Academic Unit of Elderly Care and Rehabilitation, Bradford Teaching Hospitals NHS Foundation Trust, Bradford, UK.
Clinical Trials Research Unit, University of Leeds, Leeds, UK.
Trials. 2018 Sep 24;19(1):521. doi: 10.1186/s13063-018-2863-5.
Residents of care homes have high levels of disability and poor mobility, but the promotion of health and wellbeing within care homes is poorly realised. Residents spend the majority of their time sedentary which leads to increased dependency and, coupled with poor postural management, can have many adverse outcomes including pressure sores, pain and reduced social interaction. The intervention being tested in this project (the Skilful Care Training Package) aims to increase the awareness and skills of care staff in relation to poor posture in the older, less mobile adult and highlight the benefits of activity, and how to skilfully assist activity, in this group to enable mobility and reduce falls risk. Feasibility work will be undertaken to inform the design of a definitive cluster randomised controlled trial.
This is a cluster randomised controlled feasibility trial, aiming to recruit at least 12-15 residents at each of 10 care homes across Yorkshire. Care homes will be randomly allocated on a 1:1 basis to receive either the Skilful Care Training Package alongside usual care or to continue to provide usual care alone. Assessments will be undertaken by blinded researchers with participating residents at baseline (before care home randomisation) and at three and six months post randomisation. Data relating to changes in physical activity, mobility, posture, mood 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 NHS service usage will be collected to inform the economic analysis. An embedded process evaluation will explore intervention delivery and its acceptability to staff and residents.
Participant uptake, engagement and retention are key feasibility outcomes. Exploration of barriers and facilitators to intervention delivery will inform intervention optimisation. Study results will inform progression to a definitive trial and add to the body of evidence for good practice in care home research.
ISRCTN Registry, ISRCTN50080330 . Registered on 27 March 2017.
养老院的居民身体残疾程度高，行动不便，但养老院在促进健康和福祉方面的工作做得很差。居民大部分时间都处于久坐状态，这导致他们的依赖性增加，再加上姿势管理不善，可能会导致许多不良后果，包括压疮、疼痛和社交互动减少。本项目正在测试的干预措施（熟练护理培训包）旨在提高护理人员对年老、行动不便的成年人不良姿势的认识和技能，并强调活动的好处，以及如何在这一群体中熟练地协助活动，以提高他们的活动能力并降低跌倒风险。可行性研究将为确定的群组随机对照试验的设计提供信息。
这是一项群组随机对照可行性试验，旨在每个约克郡的 10 家养老院中各招募至少 12-15 名居民。养老院将按照 1:1 的比例随机分配，接受熟练护理培训包加常规护理或仅继续提供常规护理。参与研究的居民将在基线（养老院随机分组前）、随机分组后 3 个月和 6 个月接受盲法研究人员的评估。将收集与身体活动、移动能力、姿势、情绪和生活质量变化相关的数据。还将收集与家庭相关的数据，包括工作人员对护理的体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 NHS 服务使用的详细信息，以进行经济分析。嵌入式过程评估将探索干预措施的实施情况及其对工作人员和居民的可接受性。
参与者的参与率、参与度和保留率是关键的可行性结果。对干预措施实施的障碍和促进因素的探索将为干预措施的优化提供信息。研究结果将为进一步进行确定性试验提供信息，并为养老院研究中的良好实践提供更多证据。
ISRCTN 注册表，ISRCTN50080330。于 2017 年 3 月 27 日注册。
