Understanding magnetic resonance imaging in multiple sclerosis (UMIMS) and accompanying process evaluation: study protocol for a double-blind, randomized controlled trial using an evidence-based patient information website

Background: While Magnetic Resonance Imaging (MRI) plays a major role in the lives of people with multiple sclerosis (pwMS), studies have shown that MRI-specific knowledge in pwMS is limited. Moreover, poor knowledge was associated with negative feelings towards MRI (e.g. anxiety concerning MRI scan). Because information sources about MRI in MS for pwMS are not available, we designed and evaluated an evidence-based online educational platform about MRI in MS called “Understanding MRI in MS” (UMIMS). Based on a pilot study in 104 subjects, an educational intervention was found to be feasible and effective. We hypothesize, that MRI-specific knowledge can be increased by using UMIMS and that, subsequently, negative feelings towards MRI will be reduced and shared decision making competences increased.Methods: This randomized, controlled, double-blinded trial will recruit n=120 pwMS. The intervention group will receive access to UMIMS. The control group will get access to a specifically developed control website, which visually imitates UMIMS, and contains the standard information available by several MS self-help organisations. The change in MRI-specific knowledge assessed via the MRI-risk knowledge questionnaire (MRI-RIKNO) after the intervention is the primary endpoint at 2 weeks. Several secondary endpoints will be assessed at different timepoints throughout the study, e.g. emotions towards MRI, autonomy preferences, threat by MS and shared decision-making competences. The study includes a process evaluation.Discussion: The aim of this randomized, controlled, double-blind trial recruiting n=120 pwMSis to assess the effect of the evidence-based online educational tool “UMIMS” on MRI-specific knowledge.Additonally, secondary endpoints (e.g. emotions towards MRI) will be assessed and a process evaluation will be included.Trial registration: Clinicaltrials.gov, NCT03872583, registration date: 13th March 2019.