- ICH GCP
- Registro de ensaios clínicos dos EUA
- Ensaio Clínico NCT02373319
Self-screening of Cardiovascular Risk (ACRISC)
Validity and Effectiveness of a Method for Self-screening of Cardiovascular Risk
Visão geral do estudo
Status
Condições
Descrição detalhada
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.
Tipo de estudo
Inscrição (Real)
Estágio
- Não aplicável
Contactos e Locais
Locais de estudo
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Girona, Espanha, 17002
- Unitat de Suport a la Recerca de Girona IDIAP Jordi Gol
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Critérios de participação
Critérios de elegibilidade
Idades elegíveis para estudo
Aceita Voluntários Saudáveis
Gêneros Elegíveis para o Estudo
Descrição
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
Plano de estudo
Como o estudo é projetado?
Detalhes do projeto
- Finalidade Principal: Triagem
- Alocação: Randomizado
- Modelo Intervencional: Atribuição Paralela
- Mascaramento: Nenhum (rótulo aberto)
Armas e Intervenções
Grupo de Participantes / Braço |
Intervenção / Tratamento |
---|---|
Experimental: 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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Experimental: 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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Comparador Ativo: 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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Comparador Ativo: 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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O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
---|---|---|
Pre-post changes in blood lipid levels
Prazo: [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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Medidas de resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
---|---|---|
Pre-post changes in controlled blood lipid levels
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: From baseline to 12 months after the intervention
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Pre-post changes in mean levels of systolic and diastolic blood pressure.
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 body mass index
Prazo: 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.
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From baseline to 12 months after the intervention
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Colaboradores e Investigadores
Patrocinador
Investigadores
- Investigador principal: Maria Grau, MD, PhD, MPH, IMIM
- Diretor de estudo: Jaume Marrugat, MD, PhD, IMIM
Publicações e links úteis
Publicações Gerais
- 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.
Datas de registro do estudo
Datas Principais do Estudo
Início do estudo (Real)
Conclusão Primária (Real)
Conclusão do estudo (Real)
Datas de inscrição no estudo
Enviado pela primeira vez
Enviado pela primeira vez que atendeu aos critérios de CQ
Primeira postagem (Estimativa)
Atualizações de registro de estudo
Última Atualização Postada (Real)
Última atualização enviada que atendeu aos critérios de controle de qualidade
Última verificação
Mais Informações
Termos relacionados a este estudo
Palavras-chave
Outros números de identificação do estudo
- 5815/I
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