novel Mobile App and Population Management System to Manage Rheumatoid Arthritis Flares: Protocol for a Randomized Controlled Trial. JMIR Res Protoc. 2018 Apr 11;7(4):e84. doi: 10.2196/resprot.8771.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Mobile Application and Population Management System in people with Arthritis and Rheumatoid Arthritis, run by Brigham and Women's Hospital 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 4 inclusion and 1 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 18 Sep 2025. 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?
Treatment Satisfaction Questionnaire for Medication (TSQM) (time frame: 6 months). The study lists 3 primary outcomes in all. 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 NCT02822521, which also lists 3 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 18 Sep 2025.