Development of the Better Balance Program for People with Multiple Sclerosis: A Complex Fall-Prevention Intervention.
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ABSTRACT: Background
Approximately 56% of people with multiple sclerosis (MS) will fall in any 3-month period, with the potential for physical, psychological, and social consequences. Fall-prevention research for people with MS is in its infancy, with a timely need to develop theory-based interventions that reflect the complexity of falls. The clear articulation of the development of any complex intervention is paramount to its future evaluation, usability, and effectiveness. Our aim was to describe how the development of Better Balance, a complex multicomponent fall-prevention intervention for people with MS, was guided by the Medical Research Council framework for the development of complex interventions.Methods
Sources of information included existing literature, original research, clinician interviews, and views of people with MS. These sources were synthesized and refined through an iterative process of intervention development involving researchers, clinicians, and people with MS.Results
The resulting intervention is outlined through a variety of key tasks supplementing the original Medical Research Council framework. Use of this framework resulted in a theoretically based and user-informed complex intervention designed to address the physiological, personal, and behavioral risk factors associated with falls in people with MS.Conclusions
The articulation of the systematic process used to develop Better Balance will inform the future evaluation and usability of the intervention.
SUBMITTER: Comber L
PROVIDER: S-EPMC8218582 | biostudies-literature |
REPOSITORIES: biostudies-literature
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Project description:To examine the efficacy of a fall prevention/management intervention among persons with multiple sclerosis (PwMS) who use a wheelchair (WC) or scooter full-time. Pre-post/follow-up trial. Community and research laboratory. Twenty-one PwMS who used a WC or scooter full-time, self-reported at least 1 fall/12 months, and could transfer independently or with minimal/moderate assistance (N=21). Six-week, group and community-based fall prevention and management intervention. The intervention included six 2-hour in-person weekly sessions led by a physical or occupational therapist featuring interactive group discussions, skill practice, and action planning opportunities. Fall frequency tracked 12 weeks pre- and 24 weeks post intervention. Outcomes were assessed pre- and post intervention and 12 weeks post intervention. Measures included surveys to examine fear of falling (FOF), fall prevention/management, quality of life, community participation, and assessment of functional mobility skills. Semistructured interviews were administered post intervention to ascertain overall experiences with the program and effect on daily life. A Friedman test with signed-rank post hoc analysis was run to determine differences across the 3 study visits. After the intervention, fall incidence did not significantly change, but fall management strategies (P=.01-0.05), importance of community participation (P=.01), and transfer quality (P=.02) significantly improved. Moderate effect sizes were noted among concerns about falling, activity curtailment because of to FOF, and WC skills. Qualitative results indicate that participants found the intervention beneficial and applied intervention content in their daily lives. This study is the first to describe the effect of a multicomponent fall prevention/management intervention designed specifically for PwMS who use a WC or scooter full-time. Results indicate the program has potential to reduce fall risk; however, further testing is needed to fully examine the effect of the program.
| S-EPMC9761259 | biostudies-literature
Project description:IntroductionFalls 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 analysisA 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 disseminationEthical 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 numberNCT04317716.
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Project description:Falls are a serious health concern for persons with multiple sclerosis (PwMS) who use wheelchairs or scooters as their primary mode of mobility. Unfortunately, little is known about the fall prevalence and characteristics of this large segment of the multiple sclerosis (MS) community. The purpose of this study is to determine the prevalence and circumstances of falls in wheelchair and scooter users living with MS. Forty-four PwMS were recruited from research and medical centers in the United States and Asia. Participants completed a survey focusing on prevalence of falls, frequency of injurious falls, circumstances of the fall, and various quality of life indicators. A total of 44 individuals (32 females/11 males/1 not reported) aged 27 to 82 years (mean = 58 yrs) completed the survey. Seventy-five percent (n = 33) reported falling at least once in 6 months and 48% (n = 12) of those that fell sustained an injury. The majority (87.5%) of the falls occurred inside the home. Most individuals (76.7%; n = 33) reported concerns about falling and 65.9% (n = 29) limited their activities because of their concern of falling. Falls are prevalent in wheelchair and scooter users with MS. The observations highlight the need for interventions targeting this segment of the MS community.
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Project description:BackgroundFatigue, inactivity, and falls are major health issues for people with multiple sclerosis (MS). We examined the extent to which fatigue and low walking activity are associated with quality of life and increased fall risk in people with MS.MethodsPeople with MS (N = 210, aged 21-74 years) were categorized as having either high or low reported fatigue and walking activity levels and were then followed up for falls using monthly fall diaries for 6 months.ResultsA high level of fatigue was significantly associated with higher MS Disease Steps scores, worse balance, high composite physiological (Physiological Profile Assessment) fall risk scores, greater fear of falling, lower World Health Organization Disability Assessment Schedule (WHODAS) quality of life scores, and more prospectively recorded falls. Low walking activity was significantly associated with higher MS Disease Steps scores, reduced proprioception, worse standing and leaning balance, slow stepping, slow gait speed, worse fine motor control, high Physiological Profile Assessment fall risk scores, more fear of falling, and lower WHODAS quality of life scores.ConclusionsIncreased fatigue and low walking activity levels were significantly associated with increased fall risk and lower quality of life in people with MS. Interventions aimed at addressing fatigue and inactivity may have multiple benefits for this group.
