Abstract
IntroductionMultiple sclerosis is a chronic inflammatory, degenerative disease of the central nervous system manifesting at first with relapses in about 85% of cases. In Germany, intravenous therapy with high-dose corticosteroids is the treatment standard of acute relapses. The treatment leads to a faster reduction of symptoms in about 25 of 100 treated patients but has no proven long-term benefits over placebo treatment. Intravenous treatment is not superior to oral treatment. Therefore, informed decisions on relapse management are required. An earlier randomised controlled trial showed that evidence-based patient information and education on relapse management leads to more informed decisions and more relapses not treated or treated with oral corticosteroids. This study aims to evaluate whether a web-based relapse management programme will positively change relapse management and strengthen autonomy in people with multiple sclerosis.MethodsThe pragmatic double-blind randomised controlled trial is accompanied by a mixed-methods process evaluation and a health economic evaluation and follows the UK Medical Research Council guidance on developing and evaluating complex interventions. A total of 188 people with possible or relapsing-remitting multiple sclerosis with ≥ 1 relapse within the last year and/or ≥ 2 relapses within the last 2 years will be recruited and randomised using blocks. The intervention group receives a web- and dialogue-based decision aid on relapse management, a nurse-led webinar and access to a monitored chat forum. The control group receives standard information, which will be made available via the same online platform as the intervention. The primary endpoint is the proportion of relapses not treated or treated with oral corticosteroids. Key secondary endpoints are the annualised relapse rate, decision-making, empowerment, quality of life and cost-effectiveness. Facilitators and barriers will be assessed by mixed-methods process evaluation measures. The study ends when 81 relapses have been documented or after 24 months of observation per individual patient. Analyses will follow the intention-to-treat principle.DiscussionWe hypothesise that the intervention will enhance patient empowerment and have a positive impact on patients’ relapse management.Trial registrationClinicalTrials.govNCT04233970. Registered on 18 January 2020
Highlights
Multiple sclerosis is a chronic inflammatory, degenerative disease of the central nervous system manifesting at first with relapses in about 85% of cases
The fit between the technology, users and context factors will be explored by a process evaluation addressing fidelity and dose as facilitators and barriers
The proposed Randomised controlled trial (RCT) aims to assess the effectiveness of a web-based decision support programme concerning relapse management in Multiple sclerosis (MS) in Germany
Summary
Multiple sclerosis is a chronic inflammatory, degenerative disease of the central nervous system manifesting at first with relapses in about 85% of cases. In Germany, intravenous therapy with high-dose corticosteroids is the treatment standard of acute relapses. An earlier randomised controlled trial showed that evidence-based patient information and education on relapse management leads to more informed decisions and more relapses not treated or treated with oral corticosteroids. Despite a lack of evidence, intravenous (IV) inpatient therapy of MS relapses with high-dose corticosteroids is the dominating management approach in Germany [6]. The German guideline on MS management is currently under revision and it is expected that the new recommendations will reflect the evidence showing that IV corticosteroids are not superior to oral administration [7, 8]. The “White Paper Multiple Sclerosis” calls for intelligent care concepts to counteract the undersupply of PwMS, especially in rural areas [15]
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