Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT02607917 |
| Other study ID # |
1201M8921 |
| Secondary ID |
|
| Status |
Completed |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
February 16, 2015 |
| Est. completion date |
July 1, 2020 |
Study information
| Verified date |
March 2021 |
| Source |
University of Minnesota |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial 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.
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.
