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

Not Applicable

Active, not recruiting

• Conditions: Arthritis; Rheumatoid Arthritis
• Interventions: Other: Mobile Application; Other: Population Management System

• 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
• Status Verified: 2024-08
• Last Update Submitted: 2024-08-07
• Last Update Posted: 2024-08-09
• Primary Completion: 2025-05
• Study Completion: 2025-06

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• 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

Arm && Interventions

Group	Intervention	Description
Mobile Application + Population Manager	Population Management System	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.
Mobile Application + Population Manager	Mobile Application	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.

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