Introduction Multiple sclerosis (MS) is a degenerative disease of the central nervous system that initially progresses in relapses in around 85% of cases. In Germany, relapse therapy usually includes inpatient intravenous cortisone therapy. To promote informed decisions about relapse management and strengthen the empowerment of people with MS, a web-based relapse management programme (ABouts) was developed.

Methods ABouts was evaluated through a pragmatic, double-blind randomised controlled trial and accompanied by a process evaluation and health economic evaluation. People with relapsing-remitting MS were included in 18 centres in Germany between 2020 and 2022. Participants in the intervention group (IG) received web-based evidence-based health information with dialogue-style decision support, a webinar with an MS nurse and an online guided chat via MS Connect. Participants in the control group (CG) received optimised standard care. The primary endpoint was the proportion of relapses not treated or treated with oral cortisone within up to 36 months. Key secondary outcomes included knowledge and empowerment.

Results 160 participants were included (80 IG/80 CG). The participants were comparable at baseline, had MS symptoms for an average of 4.1 years and mild disability. Of 160 participants, 113 (60 IG/53 CG) reported at least one relapse during the course of the study. There were no significant differences between groups in relapse treatment (OR = 0.87, 95% CI 0.36 – 2.1, p = 0.75). After 12 months, participants in the IG showed better relapse knowledge (mean difference (MD) = 1.63/11, 95% CI 1.1 - 2.16) and a higher level of empowerment (MD = 5.63/100, 95% CI 1.97 - 9.3).

Discussion Fewer relapses as well as treated relapses than anticipated led to a loss of statistical power, precluding possible changes concerning the primary endpoint.

Conclusion The programme had no influence on the frequency or type of cortisone treatments, but increased participants’ knowledge and empowerment.