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临床试验/NCT02607917
NCT02607917已完成不适用

Testing a Community Intervention to Increase Aspirin Use for Primary Prevention of Cardiovascular Disease

University of Minnesota2 个研究点 分布在 1 个国家目标入组 10,800 人开始时间: 2015年2月16日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
10,800
试验地点
2
主要终点
Appropriate aspirin use.

研究概览

简要总结

This research will test the effect of mass media or mass media plus a clinic based education program will improve appropriate aspirin use for cardiovascular disease prevention. It is a group randomized design of 24 geographic areas in Minnesota with adjacent states serving as controls.

详细描述

Proposed is a demonstration and implementation project to increase the appropriate use of aspirin for primary prevention of acute myocardial infarction and stroke in the population of Minnesota. Although significant progress in the reduction of acute myocardial infarction and stroke is apparent, these cardiovascular disorders continue as the leading causes of morbidity and mortality. In recent years, and in the context of the positive results from large randomized clinical trials, there is growing consensus that aspirin, when appropriately used, reduces cardiovascular morbidity in men aged 45-79 and women aged 55-79 years. The use of aspirin for primary prevention was recommended in the U.S. Preventive Services Task Force Report in 2009 and more recently in the CDC/CMS 'Million Hearts' ABCs (aspirin, blood pressure, cholesterol, smoking) campaign. Aspirin use is also recommended in the Healthy People 2020 goals. However, many adults who would benefit, are not taking aspirin.

The investigators have been fortunate to receive a large philanthropic donation to launch a campaign to increase appropriate aspirin use in the State of Minnesota. The proposed grant requests funding to evaluate that campaign and the innovative approaches it proposes. In the context of a innovative mass media effort, the investigators intend to test new methods for health system change to increase appropriate aspirin use. Using a two-arm design, the investigators have defined 24 geographic areas in the state that will form the basis for a group-randomized trial. This design will allow us to distinguish the effects of the intervention methods. The interventions will be evaluated by sequential surveys of the target-age general population at baseline and follow-up. Appropriate aspirin use in that population will be the primary goal and endpoint. Simultaneous surveys of adjacent Upper Midwestern states (Iowa, North and South Dakota, Wisconsin) will assess secular trends. Morbidity and mortality data will monitor disease trends and complications associated with aspirin use.

A substantial pilot study in a middle sized community in Northern Minnesota allows us to refine and validate our intervention and measurement methods at the community level. This pilot also demonstrated behavior change of a magnitude supportive of our design assumptions.

This program, if successful, should result in a generalizable program tested in a real world population setting.

研究设计

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

入排标准

年龄范围
45 Years 至 75 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Healthy men age 45-
  • Healthy women age 55-79
  • per USPSTF 2009 recommendations

排除标准

  • History of cardiovascular disease
  • aspirin allergy
  • serious life-limiting illness

结局指标

主要结局

Appropriate aspirin use.

时间窗: 4-5 years

Aspirin use will be determined by standardized surveys of randomly selected adults.

次要结局

  • Cardiovascular disease morbidity(4-5 years)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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