N/A
Completed N=122
App-based Education and GOal-setting in Rheumatoid Arthritis
Source: ClinicalTrials.gov NCT05888181 ↗Enrolled (actual)
122
Serious AEs
0.0%
Results posted
May 2025
Primary outcomePrimary: Arthritis Self-Efficacy Scale (ASES) — 74; 74 score on a scale
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Arthritis Self-Efficacy Scale (ASES) |
74; 74 | — |
| SECONDARY Pain Catastrophizing Scale (PCS) |
11; 13 | — |
| SECONDARY Rheumatoid Arthritis Impact of Disease (RAID) |
3.6; 3.5 | — |
| SECONDARY International Physical Activity Questionnaire Short Form (IPAQ-S) |
5036; 4674 | — |
| SECONDARY Pittsburgh Sleep Quality Index (PSQI) |
7.5; 8.0 | — |
Eligibility Criteria
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.
Data sourced from ClinicalTrials.gov (NCT05888181). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.