A Comprehensive and Structured Follow-Up for Persons With Multiple Sclerosis (CoreDISTparticipation) to Optimize Physical Functions, Health, and Employment: Protocol for a Prospective, Single-Blinded Randomized Controlled Trial and Health Economic Evaluation.

Abstract

Background: Multiple sclerosis (MS) is a chronic neurological disease of the central nervous system, primarily affecting young adults. Common challenges in MS include fatigue, physical impairments, and cognitive impairments, associated with low levels of physical activity, unemployment, reduced health-related quality of life (HRQoL), and substantial personal and societal costs. Many leave the workforce or reduce hours even when disability is low and despite a desire to increase work hours if the job is adjusted to their needs. Existing services aiming to optimize physical functions and work participation only initiate retrospectively, and there is a lack of knowledge regarding the possible effect of more proactive services.

Objective: The objective of this study is to investigate the effects of a comprehensive multidisciplinary intervention, CoreDISTparticipation, delivered across health care levels (hospitals and municipalities) and sectors (health and employment/welfare), on barriers to work, physical activity, and physical functions; fatigue; and HRQoL for employed people with multiple sclerosis (pwMS) and to perform a health economic evaluation.

Methods: This prospective, single-blinded randomized controlled trial (RCT) will include 115 pwMS with Expanded Disability Status Scale (EDSS) scores of 0-4 randomly allocated to either a CoreDISTparticipation intervention group or usual care (control group). The CoreDISTparticipation intervention includes (1) information videos, hospital outpatient physiotherapist assessments, and meetings with employment consultants; (2) group-based physiotherapy in municipalities for 60 minutes over 6 weeks, one indoor CoreDIST balance session, one outdoor CoreDIST balance and high-intensity interval session, and tailored work follow-up; and (3) 6 weeks of digitally supported independent training, twice weekly. Assessments will be conducted at baseline, week 9, and week 16. Primary outcomes include Multiple Sclerosis Work Difficulties Questionnaire-23 - Norwegian version (MSWDQ-23NV) and ActiGraph wGT3x-BT monitor scores. Secondary outcomes include Trunk Impairment Scale - modified Norwegian Version (TIS-modNV), Mini Balance Evaluation Systems Test (MiniBESTest), AccuGait Optimized force platform, 6-minute walk test (6MWT), Multiple Sclerosis Walking Scale-12, Multiple Sclerosis Impact Scale-29 - Norwegian version, EQ-5D-5L, and Fatigue Severity Scale - Norwegian version scores. The study will identify effects of CoreDISTparticipation versus usual care on work barriers, physical activity, balance, walking, fatigue, and quality of life, along with a health economic evaluation. Descriptive statistics and repeated measures mixed models will be performed using IBM SPSS version29.

Results: We completed the enrolment phase and enrolled and randomized 115 participants in two phases by August 1, 2024. The 15-week retests were completed in December 2024, and data collection is estimated to be completed by September 2025. Results are expected to be published in the first quarter of 2026.

Conclusions: CoreDISTparticipation is an innovative approach proactively addressing physical functions, physical activity, and work participation. If effective, it can offer a low-cost approach that potentially may enhance the quality of life and workforce sustainability and reduce societal costs.

Trial registration: ClinicalTrials.gov NCT06110468; https://www.clinicaltrials.gov/study/NCT06110468.

International registered report identifier (irrid): DERR1-10.2196/74988.