ACRISC: Self-screening of Cardiovascular Risk

Sponsor

Parc de Salut Mar (Other)

Overall Status

Completed

CT.gov ID

NCT02373319

Collaborator

(none)

960

Enrollment

Location

Arms

Actual Duration (Months)

38.4

Patients Per Site Per Month

Study Details

Study Description

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	N/A

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.

Study Design

Study Type:

Interventional

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 :

Mar 1, 2016

Actual Primary Completion Date :

Apr 1, 2017

Actual Study Completion Date :

Apr 1, 2018

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

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 Outcome Measures

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 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
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
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.