Clinical trial NCT02822521: A Novel Mobile App & Population Management System to Manage Rheumatoid Arthritis Flares
Official title: A Novel Mobile App & Population Management System to Manage Rheumatoid Arthritis Flares
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Arthritis
Rheumatoid Arthritis
Keywords: Rheumatoid Arthritis
Mobile Health
Pain
Arthritis
Lead sponsor: Brigham and Women's Hospital
Sponsor class: OTHER
Collaborators: name: Pfizer
First posted: 2016-07-04
Enrollment: 190
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.


Eligibility criteria: 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

Primary outcomes:
measure: Treatment Satisfaction Questionnaire for Medication (TSQM)
timeFrame: 6 months
measure: Clinical Disease Activity Index (CDAI)
timeFrame: 6 months
measure: Perceived Efficacy in Patient-Physician Interactions Questionnaire (PEPPI)
timeFrame: 6 months
Secondary outcomes:
measure: Patient Activity Scale-II (PAS-II)
timeFrame: 6 months
measure: Flare Assessment in Rheumatoid Arthritis (FLARE) questionnaire
timeFrame: 6 months
Other outcomes:
Locations:
city: Boston
country: United States
facility: Brigham and Women's Hospital
state: Massachusetts
Study officials:
References:
citation: Lee YC, Lu F, Colls J, Luo D, Wang P, Dunlop DD, Muhammad LN, Song J, Michaud K, Solomon DH. Outcomes of a Mobile App to Monitor Patient-Reported Outcomes in Rheumatoid Arthritis: A Randomized Controlled Trial. Arthritis Rheumatol. 2021 Aug;73(8):1421-1429. doi: 10.1002/art.41686. Epub 2021 Jun 18.
citation: Colls J, Lee YC, Xu C, Corrigan C, Lu F, Marquez-Grap G, Murray M, Suh DH, Solomon DH. Patient adherence with a smartphone app for patient-reported outcomes in rheumatoid arthritis. Rheumatology (Oxford). 2021 Jan 5;60(1):108-112. doi: 10.1093/rheumatology/keaa202.
citation: Wang P, Luo D, Lu F, Elias JS, Landman AB, Michaud KD, Lee YC. A Novel Mobile App and Population Management System to Manage Rheumatoid Arthritis Flares: Protocol for a Randomized Controlled Trial. JMIR Res Protoc. 2018 Apr 11;7(4):e84. doi: 10.2196/resprot.8771.