App-based Education and GOal-setting in Rheumatoid Arthritis (AEGORA)

May 15, 2025 updated by: Universitaire Ziekenhuizen KU Leuven

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

128

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Belgium
    • Vlaams Brabant
      • Leuven, Vlaams Brabant, Belgium, 3000
        • UZ Leuven
    • West-Vlaanderen
      • Brugge, West-Vlaanderen, Belgium, 8310
        • AZ Sint-Lucas Brugge

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Arthritis Self-Efficacy Scale (ASES)
Time Frame: 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.
At follow-up visit (4-6 months from baseline)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Pain Catastrophizing Scale (PCS)
Time Frame: 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.
At follow-up visit (4-6 months from baseline)
Pittsburgh Sleep Quality Index (PSQI)
Time Frame: 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.
At follow-up visit (4-6 months from baseline)
Rheumatoid Arthritis Impact of Disease (RAID)
Time Frame: 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. 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.
At follow-up visit (4-6 months from baseline)
International Physical Activity Questionnaire Short Form (IPAQ-S)
Time Frame: 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.
At follow-up visit (4-6 months from baseline)

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Participant Engagement With Study Application: Remote Monitoring of RAID
Time Frame: 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.
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
Time Frame: 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.
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
Time Frame: 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).
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.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Universitaire Ziekenhuizen KU Leuven

Collaborators

Sidekick Health

Investigators

  • Principal Investigator: Patrick Verschueren, MD, PhD, University Hospitals KU Leuven

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 3, 2023

Primary Completion (Actual)

February 6, 2024

Study Completion (Actual)

February 29, 2024

Study Registration Dates

First Submitted

March 23, 2023

First Submitted That Met QC Criteria

May 23, 2023

First Posted (Actual)

June 5, 2023

Study Record Updates

Last Update Posted (Actual)

May 16, 2025

Last Update Submitted That Met QC Criteria

May 15, 2025

Last Verified

May 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • S66633

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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