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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 6 months

Awards & highlights

Study 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.Check my eligibility

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.See study design

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 below

Select...

I am currently taking medication for my autoimmune disease.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 6 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~6 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and 6 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Clinical Disease Activity Index (CDAI)

Perceived Efficacy in Patient-Physician Interactions Questionnaire (PEPPI)

Treatment Satisfaction Questionnaire for Medication (TSQM)

Secondary outcome measures

Flare Assessment in Rheumatoid Arthritis (FLARE) questionnaire

Patient Activity Scale-II (PAS-II)

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.

0 / 1Eligibility criteria met