A Novel Mobile App & Population Management System to Manage Rheumatoid Arthritis Flares
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|ClinicalTrials.gov Identifier: NCT02822521|
Recruitment Status : Active, not recruiting
First Posted : July 4, 2016
Last Update Posted : July 11, 2019
|Condition or disease||Intervention/treatment||Phase|
|Arthritis Rheumatoid Arthritis||Other: Mobile Application Other: Population Management System||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||190 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Single (Outcomes Assessor)|
|Primary Purpose:||Supportive Care|
|Official Title:||A Novel Mobile App & Population Management System to Manage Rheumatoid Arthritis Flares|
|Study Start Date :||November 2016|
|Estimated Primary Completion Date :||December 2019|
|Estimated Study Completion Date :||June 2020|
Experimental: Mobile Application + Population Manager
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
A mobile health application that asks daily questions about participants' pain, function, and disease activity.
Other: 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.
No Intervention: No Mobile Application
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.
- Treatment Satisfaction Questionnaire for Medication (TSQM) [ Time Frame: 6 months ]
- Clinical Disease Activity Index (CDAI) [ Time Frame: 6 months ]
- Perceived Efficacy in Patient-Physician Interactions Questionnaire (PEPPI) [ Time Frame: 6 months ]
- Patient Activity Scale-II (PAS-II) [ Time Frame: 6 months ]
- Flare Assessment in Rheumatoid Arthritis (FLARE) questionnaire [ Time Frame: 6 months ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02822521
|United States, Massachusetts|
|Brigham and Women's Hospital|
|Boston, Massachusetts, United States, 02115|