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

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02822521
Enrollment
190
Registered
2016-07-04
Start date
2016-11-30
Completion date
2025-09-30
Last updated
2025-09-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Arthritis, Rheumatoid Arthritis

Keywords

Rheumatoid Arthritis, Mobile Health, Pain, Arthritis

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.

Interventions

OTHERMobile Application

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

OTHERPopulation 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.

Sponsors

Pfizer
CollaboratorINDUSTRY
Brigham and Women's Hospital
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frame
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

MeasureTime frame
Patient Activity Scale-II (PAS-II)6 months
Flare Assessment in Rheumatoid Arthritis (FLARE) questionnaire6 months

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 24, 2026