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Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT02822521
Other study ID # 2014P002312
Secondary ID
Status Active, not recruiting
Phase N/A
First received
Last updated
Start date November 2016
Est. completion date June 2024

Study information

Verified date February 2023
Source Brigham and Women's Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Active, not recruiting
Enrollment 190
Est. completion date June 2024
Est. primary completion date May 2024
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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

Study Design


Related Conditions & MeSH terms


Intervention

Other:
Mobile Application
A mobile health application that asks daily questions about participants' pain, function, and disease activity.
Population 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.

Locations

Country Name City State
United States Brigham and Women's Hospital Boston Massachusetts

Sponsors (2)

Lead Sponsor Collaborator
Brigham and Women's Hospital Pfizer

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Treatment Satisfaction Questionnaire for Medication (TSQM) 6 months
Primary Clinical Disease Activity Index (CDAI) 6 months
Primary Perceived Efficacy in Patient-Physician Interactions Questionnaire (PEPPI) 6 months
Secondary Patient Activity Scale-II (PAS-II) 6 months
Secondary Flare Assessment in Rheumatoid Arthritis (FLARE) questionnaire 6 months
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