Smartphone app to help people with inflammatory arthritis use their treatments safely
Tests a smartphone app for safe medicine use in adults with inflammatory arthritis.
Plain-language title generated from the registry record
Registry title: Efficacy of a Self-Management Smartphone App to Improve Safety Skills in Patients With Inflammatory Arthritis
Key facts
- Where
- Paris, FranceSee the site
Could this be for you?
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 18 and 75 years old?
Source: NCT07460739, who can take part
Where in France
- Rheumatology Hopital Saint AntoineParis, FranceTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Assistance Publique - Hôpitaux de Paris
- Trial code
- NCT07460739
- Record updated
- 6 November 2026
- Original description
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.Read full original descriptionShow less
Efficacy of a Self-Management Smartphone App in Promoting Safety Skills of Patients With Inflammatory Arthritis Treated by Anti-Rheumatic Drugs
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 usual care, including access to the SFR patient information website.
The secondary hypothesis is that using the app will improve patient adherence and the patient-rheumatologist relationship.
Objectives : To determine whether the mobile application improves patients' ability to acquire safety-related skills in the daily use of targeted disease-modifying antirheumatic drugs (tDMARDs), compared to usual care, including access to an informational website for patients.
The primary outcome will be the change in the BioSecure questionnaire score at 6 months after inclusion, comparing the group using the mobile application with the group using the informational website.
Inclusion: 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: Planned treatment with intravenous bDMARDs in the upcoming year; 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; Any condition that may affect comprehension or treatment adherence (chronic alcoholism, language barrier, severe psychiatric disorders, cognitive impairment); 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; Participation in another interventional clinical trial; Pregnant or breast-feeding woman; Individual under legal protection (tutorship or guardianship) or deprived of freedom.