AEGORA: App-based Education and GOal-setting in Rheumatoid Arthritis
Study Details
Study Description
Brief 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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
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N/A |
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Intervention group A (weekly RAID) 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
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).
|
| Experimental: Intervention group B (monthly RAID) 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
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).
|
| No Intervention: Control group (usual care) 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. |
Outcome Measures
Primary Outcome Measures
- Arthritis Self-Efficacy Scale (ASES) [At follow-up visit (4-6 months from baseline)]
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.
Secondary Outcome Measures
- Pain Catastrophizing Scale (PCS) [At follow-up visit (4-6 months from baseline)]
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.
- Rheumatoid Arthritis Impact of Disease (RAID) [At follow-up visit (4-6 months from baseline)]
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.
- International Physical Activity Questionnaire Short form (IPAQ-S) [At follow-up visit (4-6 months from baseline)]
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.
- Pittsburgh Sleep Quality Index (PSQI) [At follow-up visit (4-6 months from baseline)]
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.
Other Outcome Measures
- Participant engagement with study application: remote monitoring of RAID [Throughout study period (intervention arms only): 4-6 months. Specifically, these data will be collected at the follow-up visit (4-6 months from baseline) and reported for the whole study period.]
The proportion of in-app completed RAID questionnaires will be calculated as the ratio (%) between completed questionnaires and the total number of questionnaires that were prompted throughout the study period.
- Participant engagement with study application: usage of the app [Throughout study period (intervention arms only): 4-6 months. Specifically, these data will be collected at the follow-up visit (4-6 months from baseline) and reported for the whole study period.]
Usage data will be logged passively in the study app. Usage data consist of information concerning how often the app and its core functions are accessed. Specifically, we will calculate the proportion of days where the study app was accessed, and the proportion of days where an educational video was viewed within the study app.
- Participant engagement with study application: daily step count [Throughout study period (intervention arms only): 4-6 months. Specifically, these data will be collected at the follow-up visit (4-6 months from baseline) and reported for the whole study period.]
When users choose to activate this function, the number of steps per day will also be passively logged in the study app. When available, we will analyze daily step patterns descriptively (proportion meeting the WHO-recommended daily target, evolution over time, correlation with IPAQ-S score, and correlation with symptoms based on the RAID).
Eligibility Criteria
Criteria
Patients will be considered eligible for participation in the study if they:
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Are able and willing to provide written informed consent for participation.
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Are 18 years of age or older.
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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.
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Are able to understand and read Dutch.
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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.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | UZ Leuven | Leuven | Vlaams Brabant | Belgium | 3000 |
| 2 | AZ Sint-Lucas Brugge | Brugge | West-Vlaanderen | Belgium | 8310 |
Sponsors and Collaborators
- Universitaire Ziekenhuizen KU Leuven
- Sidekick Health
Investigators
- Principal Investigator: Patrick Verschueren, MD, PhD, University Hospitals KU Leuven
Study Documents (Full-Text)
None provided.More Information
Publications
- Doumen 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.
- Doumen 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. Erratum In: Arthritis Res Ther. 2021 Nov 15;23(1):285.
- Doumen 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.
- Doumen 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.
- 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.
- Van 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.
- Van 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.
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