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Reducing dementia risk by targeting modifiable risk factors in mid-life: study protocol for the Innovative Midlife Intervention for Dementia Deterrence (In-MINDD) randomised controlled feasibility trial

机译:通过针对中年人群中可调整的危险因素降低痴呆症风险:痴呆症抵抗力创新中年干预研究(In-MINDD)的随机对照可行性试验研究方案

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Dementia prevalence is increasing as populations live longer, with no cure and the costs of caring exceeding many other conditions. There is increasing evidence for modifiable risk factors which, if addressed in mid-life, can reduce the risk of developing dementia in later life. These include physical inactivity, low cognitive activity, mid-life obesity, high blood pressure, and high cholesterol. This study aims to assess the acceptability and feasibility and impact of giving those in mid-life, aged between 40 and 60?years, an individualised dementia risk modification score and profile and access to personalised on-line health information and goal setting in order to support the behaviour change required to reduce such dementia risk. A secondary aim is to understand participants’ and practitioners’ views of dementia prevention and explore the acceptability and integration of the Innovative Midlife Intervention for Dementia Deterrence (In-MINDD) intervention into daily life and routine practice.Methods/designIn-MINDD is a multi-centre, primary care-based, single-blinded randomised controlled feasibility trial currently being conducted in four European countries (France, Ireland, the Netherlands and the UK). Participants are being recruited from participating general practices. Inclusion criteria will include age between 40 and 60?years; at least one modifiable risk factor for dementia risk (including diabetes, hypertension, obesity, renal dysfunction, current smoker, raised cholesterol, coronary heart disease, current or previous history of depression, self-reported sedentary lifestyle, and self-reported low cognitive activity) access to the Internet. Primary outcome measure will be a change in dementia risk modification score over the timescale of the trial (6?months). A qualitative process evaluation will interview a sample of participants and practitioners about their views on the acceptability and feasibility of the trial and the links between modifiable risk factors and dementia prevention. This work will be underpinned by Normalisation Process Theory.DiscussionThis study will explore the feasibility and acceptability of a risk profiler and on-line support environment to help individuals in mid-life assess their risk of developing dementia in later life and to take steps to alleviate that risk by tackling health-related behaviour change. Testing the intervention in a robust and theoretically informed manner will inform the development of a future, full-scale randomised controlled trial.Trial registrationISRCTN Registry: ISRCTN 98553005 (DOI: ?10.1186/ISRCTN98553005).
机译:痴呆症的患病率随着人口寿命的增长而增加,无法治愈且护理费用超过许多其他条件。越来越多的证据表明,可改变的危险因素,如果在中年得到解决,可以减少以后生活中痴呆的风险。这些包括缺乏运动,低认知活动,中年肥胖,高血压和高胆固醇。这项研究旨在评估为年龄在40至60岁之间的中年人群提供个性化的痴呆风险修改评分和资料以及获得个性化在线健康信息和目标设定的机会,以评估其可接受性,可行性和影响。支持减少这种痴呆症风险所需的行为改变。次要目的是了解参与者和从业者对痴呆症预防的看法,并探讨将创新性中年痴呆症干预(In-MINDD)干预措施纳入日常生活和常规实践的可接受性和整合方法/设计中心,基于初级保健的单盲随机对照对照可行性试验,目前在四个欧洲国家(法国,爱尔兰,荷兰和英国)进行。正在从参与的一般实践中招募参与者。纳入标准将包括40至60岁之间的年龄;至少一种可改变的痴呆症风险因素(包括糖尿病,高血压,肥胖,肾功能不全,当前吸烟者,胆固醇升高,冠心病,当前或以前的抑郁史,自我报告的久坐生活方式和自我报告的认知能力低下) )访问互联网。主要结局指标是在试验的时间范围内(6个月),痴呆症风险修正评分的变化。定性过程评估将采访参与者和从业人员样本,了解他们对试验的可接受性和可行性以及可修改的风险因素与痴呆预防之间的联系的看法。这项工作将以归一化过程理论为基础。讨论本研究将探讨风险分析器和在线支持环境的可行性和可接受性,以帮助中年个体评估其晚年发展为痴呆症的风险,并采取措施缓解这种情况。通过应对与健康相关的行为改变来解决这种风险。以健壮且理论上合理的方式测试干预措施将为将来的全面随机对照试验的开展提供信息。试用注册ISRCTN注册中心:ISRCTN 98553005(DOI:?10.1186 / ISRCTN98553005)。

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