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?
How is the Arthritis smartphone app treatment different from other arthritis treatments?
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
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
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
Brigham and Women's HospitalBoston, MA
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Who Is Running the Clinical Trial?
Brigham and Women's HospitalLead Sponsor
Janssen Scientific Affairs, LLCIndustry Sponsor
References
Self-Management of Rheumatoid Arthritis: Mobile Applications. [2021]To review the self-management of rheumatoid arthritis (RA) using mobile applications.
A Mobile App With Optical Imaging for the Self-Management of Hand Rheumatoid Arthritis: Pilot Study. [2019]Patient outcomes are improved and the burden to the health care system is reduced when individuals are active self-managers of their own health. There is a need for technology that facilitates self-management of rheumatoid arthritis (RA) and can reduce the number of patient visits, promptly identify treatment needs, and reduce the costs associated with poor RA management. A mobile app named LiveWith Arthritis (eTreatMD, Vancouver, BC) has been developed that allows patients with RA to use their mobile device to regularly collect self-management data and to take objective measurements of the impact of RA on their finger joints using optical imaging technology.
Mobile App-based documentation of patient-reported outcomes - 3-months results from a proof-of-concept study on modern rheumatology patient management. [2023]Mobile medical applications (Apps) offer innovative solutions for patients' self-monitoring and new patient management opportunities. Prior to routine clinical application feasibility and acceptance of disease surveillance using an App that includes electronic (e) patient-reported outcome measures (PROMs) warrant evaluation. Therefore, we performed a proof-of-concept study in which rheumatoid arthritis (RA) patients used an App (RheumaLive) to document their disease.
Patient adherence with a smartphone app for patient-reported outcomes in rheumatoid arthritis. [2021]Electronic patient-reported outcomes (ePROs) transmitted digitally allow patients to communicate with their clinicians and track the activity of chronic diseases, such as RA. Several ePRO smartphone apps have been developed in rheumatology, yet few data have been reported regarding patient adherence. We developed a PRO app for RA and assessed adherence over 6 months.
A Real-World Effectiveness Study Using a Mobile Application to Evaluate Early Outcomes with Upadacitinib in Rheumatoid Arthritis. [2023]The impact of upadacitinib on rheumatoid arthritis (RA) symptoms was evaluated during the first 12 weeks of treatment via patient-reported outcomes (PROs) using a mobile health application (app).
Smartphone application for rheumatoid arthritis self-management: cross-sectional study revealed the usefulness, willingness to use and patients' needs. [2018]Patient-centered smartphone applications have potential to support rheumatoid arthritis (RA) self-management but remain almost unexplored in literature. Therefore, this study evaluated the usefulness of a smartphone application to support RA self-management, the willingness of RA patients to use and pay for it and the features the application should have. In this cross-sectional study, a questionnaire was developed to collect information on population, device ownership, usefulness and willingness to use and pay for a RA self-management application and application features. Descriptive statistics, Chi-square, Fisher's exact test, t test or Mann-Whitney's test and multivariate analysis were used. One hundred RA patients answered the questionnaire. Patients' mean age was 57 ± 11.9 years, most were females (91 %), with multiple drug regimens and a 40 % treatment non-compliance rate. Most patients believed that could have a more active role in self-management (94 %) and reported it would be useful to develop a RA self-management application (86 %). Patients willing to use an application (83 %) were younger, with a possible more active role in self-management, with access to a smartphone, and using short message service, electronic mail and Internet. Multivariate analysis confirmed these results, except the associations regarding access to a smartphone and use of electronic mail and Internet. Fifty-eight patients (82 %) were willing to pay for a RA self-management application and the most requested feature for it was information in a simple format. This study suggested the usefulness and patients' willingness to use and pay for a RA self-management application and provided insight on patients' needs.
Smartphone-Assisted Patient-Initiated Care Versus Usual Care in Patients With Rheumatoid Arthritis and Low Disease Activity: A Randomized Controlled Trial. [2023]We developed a smartphone application for patients with rheumatoid arthritis (RA) that allows them to self-monitor their disease activity in between clinic visits by answering a weekly Routine Assessment of Patient Index Data 3. This study was undertaken to assess the safety (noninferiority in the Disease Activity Score in 28 joints using the erythrocyte sedimentation rate [DAS28-ESR]) and efficacy (reduction in number of visits) of patient-initiated care assisted using a smartphone app, compared to usual care.
Apps for People With Rheumatoid Arthritis to Monitor Their Disease Activity: A Review of Apps for Best Practice and Quality. [2023]Rheumatoid arthritis (RA) is a chronic inflammatory arthritis requiring long-term treatment with regular monitoring by a rheumatologist to achieve good health outcomes. Since people with RA may wish to monitor their own disease activity with a smartphone app, it is important to understand the functions and quality of apps for this purpose.