Self-screening of Cardiovascular Risk (ACRISC)

Parc de Salut Mar

Status: Completed

Conditions: Risk Factor, Cardiovascular

Treatments: Behavioral: CV-screening-2 plus standard; Behavioral: CV-screening-1 plus personalized; Behavioral: CV-screening-2 plus personalized; Behavioral: CV-screening-1 plus standard

Study type: Interventional

Funder types: Other

Identifiers

NCT02373319

5815/I

Details and patient eligibility

About

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.

Full 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.

Enrollment: 960 patients

Sex: All

Ages: 35 to 74 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Screening

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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960 participants in 4 patient groups

CV-screening-1 plus personalized

Experimental group

Description:

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

Treatment:

Behavioral: CV-screening-1 plus personalized

CV-screening-2 plus personalized

Experimental group

Description:

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

Treatment:

Behavioral: CV-screening-2 plus personalized

CV-screening-1 plus standard

Active Comparator group

Description:

Cardiovascular risk screening supervised by health professional - 15 minutes wash-out - Self-screening of cardiovascular risk; Standard communication of the health exam results

Treatment:

Behavioral: CV-screening-1 plus standard

CV-screening-2 plus standard

Active Comparator group

Description:

Self-screening of cardiovascular risk - 15 minutes wash-out - Cardiovascular risk screening supervised by health professional; Standard communication of the health exam results

Treatment:

Behavioral: CV-screening-2 plus standard