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

Rheumatoid Arthritis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT02822521
• Other study ID #: 2014P002312
• Status: Active, not recruiting
• Phase: N/A
• Start date: November 2016
• Est. completion date: June 2024

Study information

• Verified date: February 2023
• Source: Brigham and Women's Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 190
• Est. completion date: June 2024
• Est. primary completion date: May 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Arthritis
• Arthritis, Rheumatoid
• Rheumatoid Arthritis

Intervention

Other:
• Mobile Application
A mobile health application that asks daily questions about participants' pain, function, and disease activity.
• 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.

Locations

Country	Name	City	State
United States	Brigham and Women's Hospital	Boston	Massachusetts

Sponsors (2)

Lead Sponsor	Collaborator
Brigham and Women's Hospital	Pfizer

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Treatment Satisfaction Questionnaire for Medication (TSQM)		6 months
Primary	Clinical Disease Activity Index (CDAI)		6 months
Primary	Perceived Efficacy in Patient-Physician Interactions Questionnaire (PEPPI)		6 months
Secondary	Patient Activity Scale-II (PAS-II)		6 months
Secondary	Flare Assessment in Rheumatoid Arthritis (FLARE) questionnaire		6 months