Efficacy of a Self-Management Smartphone App in Promoting Safety Skills of Patients With Inflammatory Arthritis Treated by Anti-Rheumatic Drugs
New app to help inflammatory arthritis patients manage treatment safety
Plain English Summary
Efficacy of a Self-Management Smartphone App to Improve Safety Skills in Patients With Inflammatory Arthritis is a Not Applicable clinical trial sponsored by Assistance Publique - Hôpitaux de Paris studying Rhumatoid Arthisis, Spondyloarthritis (SA), Psoriatic Arthritis (PsA). This study tests a smartphone app designed to help patients with inflammatory arthritis manage their medications safely. It's for adults aged 18-75 with rheumatoid arthritis, spondyloarthritis, or psoriatic arthritis who are starting a new type of advanced medication. Participants will use the app and complete questionnaires over 6 months, while receiving standard care. Alternatives include traditional patient education programs, but this app aims for more accessible, ongoing support. The trial aims to enroll 144 participants.
Official Summary
Rheumatoid arthritis (RA) and spondyloarthritis (SpA), including psoriatic arthritis (PsA), are chronic painful diseases that impair quality of life. Disease-modifying antirheumatic drugs (DMARDs) are used to control disease activity, reduce functional disability, and improve prognosis. These include conventional DMARDs such as methotrexate, as well as targeted DMARDs (tDMARDs), i.e., biological agents (bDMARDs) like anti-TNF alpha and JAK inhibitors. Patients treated with tDMARDs face a risk of adverse effects, including an increased risk of infections. Therapeutic patient education has been shown to help patients develop safety skills, but its effectiveness is only short-term. Mobile health applications are increasingly used by patients to manage their health. The French Society of Rheumatology (SFR) has developed a smartphone self-management application aimed at supporting people with inflammatory arthritis in managing their treatments, symptoms, and information needs. It provides advice on lifestyle and daily living, promotes treatment adherence, and enables self-assessment of disease status. The app includes seven features: a safety checklist before treatment administration, daily life aids based on French academic recommendations, treatment reminders, self-assessment of overall well-being, disease monitoring (pain, fatigue, patient global assessment of disease activity), periodic advisory messages, and a diary. The application is not a medical device; collected data are stored on the user's smartphone. Patient data are not directly shared with physicians. Patients can use the app during consultations or share screenshots with their doctors. The app is more widely used and has a longer lifespan than most available apps, but its impact on patients still needs evaluation in a randomized controlled trial. The primary hypothesis of the study is that using the app will improve safety skills in patients with inflammatory arthritis treated with tDMARDs compared to
Who Can Participate
Here is what you need to know about eligibility for this trial. You can join if you are between 18 and 75 years old and have been diagnosed with rheumatoid arthritis, spondyloarthritis, or psoriatic arthritis. You must be starting a new advanced medication (biologic or JAK inhibitor) and haven't had recent patient education on these drugs. You need to be able to use a smartphone app, a website, and complete questionnaires, and have social security coverage. You cannot join if you have conditions affecting comprehension or adherence, are planning certain treatments, have already used similar apps, are in another education program, are pregnant or breastfeeding, or are under legal protection. This trial is studying Rhumatoid Arthisis, Spondyloarthritis (SA), Psoriatic Arthritis (PsA), so participants generally need a confirmed diagnosis.
What They're Measuring
The primary outcome measures how well patients learn and use safety skills related to their new medications, meaning patients will be better equipped to handle their treatment safely. The specific primary outcome measures are: safety skills regarding the use of tDMARDS (6 month). These endpoints are how researchers determine whether the treatment is effective and will form the basis of any future regulatory submissions.
About This Phase
This study does not have a traditional clinical phase designation. It may be an observational study that follows patients without intervening in their care, an expanded access or compassionate use program, or other non-interventional research. These studies contribute valuable data about disease progression, treatment patterns, and patient outcomes.
Why This Trial Matters
This trial addresses the need for better, long-term patient support in managing advanced arthritis medications, which carry risks like infections, by evaluating a novel smartphone application. This research targets Rhumatoid Arthisis, Spondyloarthritis (SA), Psoriatic Arthritis (PsA), where improved treatment options are needed.
Investor Insight
This trial signals a growing trend in digital health for chronic disease management, targeting a significant patient population with advanced therapies, and could lead to wider adoption of mHealth too
Is This Trial Right for Me?
Ask your doctor if this app is right for you and how it fits with your treatment plan. You'll be using the app regularly to track symptoms, get reminders, and learn about safe medication use. You can share information from the app, like screenshots, with your doctor during appointments. The trial is being conducted at 1 site. Always discuss clinical trial participation with your healthcare provider before making any decisions. This information is for educational purposes only and is not medical advice.
AI-generated analysis for educational purposes only. This is not medical advice. Discuss clinical trial participation with your doctor. Data sourced from ClinicalTrials.gov.
Study Design
- Study Type: INTERVENTIONAL
- Allocation: RANDOMIZED
- Model: PARALLEL
- Masking: SINGLE
- Enrollment: 144 participants
Interventions
- DEVICE: SFR application — The app includes seven functionalities: a safety checklist before treatment administration, aids in daily life situations based on the French academic recommendations, treatment reminders, global well-being self-assessment, disease monitoring (pain, fatigue, patient global assessment (PGA) of disease activity), periodic counselling messages, and a diary.
