Meena Kannan1, Andrea Hildebrand2, Cinda L Hugos3, Rouba Chahine4, Gary Cutter5, Michelle H Cameron6. 1. University of Virginia, 1221 Lee Street, Charlottesville, VA 22908, USA. Electronic address: Mk8tf@virginia.edu. 2. Oregon Health & Science University, VA Portland Health Care System, 3710 SW US Veterans Hospital Road, Portland, OR 97239, USA. Electronic address: hildeand@ohsu.edu. 3. Oregon Health & Science University, VA Portland Health Care System, 3710 SW US Veterans Hospital Road, Portland, OR 97239, USA. 4. University of Alabama Birmingah, School of Public Health, Birmingham, AL, USA. Electronic address: chahine@uab.edu. 5. University of Alabama Birmingah, School of Public Health, Birmingham, AL, USA. Electronic address: cutterg@uab.edu. 6. Oregon Health & Science University, VA Portland Health Care System, 3710 SW US Veterans Hospital Road, Portland, OR 97239, USA. Electronic address: cameromi@ohsu.edu.
Abstract
BACKGROUND: Falls are common and impactful in people with multiple sclerosis (MS) but currently there is no accepted standard of care for fall prevention in MS. Evidence supports that the in-person, group-based, Free from Falls (FFF) program is associated with both immediate and six-month sustained improvements in mobility and balance and a reduction in falls, but program attendance is limited by access to the class at a given time and location and by the cost and availability of trained facilitators. Therefore, we developed and evaluated an online, web-based version of FFF, Free from Falls Online (FFFO). METHODS:Thirty people with MS who reported falling at least twice in the previous two months were randomized to FFFO or to a control group. FFFO consists of eight weekly sessions, each with an instructional and exercise component. Subjects in the control group were given a brochure on minimizing fall risk, a letter was sent to their treating physician informing them that the subject reported falling, and these subjects were invited to use the FFFO program at study completion. Outcomes included baseline demographics, falls prospectively reported for the eight weeks of intervention and the following three months, and a program satisfaction survey for the active group. Regression models were used to test for associations between treatment group and fall incidence. RESULTS:Subjects' mean age was 55.8 years, 70% were female, 73% hadprogressive MS, median Expanded Disability Status Scale (EDSS) score was 6.0, and subjects reported a median of two falls in the month prior to study enrollment. Although, in general, regression models demonstrated trends that those in the intervention group were less likely to fall than those in the control group, statistical significance was only achieved (p = 0.0038) with a post hoc model evaluating the relationship between the square of days and the probability of not falling. This model supported that those in the intervention group were slightly less likely to fall than those in the control group. This difference was most prominent in the first month of the study, less prominent in the following month, and not sustained three months following the intervention. User experience with FFFO was overall positive, with over 75% reporting the web-based program easy to learn and to use, 85% reporting the program was easy to follow, 62% reporting the material to be useful, and 77% finding the exercises to be a useful component of the program. CONCLUSION: This study supports the viability of online delivery of self-management strategies in MS, suggests that FFFO may help prevent falls in people with MS, and provides the preliminary data needed to verify the findings of this pilot study of FFFO with a fully powered randomized controlled trial in people with MS.
RCT Entities:
BACKGROUND: Falls are common and impactful in people with multiple sclerosis (MS) but currently there is no accepted standard of care for fall prevention in MS. Evidence supports that the in-person, group-based, Free from Falls (FFF) program is associated with both immediate and six-month sustained improvements in mobility and balance and a reduction in falls, but program attendance is limited by access to the class at a given time and location and by the cost and availability of trained facilitators. Therefore, we developed and evaluated an online, web-based version of FFF, Free from Falls Online (FFFO). METHODS: Thirty people with MS who reported falling at least twice in the previous two months were randomized to FFFO or to a control group. FFFO consists of eight weekly sessions, each with an instructional and exercise component. Subjects in the control group were given a brochure on minimizing fall risk, a letter was sent to their treating physician informing them that the subject reported falling, and these subjects were invited to use the FFFO program at study completion. Outcomes included baseline demographics, falls prospectively reported for the eight weeks of intervention and the following three months, and a program satisfaction survey for the active group. Regression models were used to test for associations between treatment group and fall incidence. RESULTS: Subjects' mean age was 55.8 years, 70% were female, 73% had progressive MS, median Expanded Disability Status Scale (EDSS) score was 6.0, and subjects reported a median of two falls in the month prior to study enrollment. Although, in general, regression models demonstrated trends that those in the intervention group were less likely to fall than those in the control group, statistical significance was only achieved (p = 0.0038) with a post hoc model evaluating the relationship between the square of days and the probability of not falling. This model supported that those in the intervention group were slightly less likely to fall than those in the control group. This difference was most prominent in the first month of the study, less prominent in the following month, and not sustained three months following the intervention. User experience with FFFO was overall positive, with over 75% reporting the web-based program easy to learn and to use, 85% reporting the program was easy to follow, 62% reporting the material to be useful, and 77% finding the exercises to be a useful component of the program. CONCLUSION: This study supports the viability of online delivery of self-management strategies in MS, suggests that FFFO may help prevent falls in people with MS, and provides the preliminary data needed to verify the findings of this pilot study of FFFO with a fully powered randomized controlled trial in people with MS.
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