Self-screening of Cardiovascular Risk (ACRISC)
Validity and Effectiveness of a Method for Self-screening of Cardiovascular Risk
調査の概要
状態
条件
詳細な説明
Primary prevention activities based on some admittedly blunt screening instruments such as cardiovascular (CV) risk functions must be addressed to the whole population, prioritizing certain sectors of the population. However, the main limitation of current risk screening procedures is related to the natural history of cardiovascular disease, whose expression depends on the cumulative exposure to cardiovascular risk factors throughout a person's lifetime. Early prevention of cardiovascular disease is key to reduce this cumulative risk, thereby reducing the incidence of cardiovascular events.
The objectives of this study are (1) to validate a self-screening method for cardiovascular risk that does not require the supervision of a health professional (including self-measurement of blood pressure, lipid profile evaluated by dry chemistry, and self-administered questionnaires on sex, age, diabetes, and tobacco consumption). (2) From these data, the investigators will generate personalized recommendations based on the best available evidence. The investigators will also analyze whether this innovative approach improves adherence to preventive recommendations for cardiovascular and other chronic diseases.
Cardiovascular risk measured with the self-screening method will be compared with the gold standard (cardiovascular risk supervised by health professional). Participants will be randomly assigned to the intervention (communication of cardiovascular risk and recommendation of personalized preventive actions) or control groups (communication of cardiovascular risk). Subjects will be reexamined one year after recruitment for assessing adherence to the preventive recommendations in terms of improvement in the control of cardiovascular risk factors.
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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-
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Girona、スペイン、17002
- Unitat de Suport a la Recerca de Girona IDIAP Jordi Gol
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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:
- Understand and accept the study's procedures and sign an informed consent form
- Inhabitants of Girona (Gerona, Spain) and the metropolitan area
Exclusion Criteria:
- History of cardiovascular disease
- Individuals with terminal disease
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:ふるい分け
- 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:CV-screening-1 plus personalized
Cardiovascular risk screening supervised by health professional - 15 minutes wash-out - Self-screening of cardiovascular risk; Communication of personalized recommendations according to the health exam results for the control of cardiovascular risk factors
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Cardiovascular risk screening supervised by health professional - 15 minutes wash-out - Self-screening of cardiovascular risk; Communication of personalized recommendations according to the health exam results for the control of cardiovascular risk factors
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実験的:CV-screening-2 plus personalized
Self-screening of cardiovascular risk - 15 minutes wash-out - Cardiovascular risk screening supervised by health professional; Communication of personalized recommendations according to the health exam results for the control of cardiovascular risk factors
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Self-screening of cardiovascular risk - 15 minutes wash-out - Cardiovascular risk screening supervised by health professional; Communication of personalized recommendations according to the health exam results for the control of cardiovascular risk factors
|
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アクティブコンパレータ:CV-screening-1 plus standard
Cardiovascular risk screening supervised by health professional - 15 minutes wash-out - Self-screening of cardiovascular risk; Standard communication of the health exam results
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Cardiovascular risk screening supervised by health professional - 15 minutes wash-out - Self-screening of cardiovascular risk; Standard communication of the health exam results
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アクティブコンパレータ:CV-screening-2 plus standard
Self-screening of cardiovascular risk - 15 minutes wash-out - Cardiovascular risk screening supervised by health professional; Standard communication of the health exam results
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Self-screening of cardiovascular risk - 15 minutes wash-out - Cardiovascular risk screening supervised by health professional; Standard communication of the health exam results
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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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Pre-post changes in blood lipid levels
時間枠:[Time frame: From baseline to 12 months after the intervention]
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Pre-post changes in mean levels of blood lipid levels (total, HDL and LDL cholesterol).
Blood samples will be obtained at baseline and 12 months after the intervention.
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[Time frame: From baseline to 12 months after the intervention]
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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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Pre-post changes in controlled blood lipid levels
時間枠:From baseline to 12 months after the intervention
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Pre-post changes in the percentage of individuals with controlled blood lipid levels according to the most updated European Clinical Practice Guidelines (total, HDL and LDL cholesterol).
Blood samples will be obtained at baseline and 12 months after the intervention.
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From baseline to 12 months after the intervention
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Pre-post changes in controlled blood pressure
時間枠:From baseline to 12 months after the intervention
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Pre-post changes in the percentage of individuals with controlled systolic and diastolic blood pressure levels (140 and 90 mmHg, respectively).
Measures will be obtained at baseline and 12 months after the intervention
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From baseline to 12 months after the intervention
|
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Pre-post changes in controlled body mass index
時間枠:From baseline to 12 months after the intervention
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Pre-post changes in the percentage of individuals with body mass index below 25 kg/m2.
Measures will be obtained at baseline and 12 months after the intervention.
