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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
NONE
Enrollment
128
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).
UZ Leuven
Leuven, Vlaams Brabant, Belgium
AZ Sint-Lucas Brugge
Bruges, West-Vlaanderen, Belgium
Arthritis Self-Efficacy Scale (ASES)
Superiority outcome. The ASES is a patient-reported questionnaire consisting of 20 items across 2 subscales: self-efficacy for managing pain (range 5-50), and self-efficacy for controlling other symptoms (range 6-60). Both scores can be summed to derive a total ASES-score (range 11-110). Higher scores indicate higher perceived self-efficacy.
Time frame: At follow-up visit (4-6 months from baseline)
Pain Catastrophizing Scale (PCS)
Non-inferiority outcome. The PCS comprises 13 items on a 0-4 Likert scale, resulting in a total score of 0-52 with subscales for rumination, magnification, and helplessness. Higher scores indicate more catastrophic perceptions concerning pain. Additionally, a post-hoc analysis will be carried out comparing the PCS between intervention group A and B, to study the influence of PRO-reporting frequency on pain catastrophising.
Time frame: At follow-up visit (4-6 months from baseline)
Rheumatoid Arthritis Impact of Disease (RAID)
Superiority outcome. The RAID consists of 7 items on a 0-10 numeric rating scale, enquiring about the impact of RA on pain, functional limitations, fatigue, sleep, physical wellbeing, emotional wellbeing, and coping. A total RAID score (0-10) is derived as a weighted average of the 7 subscores (Pain: 21%, Functional disability: 16%, Fatigue: 15%, Emotional well-being: 12%, Sleep: 12%, Coping: 12%, Physical well-being: 12%). Higher scores on both the total scale and the subscales indicate more perceived disease impact.
Time frame: At follow-up visit (4-6 months from baseline)
International Physical Activity Questionnaire Short Form (IPAQ-S)
Superiority outcome. The IPAQ-S is a 7-item questionnaire enquiring about physical activities during the last 7 days. An activity score is obtained for different domains, each multiplied with the accompanying metabolic equivalent of task (MET) value, leading to a sum score corresponding with low, moderate, or high physical activity.
Time frame: At follow-up visit (4-6 months from baseline)
Pittsburgh Sleep Quality Index (PSQI)
Superiority outcome. The PSQI measures sleep quality through 19 items across 7 domains, with a resulting total score ranging from 0-21.Higher scores indicate worse sleep quality.
Time frame: At follow-up visit (4-6 months from baseline)
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