A Novel Mobile App & Population Management System to Manage Rheumatoid Arthritis Flares
1 other identifier
interventional
190
1 country
1
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Nov 2016
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 22, 2016
CompletedFirst Posted
Study publicly available on registry
July 4, 2016
CompletedStudy Start
First participant enrolled
November 1, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
September 1, 2025
CompletedSeptember 18, 2025
September 1, 2025
8.8 years
June 22, 2016
September 15, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (3)
Treatment Satisfaction Questionnaire for Medication (TSQM)
6 months
Clinical Disease Activity Index (CDAI)
6 months
Perceived Efficacy in Patient-Physician Interactions Questionnaire (PEPPI)
6 months
Secondary Outcomes (2)
Patient Activity Scale-II (PAS-II)
6 months
Flare Assessment in Rheumatoid Arthritis (FLARE) questionnaire
6 months
Study Arms (2)
Mobile Application + Population Manager
EXPERIMENTALThis 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 INTERVENTIONThis 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
A mobile health application that asks daily questions about participants' pain, function, and disease activity.
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.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- Patients who do not plan on receiving follow-up care at the Brigham and Women's Hospital Arthritis Center
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Brigham and Women's Hospitallead
- Pfizercollaborator
Study Sites (1)
Brigham and Women's Hospital
Boston, Massachusetts, 02115, United States
Related Publications (3)
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.
PMID: 33559338DERIVEDColls 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.
PMID: 32572490DERIVEDWang 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.
PMID: 29643053DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- SUPPORTIVE CARE
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor of Medicine
Study Record Dates
First Submitted
June 22, 2016
First Posted
July 4, 2016
Study Start
November 1, 2016
Primary Completion
September 1, 2025
Study Completion
September 1, 2025
Last Updated
September 18, 2025
Record last verified: 2025-09
Data Sharing
- IPD Sharing
- Will not share