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一项痴呆症预防随机对照试验中退出和不依从的决定因素:强化血管护理预防痴呆症试验

Determinants of Dropout and Nonadherence in a Dementia Prevention Randomized Controlled Trial: The Prevention of Dementia by Intensive Vascular Care Trial.

作者信息

Beishuizen Cathrien R L, Coley Nicola, Moll van Charante Eric P, van Gool Willem A, Richard Edo, Andrieu Sandrine

机构信息

Department of Neurology, Academic Medical Center, University of Amsterdam, Amsterdam, The Netherlands.

Department of Epidemiology and Public Health, UMR1027, Université de Toulouse, Université Paul Sabatier, Institut National de la Santé et de la Recherche Médicale, Centre Hospitalier Universitaire de Toulouse, Toulouse, France.

出版信息

J Am Geriatr Soc. 2017 Jul;65(7):1505-1513. doi: 10.1111/jgs.14834. Epub 2017 Mar 6.

DOI:10.1111/jgs.14834
PMID:28263374
Abstract

OBJECTIVES

To explore and compare sociodemographic, clinical, and neuropsychiatric determinants of dropout and nonadherence in older people participating in an open-label cluster-randomized controlled trial-the Prevention of Dementia by Intensive Vascular care (preDIVA) trial-over 6 years.

DESIGN

Secondary analysis.

SETTING

One hundred sixteen general practices in the Netherlands.

PARTICIPANTS

Community-dwelling individuals aged 70 to 78 (N = 2,994).

INTERVENTION

Nurse-led multidomain intervention targeting cardiovascular risk factors to prevent dementia.

MEASUREMENTS

The associations between participant baseline sociodemographic (age, sex, education), clinical (medical history, disability, cardiovascular risk), neuropsychiatric (depressive symptoms (Geriatric Depression Scale-15), and cognitive (Mini-Mental State Examination)) characteristics and dropout from the trial and nonadherence to the trial intervention were explored using multilevel logistic regression models.

RESULTS

Older age, poorer cognitive function, more symptoms of depression, and greater disability were the most important determinants of dropout of older people. The presence of cardiovascular risk factors was not associated with dropout but was associated with nonadherence. Being overweight was a risk factor for nonadherence, whereas people with high blood pressure or a low level of physical exercise adhered better to the intervention. The association between poorer cognitive function and symptoms of depression and dropout was stronger in the control group than in the intervention group, and vice versa for increased disability.

CONCLUSION

In a large dementia prevention trial with 6-year follow-up, dropout was associated with older age, poorer cognitive function, symptoms of depression, and disability at baseline. These findings can help to guide the design of future dementia prevention trials in older adults. The associations found between cardiovascular risk factors and nonadherence need to be confirmed in other older populations receiving cardiovascular prevention interventions.

摘要

目的

在一项为期6年的开放标签整群随机对照试验——强化血管护理预防痴呆(preDIVA)试验中,探究并比较参与试验的老年人退出试验和不依从的社会人口学、临床及神经精神学决定因素。

设计

二次分析。

地点

荷兰的116家普通诊所。

参与者

70至78岁的社区居住个体(N = 2994)。

干预措施

由护士主导的针对心血管危险因素以预防痴呆的多领域干预。

测量方法

使用多水平逻辑回归模型,探究参与者基线社会人口学特征(年龄、性别、教育程度)、临床特征(病史、残疾、心血管风险)、神经精神学特征(抑郁症状(老年抑郁量表-15项))及认知特征(简易精神状态检查表)与退出试验及不依从试验干预之间的关联。

结果

年龄较大、认知功能较差、抑郁症状较多及残疾程度较高是老年人退出试验的最重要决定因素。心血管危险因素的存在与退出试验无关,但与不依从有关。超重是不依从的一个危险因素,而患有高血压或体育锻炼水平较低的人对干预的依从性更好。在对照组中,较差的认知功能和抑郁症状与退出试验之间的关联比干预组更强,而残疾程度增加则相反。

结论

在一项为期6年随访的大型痴呆预防试验中,退出试验与基线时年龄较大、认知功能较差、抑郁症状及残疾有关。这些发现有助于指导未来针对老年人的痴呆预防试验的设计。心血管危险因素与不依从之间的关联需要在其他接受心血管预防干预的老年人群中得到证实。

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