Self-screening of Cardiovascular Risk

Risk Factor, Cardiovascular Clinical Trial

— ACRISC  

Official title:

Validity and Effectiveness of a Method for Self-screening of Cardiovascular Risk

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02373319
• Other study ID #: 5815/I
• Status: Completed
• Phase: N/A
• Start date: March 2016
• Est. completion date: April 2018

Study information

• Verified date: August 2019
• Source: Parc de Salut Mar
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The aims of this study are (1) to validate a self-screening method for cardiovascular (CV) 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.

Description:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 960
• Est. completion date: April 2018
• Est. primary completion date: April 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 35 Years to 74 Years

Eligibility

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

Related Conditions & MeSH terms

• Risk Factor, Cardiovascular

Intervention

Behavioral:
• 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
• 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
• 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
• 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

Locations

Country	Name	City	State
Spain	Unitat de Suport a la Recerca de Girona IDIAP Jordi Gol	Girona

Sponsors (1)

Lead Sponsor	Collaborator
Parc de Salut Mar

Country where clinical trial is conducted

Spain, 

References & Publications (6)

Anderson KM, Odell PM, Wilson PW, Kannel WB. Cardiovascular disease risk profiles. Am Heart J. 1991 Jan;121(1 Pt 2):293-8. — View Citation

Grau M, Subirana I, Elosua R, Solanas P, Ramos R, Masiá R, Cordón F, Sala J, Juvinyà D, Cerezo C, Fitó 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. Erratum in: Eur J Cardiovasc Prev Rehabil. 2008 Aug;15(4):502. — View Citation

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. — View Citation

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. — View Citation

Marrugat J, Subirana I, Comín E, Cabezas C, Vila J, Elosua R, Nam BH, Ramos R, Sala J, Solanas P, Cordón F, Gené-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. Erratum in: J Epidemiol Community Health. 2007 Jul;61(7):655. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pre-post changes in blood lipid levels	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.	[Time frame: From baseline to 12 months after the intervention]
Secondary	Pre-post changes in controlled blood lipid levels	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.	From baseline to 12 months after the intervention
Secondary	Pre-post changes in controlled blood pressure	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	From baseline to 12 months after the intervention
Secondary	Pre-post changes in controlled body mass index	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.	From baseline to 12 months after the intervention
Secondary	Pre-post differences in smoking status	Pre-post changes in the percentage of smokers. Smoking status will be assessed at baseline and 12 months after the intervention	From baseline to 12 months after the intervention
Secondary	Mean difference between two methods of cardiovascular risk estimation	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	From baseline to 30 minutes
Secondary	Pre-post changes in blood pressure	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
Secondary	Pre-post changes in body mass index	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