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

Not Applicable

Completed

• Conditions: Arthritis; Rheumatoid Arthritis

• Registration Number: NCT02822521
• Lead Sponsor: Brigham and Women's Hospital

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2016-06-22
• Study First Submitted QC: 2016-06-30
• Study First Posted: 2016-07-04
• Study Start: 2016-11-01
• Status Verified: 2025-09
• Primary Completion: 2025-09
• Study Completion: 2025-09-01
• Last Update Submitted: 2025-09-15
• Last Update Posted: 2025-09-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 190

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
Flare Assessment in Rheumatoid Arthritis (FLARE) questionnaire	6 months
Patient Activity Scale-II (PAS-II)	6 months

Trial Locations

Locations (1)

Brigham and Women's Hospital; 🇺🇸 Boston, Massachusetts, United States