NCT05888181Completed
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
Source: ClinicalTrials.gov · Last updated 16 May 2025
Brief summary (registry, in English)
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.
- Status (registry)
- Completed
- Study type
- Interventional
- Enrollment
- 128 (actual)
- First submitted
- 23 Mar 2023
- Start date
- 3 Mar 2023
- Primary completion date
- 6 Feb 2024
- Lead sponsor
- Universitaire Ziekenhuizen KU Leuven
- Diseases
- Rheumatoid arthritis
- NCT number
- NCT05888181
What you commit to
- Study type: Interventional
- Participants enrolled: 128
- From 3 Mar 2023 to the primary completion date, 6 Feb 2024
- 2 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Criteria the registry did not label
- 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.
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (2)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| AZ Sint Lucas, Brugge Coordinator of this site? Confirm its status | Bruges | Belgium | Unknown status |
| UZ Leuven Coordinator of this site? Confirm its status | Leuven | Belgium | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.