~57 spots leftby Jun 2025

Mobile App for Arthritis

(RAPID-PsA Trial)

Recruiting in Palo Alto (17 mi)
Age: 18+
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Academic
Recruiting
Sponsor: Brigham and Women's Hospital
Must be taking: Guselkumab, Infliximab, Golimumab, Ustekinumab
Disqualifiers: Non-follow-up at center
No Placebo Group
Approved in 1 Jurisdiction

Trial Summary

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.

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.12345

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.12678

Research Team

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 am 18 years old or older.
See 2 more

Exclusion Criteria

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

Trial 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 (Behavioural Intervention)
Trial OverviewThe 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
2Treatment groups
Experimental Treatment
Active Control
Group I: Mobile ApplicationExperimental Treatment1 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: ControlsActive Control1 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

Find a Clinic Near You

Who Is Running the Clinical Trial?

Brigham and Women's Hospital

Lead Sponsor

Trials
1,694
Recruited
14,790,000+
Dr. William Curry profile image

Dr. William Curry

Brigham and Women's Hospital

Chief Medical Officer

MD from Columbia University College of Physicians and Surgeons

Dr. Scott Schissel profile image

Dr. Scott Schissel

Brigham and Women's Hospital

Chief Executive Officer since 2021

MD from Columbia University College of Physicians and Surgeons

Janssen Scientific Affairs, LLC

Industry Sponsor

Trials
165
Recruited
579,000+
Ricardo Attar profile image

Ricardo Attar

Janssen Scientific Affairs, LLC

Chief Executive Officer since 2008

PhD in Molecular Biology, University of Buenos Aires

Dr. Anastasia G. Daifotis profile image

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.
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.
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.
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

Self-Management of Rheumatoid Arthritis: Mobile Applications. [2021]
A Mobile App With Optical Imaging for the Self-Management of Hand Rheumatoid Arthritis: Pilot Study. [2019]
Mobile App-based documentation of patient-reported outcomes - 3-months results from a proof-of-concept study on modern rheumatology patient management. [2023]
Patient adherence with a smartphone app for patient-reported outcomes in rheumatoid arthritis. [2021]
A Real-World Effectiveness Study Using a Mobile Application to Evaluate Early Outcomes with Upadacitinib in Rheumatoid Arthritis. [2023]
Smartphone application for rheumatoid arthritis self-management: cross-sectional study revealed the usefulness, willingness to use and patients' needs. [2018]
Smartphone-Assisted Patient-Initiated Care Versus Usual Care in Patients With Rheumatoid Arthritis and Low Disease Activity: A Randomized Controlled Trial. [2023]
Apps for People With Rheumatoid Arthritis to Monitor Their Disease Activity: A Review of Apps for Best Practice and Quality. [2023]