Testing a Community Intervention to Increase Aspirin Use
Testing a Community Intervention to Increase Aspirin Use for Primary Prevention of Cardiovascular Disease
調査の概要
詳細な説明
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.
研究の種類
入学 (実際)
段階
- 適用できない
連絡先と場所
研究場所
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Minnesota
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Minneapolis、Minnesota、アメリカ、55455
- University of Minnesota
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参加基準
適格基準
就学可能な年齢
健康ボランティアの受け入れ
受講資格のある性別
説明
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
研究計画
研究はどのように設計されていますか?
デザインの詳細
- 主な目的:防止
- 割り当て:ランダム化
- 介入モデル:並列代入
- マスキング:なし(オープンラベル)
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
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実験的:Mass Media plus clinic intervention.
These geographic areas will receive the media plus clinic intervention over a two year period.
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実験的:Media
These geographic areas will receive the media intervention over a two year period.
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介入なし:No Intervention
Adjacent states will receive no intervention.
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この研究は何を測定していますか?
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Appropriate aspirin use.
時間枠:4-5 years
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Aspirin use will be determined by standardized surveys of randomly selected adults.
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4-5 years
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二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Cardiovascular disease morbidity
時間枠:4-5 years
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Collected from hospital records of the Minnesota Hospital Association.
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4-5 years
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協力者と研究者
スポンサー
出版物と役立つリンク
一般刊行物
- 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.
- 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.
- 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.
研究記録日
主要日程の研究
研究開始 (実際)
一次修了 (実際)
研究の完了 (実際)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (見積もり)
学習記録の更新
投稿された最後の更新 (実際)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
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