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Testing a Community Intervention to Increase Aspirin Use

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT02607917
Recruitment Status : Recruiting
First Posted : November 18, 2015
Last Update Posted : January 23, 2020
Information provided by (Responsible Party):
University of Minnesota

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Myocardial Infarction Stroke Other: Mass Media plus clinic intervention. Other: Media Not Applicable

Detailed Description:

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 10800 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Testing a Community Intervention to Increase Aspirin Use for Primary Prevention of Cardiovascular Disease
Actual Study Start Date : December 1, 2014
Estimated Primary Completion Date : February 29, 2020
Estimated Study Completion Date : July 1, 2020

Arm Intervention/treatment
Experimental: Mass Media plus clinic intervention.
These geographic areas will receive the media plus clinic intervention over a two year period.
Other: Mass Media plus clinic intervention.
Experimental: Media
These geographic areas will receive the media intervention over a two year period.
Other: Media
No Intervention: No Intervention
Adjacent states will receive no intervention.

Primary Outcome Measures :
  1. Appropriate aspirin use. [ Time Frame: 4-5 years ]
    Aspirin use will be determined by standardized surveys of randomly selected adults.

Secondary Outcome Measures :
  1. Cardiovascular disease morbidity [ Time Frame: 4-5 years ]
    Collected from hospital records of the Minnesota Hospital Association.

Information from the National Library of Medicine

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Ages Eligible for Study:   45 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

Inclusion Criteria:

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

Exclusion Criteria:

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT02607917

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Contact: Russell V Luepker, MD, MS 612-624-6362
Contact: Alan T Hirsch, MD 612-626-7715

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United States, Minnesota
University of Minnesota Recruiting
Minneapolis, Minnesota, United States, 55455
Contact: Russell Luepker    612-624-6362   
Sponsors and Collaborators
University of Minnesota
Publications automatically indexed to this study by Identifier (NCT Number):
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Responsible Party: University of Minnesota Identifier: NCT02607917    
Other Study ID Numbers: 1201M8921
First Posted: November 18, 2015    Key Record Dates
Last Update Posted: January 23, 2020
Last Verified: January 2020
Keywords provided by University of Minnesota:
Cardiovascular Disease
Additional relevant MeSH terms:
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Myocardial Infarction
Pathologic Processes
Cardiovascular Diseases
Myocardial Ischemia
Heart Diseases
Vascular Diseases