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

Primary Purpose

Arthritis, Rheumatoid Arthritis

Status
Active
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Mobile Application
Population Management System
Sponsored by
Brigham and Women's Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Arthritis focused on measuring Rheumatoid Arthritis, Mobile Health, Pain, Arthritis

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Brigham and Women's Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Mobile Application + Population Manager

No Mobile Application

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

Treatment Satisfaction Questionnaire for Medication (TSQM)
Clinical Disease Activity Index (CDAI)
Perceived Efficacy in Patient-Physician Interactions Questionnaire (PEPPI)

Secondary Outcome Measures

Patient Activity Scale-II (PAS-II)
Flare Assessment in Rheumatoid Arthritis (FLARE) questionnaire

Full Information

First Posted
June 22, 2016
Last Updated
February 16, 2023
Sponsor
Brigham and Women's Hospital
Collaborators
Pfizer
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1. Study Identification

Unique Protocol Identification Number
NCT02822521
Brief Title
A Novel Mobile App & Population Management System to Manage Rheumatoid Arthritis Flares
Official Title
A Novel Mobile App & Population Management System to Manage Rheumatoid Arthritis Flares
Study Type
Interventional

2. Study Status

Record Verification Date
February 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
November 2016 (undefined)
Primary Completion Date
May 2024 (Anticipated)
Study Completion Date
June 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Brigham and Women's Hospital
Collaborators
Pfizer

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Arthritis, Rheumatoid Arthritis
Keywords
Rheumatoid Arthritis, Mobile Health, Pain, Arthritis

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
190 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Mobile Application + Population Manager
Arm Type
Experimental
Arm Description
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.
Arm Title
No Mobile Application
Arm Type
No Intervention
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
Mobile Application
Intervention Description
A mobile health application that asks daily questions about participants' pain, function, and disease activity.
Intervention Type
Other
Intervention Name(s)
Population Management System
Intervention Description
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.
Primary Outcome Measure Information:
Title
Treatment Satisfaction Questionnaire for Medication (TSQM)
Time Frame
6 months
Title
Clinical Disease Activity Index (CDAI)
Time Frame
6 months
Title
Perceived Efficacy in Patient-Physician Interactions Questionnaire (PEPPI)
Time Frame
6 months
Secondary Outcome Measure Information:
Title
Patient Activity Scale-II (PAS-II)
Time Frame
6 months
Title
Flare Assessment in Rheumatoid Arthritis (FLARE) questionnaire
Time Frame
6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Facility Information:
Facility Name
Brigham and Women's Hospital
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02115
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
33559338
Citation
Lee YC, Lu F, Colls J, Luo D, Wang P, Dunlop DD, Muhammad LN, Song J, Michaud K, Solomon DH. Outcomes of a Mobile App to Monitor Patient-Reported Outcomes in Rheumatoid Arthritis: A Randomized Controlled Trial. Arthritis Rheumatol. 2021 Aug;73(8):1421-1429. doi: 10.1002/art.41686. Epub 2021 Jun 18.
Results Reference
derived
PubMed Identifier
32572490
Citation
Colls J, Lee YC, Xu C, Corrigan C, Lu F, Marquez-Grap G, Murray M, Suh DH, Solomon DH. Patient adherence with a smartphone app for patient-reported outcomes in rheumatoid arthritis. Rheumatology (Oxford). 2021 Jan 5;60(1):108-112. doi: 10.1093/rheumatology/keaa202.
Results Reference
derived
PubMed Identifier
29643053
Citation
Wang P, Luo D, Lu F, Elias JS, Landman AB, Michaud KD, Lee YC. A Novel Mobile App and Population Management System to Manage Rheumatoid Arthritis Flares: Protocol for a Randomized Controlled Trial. JMIR Res Protoc. 2018 Apr 11;7(4):e84. doi: 10.2196/resprot.8771.
Results Reference
derived

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

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