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OpenTrials
Completed

NCT Number: NCT02822521

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

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.

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Key information

Conditions

Arthritis Arthritis, Rheumatoid Autoimmune Diseases Connective Tissue Diseases Immune System Diseases Joint Diseases Musculoskeletal Diseases Neurologic Manifestations Pain Pathological Conditions, Signs and Symptoms Rheumatic Diseases Rheumatoid Arthritis Signs and Symptoms Skin and Connective Tissue Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Brigham and Women's Hospital

Boston, Massachusetts, 02115, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Mobile application

Other

A mobile health application that asks daily questions about participants' pain, function, and disease activity.

Population Management System

Other

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.

Primary outcomes

  1. Treatment Satisfaction Questionnaire for Medication (TSQM)

    Time frame: 6 months

  2. Clinical Disease Activity Index (CDAI)

    Time frame: 6 months

  3. Perceived Efficacy in Patient-Physician Interactions Questionnaire (PEPPI)

    Time frame: 6 months

Secondary outcomes

  1. Patient Activity Scale-II (PAS-II)

    Time frame: 6 months

  2. Flare Assessment in Rheumatoid Arthritis (FLARE) questionnaire

    Time frame: 6 months

Sponsors and collaborators

Lead sponsor

Brigham and Women's Hospital

Other

Collaborators

  • Pfizer

Registry information

Important dates

Study start
2016
Primary completion
2025
Study completion
2025
First posted
Jul 4, 2016
Registry last updated
Sep 18, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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