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Cardiovascular Risk in People Older Than 55 Years and Cognitive Performance at 5 Years (NEDICES2RISK)

2021年2月7日更新者：Ester Tapias Merino、Gerencia de Atención Primaria, Madrid

Cardiovascular Risk in People Older Than 55 Years and Cognitive Performance at 5 Years: an Estimation Model Based on Spanish Population. NEDICES-2-RISK Study.

This study assesses whether people's cardiovascular risk influences cognitive performance in later years. To do this, the cardiovascular risk and cognitive performance of each patient will be evaluated at the beginning of the study and 5 years later.

研究概览

地位

未知

条件

干预/治疗

其他：Classification according to the cardiovascular risk

研究类型

观察性的

注册 (预期的)

965

联系人和位置

本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。

学习地点

西班牙
- - Madrid、西班牙、28033
    - Gerencia Atencion Primaria

参与标准

研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

55年至 74年 (成人、年长者)

接受健康志愿者

不适用

有资格学习的性别

全部

取样方法

概率样本

研究人群

The study population comes from the cohort NEDICES 2. NEDICES 2 population comes from primary care physician´s lists.

描述

Inclusion Criteria:

population aged 55 to 74 years from NEDICES 2 study
to have signed informed consent
to have done the neuropsicological assessment

Exclusion Criteria:

to have a dementia diagnosis at baseline.

学习计划

本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。

研究是如何设计的？

设计细节

研究衡量的是什么？

主要结果指标

结果测量	措施说明	大体时间
Change in the 37-item versión of the Mini-Mental State Examination score 大体时间：Baseline and 5 years	The 37 item Version of the Mini-Mental State Examination is a Spanish adapted version of the original MMSE by Folstein. It contains 37 items. Includes temporal and spatial orientation, memory, attention, calculus, language, object recognition, elementary commands and visuoconstructive capacity. The minimun score is 0 and the maximum score is 37 points. Higher values are considered a better outcome.	Baseline and 5 years
Change in the Clock-drawing test score 大体时间：Baseline and 5 years	The Clock-drawing test is a brief test that explores comprehension, concentration, visual memory and abstraction and visuoconstructive praxis. The subject is asked to draw a clock from memory on a blank sheet, including the numbers and hands at a fixed time. The minimum score is 0 and the maximum score is 4. Higher values are considered a better outcome. Performance time is recorded. A shorter time is considered a better outcome.	Baseline and 5 years
Change in the Center for Epidemiologic Studies Depression Scale (CES-D) score 大体时间：Baseline and 5 years	The Center for Epidemiologic Studies Depression Scale (CES-D) is a screening instrument for depression, self-administared, which records depressive symptoms and their different manifestations in the last 7 days and each symptom is classified in four frequency levels. The score ranges from 20 to 80. Higher values are considered a worse outcome.	Baseline and 5 years
Change in the Semantic verbal fluency test score 大体时间：Baseline and 5 years	The Semantic verbal fluency test evaluates semantic memory, executive and verbal planning capabilities. It is used a shorter version that evaluates the number of elements in a category (animals). There is a minimum score of 0, there is not a maximun score. Higher values are considered a better outcome.	Baseline and 5 years
Change in the Six-object memory recall test score 大体时间：Baseline and 5 years	The Six-Object Memory Recall Tests shows six sheets with common objects and explores object recognition, immediate recall and delayed memory after 5 minutes. Both, object recognition, inmediate recall and delayed memory have a scale ranging from 0 to 6.Therefore, the total score has a minimun score of 0 and a maximum score of 18 points. Higher values are considered a better outcome.	Baseline and 5 years
Change in the Mental Function Index score 大体时间：Baseline and 5 years	The Mental Function Index is a questionnaire that evaluates 11 instrumental activities of daily life and competencies in the home and occupational and social functioning that is administered to a family member or caregiver. It explores 11 sections, each one with three levels of functionality. The minimum score is 0 and the maximum score is 33. Higher values are considered a worse outcome.	Baseline and 5 years
Change in the Trail Making Test score 大体时间：Baseline and 5 years	The Trail Making Test is a visuomotor integration test from which is collected the score, the number of mistakes and the performance time. The score ranges from 1 to 20. Higher values are considered a better outcome. A shorter performance time and fewer mistakes are considered a better outcome.	Baseline and 5 years
Change in the Word accentuation test score 大体时间：Baseline and 5 years	The Word accentuation test is a verbal intelligence test in which the participant reads 30 unusual words that are shown to him without tildes and whose accentuation he has to do correctly. The score ranges from 0 to 30. Higher values are considered a better outcome.	Baseline and 5 years

次要结果测量

结果测量	措施说明	大体时间
New cases of cancer during the 5-years follow-up 大体时间：5 years	It will be recorded all new cases of cancer during the 5-years follow-up	5 years

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

赞助

Gerencia de Atención Primaria, Madrid

调查人员

首席研究员：Ester Tapias-Merino, MD、Gerencia de Atención Primaria, Madrid

出版物和有用的链接

负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。

一般刊物

Hernandez-Gallego J, Llamas-Velasco S, Bermejo-Pareja F, Vega S, Tapias-Merino E, Rodriguez-Sanchez E, Boycheva E, Serrano JI, Gil-Garcia JF, Trincado R, Sanchez-Rodrigo JV, Cacho J, Contador I, Garcia-Ptacek S, Sierra-Hidalgo F, Cubo E, Carro E, Villarejo-Galende A, Garcia Garcia-Patino R, Benito-Leon J. Neurological Disorders in Central Spain, Second Survey: Feasibility Pilot Observational Study. JMIR Res Protoc. 2019 Jan 10;8(1):e10941. doi: 10.2196/10941.

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始 (实际的)

2014年1月1日

初级完成 (预期的)

2022年6月1日

研究完成 (预期的)

2022年6月1日

研究注册日期

首次提交

2019年3月24日

首先提交符合 QC 标准的

2019年4月21日

首次发布 (实际的)

2019年4月24日

研究记录更新

最后更新发布 (实际的)

2021年2月9日

上次提交的符合 QC 标准的更新

2021年2月7日

最后验证

2021年2月1日