Abstract
BACKGROUND: Patient education is integral to the treatment and care of patients with rheumatoid arthritis. Change is taking place in the organisation of healthcare systems because of a demographic shift towards ageing populations, an increasing use of technology and advancements in digital technologies, allowing for new interventions. This study will aim to evaluate the effectiveness of a newly developed e-learning patient education programme based on self-management that targets patients with rheumatoid arthritis. METHODS: A pragmatic multi-centre randomised controlled trial is planned. We intend to recruit approximately 200 patients with a new diagnosis (< 3 months) of rheumatoid arthritis. Participants will be randomised 1:1 to web-based patient education delivered through an e-learning programme at home or standard face-to-face patient education provided at the hospital. The primary outcome is self-efficacy. Secondary outcomes are improved knowledge of rheumatoid arthritis, adherence to medication, health literacy level and quality of life. Outcomes will be measured at baseline and follow-up occurring 1, 3, 6 and 12 months after enrolment. Furthermore, data on healthcare utilisation and utilisation of the e-learning programme will be assessed at the 12-month follow-up. Statistical analysis, including differences between groups, will be evaluated using the chi-square and Kruskal-Wallis tests. Statistical analysis will follow the intention-to-treat principle, and analysis of variance will be used to evaluate the within- and between-groups differences testing the hypothesis of the 'superiority' of web-based patient education over standard face-to-face education provided at the hospital. Per protocol analysis will be used to assess the impact of missing data. Enrolment started in February 2021 and will end in June 2022. DISCUSSION: The study is expected to contribute to the evidence on the effectiveness of web-based patient education within rheumatic diseases. If the e-learning programme is effective, it will be incorporated into existing services to improve the self-management of patients with rheumatoid arthritis. Further, this mode of providing patient education may impact the organisation of health care for both rheumatic diseases and other chronic diseases by offering different modes of delivering patient education based on the needs and preferences of patients. TRIAL REGISTRATION: ClinicalTrials.gov identifier NCT04669340. Registered on November 27, 2020. https://www.clinicaltrials.gov/ct2/show/NCT04669340?term=e-learning&cond=Rheumatoid+Arthritis&draw=2&rank=1 . See Additional file 1 for detailed information on the dataset according to the World Health Organization Trial Registration Data Set.