Factors influencing health behavior changes in people with early multiple sclerosis: process evaluation of the multicenter randomized controlled POWER@MS1 trial

Barbara von Glasenapp^1*Nicole Krause¹Carlotta Derad²Karin Riemann-Lorenz¹Björn Meyer³Markus van de Loo⁴Herbert Temmes⁴Stefan Gold⁵Christoph Heesen¹POWER@MS1 study group¹

• ¹Institute of Neuroimmunology and Multiple Sclerosis (INIMS), University Medical Center Hamburg-Eppendorf, Hamburg, Germany
• ²Department of Medical Statistics, University Medical Centre Göttingen, Göttingen, Germany
• ³Research and Development Department, GAIA Group, Hamburg, Germany
• ⁴German Multiple Sclerosis Society, Federal Association, Hannover, Germany
• ⁵Department of Psychiatry (CBF), Charité Universitätsmedizin Berlin, Berlin, Germany

Background: Health behavior changes, i.e. optimizations of physical activity, diet, sleep and stress management, are increasingly considered as modifiers of prognostic risk in multiple sclerosis (MS). A personalized digital lifestyle management application ("levidex"), designed to support people with MS (pwMS) in coping with their diagnosis and adopting healthier behaviors, was evaluated against an active psychoeducational control program ("dexilev") in a randomized controlled trial (RCT; "POWER@MS1"). Objectives: This study evaluates the POWER@MS1 trial, focusing on the processes and organizational aspects of the study. Specifically, it seeks to (1) identify the contextual factors that influence behavior change in pwMS and (2) assess how the intervention and study design were perceived by pwMS and involved health care professionals (HCPs; neurologists, study nurses, radiologists). Methods: A mixed methods approach was applied. During the study period questionnaire data were collected from all trial participants (n=234) and HCPs (n=91) and were analyzed quantitatively.After the RCT ended, semi-structured interviews were conducted with 15 HCPs and 16 pwMS. Participants were selected according to the maximum variation sampling. Data was analyzed thematically. Results: Quantitative trial data revealed that the levidex group significantly agreed more to behavioral changes after three months (levidex (6.65); dexilev (5.23), p<0.001). Improvements in diet, physical activity and stress management were reported. PwMS considered evidence-based information, meditation instructions and self-monitoring tools embedded in levidex as particularly helpful. In the interviews, they reported close monitoring through regular clinical visits as reassuring after MS diagnosis. A healthy lifestyle was considered an important component of MS treatment by both HCPs and pwMS. Both perceived levidex as a useful addition to standard care, but reported a need for additional personal consultation. Conclusion: Health behavior change was rated as an important component of MS treatment. A digital application was perceived to be beneficial for the facilitation of relevant behavior change.