Clinical Trials Directory

Trials / Completed

CompletedNCT02373319

Self-screening of Cardiovascular Risk

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

Status
Completed
Phase
N/A
Study type
Interventional
Enrollment
960 (actual)
Sponsor
Parc de Salut Mar · Academic / Other
Sex
All
Age
35 Years – 74 Years
Healthy volunteers
Accepted

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.

Conditions

Interventions

TypeNameDescription
BEHAVIORALCV-screening-1 plus personalizedCardiovascular 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 personalizedSelf-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 standardCardiovascular 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 standardSelf-screening of cardiovascular risk - 15 minutes wash-out - Cardiovascular risk screening supervised by health professional; Standard communication of the health exam results

Timeline

Start date
2016-03-01
Primary completion
2017-04-01
Completion
2018-04-01
First posted
2015-02-27
Last updated
2019-08-29

Locations

1 site across 1 country: Spain

Source: ClinicalTrials.gov record NCT02373319. Inclusion in this directory is not an endorsement.