Follow-up of Sollentuna Prevention Program (SoPP)
2015年1月19日 更新者：Mai-Lis Hellénius, Professor、Karolinska Institutet
Long-term Follow-up of an Individual and Population-based Program Aimed at Preventing Cardiovascular Disease in Sollentuna Municipality
To evaluate long-term effects of one individual- and population-oriented cardiovascular prevention programs in primary care.
研究概览
地位
未知
条件
详细说明
In Sweden there are unique opportunities to create a relevant comparison group for this study, which is of great importance to the value of this cohort study.
Of the three study populations two (2-3)will be created by using national registries.
- The screened group consists of the individuals (n = 5938) who had direct contact with the prevention program, ie undergone a voluntary opportunistic cardiovascular screening (questionnaire, physical examination and testing in connection with visits to health centers) and the rest of all individuals who lived in Sollentuna Municipality between 1988-1993.
- Relatives of individuals included in the screened group who lived in Stockholm county at the time of the intervention will be identified by the use of the Medical Birth Register and the Multi-Generation Register. Family members are defined as parents, siblings and children and husband / wife to those in thescreened group and will be analyzed in the same way as those who participated in the intervention for risk of developing cardiovascular disease and cancer.
- The comparison group consists of the entire population of Stockholm County minus Sollentuna 1988-93, taking into account population changes (migration, birth, death) during the period.
This three populations will be followed-up in national registries and databases
All subjects will be monitored for example disease history, socio-economics and biochemical risk factors presented below national registries and research databases. When all the matches of national registers and a local register (AMORIS)have been done the database will de-identified and anonymized data to be available for statistical processing.
研究类型
观察性的
注册 (预期的)
1600000
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
15年 及以上 (孩子、成人、年长者)
接受健康志愿者
是的
有资格学习的性别
全部
取样方法
非概率样本
研究人群
The screened group who participated in the cardiovascular prevention program:
(n=5938) and the rest of the population in Sollentuna Municipality.
- To the screened group matched "controls" will be selected randomly from the population of Stockholm County minus Sollentuna. The population in Sollentuna will compared to the population of Stockholm County minus Sollentuna Municipality.
- Relatives of individuals included in the intervention group and who lived in Stockholm County at the time of the intervention will be identified by use of national registers.
描述
Inclusion Criteria in the risk intervention group:
- Individuals 15 years of age or more who visited three (four) health care centres in Sollentuna 1988-1993 were offered to participate in the prevention program
Exclusion Criteria in the screened intervention group:
- Age < 15 years
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
队列和干预
团体/队列 |
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Screened group
Screened group is defined as those individuals who were willing to participate in the cardiovascular prevention program and all the individuals who lived in Sollentuna during the intervention.
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Relatives to the screened group
Relatives to individuals included in the screened group, who lived in Stockholm County at least during one year at the time of the intervention.
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Control group
Matched "controls" is going to be selected randomly from the population of Stockholm County minus Sollentuna Municipality with relevant background factors.
The whole population will be used as a comparison group when evaluating the result from all the municipality of Sollentuna during 1988-1993.
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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 |
|---|---|---|
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Incidence and mortality in acute myocardial infarction, stroke, cardiovascular disease, and overall mortality, a twenty year follow-up of a prevention program.
大体时间：24 years
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Long term follow-up of a cardiovascular prevention program by using Swedish national patient registries
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24 years
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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A follow-up of drug treatment of diabetes, dyslipidemia and hypertension
大体时间：24 years
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By using the drug register in Sweden do a follow-up of drug treatment in the cohort
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24 years
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其他结果措施
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Incidence and mortality in cancer
大体时间：24 years
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Incidence and mortality in cancer - a twenty year follow-up by using the swedish cancer register
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24 years
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Consumption of medical care overall and for different diagnostic groups
大体时间：24 years
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To study medical care consumption overall for different diagnostic groups by using different registers in Sweden
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24 years
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Health economic aspects
大体时间：24 years
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Health economic aspects such as
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24 years
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Time trends of morbidity and mortality in acute myocardial infarction, stroke, cardiovascular disease and total mortality
大体时间：24 years
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To study time trends of morbidity and mortality in acute myocardial infarction, stroke, cardiovascular disease and total mortality by use of National Swedish registries.
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24 years
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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。
调查人员
- 首席研究员：Gunilla Journath, PhD、Karolinska Institutet
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。
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
1988年6月1日
初级完成 (预期的)
2015年9月1日
研究完成 (预期的)
2016年12月1日
研究注册日期
首次提交
2014年8月7日
首先提交符合 QC 标准的
2014年8月7日
首次发布 (估计)
2014年8月8日
研究记录更新
最后更新发布 (估计)
2015年1月21日
上次提交的符合 QC 标准的更新
2015年1月19日
最后验证
2015年1月1日
更多信息
此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.