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
Overview
- Phase
- N/A
- Intervention
- Not specified
- Conditions
- Rheumatoid Arthritis
- Sponsor
- Universitaire Ziekenhuizen KU Leuven
- Enrollment
- 128
- Locations
- 2
- Primary Endpoint
- Arthritis Self-Efficacy Scale (ASES)
- Status
- Completed
- Last Updated
- 11 months ago
Overview
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.
Investigators
Eligibility Criteria
Inclusion Criteria
- Not provided
Exclusion Criteria
- Not provided
Outcomes
Primary Outcomes
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.
Secondary Outcomes
- 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))