Clinical trial NCT05693857: Perceive and Calculated CV Risk
Official title: Patient-Perceived Versus Actual Risk of Cardiovascular Disease and Willingness to Follow Recommendations for Cardiovascular Prevention
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Patient-Perceived Versus
Keywords: Cardiovascular Disease
lipid-lowering therapy
Lead sponsor: Chinese University of Hong Kong
Sponsor class: OTHER
Collaborators: name: Gormin Tan gtan
First posted: 2023-01-23
Enrollment: 1500
Sex: ALL
Minimum age (years): 40
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: The study will recruit up to 1500 patients from PWH outpatient clinics (stratified by age groups 40-59, 60-79 and ≥80 years of age)

Brief summary: Cardiovascular prevention guidelines use estimated 10-year atherosclerotic cardiovascular disease (ASCVD) risk to guide treatment decisions and engage patients in shared decision-making. Research has focused on refining the accuracy of these CV risk calculators for different populations, relatively little has been done to understand how patients perceive their own ASCVD risk. Accurate perception of a patient's risk by both the patient and the doctors is important because this is an important determinant of health-related behaviour. Patients often show optimistic bias when considering their own CV risk and consistently underestimate it.

We aim to determine patient perceived versus actual risk of ASCVD in a Chinese population. We aim to better understand the degree to which patients underestimate or overestimate their ASCVD risk and whether patients are better or worse at estimating their ASCVD risk relative to their peers of the same age and sex. Finally, we aim to evaluate patients willingness to follow guideline recommended CV prevention and specifically lipid-lowering therapy.

Detailed description: Cardiovascular prevention guidelines use estimated 10-year atherosclerotic cardiovascular disease (ASCVD) risk to guide treatment decisions and engage patients in shared decision-making. Research has focused on refining the accuracy of these CV risk calculators for different populations, relatively little has been done to understand how patients perceive their own ASCVD risk. Accurate perception of a patient's risk by both the patient and the doctors is important because this is an important determinant of health-related behaviour. Patients often show optimistic bias when considering their own CV risk and consistently underestimate it.

We aim to determine patient perceived versus actual risk of ASCVD in a Chinese population. We aim to better understand the degree to which patients underestimate or overestimate their ASCVD risk and whether patients are better or worse at estimating their ASCVD risk relative to their peers of the same age and sex. Finally, we aim to evaluate patients willingness to follow guideline recommended CV prevention and specifically lipid-lowering therapy.

Eligibility criteria: Inclusion Criteria:

1. Aged 40 years and above
2. Consent to complete questionnaire
3. Lipid profile within 12 months

Exclusion Criteria:

1. Known ASCVD defined as history of coronary heart disease (i.e. obstructive coronary disease, prior myocardial infarction, or prior coronary revascularization); cerebrovascular disease (i.e. stroke or transient ischemic attack); and peripheral arterial disease (i.e. obstructive peripheral disease, prior vascular amputation or prior revascularization)
2. Other chronic illness with life-expectancy \<12 months

Primary outcomes:
measure: Evaluate correlation between patients' own estimates of their 10-year risk of heart disease or stroke with actual pooled-cohort-equation calculated risk estimates (using a validated CV risk calculation app).
timeFrame: 12-months
Secondary outcomes:
measure: Evaluate correlation between perceived and calculated 10-year CV risk in sub-groups based on age, sex, education level, known CV risks (e.g. smoking, diabetes, hyperlipidemia and hypertension
timeFrame: 12-months
measure: Evaluate patients' own estimates of 10-year CV risk relative to their peers using age- and sex-specific population risk percentiles.
timeFrame: 12-months
measure: Evaluate patients' willingness to follow recommendations for CV prevention based on their calculated 10-year CV risk profile (e.g. dietary, exercise, smoking and CV risk factor control)
timeFrame: 12-months
measure: Evaluate whether perceived or actual CVD risk is associated with current statin use or willingness to take statin.
timeFrame: 12-months
measure: Reasons for unwillingness to follow recommendations for CV preventions
timeFrame: 12-months
measure: Source of CV health information and advice
timeFrame: 12-months
Other outcomes:
Locations:
city: Shatin
country: Hong Kong
facility: The Chinese University of Hong Kong
Study officials:
References:
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