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The purpose is to evaluate the effects of a self-management fall prevention program for people with multiple sclerosis (PwMS): Is the program effective in reducing number of falls in PwMS at 6- and 12-months? What contextual factors, mechanisms of impact and implementation aspects can likely explain the effects of the program? What is the cost effectiveness of the program at 12 months? The project is carried out by our interdisciplinary team including a person with MS. The team is experienced in fall prevention, self-management, and randomized control trials (RCT) with both qualitative and quantitative methods including health economic evaluations. The program is evaluated in a RCT regarding effect, process, and cost-effectiveness, with start spring 2024 and end of data collection in fall 2025. Recruited are 208 PwMS, ambulatory and non-ambulatory. Primary effect outcome is fall incidence. For process evaluation, interviews with a strategic sample of intervention PwMS and quantitative data from the program platform are used. For cost-effectiveness analysis, quantitative data is collected from program participants and national databases. Falls among PwMS are very common and associated with injuries, fear of falling, low health-related quality of life and high socioeconomic costs, due to the many injurious falls. There are very few self-management fall prevention programs

only our has been developed using a co-design process with PwMS and healthcare professionals.

Research problem and specific questionsFalls among people with multiple sclerosis (PwMS) are common and lead to fear of falling, injuries, impaired health and high societal costs. Fall prevention interventions should focus on development of self-management skills and include non-ambulatory PwMS. We have, in a co-design process, developed a digital group based self-management fall prevention program. The aim is to evaluate this program. Research questions: 1) Is the fall prevention program effective in reducing number of falls in PwMS at 6- and 12-months post-intervention? 2) What contextual factors, mechanisms of impact and implementation aspects can likely explain the effects of the intervention? 3) How do PwMS experience their fall prevention behaviours and strategies in daily life at 6- and 12-months post-intervention?Data and methodThe program is evaluated in a randomized control trial regarding effect and process by quantitative and qualitative methods, in line with recommendation for complex interventions. Recruited are 208 PwMS, ambulatory and non-ambulatory, who are randomised to intervention or control. Number of falls are monitored from allocation until 12-months post-intervention via SMS dispatches. Primary effect outcome is fall incidence. Secondary outcomes include fall prevention behaviours, fear of falling, fall-related self-efficacy, physical activity, participation in daily activities, and impact of MS on health. Semi-structured interviews with a strategic selection of intervention PwMS and quantitative data from the program platform are used for process evaluation.Societal relevance and utilizationThe program contributes to reduce inequalities in care and rehabilitation for PwMS as the digital format gives PwMS living in communities without specialized MS-centres the opportunity to participate. The program’s focus on development of self-management skills contributes to increase social participation in PwMS, and if number of falls are reduced to decrease costs for the individual and the society.Plan for project realizationThe project is carried out by our interdisciplinary research group with expertise in quantitative and qualitative methods and MS. A PhD student will be recruited. Four trained group leaders will deliver the intervention during year 2024. Data are collected before randomization and immediately after and 6- and 12-months post-intervention. Costs are associated with project personnel (PhD student and researchers).