Mobile App for Arthritis (RAPID-PsA Trial)
Palo Alto (17 mi)Age: 18+
Sex: Any
Travel: May be covered
Time Reimbursement: Varies
Trial Phase: N/A
Recruiting
Sponsor: Brigham and Women's Hospital
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.
Is the Arthritis smartphone app a promising treatment for arthritis?Yes, the Arthritis smartphone app is promising because it helps people manage their arthritis better by allowing them to track their symptoms and treatment needs. It can reduce the number of doctor visits and healthcare costs, and many patients are willing to use and even pay for such an app.5681012
What safety data is available for the arthritis mobile app treatment?The provided research does not contain specific safety data for the arthritis mobile app treatment, including under names like REMORA or Arthritis smartphone app. The studies focus on safety data related to biological therapies and synthetic drugs for rheumatic diseases, adverse event reporting, and disease-modifying antirheumatic drugs, but do not mention mobile app interventions.12347
What data supports the idea that Mobile App for Arthritis is an effective treatment?The available research shows that using mobile apps for managing arthritis can help patients better manage their condition. For example, a study on the LiveWith Arthritis app found that it helps patients track their symptoms and manage their health more actively, which can lead to fewer doctor visits and lower healthcare costs. Another study using the RheumaLive app showed that patients could effectively document their condition, which helps in better disease management. These findings suggest that mobile apps can be a useful tool for people with arthritis to manage their symptoms and improve their quality of life.89101113
Do I have to stop taking my current medications for the trial?The trial requires that you continue using guselkumab, infliximab, golimumab, or ustekinumab.
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.
I am 18 years old or older.
I have been diagnosed with Psoriatic Arthritis by a specialist and have had at least two appointments in the last year.
Treatment Details
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.
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
Standardizing assessment of adverse effects in rheumatology clinical trials. Status of OMERACT Toxicity Working Group March 2000: towards a common understanding of comparative toxicity/safety profiles for antirheumatic therapies. [2007]This paper describes the background and current status of an OMERACT facilitated effort to improve the consistency of adverse event reporting in rheumatology clinical trials. The overall goal is the development of an adverse event assessment tool that would provide a basis for use of common terminology and improve the consistency of reporting severity of side effects within rheumatology clinical trials and during postmarketing surveillance. The resulting Rheumatology Common Toxicity Criteria Index encompassed the following organ systems: allergic/immunologic, cardiac, ENT, gastrointestinal, musculoskeletal, neuropsychiatric, ophthalmologic, pulmonary and skin/integument. Before this tool is widely accepted, its validity, consistency, and feasibility need to be assessed in clinical trials.
Monitoring and assessing the safety of disease-modifying antirheumatic drugs: a West Midlands experience. [2022]Serious adverse events may occur from the use of disease modifying antirheumatic drugs (DMARDs) used to treat rheumatoid arthritis. We describe preliminary data from a regional surveillance scheme. Our aims were to identify a broad range of potential adverse events, to identify deficiencies in care and examine the management of common events in order to improve care.
EULAR points to consider when establishing, analysing and reporting safety data of biologics registers in rheumatology. [2022]The introduction of biological therapies for the treatment of rheumatic diseases has drawn attention to the limitations of traditional means of assessing drug safety. Consequently, a series of European academic biologics registers dedicated to this task have been established. Increasing reliance upon safety data generated from observational drug registers makes it important to convert the lessons learned from such registers into recommendations for rheumatologists embarking upon the establishment of future registers, or analysing and reporting from new and existing registers.
[Severe adverse events from treatment with genetically engineered biological agents in patients with rheumatic diseases]. [2015]To assess the risk of severe adverse events (AEs) within 6 months after treatment with biological agents in patients with rheumatic diseases (RD).
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.
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.
Objectives and methodology of BIOBADASER phase iii. [2021]Describe the objectives, methods and results of the first year of the new version of the Spanish registry of adverse events involving biological therapies and synthetic drugs with an identifiable target in rheumatic diseases (BIOBADASER III).
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.
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.
Self-Management of Rheumatoid Arthritis: Mobile Applications. [2021]To review the self-management of rheumatoid arthritis (RA) using mobile applications.
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.
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.
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).