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CompletedNCT02822521Updated Sep 18, 2025

A Novel Mobile App & Population Management System to Manage Rheumatoid Arthritis Flares

An interventional study of Mobile Application and Population Management System in Arthritis and Rheumatoid Arthritis, sponsored by Brigham and Women's Hospital. Completed at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-09-18.

Sponsored by Brigham and Women's Hospital · Not applicable, Interventional, and Supportive care

Phase
Not applicable
Study type
Interventional
Enrollment
190
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study 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. 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.

02

Conditions studied

  • Arthritis
  • Rheumatoid Arthritis

Keywords

  • Rheumatoid Arthritis
  • Mobile Health
  • Pain
  • Arthritis
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 190 is above the median of 90 across 2,377 interventional studies indexed under Arthritis.

Browse Arthritis studies →

Lead sponsor

Brigham and Women's Hospital is the lead sponsor of 1,236 studies on the registry; 224 are open to participants now.

Of its 116 completed or terminated interventional studies of FDA-regulated products, 64 (55%) have results posted.

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

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • 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

Exclusion criteria

Exclusion Criteria:

  • Patients who do not plan on receiving follow-up care at the Brigham and Women's Hospital Arthritis Center
05

Study design

Phase
Not applicable
Primary purpose
Supportive care
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Outcomes assessor)
Enrollment
190 participants (actual)

Study arms

  • Experimental
    Mobile Application + Population Manager

    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.

    Other: Mobile Application · Other: Population Management System

  • No intervention
    No Mobile Application

    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.

Interventions

  • OtherMobile Application

    A mobile health application that asks daily questions about participants' pain, function, and disease activity.

  • OtherPopulation Management System

    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.

06

What researchers measure

Primary outcomes

  1. Treatment Satisfaction Questionnaire for Medication (TSQM)

    Time frame: 6 months

  2. Clinical Disease Activity Index (CDAI)

    Time frame: 6 months

  3. Perceived Efficacy in Patient-Physician Interactions Questionnaire (PEPPI)

    Time frame: 6 months

Secondary outcomes

  1. Patient Activity Scale-II (PAS-II)

    Time frame: 6 months

  2. Flare Assessment in Rheumatoid Arthritis (FLARE) questionnaire

    Time frame: 6 months

07

Study locations

1 site
  • Brigham and Women's Hospital
    Boston, Massachusetts 02115, United States
08

References and documents

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 33559338 ↗
  • Colls 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 32572490 ↗
  • Wang 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 ↗

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 18, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT02822521
Lead sponsor
Brigham and Women's Hospital
Collaborators
Pfizer
Responsible party
Daniel H. Solomon, M.D.,MPH (Professor of Medicine, Brigham and Women's Hospital) — Principal investigator
First posted
Jul 4, 2016
Start date
Nov 2016
Primary completion
Sep 2025
Completion
Sep 2025
Last update
Sep 18, 2025

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Sep 2025. You cannot join it, but the record below documents what was studied.

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