Patient-Perceived VersusNCT05693857
Perceive and Calculated CV Risk
An observational study of Patient-Perceived Versus, run by Chinese University of Hong Kong at 1 site in Hong Kong.
Trial summary
Cardiovascular prevention guidelines use estimated 10-year atherosclerotic cardiovascular disease (ASCVD) risk to guide treatment decisions and engage patients in shared decision-making. Read more about this study
- Who is it for?
- Ages 40 to 90 years
- Conditions the study is for
- Patient-Perceived Versus
- What is being tested?
- Cardiovascular prevention guidelines
- How many people
- 1,500 participants
- Where
- 1 siteHong Kong
- Study dates
- 11 Jun 2023to 11 Aug 2028
- How long will I take part?
- 12 Months
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
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)
Who may be able to join
- Aged 40 years and above
- Consent to complete questionnaire
- Lipid profile within 12 months
Who cannot join
- 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)
- Other chronic illness with life-expectancy <12 months
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Hong Kong1 site, 1 recruiting
- Recruiting
The Chinese University of Hong Kong
Shatin, 999077
Daniel Xu, 35051518 ext. 1518, danielxu@cuhk.edu.hk
About this study
Official title: Patient-Perceived Versus Actual Risk of Cardiovascular Disease and Willingness to Follow Recommendations for Cardiovascular Prevention
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.
Read the 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.
- Conditions
- Patient-Perceived Versus
- Being tested
- Cardiovascular prevention guidelines
- Keywords
- Cardiovascular Disease, lipid-lowering therapy
- Medical subject headings
- Cardiovascular Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cardiovascular prevention guidelinesOther
Cardiovascular prevention guidelines use estimated 10-year atherosclerotic cardiovascular disease (ASCVD) risk to guide treatment decisions and engage patients in shared decision-making
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 12-months
Secondary outcomes (6)
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
Measured: 12-months
Evaluate patients' own estimates of 10-year CV risk relative to their peers using age- and sex-specific population risk percentiles.
Measured: 12-months
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)
Measured: 12-months
Evaluate whether perceived or actual CVD risk is associated with current statin use or willingness to take statin.
Measured: 12-months
Reasons for unwillingness to follow recommendations for CV preventions
Measured: 12-months
Source of CV health information and advice
Measured: 12-months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jan 2023
- Study start11 Jun 2023
- Primary completion11 Feb 2028 (estimated)
- Study completion11 Aug 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Patient-Perceived VersusStudies of the same condition, open and under way.
- More trials run by Chinese University of Hong KongThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 1,500 participants (estimated)
- Target duration
- 12 Months
Sponsor and investigators
- Lead sponsor
- Chinese University of Hong Kong
- Sponsor type
- University, hospital or other
- Collaborators
- Gormin Tan gtan
- Responsible party
- Principal investigator, Professor Bryan Ping Yen YAN, Chinese University of Hong Kong
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05693857
- Sponsor's protocol ID
- 2022.573
- Status last verified
- Feb 2024
- First submitted
- 12 Jan 2023
- Last updated
- 16 Feb 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Visseren FLJ, Mach F, Smulders YM, Carballo D, Koskinas KC, Back M, Benetos A, Biffi A, Boavida JM, Capodanno D, Cosyns B, Crawford C, Davos CH, Desormais I, Angelantonio ED, Franco OH, Halvorsen S, Richard Hobbs FD, Hollander M, Jankowska EA, Michal M, Sacco S, Sattar N, Tokgozoglu L, Tonstad S, Tsioufis KP, van Dis I, van Gelder IC, Wanner C, Williams B; ESC Scientific Document Group. 2021 ESC Guidelines on cardiovascular disease prevention in clinical practice: Developed by the Task Force for cardiovascular disease prevention in clinical practice with representatives of the European Society of Cardiology and 12 medical societies With the special contribution of the European Association of Preventive Cardiology (EAPC). Rev Esp Cardiol (Engl Ed). 2022 May;75(5):429. doi: 10.1016/j.rec.2022.04.003. No abstract available. English, Spanish.
PubMed 35525570Arnett DK, Blumenthal RS, Albert MA, Buroker AB, Goldberger ZD, Hahn EJ, Himmelfarb CD, Khera A, Lloyd-Jones D, McEvoy JW, Michos ED, Miedema MD, Munoz D, Smith SC Jr, Virani SS, Williams KA Sr, Yeboah J, Ziaeian B. 2019 ACC/AHA Guideline on the Primary Prevention of Cardiovascular Disease: Executive Summary: A Report of the American College of Cardiology/American Heart Association Task Force on Clinical Practice Guidelines. Circulation. 2019 Sep 10;140(11):e563-e595. doi: 10.1161/CIR.0000000000000677. Epub 2019 Mar 17.
PubMed 30879339Lloyd-Jones DM, Braun LT, Ndumele CE, Smith SC Jr, Sperling LS, Virani SS, Blumenthal RS. Use of Risk Assessment Tools to Guide Decision-Making in the Primary Prevention of Atherosclerotic Cardiovascular Disease: A Special Report From the American Heart Association and American College of Cardiology. J Am Coll Cardiol. 2019 Jun 25;73(24):3153-3167. doi: 10.1016/j.jacc.2018.11.005. Epub 2018 Nov 10.
PubMed 30423392Webster R, Heeley E. Perceptions of risk: understanding cardiovascular disease. Risk Manag Healthc Policy. 2010;3:49-60. doi: 10.2147/RMHP.S8288. Epub 2010 Sep 6.
