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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02822521
Recruitment Status : Active, not recruiting
First Posted : July 4, 2016
Last Update Posted : July 21, 2021
Sponsor:
Collaborator:
Pfizer
Information provided by (Responsible Party):
Daniel H. Solomon, M.D.,MPH, Brigham and Women's Hospital

Study Description
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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.

Condition or disease Intervention/treatment Phase
Arthritis Rheumatoid Arthritis Other: Mobile Application Other: Population Management System Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 190 participants
Allocation: Randomized
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 2021
Estimated Study Completion Date : June 2022

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
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.


Outcome Measures
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Primary Outcome Measures :
  1. Treatment Satisfaction Questionnaire for Medication (TSQM) [ Time Frame: 6 months ]
  2. Clinical Disease Activity Index (CDAI) [ Time Frame: 6 months ]
  3. Perceived Efficacy in Patient-Physician Interactions Questionnaire (PEPPI) [ Time Frame: 6 months ]

Secondary Outcome Measures :
  1. Patient Activity Scale-II (PAS-II) [ Time Frame: 6 months ]
  2. Flare Assessment in Rheumatoid Arthritis (FLARE) questionnaire [ Time Frame: 6 months ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

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


Locations
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United States, Massachusetts
Brigham and Women's Hospital
Boston, Massachusetts, United States, 02115
Sponsors and Collaborators
Brigham and Women's Hospital
Pfizer
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Daniel H. Solomon, M.D.,MPH, Professor of Medicine, Brigham and Women's Hospital
ClinicalTrials.gov Identifier: NCT02822521    
Other Study ID Numbers: 2014P002312
First Posted: July 4, 2016    Key Record Dates
Last Update Posted: July 21, 2021
Last Verified: July 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by Daniel H. Solomon, M.D.,MPH, Brigham and Women's Hospital:
Rheumatoid Arthritis
Mobile Health
Pain
Arthritis
Additional relevant MeSH terms:
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Arthritis
Arthritis, Rheumatoid
Joint Diseases
Musculoskeletal Diseases
 Rheumatic Diseases
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases