A Novel Mobile App & Population Management System to Manage Rheumatoid Arthritis Flares
NCT02822521
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- 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
- Patients who do not plan on receiving follow-up care at the Brigham and Women's
Hospital Arthritis Center
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Descriptive Information | |||
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Brief Title ICMJE | A Novel Mobile App & Population Management System to Manage Rheumatoid Arthritis Flares | ||
Official Title ICMJE | A Novel Mobile App & Population Management System to Manage Rheumatoid Arthritis Flares | ||
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. | ||
Detailed Description | Not Provided | ||
Study Type ICMJE | Interventional | ||
Study Phase ICMJE | Not Applicable | ||
Study Design ICMJE | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Single (Outcomes Assessor) Primary Purpose: Supportive Care | ||
Condition ICMJE |
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Intervention ICMJE |
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Study Arms ICMJE |
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Publications * |
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. | |||
Recruitment Information | |||
Recruitment Status ICMJE | Active, not recruiting | ||
Actual Enrollment ICMJE | 190 | ||
Original Estimated Enrollment ICMJE | Same as current | ||
Estimated Study Completion Date ICMJE | June 2021 | ||
Estimated Primary Completion Date | December 2020 (Final data collection date for primary outcome measure) | ||
Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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Sex/Gender ICMJE |
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Ages ICMJE | 18 Years and older (Adult, Older Adult) | ||
Accepts Healthy Volunteers ICMJE | No | ||
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||
Listed Location Countries ICMJE | United States | ||
Removed Location Countries | |||
Administrative Information | |||
NCT Number ICMJE | NCT02822521 | ||
Other Study ID Numbers ICMJE | 2014P002312 | ||
Has Data Monitoring Committee | No | ||
U.S. FDA-regulated Product | Not Provided | ||
IPD Sharing Statement ICMJE |
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Responsible Party | Daniel H. Solomon, M.D.,MPH, Brigham and Women's Hospital | ||
Study Sponsor ICMJE | Brigham and Women's Hospital | ||
Collaborators ICMJE | Pfizer | ||
Investigators ICMJE | Not Provided | ||
PRS Account | Brigham and Women's Hospital | ||
Verification Date | July 2020 | ||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |