Peripheral Arterial DiseaseNCT05552079
PAD Awareness Study
An observational study of Peripheral Arterial Disease, run by Chinese University of Hong Kong at 1 site in Hong Kong.
Trial summary
Peripheral arterial disease (PAD) is one of the most common cardiovascular diseases in developed countries [1] and is an emerging problem in developing countries [2, 3]. The prevalence of PAD in European population studies ranged from 3.6 to 9.2 % and 10-20 % in those aged over 70 years [4]. Read more about this study
- Who is it for?
- Ages 40 years and older
- Conditions the study is for
- Peripheral Arterial Disease
- How many people
- 1,000 participants
- Where
- 1 siteHong Kong
- Study dates
- 21 Jan 2020to 28 Aug 2020
- Phase
- Observational
- Are there results?
- None posted in the registry
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 years and older
- All sexes
- Adult, Older adult
Study population: A sample size of 1000 is associated with a margin of error of less than 4.5% and a confidence level of 95%. The study population is weighted by age (into three 20-year categories: 40 to 59, 60 to 79 and ≥80 years of age) and on gender to reflect Hong Kong census estimates for 2016.
Who may be able to join
- Age 40 or above
- Patients who attend outpatient clinics at the Prince of Wales Hospital
Who cannot join
- Vulnerable subjects that are illiterate and have severe hearing impairment.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Gaps In Awareness of Peripheral Arterial Disease in Hong Kong: A Cross Sectional Study
Peripheral arterial disease (PAD) is one of the most common cardiovascular diseases in developed countries [1] and is an emerging problem in developing countries [2, 3]. The prevalence of PAD in European population studies ranged from 3.6 to 9.2 % and 10-20 % in those aged over 70 years [4]. In a recent meta-analysis, the prevalence of PAD in China increased gradually by age until mid-60s, after which the increase accelerated. In the early stages, PAD is mostly silent. With the progression of disease, it may manifest as intermittent claudication, pain at rest, non-healing ulcer and gangrene resulting in lower-extremity amputation [5]. PAD is a major cause of disability, loss of employment, and lifestyle changes, and is a marker for systemic atherosclerotic diseases. Patients with symptomatic PAD have at least a 30% risk of death within 5 years rising to almost 50% within 10 years, resulting primarily from myocardial infarction or stroke [4]. Despite the major health risks associated with PAD, it is generally not recognized by clinicians or the general public in comparison with other cardiovascular diseases. However, asymptomatic individuals also have higher risk of adverse cardiovascular events similar to those with symptomatic PAD [6]. Many studies have shown that public awareness of PAD is much lower than that of other diseases. It has been reported that awareness of PAD ranged from 20 to 36 %, whereas awareness of other common diseases was more than 60 % in the same population [6-9]. Awareness is important for patients and physicians, and the need for public awareness programs has been highlighted [10, 11]. There is paucity of published literature on public awareness of PAD in Asian countries. It is difficult to reduce the morbidity and mortality of untreated PAD without adequate public awareness of PAD and its risk factors and consequences [7]. Insights into public awareness of PAD will help in developing strategies for behavioral change communication and health promotion. In this study we aimed to assess awareness of PAD among adults in Hong Kong. The survey is designed to measure knowledge of factors that increase the risk for PAD and the clinical risk consequences of having PAD. These data will provide useful information to guide future local public cardiovascular educational efforts.
Read the detailed description
Peripheral arterial disease (PAD) is one of the most common cardiovascular diseases in developed countries [1] and is an emerging problem in developing countries [2, 3]. The prevalence of PAD in European population studies ranged from 3.6 to 9.2 % and 10-20 % in those aged over 70 years [4]. In a recent meta-analysis, the prevalence of PAD in China increased gradually by age until mid-60s, after which the increase accelerated. In males, the prevalence of PAD ranged from 2.81% (95% CI = 1.77-4.43) in those aged 25-29 years to 21.95% (95% CI = 15.39-30.31) in those 95-99 years old. In females, the PAD prevalence increased from 3.84% (95% CI = 2.44-5.98) in those aged 25-29 years to 27.95% (95% CI = 20.14-37.37) in those aged 95-99 years (3). Between 2000 and 2020, the total number of Chinese people with PAD is expected to increase by 40% from 29.44 million in 2000 to 41.13 million in 2020.
In the early stages, PAD is mostly silent. With the progression of disease, it may manifest as intermittent claudication, pain at rest, non
-healing ulcer and gangrene resulting in lower-extremity amputation [5]. PAD is a major cause of disability, loss of employment, and lifestyle changes, and is a marker for systemic atherosclerotic diseases. Patients with symptomatic PAD have at least a 30% risk of death within 5 years rising to almost 50% within 10 years, resulting primarily from myocardial infarction or stroke [4]. Despite the major health risks associated with PAD, it is generally not recognized by clinicians or the general public in comparison with other cardiovascular diseases. Most individuals with lower extremity PAD are asymptomatic and do not experience recognizable ischemic symptoms until late in the disease progression. However, asymptomatic individuals also have higher risk of adverse cardiovascular events similar to those with symptomatic PAD [6]. Low awareness makes addressing the public health impact of PAD challenging [7]. Many studies have shown that public awareness of PAD is much lower than that of other diseases. It has been reported that awareness of PAD ranged from 20 to 36 %, whereas awareness of other common diseases was more than 60 % in the same population [6-9]. Awareness is important for patients and physicians, and the need for public awareness programs has been highlighted [10, 11]. There is paucity of published literature on public awareness of PAD in Asian countries. It is difficult to reduce the morbidity and mortality of untreated PAD without adequate public awareness of PAD and its risk factors and consequences [7]. Insights into public awareness of PAD will help in developing strategies for behavioral change communication and health promotion. In this study we aimed to assess awareness of PAD among adults in Hong Kong. The survey is designed to measure knowledge of factors that increase the risk for PAD and the clinical risk consequences of having PAD. These data will provide useful information to guide future local public cardiovascular educational efforts.
- Conditions
- Peripheral Arterial Disease
- Being tested
- No intervention
- Keywords
- peripheral arterial disease
- Medical subject headings
- Peripheral Arterial Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
No interventionOther
Patients will be asked to show their consultation slip to confirm they attend to clinic on the day. The will also be asked to show their HKID card to comfirm they are aged 40 or above. The purpose of the study will be explained. If patient agrees to proceed, he/she will be given a self-administered questionniare. An interviewer-administered questionnaire will be provided for subjects who have poor sightedness or are illiterate. Since only anonymous data and no identifiable information will be collected, participants cannot be identified from the questionnaire. Therefore, inform consent will not be obtained.
What is being measured
The primary outcome is the main question the study is designed to answer.
Participants' awareness of PAD
Awareness of PAD among adults in Hong Kong will be measured by questionnaire
Measured: 7 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Sep 2022
- Study start21 Jan 2020
- Primary completion28 Aug 2020
- Study completion28 Aug 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Peripheral Arterial DiseaseStudies 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
- Other
- Time perspective
- Prospective
- Enrolment
- 1,000 participants (actual)
Sponsor and investigators
- Lead sponsor
- Chinese University of Hong Kong
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Professor Bryan Ping Yen YAN, Chinese University of Hong Kong
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05552079
- Sponsor's protocol ID
- 2019.571
- Status last verified
- Sep 2022
- First submitted
- 23 Mar 2021
- Last updated
- 23 Sep 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Sep 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Gaps In Awareness of Peripheral Arterial Disease in Hong Kong: A Cross Sectional Study
- ClinicalTrials.gov ID
- NCT05552079
- Acronym / sponsor ID
- 2019.571
- Conditions
- Peripheral Arterial Disease
- Keywords
- peripheral arterial disease
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,000 participants (actual)
- Lead sponsor
- Chinese University of Hong KongUniversity, hospital or other
- Study start
- 21 Jan 2020 (actual)
- Primary completion
- 28 Aug 2020 (actual)
- Study completion
- 28 Aug 2020 (actual)
- First posted
- 23 Sep 2022 (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.
Peripheral arterial disease (PAD) is one of the most common cardiovascular diseases in developed countries [1] and is an emerging problem in developing countries [2, 3]. The prevalence of PAD in European population studies ranged from 3.6 to 9.2 % and 10-20 % in those aged over 70 years [4]. In a recent meta-analysis, the prevalence of PAD in China increased gradually by age until mid-60s, after which the increase accelerated. In the early stages, PAD is mostly silent. With the progression of disease, it may manifest as intermittent claudication, pain at rest, non-healing ulcer and gangrene resulting in lower-extremity amputation [5]. PAD is a major cause of disability, loss of employment, and lifestyle changes, and is a marker for systemic atherosclerotic diseases. Patients with symptomatic PAD have at least a 30% risk of death within 5 years rising to almost 50% within 10 years, resulting primarily from myocardial infarction or stroke [4]. Despite the major health risks associated with PAD, it is generally not recognized by clinicians or the general public in comparison with other cardiovascular diseases. However, asymptomatic individuals also have higher risk of adverse cardiovascular events similar to those with symptomatic PAD [6]. Many studies have shown that public awareness of PAD is much lower than that of other diseases. It has been reported that awareness of PAD ranged from 20 to 36 %, whereas awareness of other common diseases was more than 60 % in the same population [6-9]. Awareness is important for patients and physicians, and the need for public awareness programs has been highlighted [10, 11]. There is paucity of published literature on public awareness of PAD in Asian countries. It is difficult to reduce the morbidity and mortality of untreated PAD without adequate public awareness of PAD and its risk factors and consequences [7]. Insights into public awareness of PAD will help in developing strategies for behavioral change communication and health promotion. In this study we aimed to assess awareness of PAD among adults in Hong Kong. The survey is designed to measure knowledge of factors that increase the risk for PAD and the clinical risk consequences of having PAD. These data will provide useful information to guide future local public cardiovascular educational efforts.
Detailed description
Peripheral arterial disease (PAD) is one of the most common cardiovascular diseases in developed countries [1] and is an emerging problem in developing countries [2, 3]. The prevalence of PAD in European population studies ranged from 3.6 to 9.2 % and 10-20 % in those aged over 70 years [4]. In a recent meta-analysis, the prevalence of PAD in China increased gradually by age until mid-60s, after which the increase accelerated. In males, the prevalence of PAD ranged from 2.81% (95% CI = 1.77-4.43) in those aged 25-29 years to 21.95% (95% CI = 15.39-30.31) in those 95-99 years old. In females, the PAD prevalence increased from 3.84% (95% CI = 2.44-5.98) in those aged 25-29 years to 27.95% (95% CI = 20.14-37.37) in those aged 95-99 years (3). Between 2000 and 2020, the total number of Chinese people with PAD is expected to increase by 40% from 29.44 million in 2000 to 41.13 million in 2020.
In the early stages, PAD is mostly silent. With the progression of disease, it may manifest as intermittent claudication, pain at rest, non
-healing ulcer and gangrene resulting in lower-extremity amputation [5]. PAD is a major cause of disability, loss of employment, and lifestyle changes, and is a marker for systemic atherosclerotic diseases. Patients with symptomatic PAD have at least a 30% risk of death within 5 years rising to almost 50% within 10 years, resulting primarily from myocardial infarction or stroke [4]. Despite the major health risks associated with PAD, it is generally not recognized by clinicians or the general public in comparison with other cardiovascular diseases. Most individuals with lower extremity PAD are asymptomatic and do not experience recognizable ischemic symptoms until late in the disease progression. However, asymptomatic individuals also have higher risk of adverse cardiovascular events similar to those with symptomatic PAD [6]. Low awareness makes addressing the public health impact of PAD challenging [7]. Many studies have shown that public awareness of PAD is much lower than that of other diseases. It has been reported that awareness of PAD ranged from 20 to 36 %, whereas awareness of other common diseases was more than 60 % in the same population [6-9]. Awareness is important for patients and physicians, and the need for public awareness programs has been highlighted [10, 11]. There is paucity of published literature on public awareness of PAD in Asian countries. It is difficult to reduce the morbidity and mortality of untreated PAD without adequate public awareness of PAD and its risk factors and consequences [7]. Insights into public awareness of PAD will help in developing strategies for behavioral change communication and health promotion. In this study we aimed to assess awareness of PAD among adults in Hong Kong. The survey is designed to measure knowledge of factors that increase the risk for PAD and the clinical risk consequences of having PAD. These data will provide useful information to guide future local public cardiovascular educational efforts.
Study design
- Observational model
- Other
- Time perspective
- Prospective
Who may qualify
- Ages
- 40 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- A sample size of 1000 is associated with a margin of error of less than 4.5% and a confidence level of 95%. The study population is weighted by age (into three 20-year categories: 40 to 59, 60 to 79 and ≥80 years of age) and on gender to reflect Hong Kong census estimates for 2016.
Key inclusion criteria (2 listed)
- Age 40 or above
- Patients who attend outpatient clinics at the Prince of Wales Hospital
Key exclusion criteria (1 listed)
- Vulnerable subjects that are illiterate and have severe hearing impairment.
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 |
|---|---|---|
| No interventionPatients will be asked to show their consultation slip to confirm they attend to clinic on the day. The will also be asked to show their HKID card to comfirm they are aged 40 or above. The purpose of the study will be explained. If patient agrees to proceed, he/she will be given a self-administered questionniare. An interviewer-administered questionnaire will be provided for subjects who have poor sightedness or are illiterate. Since only anonymous data and no identifiable information will be collected, participants cannot be identified from the questionnaire. Therefore, inform consent will not be obtained. | Other | – |
Primary outcome
Participants' awareness of PAD
Time frame: 7 months
Awareness of PAD among adults in Hong Kong will be measured by questionnaire
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Sep 2022.
- Individual participant dataSharing planned: No
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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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
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 Peripheral Arterial Disease, 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 2 inclusion and 1 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: finished, as of the sponsor's last update on 23 Sep 2022. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Participants' awareness of PAD (time frame: 7 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 23 Sep 2022.