Harwood Rowan H, van der Wardt Veronika, Goldberg Sarah E, Kearney Fiona, Logan Pip, Hood-Moore Vicky, Booth Vicky, Hancox Jennie E, Masud Tahir, Hoare Zoe, Brand Andrew, Edwards Rhiannon Tudor, Jones Carys, das Nair Roshan, Pollock Kristian, Godfrey Maureen, Gladman John R F, Vedhara Kavita, Smith Helen, Orrell Martin
1Health Care of Older People, Nottingham University Hospitals NHS Trust, Queens Medical Centre, Nottingham, NG7 2UH UK.
2Division of Rehabilitation and Ageing, University of Nottingham, Nottingham, NG7 2UH UK.
Pilot Feasibility Stud. 2018 Feb 17;4:49. doi: 10.1186/s40814-018-0239-y. eCollection 2018.
People with dementia progressively lose abilities and are prone to falling. Exercise- and activity-based interventions hold the prospect of increasing abilities, reducing falls, and slowing decline in cognition. Current falls prevention approaches are poorly suited to people with dementia, however, and are of uncertain effectiveness. We used multiple sources, and a co-production approach, to develop a new intervention, which we will evaluate in a feasibility randomised controlled trial (RCT), with embedded adherence, process and economic analyses.
We will recruit people with mild cognitive impairment or mild dementia from memory assessment clinics, and a family member or carer. We will randomise participants between a therapy programme with high intensity supervision over 12 months, a therapy programme with moderate intensity supervision over 3 months, and brief falls assessment and advice as a control intervention. The therapy programmes will be delivered at home by mental health specialist therapists and therapy assistants. We will measure activities of daily living, falls and a battery of intermediate and distal health status outcomes, including activity, balance, cognition, mood and quality of life. The main aim is to test recruitment and retention, intervention delivery, data collection and other trial processes in advance of a planned definitive RCT. We will also study motivation and adherence, and conduct a process evaluation to help understand why results occurred using mixed methods, including a qualitative interview study and scales measuring psychological, motivation and communication variables. We will undertake an economic study, including modelling of future impact and cost to end-of-life, and a social return on investment analysis.
In this study, we aim to better understand the practicalities of both intervention and research delivery, and to generate substantial new knowledge on motivation, adherence and the approach to economic analysis. This will enable us to refine a novel intervention to promote activity and safety after a diagnosis of dementia, which will be evaluated in a definitive randomised controlled trial.
ClinicalTrials.gov: NCT02874300; ISRCTN 10550694.
痴呆症患者的能力会逐渐丧失，且容易跌倒。基于运动和活动的干预措施有望增强能力、减少跌倒并减缓认知能力下降。然而，目前的跌倒预防方法并不适合痴呆症患者，其有效性也不确定。我们利用多种资源并采用共同生产的方法开发了一种新的干预措施，并将在一项可行性随机对照试验（RCT）中对其进行评估，该试验将嵌入依从性、过程和经济分析。
我们将从记忆评估诊所招募轻度认知障碍或轻度痴呆症患者以及一名家庭成员或护理人员。我们将把参与者随机分为三组，一组接受为期12个月的高强度监督治疗方案，一组接受为期3个月的中等强度监督治疗方案，还有一组接受简短的跌倒评估和建议作为对照干预措施。治疗方案将由心理健康专家治疗师和治疗助理在家中实施。我们将测量日常生活活动、跌倒情况以及一系列中期和远期健康状况指标，包括活动能力、平衡能力、认知能力、情绪和生活质量。主要目的是在计划进行的确定性RCT之前，测试招募和保留情况、干预措施的实施、数据收集及其他试验过程。我们还将研究动机和依从性，并进行过程评估，以帮助理解结果产生的原因，采用包括定性访谈研究以及测量心理、动机和沟通变量的量表等混合方法。我们将进行一项经济研究，包括对未来影响和终末期成本的建模以及社会投资回报分析。
在本研究中，我们旨在更好地了解干预措施和研究实施的实际情况，并就动机、依从性和经济分析方法产生大量新知识。这将使我们能够完善一种新的干预措施，以促进痴呆症诊断后的活动能力和安全性，并将在确定性随机对照试验中对其进行评估。
ClinicalTrials.gov：NCT02874300；ISRCTN 10550694。
