A Novel Mobile App & Population Management System to Manage Rheumatoid Arthritis Flares
NCT02822521
Last updated date
ABOUT THIS STUDY
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.
Study Location
FOR MORE INFORMATION
Contact a representative by phone, email, or visiting the study website. Please see the references below:
By phone
Pfizer Clinical Trials Contact Center
1-800-718-1021
Eligibility Criteria
condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Arthritis, Rheumatoid Arthritis
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
Adult Trials: 18+ Years
18 + years
Inclusion Criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details
- 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
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details
- Patients who do not plan on receiving follow-up care at the Brigham and Women's
Hospital Arthritis Center
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Questions about a trial? Call or email to reach a Pfizer Clinical Trial Contact Center Representative
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Arthritis, Rheumatoid ArthritisA Novel Mobile App & Population Management System to Manage Rheumatoid Arthritis Flares
NCT02822521
- Boston, Massachusetts
ALL GENDERS
18 Years+
years
MULTIPLE SITES
Advanced Information
| Descriptive Information | |||
|---|---|---|---|
| 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 |
| ||
| Intervention ICMJE |
| ||
| Study Arms ICMJE |
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| Publications * |
| ||
* 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:
| ||
| Sex/Gender ICMJE |
| ||
| 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 |
| ||
| 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 | |||