NCT05888181

App-based Education and GOal-setting in Rheumatoid Arthritis

Effectiveness and Feasibility of a Mobile Health Self-management Intervention for Patients With Rheumatoid Arthritis: the App-based Education and GOal-setting in Rheumatoid Arthritis Trial

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 128 (actual)
• Sponsor: Universitaire Ziekenhuizen KU Leuven · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this pragmatic, investigator-initiated, multicentre randomised controlled trial is to study the effectiveness and feasibility of a mobile app-based self-management intervention for patients with rheumatoid arthritis (RA), aiming to improve self-efficacy for the management of RA-related symptoms. The intervention consists of education, lifestyle advice and remote monitoring elements and is based on principles of goal setting, self-efficacy theory and behavioural economics, embedded within a platform supported by motivational features and gamification. The primary endpoint is defined as achieving at least a minimal clinically important difference in arthritis-related self-efficacy (the ASES-score) at the follow-up visit in favour of the intervention group when compared to the control group. Moreover, although qualitative studies have highlighted concerns among both patients and healthcare professionals that mobile apps might induce illness behaviour by increasing patients' awareness of their symptoms, this has rarely been studied in detail. Consequently, data regarding the effects of remote monitoring on symptom hypervigilance remain limited and conflicting. Therefore, this trial additionally aims to assess (as a key secondary objective) if a mobile app-based intervention is associated with changes in pain catastrophising, as a conceptualisation of hypervigilance to symptoms.

Conditions

• Rheumatoid Arthritis

Interventions

Type	Name	Description
OTHER	Mobile app-based self-management intervention	The self-management program, accessible via a smartphone app, comprises several components. First, the app contains an RA-specific educational program presented as videos in 16 weekly modules. Second, the app provides patients with tailored lifestyle advice, both as part of the educational program and in the form of personalized messages from a certified health coach. Third, the study app includes remote monitoring features underpinned by goal-setting principles. For instance, participants can use the app to log daily steps and physical activity, as well as their diet, sleep, and mental health. Personal goals, as well as physical challenges and meditation or mindfulness exercises, can be set up within the app to encourage behavioral change. Finally, patient-reported disease burden can be monitored within the study app via the RAID instrument. Based on random allocation to one of both intervention groups, the RAID will be prompted either weekly (group A) or monthly (group B).

Timeline

• Start date: 2023-03-03
• Primary completion: 2024-02-06
• Completion: 2024-02-29
• First posted: 2023-06-05
• Last updated: 2025-05-16
• Results posted: 2025-05-16

Locations

2 sites across 1 country: Belgium