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

NCT07460739 | Not Yet Recruiting

• 2 other identifiers: APHP241727IDRCB 2025-A01504-45
• Study Type: interventional
• Target: 144
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Rhumatoid Arthisis; Spondyloarthritis (SA); Psoriatic Arthritis (PsA)

Keywords

Rhumatoid Arthisis; spondyloarthritis; Psoriatic Arthritis; Mobile Application

Outcome Measures

Primary Outcomes (1)

• safety skills regarding the use of tDMARDS

  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.

  6 month

Secondary Outcomes (7)

• 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

Study Arms (2)

Mobile Application

EXPERIMENTAL

Patients in the intervention group will upload the SFR app

Device: SFR application

information web site

NO INTERVENTION

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

Interventions

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.

Mobile Application

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Assistance Publique - Hôpitaux de Paris: lead

Study Sites (1)

Rheumatology Hopital Saint Antoine

Paris, 75012, France

Location

MeSH Terms

Conditions

Spondylarthritis; Arthritis, Psoriatic

Condition Hierarchy (Ancestors)

Spondylitis; Spinal Diseases; Bone Diseases; Musculoskeletal Diseases; Arthritis; Joint Diseases; Spondylarthropathies; Psoriasis; Skin Diseases, Papulosquamous; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• Catherine BEAUVAIS, Medical Doctor

  Assistance Publique - Hôpitaux de Paris

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Catherine BEAUVAIS, Medical Doctor

CONTACT

+33149282520; catherine.beauvais@aphp.fr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 5, 2026
• First Posted: March 10, 2026
• Study Start: March 1, 2026
• Primary Completion (Estimated): April 1, 2027
• Study Completion (Estimated): April 1, 2027
• Last Updated: March 13, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)