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

Study Overview
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Brief Summary
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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.

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

Conditions
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Arthritis, Rheumatoid Arthritis

Intervention / Treatment
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* Other: Mobile Application
* Other: Population Management System


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Mobile Application + Population Manager<br>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. | Other: Mobile Application<br>* A mobile health application that asks daily questions about participants' pain, function, and disease activity.<br>Other: Population Management System<br>* 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.<br>|
| No Intervention: No Mobile Application<br>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. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Patient Activity Scale-II (PAS-II) |  | 6 months | 
| Flare Assessment in Rheumatoid Arthritis (FLARE) questionnaire |  | 6 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Rheumatoid Arthritis, Mobile Health, Pain, Arthritis