Mobile App for Arthritis

(RAPID-PsA Trial)

Overseen By Daniel H. Solomon, MD, MPH

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Brigham and Women's Hospital

Must be taking: Guselkumab, Infliximab, Golimumab, Ustekinumab

Disqualifiers: Non-follow-up at center

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

Approved in 1 Jurisdiction This treatment is already approved in other countries

Compensation: Varies

Number of Visits: Unknown

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a smartphone app designed for people with psoriatic arthritis (PsA). The app aims to help users manage their condition and potentially reduce the number of doctor visits. Researchers will divide participants into two groups: one using the app and one not using it, to determine if the app truly makes a difference. Ideal candidates for this trial are those diagnosed with PsA, who have visited their rheumatologist twice in the past year, use specific medications like guselkumab or infliximab, and own a smartphone. As an unphased study, this trial offers participants the chance to contribute to innovative research that could improve daily management of PsA.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications. However, it requires participants to be using specific medications like guselkumab, infliximab, golimumab, or ustekinumab.

What prior data suggests that this app is safe for arthritis patients?

Research has shown that using a smartphone app for arthritis is safe. Studies have found that these digital tools help track symptoms without causing harm. In one study, patients used an app to monitor their arthritis symptoms and reported improvements in managing their condition, with no serious side effects. Another study found that the app improved communication between patients and doctors, leading to better care. Overall, the app is well-tolerated and offers a safe option for those seeking to manage their arthritis more effectively. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the Mobile App for Arthritis because it leverages technology to potentially transform arthritis care. Unlike traditional treatments like medications or physical therapy, this app offers a digital solution that integrates with electronic health records (EHR) for real-time data tracking and personalized management. This innovative approach could lead to more timely interventions and a better understanding of each patient's unique condition. By offering a convenient, user-friendly platform, it aims to empower patients in managing their symptoms and improving their quality of life.

What evidence suggests that the Arthritis smartphone app is effective for reducing visit frequency in arthritis patients?

Research has shown that using a smartphone app to track arthritis symptoms can enhance communication between patients and doctors, potentially improving treatment decisions. In this trial, one group will use the Arthritis smartphone app, which integrates with electronic health records, to evaluate its impact on symptom tracking over a 12-month period. Some studies suggest that such apps offer a clearer view of symptom changes over time. However, a specific app for rheumatoid arthritis did not significantly increase patient satisfaction or reduce disease activity compared to regular care. Despite mixed results, these apps remain promising tools for managing arthritis symptoms. ^{6 7 8 9 10}

Are You a Good Fit for This Trial?

This trial is for adults over 18 with Psoriatic Arthritis (PsA), diagnosed by a specialist, who've had at least two appointments in the past year. Participants must speak English and own an Android or iPhone smartphone. They should be using specific arthritis medications like guselkumab or infliximab.

Inclusion Criteria

English-speaking

I am currently using guselkumab, infliximab, golimumab, or ustekinumab.

I have been diagnosed with Psoriatic Arthritis by a specialist and have had at least two appointments in the last year.

Exclusion Criteria

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

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

App Integration and Baseline Data Collection

Integration of the app into the EHR and collection of baseline data for PsA patients

1 month

Initial setup and data collection visit

Intervention

Participants use the EHR-integrated app to improve visit timeliness and monitor PROs

9 months

Regular virtual monitoring and in-person visits as needed

Follow-up

Participants are monitored for safety and effectiveness after the intervention period

2 months

Final assessment and satisfaction survey

What Are the Treatments Tested in This Trial?

Interventions

• Arthritis smartphone app

Trial Overview

The study tests if a new version of the Arthritis app can change how often patients need to visit doctors. It compares visit frequency before and after introducing the app, and against a control group not using the app, over 12 months.

How Is the Trial Designed?