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From baseline to 12 months after the intervention
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Pre-post differences in smoking status
時間枠:From baseline to 12 months after the intervention
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Pre-post changes in the percentage of smokers.
Smoking status will be assessed at baseline and 12 months after the intervention
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From baseline to 12 months after the intervention
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Mean difference between two methods of cardiovascular risk estimation
時間枠:From baseline to 30 minutes
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Comparison of cardiovascular risk estimates by two methods (Screening of cardiovascular risk supervised by health professional (Gold Standard) - self-screening of cardiovascular risk).
Measures with each method will be taken 30 minutes apart after a wash-out period
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From baseline to 30 minutes
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Pre-post changes in blood pressure
時間枠:From baseline to 12 months after the intervention
|
Pre-post changes in mean levels of systolic and diastolic blood pressure.
Measures will be obtained at baseline and 12 months after the intervention.
|
From baseline to 12 months after the intervention
|
|
Pre-post changes in body mass index
時間枠:From baseline to 12 months after the intervention
|
Pre-post changes in mean levels of systolic and diastolic blood pressure.
Measures will be obtained at baseline and 12 months after the intervention.
|
From baseline to 12 months after the intervention
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協力者と研究者
スポンサー
捜査官
- 主任研究者:Maria Grau, MD, PhD, MPH、IMIM
- スタディディレクター:Jaume Marrugat, MD, PhD、IMIM
出版物と役立つリンク
一般刊行物
- Kodama S, Saito K, Tanaka S, Maki M, Yachi Y, Asumi M, Sugawara A, Totsuka K, Shimano H, Ohashi Y, Yamada N, Sone H. Cardiorespiratory fitness as a quantitative predictor of all-cause mortality and cardiovascular events in healthy men and women: a meta-analysis. JAMA. 2009 May 20;301(19):2024-35. doi: 10.1001/jama.2009.681.
- Anderson KM, Odell PM, Wilson PW, Kannel WB. Cardiovascular disease risk profiles. Am Heart J. 1991 Jan;121(1 Pt 2):293-8. doi: 10.1016/0002-8703(91)90861-b.
- Yusuf S, Hawken S, Ounpuu S, Dans T, Avezum A, Lanas F, McQueen M, Budaj A, Pais P, Varigos J, Lisheng L; INTERHEART Study Investigators. Effect of potentially modifiable risk factors associated with myocardial infarction in 52 countries (the INTERHEART study): case-control study. Lancet. 2004 Sep 11-17;364(9438):937-52. doi: 10.1016/S0140-6736(04)17018-9.
- Marrugat J, Subirana I, Comin E, Cabezas C, Vila J, Elosua R, Nam BH, Ramos R, Sala J, Solanas P, Cordon F, Gene-Badia J, D'Agostino RB; VERIFICA Investigators. Validity of an adaptation of the Framingham cardiovascular risk function: the VERIFICA Study. J Epidemiol Community Health. 2007 Jan;61(1):40-7. doi: 10.1136/jech.2005.038505. Erratum In: J Epidemiol Community Health. 2007 Jul;61(7):655.
- Grau M, Subirana I, Elosua R, Solanas P, Ramos R, Masia R, Cordon F, Sala J, Juvinya D, Cerezo C, Fito M, Vila J, Covas MI, Marrugat J. Trends in cardiovascular risk factor prevalence (1995-2000-2005) in northeastern Spain. Eur J Cardiovasc Prev Rehabil. 2007 Oct;14(5):653-9. doi: 10.1097/HJR.0b013e3281764429. Erratum In: Eur J Cardiovasc Prev Rehabil. 2008 Aug;15(4):502.
- Kahn R, Robertson RM, Smith R, Eddy D. The impact of prevention on reducing the burden of cardiovascular disease. Circulation. 2008 Jul 29;118(5):576-85. doi: 10.1161/CIRCULATIONAHA.108.190186. Epub 2008 Jul 7.
- Barroso M, Zomeno MD, Diaz JL, Perez S, Marti-Lluch R, Cordon F, Ramos R, Cabezas C, Salvador G, Castell C, Schroder H, Grau M. Efficacy of tailored recommendations to promote healthy lifestyles: a post hoc analysis of a randomized controlled trial. Transl Behav Med. 2021 Aug 13;11(8):1548-1557. doi: 10.1093/tbm/ibab035.
- Barroso M, Perez-Fernandez S, Vila MM, Zomeno MD, Marti-Lluch R, Cordon F, Ramos R, Elosua R, Degano IR, Fito M, Cabezas C, Salvador G, Castell C, Grau M. Validity of a method for the self-screening of cardiovascular risk. Clin Epidemiol. 2018 May 10;10:549-560. doi: 10.2147/CLEP.S158358. eCollection 2018.
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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