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Project description:BackgroundFalls are the leading cause of fatal and non-fatal injuries among older adults. Older emergency department (ED) patients who present for evaluations after falls have a 30% higher risk of falling again in the subsequent 6 months than age-matched controls. Although EDs frequently evaluate older adults after their falls, the typical evaluation consists of an injury assessment alone. As such, an opportunity is lost to assess and address the potential causes of falls in this vulnerable population. In this manuscript, we present a multidisciplinary fall prevention protocol for a pilot study of older adult ED patients who recently sustained a fall (GAPcare: the Geriatric Acute and Post-acute Fall Prevention Intervention).MethodsGAPcare is a randomized single-blinded pilot study. Participants in GAPcare are 120 older adults (≥ 65 years old) who present to 1 of 2 academic US EDs after a fall. We randomly assign participants 1:1 to an intervention or a usual care (control) arm. In the intervention arm, the patient's ED physician, a pharmacist, and a physical therapist (PT) collaborate to identify and address any risk factors that may have contributed to the fall. Intervention arm participants and their caregivers return home with a medication-related action plan to taper or stop potentially inappropriate medications and to address polypharmacy and a PT assessment and plan. Participants in the usual care arm receive standard assessments and care in the ED and a home safety brochure. Participants in both study arms complete fall calendars for 6 months to document the number of falls and healthcare visits during follow-up. The primary outcome is feasibility of the GAPcare fall prevention intervention (number and proportion of screened participants who are eligible, recruited, and retained; impact on ED length of stay), while the secondary outcome is to estimate its initial efficacy.DiscussionThe GAPcare-ED fall prevention intervention has the potential to promote older adult-sensitive care for millions of Americans presenting to EDs after falls and establish a protocol for a future large-scale randomized controlled trial on this topic.Trial registrationClinicalTrials.gov, NCT03360305. Trial registration date: December 4, 2017. Protocol version: 1.
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Project description:BackgroundMultiple sclerosis (MS) is a chronic, neurodegenerative disease that causes a range of motor, sensory, and cognitive symptoms. Due to these symptoms, people with MS are at a high risk for falls, fall-related injuries, and reductions in quality of life. There is no cure for MS, and managing symptoms and disease progression is important to maintain a high quality of life. Mobile health (mHealth) apps are commonly used by people with MS to help manage their health. However, there are limited health apps for people with MS designed to evaluate fall risk. A fall risk app can increase access to fall risk assessments and improve self-management. When designing mHealth apps, a user-centered approach is critical for improving use and adoption.ObjectiveThe purpose of this study is to undergo a user-centered approach to test and refine the usability of the app through an iterative design process.MethodsThe fall risk app Steady-MS is an extension of Steady, a fall risk app for older adults. Steady-MS consists of 2 components: a 25-item questionnaire about demographics and MS symptoms and 5 standing balance tasks. Data from the questionnaire and balance tasks were inputted into an algorithm to compute a fall risk score. Two iterations of semistructured interviews (n=5 participants per iteration) were performed to evaluate usability. People with MS used Steady-MS on a smartphone, thinking out loud. Interviews were recorded, transcribed, and developed into codes and themes. People with MS also completed the System Usability Scale.ResultsA total of 3 themes were identified: intuitive navigation, efficiency of use, and perceived value. Overall, the participants found Steady-MS efficient to use and useful to learn their fall risk score. There were challenges related to cognitive overload during the balance tasks. Modifications were made, and after the second iteration, people with MS reported that the app was intuitive and efficient. Average System Usability Scale scores were 95.5 in both iterations, representing excellent usability.ConclusionsSteady-MS is the first mHealth app for people with MS to assess their overall risk of falling and is usable by a subset of people with MS. People with MS found Steady-MS to be usable and useful for understanding their risk of falling. When developing future mHealth apps for people with MS, it is important to prevent cognitive overload through simple and clear instructions and present scores that are understood and interpreted correctly through visuals and text. These findings underscore the importance of user-centered design and provide a foundation for the future development of tools to assess and prevent scalable falls for people with MS. Future steps include understanding the validity of the fall risk algorithm and evaluating the clinical utility of the app.
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Project description:PurposeModel-based economic evaluations require conceptualization of the model structure. Our objectives were to identify important health states, events, and patient attributes to be included in a model-based cost-effectiveness analysis of fall prevention interventions, to develop a model structure to examine cost-effectiveness of fall prevention interventions, and to assess the face validity of the model structure.MethodsAn expert panel comprising clinicians, health service researchers, health economists, a patient partner, and policy makers completed two rounds of online surveys to gain consensus on health states, events, and patient attributes important for fall prevention interventions. The surveys were informed by a literature search on fall prevention interventions for older adults (≥65 years) including economic evaluations and clinical practice guidelines. The results of the Delphi surveys and subsequent discussions can support the face validity of a state-transition model for an economic evaluation of fall prevention interventions.ResultsIn total, 11 experts rated 24 health states/events and 41 patient attributes. Consensus was achieved on 14 health states/events and 26 patient characteristics. The proposed model structure incorporated 12 of the 14 selected health states/events. Panelists confirmed the face validity of the model structure during teleconferences.ConclusionsThere is a dearth of studies presenting the model conceptualization process; consequently, this study involving multiple end user partners with opportunities for input at several stages adds to the literature as another case study. This process is an example of how a fall prevention economic model was developed using a modified Delphi process and assessed for face validity.
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