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临床试验/NCT01831908
NCT01831908已完成不适用

The "Know Your Numbers" Program in Atahualpa - An Interventional Study Aimed to Reduce Cardiovascular Diseases and Stroke Burden in Rural Coastal Ecuador.

Hospital Clínica Kennedy1 个研究点 分布在 1 个国家目标入组 350 人开始时间: 2014年2月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
350
试验地点
1
主要终点
Improvement in cardiovascular health

研究概览

简要总结

Persons voluntarily attending the Community Center of the Atahualpa Project during one calendar year will be evaluated by trained personnel to check their cardiovascular health status. A chart with information of healthy behaviors as well as the numbers of the person's blood pressure, fasting glucose, and total cholesterol levels will be given. Persons who sign the informed consent will be visited at their homes after 3 months and than every year up to five years. The idea is to check whether the person followed our advises and if that compliance iis associated with improvement in the cardiovascular status or with a decreased incidence of stroke and ischemic heart disease, when compared with persons who did not attend the community center or those who did not follow our advices.

详细描述

Campaigns aimed to increase the level of awareness on cardiovascular risk factors may encourage people to change their lifestyles and to increase compliance with medication. This intervention has been called the "know your numbers program" and has been tested in developed countries. No study have evaluated the efficacy of this program in reducing the prevalence of ischemic heart disease and stroke on the long-term follow-up, and this program has not been applied to people living in rural areas of developing countries. During the study years, a community center of the Atahualpa Project will be open and stuffed with trained paramedical personnel that will attend people that voluntarily look for information. All these persons will be invited to participate in the "know your numbers" program, and those who sign the informed consent form will be enrolled in the program. Recruitment will be during one calendar year to assure the inclusion of a significant sample size of the population. As part of the initial visit, the CVH status of all individuals will be evaluated. Thereafter, persons will be informed on their health status and the best ways to improve it according to specific situations. Those who merit treatment for a given condition will be instructed to go to the physician for proper advice and prescription. A chart containing information on stroke and ischemic heart disease warning signs, as well as on healthy behaviors will be provided to all persons. All enrolled persons will be visited at their homes three months after the initial visit to the community center, and then, every year up to five years. We will evaluate whether the person followed our advices or the reasons for poor compliance. Persons will be asked to tell us if they remember the ischemic heart disease and stroke warning signs. Anthropometric parameters, blood pressure, total cholesterol and fasting glucose levels will be recorder at every visit and, again, any specific advice to improve "their numbers" or to seek for medical attention will be given. By the end of the study, the investigators will be able to correlate the CVH status of the person as well as the occurrence of vascular outcomes or death according to whether our advices were followed or not. Statistical analysis will be directed to refute the null hypothesis that this intervention does not improve the CVH and does not reduce the risk of stroke or ischemic heart disease

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Parallel
主要目的
Prevention
盲法
None

入排标准

年龄范围
40 Years 至 95 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Atahualpa residents aged 40 years or more who seek for information at the Atahualpa Community Center and sign the informed consent.

排除标准

  • People not attending the Community Center or not signing the informed consent.

研究组 & 干预措施

Lifestyle counseling

Sham Comparator

These persons will be advised on their cardiovascular status and will receive information on how to improve it.

干预措施: Lifestyle counseling (Other)

People not seeking attention

No Intervention

Evaluation of cardiovascular health status will be performed in these persons as part of yearly door-to-door survey that will perform in Atahualpa up to the end of the study

结局指标

主要结局

Improvement in cardiovascular health

时间窗: 5 year

次要结局

  • Reduction in incident cases of stroke(5 years)

研究者

发起方
Hospital Clínica Kennedy
申办方类型
Other
责任方
Principal Investigator
主要研究者

Oscar H. Del Brutto, MD

Principal Investigator, The Atahualpa Project

Hospital Clínica Kennedy

研究点 (1)

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