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

September 15, 2025 updated by: Daniel H. Solomon, M.D.,MPH, Brigham and Women's Hospital
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 Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

190

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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
A mobile health application that asks daily questions about participants' pain, function, and disease activity.
Other: Population 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.
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Treatment Satisfaction Questionnaire for Medication (TSQM)
Time Frame: 6 months
6 months
Clinical Disease Activity Index (CDAI)
Time Frame: 6 months
6 months
Perceived Efficacy in Patient-Physician Interactions Questionnaire (PEPPI)
Time Frame: 6 months
6 months

Secondary Outcome Measures

Outcome Measure
Time Frame
Patient Activity Scale-II (PAS-II)
Time Frame: 6 months
6 months
Flare Assessment in Rheumatoid Arthritis (FLARE) questionnaire
Time Frame: 6 months
6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Brigham and Women's Hospital

Collaborators

Pfizer

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2016

Primary Completion (Actual)

September 1, 2025

Study Completion (Actual)

September 1, 2025

Study Registration Dates

First Submitted

June 22, 2016

First Submitted That Met QC Criteria

June 30, 2016

First Posted (Estimated)

July 4, 2016

Study Record Updates

Last Update Posted (Estimated)

September 18, 2025

Last Update Submitted That Met QC Criteria

September 15, 2025

Last Verified

September 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2014P002312

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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