Self-screening of Cardiovascular Risk

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

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

Conditions
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Risk Factor, Cardiovascular

Intervention / Treatment
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* Behavioral: CV-screening-1 plus personalized
* Behavioral: CV-screening-2 plus personalized
* Behavioral: CV-screening-1 plus standard
* Behavioral: CV-screening-2 plus standard


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 35 Years
Maximum Age: 74 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Screening
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: CV-screening-1 plus personalized<br>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<br>* 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<br>|
| Experimental: CV-screening-2 plus personalized<br>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<br>* 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<br>|
| Active Comparator: CV-screening-1 plus standard<br>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<br>* Cardiovascular risk screening supervised by health professional - 15 minutes wash-out - Self-screening of cardiovascular risk; Standard communication of the health exam results<br>|
| Active Comparator: CV-screening-2 plus standard<br>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<br>* Self-screening of cardiovascular risk - 15 minutes wash-out - Cardiovascular risk screening supervised by health professional; Standard communication of the health exam results<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Cardiovascular risk, Cholesterol, Hypertension, Diabetes, Smoking, Preventive Medicine, Epidemiology, Public Health, Diet, Physical Activity