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

190 Participants Needed

Trial Summary

What is the purpose of this trial?

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.

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 data supports the effectiveness of the treatment Mobile Application, Population Management System for Rheumatoid Arthritis?

Research shows that using mobile apps for rheumatoid arthritis can help patients and doctors track disease activity more effectively, leading to better management of symptoms and treatment decisions. Apps allow for continuous monitoring, which can capture disease flares and improve communication between patients and healthcare providers. ^{1 2 3 4 5}

Is the mobile app for rheumatoid arthritis safe to use?

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 usual care, suggesting it is generally safe for use in humans. ^{1 2 5 6 7}

How does the mobile app treatment for rheumatoid arthritis differ from other treatments?

This mobile app treatment for rheumatoid arthritis is unique because it allows patients to self-monitor their disease activity and manage flares between clinic visits, which is not possible with traditional treatments. It provides a way for patients to track their symptoms and communicate with healthcare providers more effectively, potentially reducing the number of in-person visits needed. ^{1 3 5 6 8}

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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

Findings from Research

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 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]

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 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]

References

1. United States pubmed.ncbi.nlm.nih.gov

Self-Management of Rheumatoid Arthritis: Mobile Applications. [2021]

2. Germany 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. [2023]

3. United States pubmed.ncbi.nlm.nih.gov

An m-Health Intervention for Rheumatoid Arthritis in China ("Rheumatism Center" app): Study Protocol for a Prospective Randomized Controlled Trial. [2022]

4. Netherlands pubmed.ncbi.nlm.nih.gov

Patient-Clinician Co-Design Co-Participation in Design of an App for Rheumatoid Arthritis Management via Telehealth Yields an App with High Usability and Acceptance. [2018]

5. Canada pubmed.ncbi.nlm.nih.gov

A Novel Mobile App and Population Management System to Manage Rheumatoid Arthritis Flares: Protocol for a Randomized Controlled Trial. [2020]

6. United States 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. [2023]

7. England 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. [2023]

8. England pubmed.ncbi.nlm.nih.gov

Patient and clinician views on an app for rheumatoid arthritis disease monitoring: Function, implementation and implications. [2021]