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

Mass General Brigham

Status: Active, not recruiting

Conditions: Arthritis; Rheumatoid Arthritis

Treatments: Other: Population Management System; Other: Mobile Application

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT02822521

2014P002312

Details and patient eligibility

About

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.

Enrollment: 190 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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190 participants in 2 patient groups

Mobile Application + Population Manager

Experimental group

Description:

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.

Treatment:

Other: Mobile Application

Other: Population Management System

No Mobile Application

No Intervention group

Description:

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.