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Mobile App for Rheumatoid Arthritis
N/A
Waitlist Available
Research Sponsored by Brigham and Women's Hospital
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Taking a DMARD (sulfasalazine, methotrexate, leflunomide, azathioprine, certolizumab, cyclosporine, adalimumab, etanercept, infliximab, golimumab, abatacept, tocilizumab, anakinra, tofacitinib, rituximab, hydroxychloroquine)
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 5 years
Awards & highlights
No Placebo-Only Group
Summary
This trial wants to use an app and monitoring system to help people with RA manage their disease activity between doctor visits. It should improve patient satisfaction and help manage RA better.
Who is the study for?
This trial is for English-speaking individuals diagnosed with rheumatoid arthritis by a certified specialist, who own a smartphone (Android or iPhone), and are taking specific RA medications like methotrexate or adalimumab. It's not open to patients not planning on follow-up care at the Brigham and Women's Hospital Arthritis Center.
What is being tested?
The study tests a mobile app combined with a population management system designed to monitor RA activity between doctor visits. The system flags increases in disease activity, alerting healthcare providers through a trained individual monitoring these updates.
What are the potential side effects?
Since this trial involves using an app and data management system rather than medication, traditional side effects aren't expected. However, there may be privacy concerns regarding personal health data handling.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am currently taking medication for my autoimmune disease.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 5 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 5 years
Treatment Details
Awards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: Mobile Application + Population ManagerExperimental Treatment2 Interventions
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.
Group II: No Mobile ApplicationActive Control1 Intervention
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.
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Who is running the clinical trial?
Brigham and Women's HospitalLead Sponsor
1,666 Previous Clinical Trials
11,840,045 Total Patients Enrolled
PfizerIndustry Sponsor
4,658 Previous Clinical Trials
17,877,097 Total Patients Enrolled
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Eligibility Criteria:
This trial includes the following eligibility criteria:- You have a smartphone that runs on either Android or iPhone operating system.You have been diagnosed with rheumatoid arthritis (RA) by a specialized doctor called a rheumatologist.I am currently taking medication for my autoimmune disease.You must be able to speak English.
Research Study Groups:
This trial has the following groups:- Group 1: No Mobile Application
- Group 2: Mobile Application + Population Manager
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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