App-based Education and GOal-setting in Rheumatoid Arthritis

Study Overview
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Brief Summary
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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.

Official Title
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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

Conditions
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Rheumatoid Arthritis

Intervention / Treatment
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* Other: Mobile app-based self-management intervention


Participation Criteria
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Eligibility Criteria
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Patients will be considered eligible for participation in the study if they: Are able and willing to provide written informed consent for participation. Are 18 years of age or older. Have a diagnosis of RA made by a rheumatologist, with a minimal time since diagnosis of 16 weeks. This time frame was chosen based on conceptual reasons and previous work of our research group, suggesting that the dynamic and impactful first weeks after diagnosis are not the ideal time window to assess psychosocial outcomes. Are able to understand and read Dutch. Have access to a smartphone that meets the technical requirements to run the study application, including an Android (8.0 or more recent) or Apple iOS (14.0 or more recent) operating system, and feel comfortable using it. In order to include an optimally representative patient population, no additional exclusion criteria will be applied for this study.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intervention group A (weekly RAID)<br>Access to the study app with weekly prompts to complete the patient-reported questionnaire Rheumatoid Arthritis Impact of Disease (RAID) | Other: Mobile app-based self-management intervention<br>* 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).<br>|
| Experimental: Intervention group B (monthly RAID)<br>Access to the study app with monthly prompts to complete the patient-reported questionnaire Rheumatoid Arthritis Impact of Disease (RAID) | Other: Mobile app-based self-management intervention<br>* 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).<br>|
| No Intervention: Control group (usual care)<br>No access to the study app, follow-up according to usual care standards. This includes informal screening for general wellbeing during outpatient clinic visits, with referral to specific allied health professionals for additional education or non-pharmacological support if needed. The scores derived from study-related questionnaires can be used as a guide for these discussions. As part of standard care, participants in both the control group and the intervention groups will also receive a standardised educational leaflet about RA. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | At follow-up visit (4-6 months from baseline) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 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. Higher scores indicate more perceived disease impact. | 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. | 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. | At follow-up visit (4-6 months from baseline) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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self-management, mobile health, smartphone applications, education, patient-reported outcomes, lifestyle, goal-setting, remote monitoring