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

Condition(s) studied

Investigational drug(s) / intervention(s)

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.

Study 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 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.

Eligibility

Primary outcome measure(s)

• safety skills regarding the use of tDMARDS — 6 month
  safety skills regarding the use of tDMARDS will be assessed by the change of the updated BioSecure questionnaire score at 6 months from baseline in the SFR mobile app group versus the control group. The scores ranges from 0 to 50. A higher scores represents higher safety skills.

Trial sites (1)

More Assistance Publique - Hôpitaux de Paris trials in France

Other trials for the same condition