PubMed 22312218Thakkar J, Heeley EL, Chalmers J, Chow CK. Inaccurate risk perceptions contribute to treatment gaps in secondary prevention of cardiovascular disease. Intern Med J. 2016 Mar;46(3):339-46. doi: 10.1111/imj.12982.
PubMed 26662342
Study at a glance
From the registry record, last updated by the sponsor on 16 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Patient-Perceived Versus Actual Risk of Cardiovascular Disease and Willingness to Follow Recommendations for Cardiovascular Prevention
- ClinicalTrials.gov ID
- NCT05693857
- Acronym / sponsor ID
- 2022.573
- Conditions
- Patient-Perceived Versus
- Keywords
- Cardiovascular Disease, lipid-lowering therapy
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 1,500 participants (estimated)
- Lead sponsor
- Chinese University of Hong KongUniversity, hospital or other
- Collaborators
- Gormin Tan gtan
- Study start
- 11 Jun 2023 (actual)
- Primary completion
- 11 Feb 2028 (estimated)
- Study completion
- 11 Aug 2028 (estimated)
- First posted
- 23 Jan 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Target follow-up
- 12 Months
Who may qualify
- Ages
- 40 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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)
Key inclusion criteria (3 listed)
- Aged 40 years and above
- Consent to complete questionnaire
- Lipid profile within 12 months
Key exclusion criteria (2 listed)
- 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)
- Other chronic illness with life-expectancy <12 months
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Cardiovascular prevention guidelinesCardiovascular prevention guidelines use estimated 10-year atherosclerotic cardiovascular disease (ASCVD) risk to guide treatment decisions and engage patients in shared decision-making | Other | – |
Primary outcome
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).
Time frame: 12-months
6 secondary outcomes
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
Time frame: 12-months
Evaluate patients' own estimates of 10-year CV risk relative to their peers using age- and sex-specific population risk percentiles.
Time frame: 12-months
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)
Time frame: 12-months
Evaluate whether perceived or actual CVD risk is associated with current statin use or willingness to take statin.
Time frame: 12-months
Reasons for unwillingness to follow recommendations for CV preventions
Time frame: 12-months
Source of CV health information and advice
Time frame: 12-months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Feb 2024.
- Results publication: PubMed 35525570Visseren FLJ, Mach F, Smulders YM, Carballo D, Koskinas KC, Back M, Benetos A, Biffi A, Boavida JM, Capodanno D, Cosyns B, Crawford C, Davos CH, Desormais I, Angelantonio ED, Franco OH, Halvorsen S, Richard Hobbs FD, Hollander M, Jankowska EA, Michal M, Sacco S, Sattar N, Tokgozoglu L, Tonstad S, Tsioufis KP, van Dis I, van Gelder IC, Wanner C, Williams B; ESC Scientific Document Group. 2021 ESC Guidelines on cardiovascular disease prevention in clinical practice: Developed by the Task Force for cardiovascular disease prevention in clinical practice with representatives of the European Society of Cardiology and 12 medical societies With the special contribution of the European Association of Preventive Cardiology (EAPC). Rev Esp Cardiol (Engl Ed). 2022 May;75(5):429. doi: 10.1016/j.rec.2022.04.003. No abstract available. English, Spanish.
- Results publication: PubMed 30879339Arnett DK, Blumenthal RS, Albert MA, Buroker AB, Goldberger ZD, Hahn EJ, Himmelfarb CD, Khera A, Lloyd-Jones D, McEvoy JW, Michos ED, Miedema MD, Munoz D, Smith SC Jr, Virani SS, Williams KA Sr, Yeboah J, Ziaeian B. 2019 ACC/AHA Guideline on the Primary Prevention of Cardiovascular Disease: Executive Summary: A Report of the American College of Cardiology/American Heart Association Task Force on Clinical Practice Guidelines. Circulation. 2019 Sep 10;140(11):e563-e595. doi: 10.1161/CIR.0000000000000677. Epub 2019 Mar 17.
- Results publication: PubMed 30423392Lloyd-Jones DM, Braun LT, Ndumele CE, Smith SC Jr, Sperling LS, Virani SS, Blumenthal RS. Use of Risk Assessment Tools to Guide Decision-Making in the Primary Prevention of Atherosclerotic Cardiovascular Disease: A Special Report From the American Heart Association and American College of Cardiology. J Am Coll Cardiol. 2019 Jun 25;73(24):3153-3167. doi: 10.1016/j.jacc.2018.11.005. Epub 2018 Nov 10.
- Results publication: PubMed 22312218Webster R, Heeley E. Perceptions of risk: understanding cardiovascular disease. Risk Manag Healthc Policy. 2010;3:49-60. doi: 10.2147/RMHP.S8288. Epub 2010 Sep 6.
- Results publication: PubMed 26662342Thakkar J, Heeley EL, Chalmers J, Chow CK. Inaccurate risk perceptions contribute to treatment gaps in secondary prevention of cardiovascular disease. Intern Med J. 2016 Mar;46(3):339-46. doi: 10.1111/imj.12982.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Patient-Perceived Versus, run by Chinese University of Hong Kong at 1 site in Hong Kong.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 16 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Hong Kong. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Daniel Xu (35051518, danielxu@cuhk.edu.hk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome 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). (time frame: 12-months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05693857, which also lists 5 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Feb 2024.