Peripheral Arterial DiseaseNCT04342481
Education and Management of PAD in Primary Care
An observational study of Peripheral Arterial Disease, run by University of Leicester at 1 site in United Kingdom.
Trial summary
Peripheral arterial disease (PAD) occurs when the vessels carrying blood to the legs become narrowed or blocked. It affects 1 in 5 people aged over 60 and are at risk of losing their leg, developing a heart attack or stroke, or die early. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Peripheral Arterial Disease
- What is being tested?
- Educational Screening tool
- How many people
- 891 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 1 Jan 2021to 1 Sep 2021
- 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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Practising healthcare practitioners within primary care
Who may be able to join
- Practising healthcare practitioners within primary care
- Participants must be aged 18 years or older
- Participants must be able to access the online questionnaire
- Participants must have the capacity to consent
- Participants should speak English
Who cannot join
- Healthcare practitioners who are not in practice.
- Participants who do not consent
- Participants who are unable to communicate in English
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
University of Leicester
Leicester, Leicestershire, Le1 7rh
About this study
Official title: To Explore the Educational Experience of UK Primary Care Health Practitioners for Peripheral Arterial Disease (PAD), Including Identification of Factors That Shape Their Preferred Learning Style and Assess Health Professionals Opinions of PAD Recognition and Management
Peripheral arterial disease (PAD) occurs when the vessels carrying blood to the legs become narrowed or blocked. It affects 1 in 5 people aged over 60 and are at risk of losing their leg, developing a heart attack or stroke, or die early.
Early symptoms of peripheral arterial disease (PAD) include aching in the legs when walking which may not be recognised by healthcare professional. Our research has shown that knowledge and recognition of PAD is poor in healthcare professionals and trainees. There appears to be little time provided within healthcare professional training for PAD.
Read more
To improve PAD recognition/management, the investigators want to identify the current level of training given to healthcare professionals; opinion towards PAD related to their training and how they prefer to receive training.
With the information gained from this research, the development of an educational training package for GPs, practice nurses and their trainees to improve recognition of PAD is anticipated.
Read the detailed description
Around 20% of people above 60 years are estimated to have PAD. The prevalence of PAD is expected to rise due to a sedentary life-style, poor dietary choices, rising prevalence of diabetes and longer life-expectancy.
The most common presentation of symptomatic PAD is intermittent claudication - pain on activity. In some cases the reduction in blood flow is so severe that it causes pain at rest, ulceration or gangrene (chronic limb threatening ischemia, CLTI). Approximately 5% of individuals between the age of 55 and 74 in the UK have IC or CLTI. Compared to age-matched individuals, these patients are more likely to suffer cardiovascular events - heart attack and strokes and cognitive impairment (10). Of those with IC, 5% will progress to CLTI. In patients with CLTI the one-year risk of limb amputation is 30% and five-year all-cause mortality is 50%, similar to various advanced forms of cancer. Recognition and management are essential to reducing the limb and life loss sequela.
Management of these high-risk individuals is shared between primary care (diagnosis, treatment of cardiovascular risk-factors, rehabilitation) and secondary care (vascular reconstruction, amputation, specialist management of cardiovascular disease).
This mutli-centre prospective cohort study will investigate the explore the educational experience of UK primary care health practitioners for peripheral arterial disease (PAD), including identification of factors that shape their preferred learning style and assess health professionals opinions of PAD recognition and management.
- Conditions
- Peripheral Arterial Disease
- Being tested
- Educational Screening tool
- Keywords
- peripheral arterial disease, peripheral artery disease, PAD - peripheral arterial disease, PAD
- 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.
Educational Screening toolOther
Educational Screening tool
What is being measured
The primary outcome is the main question the study is designed to answer.
Educational exposure do primary care health practitioners experience regarding PAD
Educational exposure do primary care health practitioners experience regarding PAD
Measured: 10 years
Secondary outcomes (1)
What opinions do UK primary care health practitioners have towards PAD recognition and management?
What opinions do UK primary care health practitioners have towards PAD recognition and management?
Measured: 10 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Apr 2020
- Study start1 Jan 2021
- Primary completion1 Sep 2021
- Study completion1 Sep 2021
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.
- 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 891 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Leicester
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute for Health Research, United Kingdom, The George Davies Charitable Trust
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04342481
- Sponsor's protocol ID
- 0782/280635
- Status last verified
- Sep 2021
- First submitted
- 8 Apr 2020
- Last updated
- 20 Jul 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: Anonymised dataset will be available on request to the Chief Investigator (Prof Rob Sayers).
