Krause Nicole, Derad Carlotta, von Glasenapp Barbara, Riemann-Lorenz Karin, Meyer Björn, Asendorf Thomas, Temmes Herbert, van de Loo Markus, Gold Stefan M, Schubert Charlotte, Stürner Klarissa H, Warnke Clemens, Schmidt Stephan, Friede Tim, Heesen Christoph
Institute of Neuroimmunology and Multiple Sclerosis (INIMS), University Medical Center Hamburg-Eppendorf (UKE), Hamburg, Germany.
Department of Medical Statistics, University Medical Centre Göttingen, Göttingen, Germany.
Mult Scler. 2025 Sep;31(10):1231-1242. doi: 10.1177/13524585251356410. Epub 2025 Aug 12.
This randomised controlled trial investigated the effect of a personalised digital lifestyle management application ('levidex') on inflammatory disease activity in newly diagnosed people with MS (pwMS), compared to a non-personalised application ('dexilev') that covered similar lifestyle-related content.
Participants ( = 234) were recruited from July 2019 to April 2022 in 20 study centres in Germany and randomised to levidex (intervention group (IG), = 115) or 'dexilev' (control group (CG), = 119). Follow-up data was collected over 1-2 years. The combined primary endpoint (new T2 lesion and/or relapse) was analysed using Cox proportional hazards regression. Key secondary endpoints included self-reported quality of life and health behaviour.
There was no difference in the time to the first relapse and/or new T2 lesion between IG and CG (Hazard Ratio: 0.91; 95% confidence interval [CI]: [0.66, 1.27], = 0.596). After 3 months, self-reported diet quality was higher in the IG (0.43; 95% CI: [0.14, 0.72], = 0.0037). There was no difference in other secondary endpoints between IG and CG after 3 and 12 months.
This study failed to meet its primary endpoint and usage of levidex did not differ from dexilev in its effects on inflammatory disease activity or behaviour change in this cohort of pwMS.
本随机对照试验调查了个性化数字生活方式管理应用程序（“levidex”）对新诊断的多发性硬化症患者（pwMS）炎症性疾病活动的影响，并与涵盖类似生活方式相关内容的非个性化应用程序（“dexilev”）进行了比较。
2019年7月至2022年4月期间，在德国的20个研究中心招募了参与者（n = 234），并将其随机分为levidex组（干预组（IG），n = 115）或“dexilev”组（对照组（CG），n = 119）。随访数据收集了1至2年。使用Cox比例风险回归分析联合主要终点（新的T2病变和/或复发）。关键次要终点包括自我报告的生活质量和健康行为。
IG组和CG组首次复发和/或新T2病变的时间没有差异（风险比：0.91；95%置信区间[CI]：[0.66, 1.27]，P = 0.596）。3个月后，IG组自我报告的饮食质量更高（0.43；95% CI：[0.14, 0.72]，P = 0.0037）。3个月和12个月后，IG组和CG组在其他次要终点方面没有差异。
本研究未达到其主要终点，在该队列的pwMS患者中，levidex的使用在对炎症性疾病活动或行为改变的影响方面与dexilev没有差异。
