Perception of Cardiovascular Risk (CV-RP)

Perception of Cardiovascular Risk: Description of the Phenomenon in Primary Prevention

The aim of the study is to describe the association between the perception of cardiovascular (CV) risk and the actual CV risk and, secondarily, to detect the actual CV risk to assess the prevalence of clinical risk factors, determined by means of appropriate instruments.

Study Overview

• Status: Active, not recruiting
• Conditions: Heart Diseases; Cardiovascular Diseases
• Intervention / Treatment: Other: Prevention events organized by participating centers

Detailed Description

Cardiovascular (CV) disease is the major cause of premature death in adults that carries serious economic consequences.

Risk perception for CV disease has been reported as the subjective judgment of the likelihood of having a CV event. Risk perception is an important precursor to adopting a healthy lifestyle. However, both overestimation and underestimation of actual risk due mostly to poor health literacy are common.

For these reasons, CV prevention services of health care professionals (e.g., nurses, physicians) should, on the one hand, include screening for the presence of risk factors, and on the other hand, know the CV risk perceptions of those being cared for.

The aim of the study is to describe the association between the perception of cardiovascular (CV) risk, investigated by means of the Perception of Risk of Heart Disease Scale and a Likert-5 scale question, and the actual CV risk according to the SCORE2 and, secondarily, to detect the actual CV risk ascertained by the SCORE2 and to assess the prevalence of clinical risk factors (alterations in the lipid, glucose, or anthropometric profile) determined by means of appropriate instruments.

• Study Type: Observational
• Enrollment (Actual): 271

Contacts and Locations

Study Locations

• Italy
  • Piedmont
    • Alessandria, Piedmont, Italy, 15121
      • Azienda Ospedaliera SS Antonio e Biagio e Cesare Arrigo

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: N/A

• Sampling Method: Probability Sample

Study Population

Convenience sample of adult subjects who voluntarily wish to participate in prevention events and who will be asked for consent to participate

Description

Inclusion Criteria:

• an age between 18 and 69 years of age
• subscription to informed consent.

Exclusion Criteria:

• patients with a positive history of hospitalization due to CV pathology at the time of enrollment;
• patients with ongoing relevant cognitive debilitation (Six Item Screener score < 4)

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Study Group; Adult individuals who voluntarily wish to participate in prevention events organized by participating centers	Other: Prevention events organized by participating centers; Cardiovascular disease primary prevention events organized by centers participating in the study where capillary sampling will be performed on subjects to quantify plasma levels of cardiovascular risk factors and validated questionnaires will be administered

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Perception of Risk of Heart Disease Scale	Individual perception of the likelihood of having heart disease	Screening
Systemic Coronary Risk Estimation version2	Individual real risk at 10 years, both for fatal CV events, and also for nonfatal CV events (myocardial infarction and stroke) in apparently healthy subjects	Screening
Patient Health Questionnaire-4	Screening for the uptake of psychological symptoms of anxiety or depression in the primary care setting	Screening
Duke-UNC Functional Social Support Questionnaire	Strength of affective support derived from people close to the enrolled subjects	Screening

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Lipid panel	Lipid panel measurement	Screening
Glucose	Glucose measurement	Screening
Height	Height measurement	Screening
Weight	Weight measurement	Screening

Collaborators and Investigators

• Sponsor: Azienda Ospedaliera SS. Antonio e Biagio e Cesare Arrigo di Alessandria
• Collaborators: IRCCS San Raffaele; Istituto Auxologico Italiano; Centro Cardiologico Monzino; Istituti Ospedalieri Bergamaschi Srl
• Investigators: Principal Investigator: Niccolò Simonelli, Study Nurse, Azienda Ospedaliera SS Antonio e Biagio e Cesare Arrigo

Study record dates

Study Major Dates

• Study Start (Actual): September 29, 2023
• Primary Completion (Actual): October 27, 2023
• Study Completion (Estimated): September 1, 2024

Study Registration Dates

• First Submitted: November 27, 2023
• First Submitted That Met QC Criteria: December 19, 2023
• First Posted (Actual): January 5, 2024

Study Record Updates

• Last Update Posted (Actual): January 5, 2024
• Last Update Submitted That Met QC Criteria: December 19, 2023
• Last Verified: December 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Heart Diseases; Cardiovascular Diseases
• Other Study ID Numbers: ASO.Card.23.01

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No