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Completed

NCT Number: NCT02373319

Self-screening of Cardiovascular Risk

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.

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Key information

Conditions

Risk Factor, Cardiovascular Behavior Cardiovascular Diseases Diabetes Mellitus Endocrine System Diseases Glucose Metabolism Disorders Hypertension Metabolic Diseases Motor Activity Nutritional and Metabolic Diseases Smoking Vascular Diseases

Age range

35 year–74 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Unitat de Suport a la Recerca de Girona IDIAP Jordi Gol

Girona, 17002, Spain

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

CV-screening-1 plus personalized

Behavioral

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

CV-screening-2 plus personalized

Behavioral

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

CV-screening-1 plus standard

Behavioral

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

CV-screening-2 plus standard

Behavioral

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

Primary outcomes

  1. Pre-post changes in blood lipid levels

    Time frame: [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 outcomes

  1. Pre-post changes in controlled blood lipid levels

    Time frame: 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.

  2. Pre-post changes in controlled blood pressure

    Time frame: 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

  3. Pre-post changes in controlled body mass index

    Time frame: 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.

  4. Pre-post differences in smoking status

    Time frame: 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

  5. Mean difference between two methods of cardiovascular risk estimation

    Time frame: 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

  6. Pre-post changes in blood pressure

    Time frame: 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.

  7. Pre-post changes in body mass index

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Parc de Salut Mar

Other

Registry information

Official study title

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

Acronym: ACRISC

Important dates

Study start
2016
Primary completion
2017
Study completion
2018
First posted
Feb 27, 2015
Registry last updated
Aug 29, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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