NCT02607917

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
10,800

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Feb 2015

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 16, 2015

Completed
9 months until next milestone

First Submitted

Initial submission to the registry

November 16, 2015

Completed
2 days until next milestone

First Posted

Study publicly available on registry

November 18, 2015

Completed
4.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 29, 2020

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2020

Completed
Last Updated

April 2, 2021

Status Verified

March 1, 2021

Enrollment Period

5 years

First QC Date

November 16, 2015

Last Update Submit

March 31, 2021

Conditions

Myocardial InfarctionStroke

Keywords

Cardiovascular Disease

Outcome Measures

Primary Outcomes (1)

  • Appropriate aspirin use.

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

    4-5 years

Secondary Outcomes (1)

  • Cardiovascular disease morbidity

    4-5 years

Study Arms (3)

Mass Media plus clinic intervention.

EXPERIMENTAL

These geographic areas will receive the media plus clinic intervention over a two year period.

Other: Mass Media plus clinic intervention.

Media

EXPERIMENTAL

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.

Interventions

Mass Media plus clinic intervention.OTHER
Mass Media plus clinic intervention.
MediaOTHER
Media

Eligibility Criteria

Age45 Years - 75 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Minnesota

Minneapolis, Minnesota, 55455, United States

Location

Related Publications (4)

  • Roeser S, Duval S, Luepker RV, Eder M, Finnegan JR, Van't Hof JR. Population cessation of aspirin use for the prevention of cardiovascular disease. Am J Prev Cardiol. 2025 Feb 8;21:100941. doi: 10.1016/j.ajpc.2025.100941. eCollection 2025 Mar.

    PMID: 40103687DERIVED

  • Luepker RV, Eder M, Finnegan JR, Van't Hof JR, Oldenburg N, Duval S. Association of a Community Population and Clinic Education Intervention Program With Guideline-Based Aspirin Use for Primary Prevention of Cardiovascular Disease: A Nonrandomized Controlled Trial. JAMA Netw Open. 2022 May 2;5(5):e2211107. doi: 10.1001/jamanetworkopen.2022.11107.

    PMID: 35536579DERIVED

  • Duval S, Van't Hof JR, Oldenburg NC, Eder M, Finnegan JR Jr, Luepker RV. A community-based group randomized trial to increase aspirin use for primary prevention of cardiovascular disease: Study protocol and baseline results for the "Ask About Aspirin" initiative. Contemp Clin Trials Commun. 2021 Apr 19;22:100772. doi: 10.1016/j.conctc.2021.100772. eCollection 2021 Jun.

    PMID: 34027223DERIVED

  • Krzyzanowski B, Manson SM, Eder MM, Kne L, Oldenburg N, Peterson K, Hirsch AT, Luepker RV, Duval S. Use of a Geographic Information System to create treatment groups for group-randomized community trials: The Minnesota Heart Health Program. Trials. 2019 Mar 28;20(1):185. doi: 10.1186/s13063-019-3284-9.

    PMID: 30922358DERIVED

MeSH Terms

Conditions

Myocardial InfarctionStrokeCardiovascular Diseases

Interventions

Culture Media

Condition Hierarchy (Ancestors)

Myocardial IschemiaHeart DiseasesVascular DiseasesInfarctionIschemiaPathologic ProcessesPathological Conditions, Signs and SymptomsNecrosisCerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System Diseases

Intervention Hierarchy (Ancestors)

Laboratory ChemicalsSpecialty Uses of ChemicalsChemical Actions and UsesEquipment and Supplies

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 16, 2015

First Posted

November 18, 2015

Study Start

February 16, 2015

Primary Completion

February 29, 2020

Study Completion

July 1, 2020

Last Updated

April 2, 2021

Record last verified: 2021-03

Locations

US(1)