App-based Education and GOal-setting in Rheumatoid Arthritis

NCT05888181 | Completed Results

• 1 other identifier: S66633
• Study Type: interventional
• Target: 128
• Locations: 1 country
• Sites: 2

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.

Conditions

Rheumatoid Arthritis

Keywords

self-management; mobile health; smartphone applications; education; patient-reported outcomes; lifestyle; goal-setting; remote monitoring

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• Pain Catastrophizing Scale (PCS)

  At follow-up visit (4-6 months from baseline)

• Rheumatoid Arthritis Impact of Disease (RAID)

  At follow-up visit (4-6 months from baseline)

• International Physical Activity Questionnaire Short Form (IPAQ-S)

  At follow-up visit (4-6 months from baseline)

• Pittsburgh Sleep Quality Index (PSQI)

  At follow-up visit (4-6 months from baseline)

Other Outcomes (3)

• 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.

• 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.

• 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.

Study Arms (3)

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)

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)

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.

Interventions

Mobile app-based self-management intervention OTHER

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).

Intervention group A (weekly RAID); Intervention group B (monthly RAID)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

Sponsors & Collaborators

• Universitaire Ziekenhuizen KU Leuven: lead
• Sidekick Health: collaborator

Study Sites (2)

UZ Leuven

Leuven, Vlaams Brabant, 3000, Belgium

Location

AZ Sint-Lucas Brugge

Bruges, West-Vlaanderen, 8310, Belgium

Location

Related Publications (9)

• 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.

  PMID: 34461875 BACKGROUND

• 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.

  PMID: 36302561 BACKGROUND

• 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.

  PMID: 32938747 BACKGROUND

• 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.

  PMID: 32371432 BACKGROUND

• 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.

  PMID: 34931480 BACKGROUND

• 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.

  PMID: 34706771 BACKGROUND

• 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.

  PMID: 35725296 BACKGROUND

• Doumen 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.

  PMID: 37898781 BACKGROUND

• Doumen 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.

  PMID: 39576683 DERIVED

MeSH Terms

Conditions

Arthritis, Rheumatoid

Condition Hierarchy (Ancestors)

Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Connective Tissue Diseases; Skin and Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases

Results Point of Contact

• Title: Patrick Verschueren
• Organization: UZ Leuven

patrick.verschueren@uzleuven.be

003216342541

Study Officials

• Patrick Verschueren, MD, PhD

  University Hospitals KU Leuven

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 23, 2023
• First Posted: June 5, 2023
• Study Start: March 3, 2023
• Primary Completion: February 6, 2024
• Study Completion: February 29, 2024
• Last Updated: May 16, 2025
• Results First Posted: May 16, 2025

Record last verified: 2023-05

Locations

BE (2)