Group I: Mobile Application Experimental Treatment 1 Intervention

This arm of the study will contain half the study population after randomization. The participants in this arm will receive the EHR integrated app and follow a 12-month interrupted time series analysis (ITSA) design. n = 260

Group II: Controls Active Control 1 Intervention

This arm of the study will contain half the study population after randomization. The participants in this arm will be from the same rheumatologists as the experimental participants and will be used as concurrent controls by accessing their data on visits from the EHR during the same time period. n = 260

Arthritis smartphone app is already approved in United Kingdom for the following indications:

Approved in United Kingdom as REMORA for:

• Remote monitoring of rheumatoid arthritis symptoms

Who Is Running the Clinical Trial?

Brigham and Women's Hospital

Lead Sponsor

Trials

1,694

Recruited

14,790,000+

Janssen Scientific Affairs, LLC

Industry Sponsor

Trials

165

Recruited

579,000+

Joaquin Duato

Janssen Scientific Affairs, LLC

Chief Executive Officer since 2022

MBA from ESADE, Master of International Management from Thunderbird School of Global Management

Dr. Jijo James, MD

Janssen Scientific Affairs, LLC

Chief Medical Officer since 2014

MD from St. Johns Medical College, MPH from Columbia University

Published Research Related to This Trial

A systematic review identified only 19 unique smartphone apps for monitoring rheumatoid arthritis (RA) disease activity, with most lacking high-quality features recommended by the American College of Rheumatology and European League against Rheumatism (ACR and EULAR).

While some apps included validated instruments for measuring RA disease activity, there is a significant gap in high-quality apps that effectively combine data tracking and the use of composite disease activity measures, highlighting the need for better tools for patients and rheumatologists.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Apps for People With Rheumatoid Arthritis to Monitor Their Disease Activity: A Review of Apps for Best Practice and Quality. Grainger, R., Townsley, H., White, B., et al.[2023]

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]

A study involving 100 rheumatoid arthritis patients found that 86% believed a smartphone application for self-management would be useful, and 83% expressed willingness to use it, indicating strong interest in digital support for managing their condition.

Most patients (82%) were also willing to pay for such an application, with a preference for features that present information in a simple format, highlighting the importance of user-friendly design in health technology.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Smartphone application for rheumatoid arthritis self-management: cross-sectional study revealed the usefulness, willingness to use and patients' needs. Azevedo, R., Bernardes, M., Fonseca, J., et al.[2018]

The LiveWith Arthritis mobile app shows promise in improving self-management behaviors and health outcomes for adults with rheumatoid arthritis, with significant improvements in self-efficacy and trends in reduced pain and disability among users.

Barriers to app usage included frustration with technology and existing self-management systems, indicating that user experience and accessibility features, like voice activation, are crucial for adoption, especially for those with significant hand disability.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A Mobile App With Optical Imaging for the Self-Management of Hand Rheumatoid Arthritis: Pilot Study. Mollard, E., Michaud, K.[2019]

A new electronic patient-reported outcomes (ePRO) app for rheumatoid arthritis (RA) was developed and showed strong adherence among 78 participants over a 6-month period, with a median adherence rate of 79%.

Older age (≥65 years) and lower disease activity at baseline were significant predictors of higher adherence to the app, suggesting that the app may be particularly beneficial for older patients managing their RA.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Patient adherence with a smartphone app for patient-reported outcomes in rheumatoid arthritis. Colls, J., Lee, YC., Xu, C., et al.[2021]

In a study of 103 patients with rheumatoid arthritis (RA) starting treatment with upadacitinib, significant improvements in disease symptoms such as pain, morning stiffness, and fatigue were observed as early as week 1 and continued through week 12.

By week 12, nearly 60% of patients achieved clinically meaningful improvements in disease activity, indicating that upadacitinib is effective for managing RA symptoms, even in patients with prior treatment experience with TNF inhibitors.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A Real-World Effectiveness Study Using a Mobile Application to Evaluate Early Outcomes with Upadacitinib in Rheumatoid Arthritis. Harrold, LR., Zueger, P., Nowell, WB., 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]

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]

Citations

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REmote MOnitoring in Rheumatoid Arthritis (REMORA) v1.0

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

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trialsjournal.biomedcentral.com

trialsjournal.biomedcentral.com/articles/10.1186/s13063-024-08497-9

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nature.com

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This study demonstrates that digital technologies can be used in a well-controlled, remote clinical setting to assess the daily impact of RA.

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