App-based Education and GOal-setting in Rheumatoid Arthritis

Rheumatoid Arthritis Clinical Trial

— AEGORA  

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05888181
• Other study ID #: S66633
• Status: Recruiting
• Phase: N/A
• Start date: March 3, 2023
• Est. completion date: February 29, 2024

Study information

• Verified date: May 2023
• Source: Universitaire Ziekenhuizen KU Leuven
• Contact: Patrick Verschueren, MD, PhD
• Phone: +3216 34 25 41
• Email: patrick.verschueren[@]uzleuven.be
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 120
• Est. completion date: February 29, 2024
• Est. primary completion date: December 31, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Arthritis
• Arthritis, Rheumatoid
• Rheumatoid Arthritis

Intervention

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).

Locations

Country	Name	City	State
Belgium	AZ Sint-Lucas Brugge	Brugge	West-Vlaanderen
Belgium	UZ Leuven	Leuven	Vlaams Brabant

Sponsors (2)

Lead Sponsor	Collaborator
Universitaire Ziekenhuizen KU Leuven	Sidekick Health

Country where clinical trial is conducted

Belgium, 

References & Publications (7)

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Participant engagement with study application: remote monitoring of RAID	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.	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.
Other	Participant engagement with study application: usage of the app	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.	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.
Other	Participant engagement with study application: daily step count	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).	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.
Primary	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	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)
Secondary	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)
Secondary	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)
Secondary	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)