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

Official title

Efficacy of a Self-Management Smartphone App in Promoting Safety Skills of Patients With Inflammatory Arthritis Treated by Anti-Rheumatic Drugs

Overview

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.

Detailed description

Rheumatoid arthritis (RA) and spondyloarthritis (SpA) including psoriatic arthritis (PsA) represent painful chronic conditions impairing quality of life and work capacities. Disease-modifying anti-rheumatic drugs (DMARDs) are used to control inflammatory Arthritis (IA) disease activity, reduce functional disability and improve prognosis. They include conventional DMARDS (cDMARDs) such as methotrexate, targeted DMARDs (tDMARDs) i.e biologic agents (bDMARDs) such as tumor necrosis factor (TNF) alpha blockers, and Janus-kinase inhibitors (JAKi). The number of DMARDs is increasing (more than 15 DMARDs in France) and have a wide variety of targets and modes of administration . Patients treated by DMARDs are at risk of adverse events, including excess risk of infection, noted more in RA than SpA , in particular because of co-medication with glucocorticoids and/or high disease activity. Measures patients can take to decrease these risks include vaccinations , self-referral and DMARD interruption in some situations such as surgery, dental care or pregnancy, which patients need to discuss with health professionals. A nurse-led patient education has been shown to be effective in promoting safety skills of patients treated by biologics but education is not routinely provided in all rheumatology centres. Moreover, patient education is effective in the short term only, not exceeding 6 months .

Mobile health applications (mhealth apps) have undergone significant development in recent years and are of increasing interest and usefulness to help patients manage their chronic inflammatory arthritis (IA) . With reference to the well-established definition of self-management . that is, "the ability of the individual to manage symptoms, treatment, lifestyle changes and psychosocial and cultural consequences of health conditions", Apps may be appropriate tools for self-management such as medications management, problem-solving, and care coordination or to offer a more holistic approach . However, an app providing information to help patients be more aware of their medications in daily life and adopt appropriate behaviours with risk situations had not been addressed in IA.

In this context, the French Society of Rheumatology ( SFR) developed a self-management smartphone app, with the objective of helping IA people with their treatments, symptoms, and information needs, provide healthy lifestyle and daily life messages and promote adherence to medication and disease self-assessment . 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. The app is not a medical device, data collected are stored within the user's smartphone. Patients' data are not to be directly communicated to the physicians, but patients can make screenshots of their app to communicate with their physician. The app was installed 20,500 times from September 2017 to October 2020 (nowadays 30,000 downloads), with 4300 regular current users. Scores were 4.4/5 stars at Android and iOS stores . The SFR app is the first published app with respect to medication management, all the more in France where very few health apps are available. Apart from SFR app, only one app has been published on medication management, tested on 85 patients . The SFR app is more widely used and has a longer lifespan than most apps available in IA: in the studies by EULAR, 75% people had stopped using m-health apps after 3 months for rheumatic and musculoskeletal diseases and only 5% of these apps were still available 2 years after their launch . Assessment of the impact of the SFR app is important since patients are more likely to download and use the app if it has a proven benefit and 2/3 of patients would use it if recommended by their physicians . Therefore, the impact of SFR app needs to be evaluated in a randomised controlled trial.

The first hypothesis of the study is that the use of the SFR app would promote safety skills of patients with IA treated with DMARDs, compared with usual care including access to a SFR patient information website.

The secondary hypothesis is that the use of the SFR app would promote adherence to tDMARDs and patient-rheumatologist's relationship.

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 outcome measures

• safety skills regarding the use of tDMARDS [Time frame: 6 month]

Secondary outcome measures (7)

• Adherence to tDMARDs [Time frame: 6 month]
• patient-rheumatologist communication [Time frame: 6 month]
• confidence in taking care of one's health [Time frame: 6 month]
• Impact on disease including coping to disease. [Time frame: 6 month]
• Disease activity for rheumatoid arthritis [Time frame: 6 months]
• Disease activity for axial spondyloarthritis [Time frame: 6 months]
• Disease activity for psoriatic arthritis [Time frame: 6 months]

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Single blind

Primary purpose

Supportive care

Study locations

France · 1 center

• Rheumatology Hopital Saint Antoine — Paris

Identifiers

NCT: NCT07460739 · APHP241727 · IDRCB 2025-A01504-45

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