Development and evaluation of an interactive web-based decision-making programme on relapse management for people with multiple sclerosis (POWER@MS2)—study protocol for a randomised controlled trial

Trials

Tim Friede¹  Andrea Icks²  Joseph Montalbo²  Markus Vomhof²  Kristina Grentzenberg³  Anne Christin Rahn⁴  Christoph Heesen⁵  Lisa Wenzel⁶  Sascha Köpke⁷  Alexander Stahmann⁸  Jutta Scheiderbauer⁹ 

[1] Department of Medical Statistics, University Medical, Göttingen, Germany;Institute for Health Services Research and Health Economics, Centre for Health and Society, Heinrich Heine University Düsseldorf, Düsseldorf, Germany;Institute of Neuroimmunology and Multiple Sclerosis, University Medical Center Hamburg-Eppendorf, Hamburg, Germany;Institute of Neuroimmunology and Multiple Sclerosis, University Medical Center Hamburg-Eppendorf, Hamburg, Germany;Department of Health Services Research, Carl von Ossietzky University Oldenburg, Oldenburg, Germany;Institute of Neuroimmunology and Multiple Sclerosis, University Medical Center Hamburg-Eppendorf, Hamburg, Germany;Department of Neurology, University Medical Center Hamburg-Eppendorf, Hamburg, Germany;Institute of Neuroimmunology and Multiple Sclerosis, University Medical Center Hamburg-Eppendorf, Hamburg, Germany;Institute of Nursing Science, University Hospital Cologne and Faculty of Medicine, University of Cologne, Cologne, Germany;Institute of Nursing Science, University Hospital Cologne and Faculty of Medicine, University of Cologne, Cologne, Germany;MS Forschungs- und Projektentwicklungs-gGmbH, Hannover, Germany;Stiftung für Selbstbestimmung und Selbstvertretung von MS-Betroffenen, Trier, Germany;

关键词: Multiple sclerosis;    Decision-making;    Relapse;    Decision aid;    Patient empowerment;    Randomized controlled trial;   

DOI  :  10.1186/s13063-021-05059-1

来源: Springer

【 摘 要 】

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

【 授权许可】

CC BY