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Online self-management fall prevention intervention for people with multiple sclerosis: a feasibility study protocol of a parallel group randomised trial
Department of Neurobiology, Care Sciences and Society, Karolinska Institutet, Stockholm, Sweden; Academic Specialist Center, Region Stockholm, Stockholm, Sweden.
Department of Occupational Therapy, College of Applied Health Sciences, University of Illinois Chicago, Chicago, IL, USA.
Department of Neurobiology, Care Sciences and Society, Karolinska Institutet, Stockholm, Sweden.
Department of Neurobiology, Care Sciences and Society, Karolinska Institutet, Stockholm, Sweden.
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2022 (English)In: BMJ Open, E-ISSN 2044-6055, Vol. 12, no 7, article id e061325Article in journal (Refereed) Published
Abstract [en]

INTRODUCTION: Falls among people with multiple sclerosis (PwMS) are common and associated with injuries, fear of falling and low health-related quality of life. Considerations of behavioural, environmental, psychological and physical influences (including ambulation status) are needed to meet fall prevention needs for PwMS. Thus, using a codesign process involving key stakeholders a novel online self-management fall prevention intervention was created specifically for ambulatory and non-ambulatory PwMS. The feasibility, acceptability, fidelity and outcome of this complex intervention will be explored. Findings will inform a future full-scale randomised controlled trial.

METHODS AND ANALYSIS: A mixed-method design will be used. Forty-eight PwMS, stratified for ambulation level, will be randomised to control (n=24) or intervention (n=24). Both groups will receive a brochure about fall risk factors and fall prevention. The intervention is group-based (eight PwMS in each group); will be delivered online; and involve six, 2-hour weekly sessions and a booster session 8 weeks after the sixth session. Each intervention group will be led by a trained facilitator. Data collection will be performed at baseline, and after seven and 18 weeks. Outcome measures will capture data on fall prevention behaviours, fear of falling, falls self-efficacy, social and everyday activities, perceived impact of MS and number of falls. Feasibility of recruitment process, data collection procedures, outcome measures, and delivery, and intervention acceptability, fidelity and outcomes will be evaluated. Both quantitative and qualitative methods will be used.

ETHICS AND DISSEMINATION: Ethical approval has been obtained from the Swedish Ethical Review Authority (registration number 2021-04817). Results will be disseminated in peer-review journals, at conferences, research meetings, in social media and through the patient organisation Neuro Sweden.

TRIAL REGISTRATION NUMBER: NCT04317716.

Place, publisher, year, edition, pages
2022. Vol. 12, no 7, article id e061325
Keywords [en]
multiple sclerosis, qualitative research, rehabilitation medicine
National Category
Nursing
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URN: urn:nbn:se:du-41926DOI: 10.1136/bmjopen-2022-061325ISI: 000823695600013PubMedID: 35803627Scopus ID: 2-s2.0-85134426555OAI: oai:DiVA.org:du-41926DiVA, id: diva2:1683204
Available from: 2022-07-14 Created: 2022-07-14 Last updated: 2023-08-28Bibliographically approved

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Elf, Marie

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