Risk Factor, Cardiovascular
Conditions
Keywords
Cardiovascular risk, Cholesterol, Hypertension, Diabetes, Smoking, Preventive Medicine, Epidemiology, Public Health, Diet, Physical Activity
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.
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.
Interventions
BEHAVIORALCV-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
BEHAVIORALCV-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
BEHAVIORALCV-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
BEHAVIORALCV-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
Sponsors
Parc de Salut Mar
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SCREENING
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
35 Years to 74 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Pre-post changes in blood lipid levels | [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
| Measure | Time frame | Description |
|---|---|---|
| Pre-post changes in controlled blood pressure | 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 |
| Pre-post changes in controlled body mass index | 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. |
| Pre-post differences in smoking status | 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 |
| Pre-post changes in controlled blood lipid levels | 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. |
| Pre-post changes in blood pressure | 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. |
| Pre-post changes in body mass index | 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. |
| Mean difference between two methods of cardiovascular risk estimation | 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 |
Countries
Spain
Outcome results
None listed