Forster Anne, Airlie Jennifer, Birch Karen, Cicero Robert, Cundill Bonnie, Ellwood Alison, Godfrey Mary, Graham Liz, Green John, Hulme Claire, Lawton Rebecca, McLellan Vicki, McMaster Nicola, Farrin Amanda
Academic Unit of Elderly Care and Rehabilitation, Bradford Teaching Hospitals NHS Foundation Trust and University of Leeds, Bradford, UK.
School of Biomedical Sciences, University of Leeds, Leeds, UK.
Trials. 2017 Apr 19;18(1):182. doi: 10.1186/s13063-017-1921-8.
As life expectancy increases and the number of older people, particularly those aged 85 years and over, expands there is an increase in demand for long-term care. A large proportion of people in a care home setting spend most of their time sedentary, and this is one of the leading preventable causes of death. Encouraging residents to engage in more physical activity could deliver benefits in terms of physical and psychological health, and quality of life. This study is the final stage of a programme of research to develop and preliminarily test an evidence-based intervention designed to enhance opportunities for movement amongst care home residents, thereby increasing levels of physical activity.
METHODS/DESIGN: This is a cluster randomised feasibility trial, aiming to recruit at least 8-12 residents at each of 12 residential care homes across Yorkshire, UK. Care homes will be randomly allocated on a 1:1 basis to receive either the intervention alongside usual care, or to continue to provide usual care alone. Assessment will be undertaken with participating residents at baseline (prior to care home randomisation) and at 3, 6, and 9 months post-randomisation. Data relating to changes in physical activity, physical function, level of cognitive impairment, mood, perceived health and wellbeing, and quality of life will be collected. Data at the level of the home will also be collected and will include staff experience of care, and changes in the numbers and types of adverse events residents experience (for example, hospital admissions, falls). Details of National Health Service (NHS) usage will be collected to inform the economic analysis. An embedded process evaluation will obtain information to test out the theory of change underpinning the intervention and its acceptability to staff and residents.
This feasibility trial with embedded process evaluation and collection of health economic data will allow us to undertake detailed feasibility work to inform a future large-scale trial. It will provide valuable information to inform research procedures in this important but challenging area.
ISRCTN registry, ISRCTN16076575 . Registered on 25 June 2015.
随着预期寿命的增加以及老年人数量的增多，尤其是85岁及以上的老年人数量不断扩大，长期护理的需求也在增加。在养老院环境中，很大一部分人大部分时间都久坐不动，这是主要的可预防死因之一。鼓励居民进行更多的体育活动可以在身心健康和生活质量方面带来益处。本研究是一项研究计划的最后阶段，该计划旨在开发并初步测试一种基于证据的干预措施，旨在增加养老院居民的活动机会，从而提高身体活动水平。
方法/设计：这是一项整群随机可行性试验，旨在从英国约克郡的12家养老院中每家至少招募8至12名居民。养老院将以1:1的比例随机分配，分别接受干预措施加常规护理，或继续仅提供常规护理。将在基线时（养老院随机分组之前）以及随机分组后的3个月、6个月和9个月对参与的居民进行评估。将收集与身体活动、身体功能、认知障碍水平、情绪、感知健康和幸福感以及生活质量变化相关的数据。还将收集养老院层面的数据，包括工作人员的护理经验以及居民经历的不良事件的数量和类型的变化（例如，住院、跌倒）。将收集国民健康服务（NHS）使用情况的详细信息，以进行经济分析。一项嵌入式过程评估将获取信息，以检验干预措施背后的变革理论及其对工作人员和居民的可接受性。
这项包含嵌入式过程评估和健康经济数据收集的可行性试验将使我们能够开展详细的可行性工作，为未来的大规模试验提供信息。它将提供有价值的信息，为这一重要但具有挑战性的领域的研究程序提供参考。
ISRCTN注册库，ISRCTN16076575。于2015年6月25日注册。
