Mobile App for Rheumatoid Arthritis

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Brigham and Women's Hospital

Must be taking: Dmards

Disqualifiers: Non-follow-up at hospital

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

Duration: 12 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new mobile app designed to help people with rheumatoid arthritis (RA) manage their condition better between doctor visits. The app, combined with a population management system, tracks symptoms and alerts healthcare providers if disease activity changes. Participants will either use the app with access to a population manager or continue with their usual care. This trial suits those diagnosed with RA by a specialist, currently taking medication like methotrexate or adalimumab, and owning a smartphone. As an unphased trial, this study offers an opportunity to explore innovative ways to manage RA and improve quality of life.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications. However, since it requires participants to be taking a DMARD (a type of medication for rheumatoid arthritis), it seems likely that you will continue your current medication.

What prior data suggests that this mobile app and population management system are safe for monitoring rheumatoid arthritis?

Research has shown that the mobile app and management system for rheumatoid arthritis (RA) is safe to use. One study found the app to be as effective in managing disease activity as traditional methods. Another study found that patients using the app communicated better with their doctors. No major safety concerns have been reported for this app, suggesting it is well-tolerated by users. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about this trial because it explores a novel way to manage rheumatoid arthritis through digital tools. Unlike traditional treatments that often involve medication and regular doctor visits, this approach uses a mobile application paired with a population management system to provide real-time symptom tracking and personalized care. The mobile app prompts daily health check-ins, while a population manager monitors responses and intervenes as needed, offering a more responsive and tailored patient experience. This method could enhance patient engagement and potentially improve outcomes by addressing symptoms more proactively than standard care methods.

What evidence suggests that this mobile app and population management system is effective for rheumatoid arthritis?

Research has shown that using a mobile app can reduce joint pain and disease activity in people with rheumatoid arthritis (RA). In this trial, one group of participants will receive a mobile application combined with a population management system. Studies have found that these apps can also improve quality of life by helping users track symptoms and communicate with doctors. When combined with a system that manages patient information, these tools can lead to better health outcomes by allowing early detection of worsening symptoms, enabling timely treatment. Overall, these tools help patients feel more in control and satisfied with their care. ^{1 6 7 8 9}

Are You a Good Fit for This Trial?

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.

Inclusion 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.

Exclusion Criteria

Patients who do not plan on receiving follow-up care at the Brigham and Women's Hospital Arthritis Center

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants use a mobile app to report daily symptoms, monitored by a population manager

12 weeks

Regular virtual check-ins via app

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Mobile Application
• Population Management System

Trial Overview 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.

How Is the Trial Designed?

Group I: Mobile Application + Population Manager Experimental Treatment 2 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 Application Active Control 1 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.

Who Is Running the Clinical Trial?

Brigham and Women's Hospital

Lead Sponsor

Trials

1,694

Recruited

14,790,000+

Pfizer

Industry Sponsor

Trials

4,712

Recruited

50,980,000+

Known For

Vaccine Innovations

Top Products

Viagra, Zoloft, Lipitor, Prevnar 13

Albert Bourla

Pfizer

Chief Executive Officer since 2019

PhD in Biotechnology of Reproduction, Aristotle University of Thessaloniki

Patrizia Cavazzoni

Pfizer

Chief Medical Officer

MD from McGill University

Published Research Related to This Trial

Self-management of rheumatoid arthritis (RA) through mobile applications has been shown to empower individuals and improve health outcomes, including reduced disease activity.

The review highlights the growing popularity of mobile health apps for RA self-management and emphasizes the need for future research to assess their efficacy and enhance user adoption and adherence.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Self-Management of Rheumatoid Arthritis: Mobile Applications. Mollard, E., Michaud, K.[2021]

The RheumaLive App was found to provide equivalent patient-reported outcome measures (PROMs) compared to traditional paper methods, indicating its reliability for monitoring rheumatoid arthritis (RA) disease activity.

