Department of Human Movement Sciences, Faculty of Behavioural and Movement Sciences, Amsterdam Movement Sciences Research Institute, Vrije Universiteit Amsterdam, Amsterdam, Netherlands.
Faculty of Health, Centre of Expertise Urban Vitality, Amsterdam University of Applied Sciences, Amsterdam, Netherlands.
BMC Geriatr. 2021 Jun 23;21(1):381. doi: 10.1186/s12877-021-02334-3.
Falls and fall-related injuries among older adults are a serious threat to the quality of life and result in high healthcare and societal costs. Despite evidence that falls can be prevented by fall prevention programmes, practical barriers may challenge the implementation of these programmes. In this study, we will investigate the effectiveness and cost-effectiveness of In Balance, a fourteen-week, low-cost group fall prevention intervention, that is widely implemented in community-dwelling older adults with an increased fall risk in the Netherlands. Moreover, we will be the first to include cost-effectiveness for this intervention. Based on previous evidence of the In Balance intervention in pre-frail older adults, we expect this intervention to be (cost-)effective after implementation-related adjustments on the target population and duration of the intervention.
This study is a single-blinded, multicenter randomized controlled trial. The target sample will consist of 256 community-dwelling non-frail and pre-frail adults of 65 years or older with an increased risk of falls. The intervention group receives the In Balance intervention as it is currently widely implemented in Dutch healthcare, which includes an educational component and physical exercises. The physical exercises are based on Tai Chi principles and focus on balance and strength. The control group receives general written physical activity recommendations. Primary outcomes are the number of falls and fall-related injuries over 12 months follow-up. Secondary outcomes consist of physical performance measures, physical activity, confidence, health status, quality of life, process evaluation and societal costs. Mixed model analyses will be conducted for both primary and secondary outcomes and will be stratified for non-frail and pre-frail adults.
This trial will provide insight into the clinical and societal impact of an implemented Dutch fall prevention intervention and will have major benefits for older adults, society and health insurance companies. In addition, results of this study will inform healthcare professionals and policy makers about timely and (cost-)effective prevention of falls in older adults.
Netherlands Trial Register: NL9248 (registered February 13, 2021).
老年人跌倒及相关伤害对生活质量构成严重威胁,并导致高额的医疗保健和社会成本。尽管有证据表明,通过预防跌倒计划可以预防跌倒,但实际障碍可能会对这些计划的实施构成挑战。在这项研究中,我们将调查 In Balance 的有效性和成本效益,In Balance 是一项为期 14 周的低成本团体预防跌倒干预措施,在荷兰,该措施广泛应用于有跌倒风险增加的社区居住的老年人中。此外,我们将首次对该干预措施的成本效益进行评估。基于之前 In Balance 干预措施对虚弱前期老年人的证据,我们预计在对目标人群和干预持续时间进行实施相关调整后,该干预措施将具有(成本)效益。
这是一项单盲、多中心随机对照试验。目标样本将包括 256 名 65 岁或以上、有跌倒风险增加的社区居住的非虚弱和虚弱前期成年人。干预组接受目前在荷兰医疗保健中广泛实施的 In Balance 干预措施,包括教育部分和体育锻炼。体育锻炼基于太极原理,侧重于平衡和力量。对照组接受一般的书面体育活动建议。主要结局是 12 个月随访期间跌倒和跌倒相关伤害的数量。次要结局包括身体表现测量、身体活动、信心、健康状况、生活质量、过程评估和社会成本。将对主要和次要结局进行混合模型分析,并按非虚弱和虚弱前期成年人进行分层。
这项试验将提供有关实施中的荷兰预防跌倒干预措施的临床和社会影响的信息,并将为老年人、社会和健康保险公司带来重大利益。此外,该研究的结果将为医疗保健专业人员和决策者提供有关及时和(成本)有效的老年人跌倒预防的信息。
荷兰试验注册处:NL9248(2021 年 2 月 13 日注册)。