Rheumatoid ArthritisAEGORANCT05888181
App-based Education and GOal-setting in Rheumatoid Arthritis
A study testing Mobile app-based self-management intervention in people with Rheumatoid Arthritis, run by Universitaire Ziekenhuizen KU Leuven at 2 sites in Belgium.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Rheumatoid Arthritis
- What is being tested?
- Mobile app-based self-management intervention
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 128 participants
- Where
- 2 sitesBelgium
- Study dates
- 3 Mar 2023to 29 Feb 2024
- Phase
- Interventional
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Trial locations and contacts
2 sites in 1 country.
Belgium2 sites
AZ Sint-Lucas Brugge
Bruges, West-Vlaanderen, 8310
UZ Leuven
Leuven, Vlaams Brabant, 3000
About this study
Official title: 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
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
- Being tested
- Mobile app-based self-management intervention
- Keywords
- self-management, mobile health, smartphone applications, education, patient-reported outcomes, lifestyle, goal-setting, remote monitoring
- Medical subject headings
- Arthritis, Rheumatoid
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mobile app-based self-management interventionOther
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).
| Study group | Role | What they receive |
|---|---|---|
| Intervention group A (weekly RAID) | Experimental | Access to the study app with weekly prompts to complete the patient-reported questionnaire Rheumatoid Arthritis Impact of Disease (RAID) Receives: Other: Mobile app-based self-management intervention |
| Intervention group B (monthly RAID) | Experimental | Access to the study app with monthly prompts to complete the patient-reported questionnaire Rheumatoid Arthritis Impact of Disease (RAID) Receives: Other: Mobile app-based self-management intervention |
| Control group (usual care) | No intervention | 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 being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: At follow-up visit (4-6 months from baseline)
Secondary outcomes (4)
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: At follow-up visit (4-6 months from baseline)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jun 2023
- Study start3 Mar 2023
- Primary completion6 Feb 2024
- Study completion29 Feb 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (9)Papers the sponsor has linked to this study.
- Other trials for Rheumatoid ArthritisStudies of the same condition, open and under way.
- More trials run by Universitaire Ziekenhuizen KU LeuvenThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 128 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universitaire Ziekenhuizen KU Leuven
- Sponsor type
- University, hospital or other
- Collaborators
- Sidekick Health
- Responsible party
- Sponsor
- Investigators
- Patrick Verschueren, MD, PhD, Principal investigator, University Hospitals KU Leuven
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05888181
- Sponsor's protocol ID
- S66633
- Acronym
- AEGORA
- Status last verified
- May 2023
- First submitted
- 23 Mar 2023
- Last updated
- 16 May 2025
- Results posted
- Yes, on ClinicalTrials.gov
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Doumen M, Westhovens R, Pazmino S, Bertrand D, Stouten V, Neys C, Creten N, Van Laeken E, Verschueren P, De Cock D. The ideal mHealth-application for rheumatoid arthritis: qualitative findings from stakeholder focus groups. BMC Musculoskelet Disord. 2021 Aug 30;22(1):746. doi: 10.1186/s12891-021-04624-8.
PubMed 34461875Doumen M, De Cock D, Van Lierde C, Betrains A, Pazmino S, Bertrand D, Westhovens R, Verschueren P. Engagement and attrition with eHealth tools for remote monitoring in chronic arthritis: a systematic review and meta-analysis. RMD Open. 2022 Oct;8(2):e002625. doi: 10.1136/rmdopen-2022-002625.
PubMed 36302561Van der Elst K, Mathijssen EGE, Landgren E, Bremander A, De Groef A, Lindqvist E, Nylander M, Peters A, Van den Hoogen F, van Eijk-Hustings Y, Verhoeven G, Vriezekolk JE, Westhovens R, Larsson I. What do patients prefer? A multinational, longitudinal, qualitative study on patient-preferred treatment outcomes in early rheumatoid arthritis. RMD Open. 2020 Sep;6(2):e001339. doi: 10.1136/rmdopen-2020-001339.
PubMed 32938747Van der Elst K, Verschueren P, De Cock D, De Groef A, Stouten V, Pazmino S, Vriezekolk J, Joly J, Moons P, Westhovens R. One in five patients with rapidly and persistently controlled early rheumatoid arthritis report poor well-being after 1 year of treatment. RMD Open. 2020 Apr;6(1):e001146. doi: 10.1136/rmdopen-2019-001146.
PubMed 32371432Doumen M, De Cock D, Pazmino S, Bertrand D, Joly J, Westhovens R, Verschueren P. Psychosocial Burden Predicts Sustained Remission in Early Rheumatoid Arthritis: Unraveling the Complex Interplay of Well-Being and Disease Activity. Arthritis Care Res (Hoboken). 2023 Apr;75(4):758-767. doi: 10.1002/acr.24847. Epub 2022 Nov 28.
PubMed 34931480Doumen M, De Cock D, Pazmino S, Bertrand D, Joly J, Westhovens R, Verschueren P. Treatment response and several patient-reported outcomes are early determinants of future self-efficacy in rheumatoid arthritis. Arthritis Res Ther. 2021 Oct 27;23(1):269. doi: 10.1186/s13075-021-02651-3.
PubMed 34706771Doumen M, Pazmino S, Bertrand D, De Cock D, Joly J, Westhovens R, Verschueren P. Longitudinal trajectories of fatigue in early RA: the role of inflammation, perceived disease impact and early treatment response. Ann Rheum Dis. 2022 Oct;81(10):1385-1391. doi: 10.1136/annrheumdis-2022-222517. Epub 2022 Jun 20.
PubMed 35725296Doumen M, De Meyst E, Lefevre C, Pazmino S, Joly J, Bertrand D, Devinck M, Westhovens R, Verschueren P. Effectiveness and feasibility of a mobile health self-management intervention in rheumatoid arthritis: study protocol for a pragmatic multicentre randomised controlled trial (AEGORA). Trials. 2023 Oct 28;24(1):697. doi: 10.1186/s13063-023-07733-y.
PubMed 37898781Doumen M, De Meyst E, Bertrand D, Pazmino S, Piessens M, Joly J, Devinck M, Westhovens R, Verschueren P. A mobile app to support self-management and remotely monitor disease impact in rheumatoid arthritis: the randomized controlled AEGORA trial. Rheumatology (Oxford). 2025 May 1;64(5):2505-2514. doi: 10.1093/rheumatology/keae638.
PubMed 39576683