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

400 Participants Needed

Trial Summary

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 data supports the effectiveness of the treatment for arthritis using the REMORA smartphone app?

Research shows that mobile apps for managing rheumatoid arthritis (RA) can help patients track their symptoms and communicate with healthcare providers, leading to better self-management and potentially reducing healthcare visits and costs. ^{1 2 3 4 5}

How is the Arthritis smartphone app treatment different from other arthritis treatments?

The Arthritis smartphone app, also known as REMORA, is unique because it empowers patients to actively manage their arthritis by using their mobile devices to track symptoms and disease activity, potentially reducing the need for frequent doctor visits and lowering healthcare costs. ^{1 2 6 7 8}

What is the purpose of this trial?

The overall objective of this proposal is to test version 3.0 of the Arthritis smartphone app in a 12-month interrupted time series analysis (ITSA) design which will allow us to observe possible differences in visit frequency between the pre-and post-intervention periods as well as between the concurrent control group and those who receive the app. Our central hypothesis is that introduction of the app will reduce visit numbers per month in the group receiving the app, compared with a concurrent control group.

Eligibility Criteria

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

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

English-speaking

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

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

Treatment Details

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.

Participant Groups

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 = 200

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 = 200

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+

Ricardo Attar

Janssen Scientific Affairs, LLC

Chief Executive Officer since 2008

PhD in Molecular Biology, University of Buenos Aires

Dr. Anastasia G. Daifotis

Janssen Scientific Affairs, LLC

Chief Medical Officer since 2023

MD

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 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]

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 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]

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]

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]

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]

References

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

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

2. Canada pubmed.ncbi.nlm.nih.gov

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

3. 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]

4. England pubmed.ncbi.nlm.nih.gov

Patient adherence with a smartphone app for patient-reported outcomes in rheumatoid arthritis. [2021]

5. England pubmed.ncbi.nlm.nih.gov

A Real-World Effectiveness Study Using a Mobile Application to Evaluate Early Outcomes with Upadacitinib in Rheumatoid Arthritis. [2023]

6. Germany pubmed.ncbi.nlm.nih.gov

Smartphone application for rheumatoid arthritis self-management: cross-sectional study revealed the usefulness, willingness to use and patients' needs. [2018]

7. 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]

8. Canada 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. [2023]