Cardiovascular DiseaseNCT02486913
Enhancing Diagnosis and Prevention of Cardiovascular Disease in Newham by Integrated Use of Electronic Health Records
A study testing Enhanced Health Check in people with Cardiovascular Disease, run by Queen Mary University of London at 1 site in United Kingdom.
Trial summary
The investigators will develop a "risk report" within the primary care electronic health record (EMIS) for patients attending for their National Health Service Health Check. The value of the report for reducing cardiovascular risk will be assessed qualitatively and also quantitatively in a non-randomised comparative… Read more about this study
- Who is it for?
- Ages 40 to 74 years
- Conditions the study is for
- Cardiovascular Disease
- What is being tested?
- Enhanced Health Check
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 190 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Aug 2015to 1 Jan 2018
- Phase
- Interventional
- 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 to 74 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adults aged 40-74 years
Who cannot join
- Prior diagnosis of heart disease, stroke, diabetes, kidney disease or dementia
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Enhancing the Diagnosis and Prevention of Cardiovascular Disease in Newham by Integrated Use of Electronic Health Records
The investigators will develop a "risk report" within the primary care electronic health record (EMIS) for patients attending for their National Health Service Health Check. The value of the report for reducing cardiovascular risk will be assessed qualitatively and also quantitatively in a non-randomised comparative trial.
Read the detailed description
The investigators will design a template within the primary care electronic health record (EMIS) that draws on Health Check data to provide a contemporary "risk report". Included in the report will be clear description of life-time cardiovascular risks, the factors driving those risks and how risk might be reduced through life-style and risk factor modification. The investigators will evaluate the benefits of providing patients with a risk report qualitatively by patient and clinician interviews. Quantitative analysis of the benefit of the risk report will be provided by a non-randomised comparative trial. First, a group of patients undergoing a conventional Health Check will be recalled after three months for a second Health Check, allowing measurement of the change in "Heart Age" - a convenient index of life-time cardiovascular risk. Following introduction of the risk report the investigators will recall a further group of patients for a second Health Check, allowing measurement of the change in "Heart Age". The effect of the risk report will be determined by comparing the change in Heart Age between the two groups of patients.
- Conditions
- Cardiovascular Disease
- Being tested
- Enhanced Health Check
- Keywords
- Primary prevention, National Health Service Health Check
- Medical subject headings
- Cardiovascular Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Enhanced Health CheckOther
National Health Service Health Check enhanced by risk report
| Study group | Role | What they receive |
|---|---|---|
| Conventional Health Check | No intervention | Patients undergoing conventional National Health Service Health Check |
| Enhanced Health Check | Experimental | Patients undergoing National Health Service Health Check enhanced by risk report Receives: Other: Enhanced Health Check |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Heart Age
Change in Heart Age between 1st Health Check and 2nd Health Check three months later
Measured: 3 months
Secondary outcomes (4)
Changes in smoking status
Changes in smoking status (number smoked per day) by direct patient enquiry between 1st Health Check and 2nd Health Check three months later.
Measured: 3 months
Change in total cholesterol
Changes in total blood cholesterol (mmol/L) by serum sampling between 1st Health Check and 2nd Health Check three months later.
Measured: 3 months
Change in systolic blood pressure
Change in systolic blood pressure (mmHg) by direct measurement using an inflatable cuff between 1st Health Check and 2nd Health Check three months later.
Measured: 3 months
Change in body mass index
Change in body mass index by measurement of height and weight between 1st Health Check and 2nd Health Check three months later.
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jul 2015 (estimated)
- Study startAug 2015
- Primary completion1 Jan 2018
- Study completion1 Jan 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Cardiovascular DiseaseStudies of the same condition, open and under way.