Study at a glance
From the registry record, last updated by the sponsor on 20 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- To Explore the Educational Experience of UK Primary Care Health Practitioners for Peripheral Arterial Disease (PAD), Including Identification of Factors That Shape Their Preferred Learning Style and Assess Health Professionals Opinions of PAD Recognition and Management
- ClinicalTrials.gov ID
- NCT04342481
- Acronym / sponsor ID
- 0782/280635
- Conditions
- Peripheral Arterial Disease
- Keywords
- peripheral arterial disease, peripheral artery disease, PAD - peripheral arterial disease, PAD
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 891 participants (actual)
- Lead sponsor
- University of LeicesterUniversity, hospital or other
- Collaborators
- National Institute for Health Research, United Kingdom, The George Davies Charitable Trust
- Study start
- 1 Jan 2021 (actual)
- Primary completion
- 1 Sep 2021 (actual)
- Study completion
- 1 Sep 2021 (actual)
- First posted
- 13 Apr 2020 (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) occurs when the vessels carrying blood to the legs become narrowed or blocked. It affects 1 in 5 people aged over 60 and are at risk of losing their leg, developing a heart attack or stroke, or die early.
Early symptoms of peripheral arterial disease (PAD) include aching in the legs when walking which may not be recognised by healthcare professional. Our research has shown that knowledge and recognition of PAD is poor in healthcare professionals and trainees. There appears to be little time provided within healthcare professional training for PAD.
To improve PAD recognition/management, the investigators want to identify the current level of training given to healthcare professionals; opinion towards PAD related to their training and how they prefer to receive training.
With the information gained from this research, the development of an educational training package for GPs, practice nurses and their trainees to improve recognition of PAD is anticipated.
Detailed description
Around 20% of people above 60 years are estimated to have PAD. The prevalence of PAD is expected to rise due to a sedentary life-style, poor dietary choices, rising prevalence of diabetes and longer life-expectancy.
The most common presentation of symptomatic PAD is intermittent claudication - pain on activity. In some cases the reduction in blood flow is so severe that it causes pain at rest, ulceration or gangrene (chronic limb threatening ischemia, CLTI). Approximately 5% of individuals between the age of 55 and 74 in the UK have IC or CLTI. Compared to age-matched individuals, these patients are more likely to suffer cardiovascular events - heart attack and strokes and cognitive impairment (10). Of those with IC, 5% will progress to CLTI. In patients with CLTI the one-year risk of limb amputation is 30% and five-year all-cause mortality is 50%, similar to various advanced forms of cancer. Recognition and management are essential to reducing the limb and life loss sequela.
Management of these high-risk individuals is shared between primary care (diagnosis, treatment of cardiovascular risk-factors, rehabilitation) and secondary care (vascular reconstruction, amputation, specialist management of cardiovascular disease).
This mutli-centre prospective cohort study will investigate the explore the educational experience of UK primary care health practitioners for peripheral arterial disease (PAD), including identification of factors that shape their preferred learning style and assess health professionals opinions of PAD recognition and management.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Practising healthcare practitioners within primary care
Key inclusion criteria (5 listed)
- Practising healthcare practitioners within primary care
- Participants must be aged 18 years or older
- Participants must be able to access the online questionnaire
- Participants must have the capacity to consent
- Participants should speak English
Key exclusion criteria (3 listed)
- Healthcare practitioners who are not in practice.
- Participants who do not consent
- Participants who are unable to communicate in English
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 |
|---|---|---|
| Educational Screening toolEducational Screening tool | Other | – |
Primary outcome
Educational exposure do primary care health practitioners experience regarding PAD
Time frame: 10 years
Educational exposure do primary care health practitioners experience regarding PAD
1 secondary outcome
What opinions do UK primary care health practitioners have towards PAD recognition and management?
Time frame: 10 years
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 20 Jul 2023.
- Individual participant dataSharing planned: Undecided. Anonymised dataset will be available on request to the Chief Investigator (Prof Rob Sayers).
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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 University of Leicester at 1 site in United Kingdom.
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 5 inclusion and 3 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 20 Jul 2023. 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 United Kingdom. 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?
Educational exposure do primary care health practitioners experience regarding PAD (time frame: 10 years). 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 20 Jul 2023.