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Self-screening of Cardiovascular Risk (ACRISC)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02373319
Recruitment Status : Completed
First Posted : February 27, 2015
Last Update Posted : August 29, 2019
Sponsor:
Information provided by (Responsible Party):
Maria Grau, Parc de Salut Mar

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.

Condition or disease Intervention/treatment Phase
Risk Factor, Cardiovascular Behavioral: CV-screening-1 plus personalized Behavioral: CV-screening-2 plus personalized Behavioral: CV-screening-1 plus standard Behavioral: CV-screening-2 plus standard Not Applicable

Detailed 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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 960 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Screening
Official Title: Validity and Effectiveness of a Method for Self-screening of Cardiovascular Risk
Actual Study Start Date : March 2016
Actual Primary Completion Date : April 2017
Actual Study Completion Date : April 2018

Arm Intervention/treatment
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
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

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
Behavioral: 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

Active Comparator: 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
Behavioral: 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

Active Comparator: 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
Behavioral: 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




Primary Outcome Measures :
  1. Pre-post changes in blood lipid levels [ Time Frame: [Time frame: From baseline to 12 months after the intervention] ]
    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.


Secondary Outcome Measures :
  1. Pre-post changes in controlled blood lipid levels [ Time Frame: From baseline to 12 months after the intervention ]
    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.

  2. Pre-post changes in controlled blood pressure [ Time Frame: From baseline to 12 months after the intervention ]
    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

  3. Pre-post changes in controlled body mass index [ Time Frame: From baseline to 12 months after the intervention ]
    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.

  4. Pre-post differences in smoking status [ Time Frame: From baseline to 12 months after the intervention ]
    Pre-post changes in the percentage of smokers. Smoking status will be assessed at baseline and 12 months after the intervention

  5. Mean difference between two methods of cardiovascular risk estimation [ Time Frame: From baseline to 30 minutes ]
    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

  6. Pre-post changes in blood pressure [ Time Frame: 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.

  7. Pre-post changes in body mass index [ Time Frame: 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.



Information from the National Library of Medicine

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Ages Eligible for Study:   35 Years to 74 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02373319


Locations
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Spain
Unitat de Suport a la Recerca de Girona IDIAP Jordi Gol
Girona, Spain, 17002
Sponsors and Collaborators
Parc de Salut Mar
Investigators
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Principal Investigator: Maria Grau, MD, PhD, MPH IMIM
Study Director: Jaume Marrugat, MD, PhD IMIM
Publications:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Maria Grau, MD, Parc de Salut Mar
ClinicalTrials.gov Identifier: NCT02373319    
Other Study ID Numbers: 5815/I
First Posted: February 27, 2015    Key Record Dates
Last Update Posted: August 29, 2019
Last Verified: August 2019
Keywords provided by Maria Grau, Parc de Salut Mar:
Cardiovascular risk
Cholesterol
Hypertension
Diabetes
Smoking
Preventive Medicine
Epidemiology
Public Health
Diet
Physical Activity