RHUMATOSMARTNCT07460739

Efficacy of a Self-Management Smartphone App to Improve Safety Skills in Patients With Inflammatory Arthritis

StatusRecruiting

PhaseNot applicable

SponsorAssistance Publique - Hôpitaux de Paris

Primary completionSep 2027 (estimated)

At risk: Primary completion moved at least 4 months later.

See at-risk trials from Assistance Publique - Hôpitaux de Paris

Track this trial

Free. We email you which fields changed when ClinicalTrials.gov updates this record.

Record History

All 3 versions: 3 with changes below. See every version on ClinicalTrials.gov ↗

Notable Nov 5, 2026 Recruitment opened Show 5 more changesShow less
- Start date changed from estimate of Mar 2026 to Aug 31, 2026
- Eligibility criteria expanded, about 17 words
- Primary and study completion pushed from Apr 2027 to Sep 2027
- Secondary endpoints: details revised at 6 of 7 entries
- Site details revised
Notable Mar 11, 2026 Eligibility criteria expanded, about 15 words
- Secondary endpoints: details revised at 2 of 7 entries
v2
Mar 4, 2026 Study First Submitted

Notable: the plan changed

Endpoints

Primary

safety skills regarding the use of tDMARDS

Timeframe: 6 month

Secondary (7)

Adherence to tDMARDs

patient-rheumatologist communication

confidence in taking care of one's health

Impact on disease including coping to disease.

Disease activity for rheumatoid arthritis

Show 2 moreShow less

Disease activity for axial spondyloarthritis

Disease activity for psoriatic arthritis

Arms and interventions

Mobile ApplicationExperimental

Patients in the intervention group will upload the SFR app

information web siteNo intervention

Patients of both group willreceive a link that will give them access to SRF web site

Devices: SFR application

Sites

1 site in 1 country

Rheumatology Hopital Saint AntoineParis, France

About this trial

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.

Trial details

Enrollment: 144 participants (estimated)
Started: Aug 31, 2026
Study completion: Sep 2027 (estimated)
Eligibility: 18 to 75, all sexes, no healthy volunteers
Design: Interventional, randomized, single blind, supportive care
Oversight: No data monitoring committee
Conditions: Arthritis, Psoriatic, Spondylarthritis, Rhumatoid Arthisis, Spondyloarthritis (SA), Psoriatic Arthritis (PsA)
Official title: Efficacy of a Self-Management Smartphone App in Promoting Safety Skills of Patients With Inflammatory Arthritis Treated by Anti-Rheumatic Drugs
First posted: Mar 10, 2026
Registry updated: Nov 6, 2026
Last verified: Nov 2026

Related trials at risk

View on ClinicalTrials.gov ↗