Patients preferred using the App for documenting their health, with a retention rate of 71.7% after three months, and 87% reported it improved their interaction with healthcare providers, suggesting strong acceptance and potential for enhancing patient management.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Mobile App-based documentation of patient-reported outcomes - 3-months results from a proof-of-concept study on modern rheumatology patient management. Richter, JG., Nannen, C., Chehab, G., et al.[2023]

A smartphone app for self-monitoring rheumatoid arthritis (RA) was found to be noninferior to usual care, meaning it effectively maintained disease activity levels as measured by the Disease Activity Score in 28 joints (DAS28-ESR) over 12 months.

Patients using the app had a 38% reduction in the number of consultations with rheumatologists compared to those receiving usual care, indicating that the app can help manage RA effectively while reducing the need for frequent doctor visits.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Smartphone-Assisted Patient-Initiated Care Versus Usual Care in Patients With Rheumatoid Arthritis and Low Disease Activity: A Randomized Controlled Trial. Seppen, B., Wiegel, J., Ter Wee, MM., et al.[2023]

The use of an electronic patient-reported outcomes (ePRO) web-app (ABATON RA) for rheumatoid arthritis patients allows for continuous remote monitoring, which enhances shared decision-making and helps track disease activity more effectively.

Despite some concerns about the app's usability and the need for reimbursement for ePRO monitoring, both patients and physicians found that the benefits, such as improved disease oversight and reduced paperwork, outweighed the drawbacks.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Digitally supported shared decision-making and treat-to-target in rheumatology: a qualitative study embedded in a multicenter randomized controlled trial. Muehlensiepen, F., May, S., Hadaschik, K., et al.[2023]

Citations

1. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/39737596/

Mobile Application-Based Care on Health Outcomes in ... Mobile app-based care has proven effective in reducing disease activity, alleviating joint pain, and improving quality of life in RA patients.

2. clinicaltrials.gov clinicaltrials.gov/study/NCT06873607?term=apply%20fruit%20oil&checkSpell=&rank=4

Effectiveness Evaluation of a Mobile Application for ... The aim of this experimental study is to develop a mobile application for patients with rheumatoid arthritis based on evidence-based recommendations and to ...

3. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/29643053/

A Novel Mobile App and Population Management System ... Objective: The objective of this study is to implement the mobile app plus the population management system to monitor rheumatoid arthritis ...

4. trialsjournal.biomedcentral.com trialsjournal.biomedcentral.com/articles/10.1186/s13063-023-07733-y

Effectiveness and feasibility of a mobile health self ... The AEGORA trial aims to study the effectiveness of mHealth-based, multicomponent self-management support to improve self-efficacy in the context of RA.

5. jamanetwork.com jamanetwork.com/journals/jamanetworkopen/fullarticle/2803893

Management of Rheumatoid Arthritis With a Digital Health ... These findings suggest that assessing patient-reported outcomes using a smartphone application resulted in clinical improvement in disease activity.

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9483251/

Efficacy and safety of a mobile app intervention in patients ... The objective of this study was to evaluate the efficacy and safety of the digital health application (DHA) in patients with inflammatory arthritis.

7. rmdopen.bmj.com rmdopen.bmj.com/content/7/1/e001566

Impact of assessing patient-reported outcomes with mobile ... App users who discussed app data with their rheumatologist reported more favourably on patient–provider interactions than app users who did not and non-app ...

8. ajmc.com ajmc.com/view/app-improves-disease-control-outcomes-in-rheumatoid-arthritis

App Improves Disease Control Outcomes in Rheumatoid ... Patients with rheumatoid arthritis (RA) who reported clinical information via an app had an increased rate of disease control, according to ...

9. withpower.com withpower.com/trial/phase-arthritis-rheumatoid-10-2016-745f3

Mobile App for Rheumatoid Arthritis · Info for Participants The mobile app for rheumatoid arthritis has been studied for safety, and it was found to be noninferior (not worse) in terms of disease activity compared to ...