Online self-management fall prevention intervention for people with multiple sclerosis: a feasibility study protocol of a parallel group randomised trial
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 pr...
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| Format: | Article |
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BMJ Publishing Group
2022-07-01
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| Series: | BMJ Open |
| Online Access: | https://bmjopen.bmj.com/content/12/7/e061325.full |
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| author | Maria Flink Elizabeth Peterson Charlotte Ytterberg Marie Elf Kristina Gottberg Marie Kierkegaard Susanna Tuvemo Johnson Sverker Johansson |
| author_facet | Maria Flink Elizabeth Peterson Charlotte Ytterberg Marie Elf Kristina Gottberg Marie Kierkegaard Susanna Tuvemo Johnson Sverker Johansson |
| author_sort | Maria Flink |
| collection | DOAJ |
| description | 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. |
| format | Article |
| id | doaj-art-27cf0b31843643cf8750d2c0dba71e90 |
| institution | OA Journals |
| issn | 2044-6055 |
| language | English |
| publishDate | 2022-07-01 |
| publisher | BMJ Publishing Group |
| record_format | Article |
| series | BMJ Open |
| spelling | doaj-art-27cf0b31843643cf8750d2c0dba71e902025-08-20T02:26:10ZengBMJ Publishing GroupBMJ Open2044-60552022-07-0112710.1136/bmjopen-2022-061325Online self-management fall prevention intervention for people with multiple sclerosis: a feasibility study protocol of a parallel group randomised trialMaria Flink0Elizabeth Peterson1Charlotte Ytterberg2Marie Elf3Kristina Gottberg4Marie Kierkegaard5Susanna Tuvemo Johnson6Sverker Johansson73 Women`s Health and Allied Health Professionals Theme, Karolinska Institutet, Stockholm, SwedenDepartment of Occupational Therapy, College of Applied Health Sciences, University of Illinois Chicago, Chicago, IL, USA1 Department of Neurobiology, Care Science and Society, Karolinska Institutet, Stockholm, SwedenSchool of Education and Learning, Dalarna University, Falun, SwedenDepartment of Neurobiology, Care Sciences and Society, Karolinska Institutet, Stockholm, Sweden1 Department of Neurobiology, Care Science and Society, Karolinska Institutet, Stockholm, Sweden1 Department of Neurobiology, Care Science and Society, Karolinska Institutet, Stockholm, SwedenDepartment of Neurobiology, Care Sciences and Society, Karolinska Institutet, Stockholm, SwedenIntroduction 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.https://bmjopen.bmj.com/content/12/7/e061325.full |
| spellingShingle | Maria Flink Elizabeth Peterson Charlotte Ytterberg Marie Elf Kristina Gottberg Marie Kierkegaard Susanna Tuvemo Johnson Sverker Johansson Online self-management fall prevention intervention for people with multiple sclerosis: a feasibility study protocol of a parallel group randomised trial BMJ Open |
| title | Online self-management fall prevention intervention for people with multiple sclerosis: a feasibility study protocol of a parallel group randomised trial |
| title_full | Online self-management fall prevention intervention for people with multiple sclerosis: a feasibility study protocol of a parallel group randomised trial |
| title_fullStr | Online self-management fall prevention intervention for people with multiple sclerosis: a feasibility study protocol of a parallel group randomised trial |
| title_full_unstemmed | Online self-management fall prevention intervention for people with multiple sclerosis: a feasibility study protocol of a parallel group randomised trial |
| title_short | Online self-management fall prevention intervention for people with multiple sclerosis: a feasibility study protocol of a parallel group randomised trial |
| title_sort | online self management fall prevention intervention for people with multiple sclerosis a feasibility study protocol of a parallel group randomised trial |
| url | https://bmjopen.bmj.com/content/12/7/e061325.full |
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