Self-screening of Cardiovascular Risk
ACRISC
Validity and Effectiveness of a Method for Self-screening of Cardiovascular Risk
1 other identifier
interventional
960
1 country
1
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Mar 2016
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
February 20, 2015
CompletedFirst Posted
Study publicly available on registry
February 27, 2015
CompletedStudy Start
First participant enrolled
March 1, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
April 1, 2018
CompletedAugust 29, 2019
August 1, 2019
1.1 years
February 20, 2015
August 28, 2019
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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 Outcomes (7)
Pre-post changes in controlled blood lipid levels
From baseline to 12 months after the intervention
Pre-post changes in controlled blood pressure
From baseline to 12 months after the intervention
Pre-post changes in controlled body mass index
From baseline to 12 months after the intervention
Pre-post differences in smoking status
From baseline to 12 months after the intervention
Mean difference between two methods of cardiovascular risk estimation
From baseline to 30 minutes
- +2 more secondary outcomes
Study Arms (4)
CV-screening-1 plus personalized
EXPERIMENTALCardiovascular 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
EXPERIMENTALSelf-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
ACTIVE COMPARATORCardiovascular 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
ACTIVE COMPARATORSelf-screening of cardiovascular risk - 15 minutes wash-out - Cardiovascular risk screening supervised by health professional; Standard communication of the health exam results
Interventions
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
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
Cardiovascular risk screening supervised by health professional - 15 minutes wash-out - Self-screening of cardiovascular risk; Standard communication of the health exam results
Self-screening of cardiovascular risk - 15 minutes wash-out - Cardiovascular risk screening supervised by health professional; Standard communication of the health exam results
Eligibility Criteria
You may qualify if:
- Understand and accept the study's procedures and sign an informed consent form
- Inhabitants of Girona (Gerona, Spain) and the metropolitan area
You may not qualify if:
- History of cardiovascular disease
- Individuals with terminal disease
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Unitat de Suport a la Recerca de Girona IDIAP Jordi Gol
Girona, 17002, Spain
Related Publications (8)
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.
PMID: 1985385BACKGROUNDGrau 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.
PMID: 17925624BACKGROUNDKahn 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.
PMID: 18606915BACKGROUNDKodama 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.
PMID: 19454641BACKGROUNDMarrugat 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.
PMID: 17183014BACKGROUNDYusuf 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.
PMID: 15364185BACKGROUNDBarroso 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.
PMID: 33837787DERIVEDBarroso 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.
PMID: 29785141DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Maria Grau, MD, PhD, MPH
IMIM
- STUDY DIRECTOR
Jaume Marrugat, MD, PhD
IMIM
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- SCREENING
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- MD
Study Record Dates
First Submitted
February 20, 2015
First Posted
February 27, 2015
Study Start
March 1, 2016
Primary Completion
April 1, 2017
Study Completion
April 1, 2018
Last Updated
August 29, 2019
Record last verified: 2019-08