- More trials run by Queen Mary University of LondonThe 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 190 participants (actual)
Sponsor and investigators
- Lead sponsor
- Queen Mary University of London
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Adam D Timmis, MD FRCP, Principal investigator, Queen Mary University of London
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02486913
- Sponsor's protocol ID
- MCPH1C8R
- Status last verified
- Feb 2017
- First submitted
- 16 Jun 2015
- Last updated
- 6 Mar 2018
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Undecided
Publications
Hawking MKD, Timmis A, Wilkins F, Potter JL, Robson J. Improving cardiovascular disease risk communication in NHS Health Checks: a qualitative study. BMJ Open. 2019 Sep 3;9(8):e026058. doi: 10.1136/bmjopen-2018-026058.
PubMed 31481364
Study at a glance
From the registry record, last updated by the sponsor on 6 Mar 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Enhancing the Diagnosis and Prevention of Cardiovascular Disease in Newham by Integrated Use of Electronic Health Records
- ClinicalTrials.gov ID
- NCT02486913
- Acronym / sponsor ID
- MCPH1C8R
- Conditions
- Cardiovascular Disease
- Keywords
- Primary prevention, National Health Service Health Check
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 190 participants (actual)
- Lead sponsor
- Queen Mary University of LondonUniversity, hospital or other
- Study start
- Aug 2015
- Primary completion
- 1 Jan 2018 (actual)
- Study completion
- 1 Jan 2018 (actual)
- First posted
- 1 Jul 2015 (estimated)
- 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.
The investigators will develop a "risk report" within the primary care electronic health record (EMIS) for patients attending for their National Health Service Health Check. The value of the report for reducing cardiovascular risk will be assessed qualitatively and also quantitatively in a non-randomised comparative trial.
Detailed description
The investigators will design a template within the primary care electronic health record (EMIS) that draws on Health Check data to provide a contemporary "risk report". Included in the report will be clear description of life-time cardiovascular risks, the factors driving those risks and how risk might be reduced through life-style and risk factor modification. The investigators will evaluate the benefits of providing patients with a risk report qualitatively by patient and clinician interviews. Quantitative analysis of the benefit of the risk report will be provided by a non-randomised comparative trial. First, a group of patients undergoing a conventional Health Check will be recalled after three months for a second Health Check, allowing measurement of the change in "Heart Age" - a convenient index of life-time cardiovascular risk. Following introduction of the risk report the investigators will recall a further group of patients for a second Health Check, allowing measurement of the change in "Heart Age". The effect of the risk report will be determined by comparing the change in Heart Age between the two groups of patients.
Study design
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Conventional Health Check | No intervention | –Patients undergoing conventional National Health Service Health Check |
| Enhanced Health Check | Experimental | Other: Enhanced Health CheckPatients undergoing National Health Service Health Check enhanced by risk report |
Who may qualify
- Ages
- 40 to 74 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Adults aged 40-74 years
Key exclusion criteria (1 listed)
- Prior diagnosis of heart disease, stroke, diabetes, kidney disease or dementia
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 |
|---|---|---|
| Enhanced Health CheckNational Health Service Health Check enhanced by risk report | Other | Enhanced Health Check |
Primary outcome
Change in Heart Age
Time frame: 3 months
Change in Heart Age between 1st Health Check and 2nd Health Check three months later
4 secondary outcomes
Changes in smoking status
Time frame: 3 months
Change in total cholesterol
Time frame: 3 months
Change in systolic blood pressure
Time frame: 3 months
Change in body mass index
Time frame: 3 months
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 6 Mar 2018.
- Derived from this study: PubMed 31481364Hawking MKD, Timmis A, Wilkins F, Potter JL, Robson J. Improving cardiovascular disease risk communication in NHS Health Checks: a qualitative study. BMJ Open. 2019 Sep 3;9(8):e026058. doi: 10.1136/bmjopen-2018-026058.
- NHS Health Check Home PageLink provided by the sponsor.
- 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. This study is not recruiting at the moment.
Adam D Timmis, MD FRCP principal investigator
Queen Mary University of London
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Enhanced Health Check in people with Cardiovascular Disease, run by Queen Mary University of London 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 1 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 6 Mar 2018. 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?
Change in Heart Age (time frame: 3 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 NCT02486913, which also lists 1 linked publication.
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 6 Mar 2018.