Primary Outcomes
- safety skills regarding the use of tDMARDS (6 month)
Secondary Outcomes
- Adherence to tDMARDs (6 month)
- patient-rheumatologist communication (6 month)
- confidence in taking care of one's health (6 month)
- Impact on disease including coping to disease. (6 month)
- Disease activity for rheumatoid arthritis (6 months)
Full Eligibility Criteria
Inclusion Criteria: * Age between 18 and 75 years * Diagnosis of rheumatoid arthritis (RA) according to the 2010 ACR/EULAR classification criteria of the American College of Rheumatology, or axial or peripheral spondyloarthritis (SpA) according to the 2009 ASAS criteria of the Assessment of SpondyloArthritis International Society, or psoriatic arthritis according to the 2009 CASPAR criteria. * Undergoing a treatment change to a tDMARD (biologic or JAK inhibitor) available in the SFR application. * No therapeutic education on tDMARDs in the past two years. * Ability to use a smartphone application. * Ability to use a website. * Ability to complete a questionnaire. * Signed informed consent for the study. * Covered by social security or entitled to social protection. Exclusion Criteria: * Any condition that may affect comprehension or treatment adherence (chronic alcoholism, language barrier, severe psychiatric disorders, cognitive impairment). * Planned treatment with intravenous bDMARDs in the upcoming year. * Patients who have already downloaded self-management applications for their rheumatic disease. * Patients enrolled in a therapeutic education program: face-to-face education by a nurse or healthcare professional, or group education. * Patients who have already received therapeutic education on targeted DMARDs in the past two years: face-to-face education by a nurse or healthcare professional, or group education. * Participation in another interventional clinical trial * Pregnant or breast-feeding woman * Individual under legal protection (tutorship or guardianship) or deprived of freedom
Trial Locations
- Rheumatology Hopital Saint Antoine, Paris, France
Frequently Asked Questions
What is clinical trial NCT07460739?
NCT07460739 is a Not Applicable INTERVENTIONAL study titled "Efficacy of a Self-Management Smartphone App to Improve Safety Skills in Patients With Inflammatory Arthritis." It is currently not yet recruiting and is sponsored by Assistance Publique - Hôpitaux de Paris. The trial targets enrollment of 144 participants.
What conditions does NCT07460739 study?
This trial investigates treatments for Rhumatoid Arthisis, Spondyloarthritis (SA), Psoriatic Arthritis (PsA). The primary condition under study is Rhumatoid Arthisis.
What treatments are being tested in NCT07460739?
The interventions being studied include: SFR application (DEVICE). The app includes seven functionalities: a safety checklist before treatment administration, aids in daily life situations based on the French academic recommendations, treatment reminders, global well-being self-assessment, disease monitoring (pain, fatigue, patient global assessment (PGA) of disease activity), periodic counselling messages, and a diary.
What does Not Applicable mean for NCT07460739?
This study does not have a defined clinical phase. It may be an observational study, expanded access program, or other non-interventional research.
What is the current status of NCT07460739?
This trial is currently "Not Yet Recruiting." It started on 2026-03. The estimated completion date is 2027-04.
Who is sponsoring NCT07460739?
NCT07460739 is sponsored by Assistance Publique - Hôpitaux de Paris. The sponsor is responsible for funding, designing, and overseeing the clinical trial.
How many people can participate in NCT07460739?
The trial aims to enroll 144 participants. The trial has not yet started recruiting.
How is NCT07460739 designed?
This is a interventional study, uses randomized allocation, follows a parallel design, employs single masking. Masking means some participants and/or investigators do not know which treatment group a participant is in, which helps reduce bias.
What are the primary outcomes being measured in NCT07460739?
The primary outcome measures are: safety skills regarding the use of tDMARDS (6 month). These are the main endpoints researchers use to determine whether the treatment is effective.
Where is NCT07460739 being conducted?
This trial is being conducted at 1 site, including Paris (France).
Where can I find official information about NCT07460739?
The official record for NCT07460739 is available on ClinicalTrials.gov at https://clinicaltrials.gov/study/NCT07460739. This government database provides the most up-to-date and detailed information about the trial.
What is NCT07460739 testing in simple terms?
This study tests a smartphone app designed to help patients with inflammatory arthritis manage their medications safely. It's for adults aged 18-75 with rheumatoid arthritis, spondyloarthritis, or psoriatic arthritis who are starting a new type of advanced medication.
Why is this trial significant?
This trial addresses the need for better, long-term patient support in managing advanced arthritis medications, which carry risks like infections, by evaluating a novel smartphone application.
What are the potential risks of participating in NCT07460739?
The app itself has minimal direct risks, but potential side effects are related to the advanced medications used for inflammatory arthritis, such as increased risk of infections. Some patients might experience challenges with smartphone use or app navigation, though the study aims to include those comfortable with technology. As with any clinical trial, participants are closely monitored and can withdraw at any time.
Should I consider participating in NCT07460739?
Ask your doctor if this app is right for you and how it fits with your treatment plan. You'll be using the app regularly to track symptoms, get reminders, and learn about safe medication use. You can share information from the app, like screenshots, with your doctor during appointments. Always discuss clinical trial participation with your healthcare provider to determine if it is appropriate for your specific situation.
What does NCT07460739 signal from an investment perspective?
This trial signals a growing trend in digital health for chronic disease management, targeting a significant patient population with advanced therapies, and could lead to wider adoption of mHealth too This is a Not Applicable trial, which is in early development stages.
What happens if the treatment in this trial doesn't work?
Participants will use the app and complete questionnaires over 6 months, while receiving standard care. Participants in clinical trials always have the right to withdraw and pursue alternative treatments. The study team will help transition patients to other available options.
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This analysis is AI-generated and does not constitute medical advice. Always consult your healthcare provider before making decisions about clinical trial participation.