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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02486913
Other study ID # MCPH1C8R
Secondary ID
Status Completed
Phase N/A
First received June 16, 2015
Last updated March 5, 2018
Start date August 2015
Est. completion date January 1, 2018

Study information

Verified date February 2017
Source Queen Mary University of London
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical 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 trial.


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.


Recruitment information / eligibility

Status Completed
Enrollment 190
Est. completion date January 1, 2018
Est. primary completion date January 1, 2018
Accepts healthy volunteers No
Gender All
Age group 40 Years to 74 Years
Eligibility Inclusion Criteria:

- Adults aged 40-74 years

Exclusion Criteria:

- Prior diagnosis of heart disease, stroke, diabetes, kidney disease or dementia

Study Design


Related Conditions & MeSH terms


Intervention

Other:
Enhanced Health Check
National Health Service Health Check enhanced by risk report

Locations

Country Name City State
United Kingdom Bart's Heart Centre London

Sponsors (1)

Lead Sponsor Collaborator
Queen Mary University of London

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type Measure Description Time frame Safety issue
Primary Change in Heart Age Change in Heart Age between 1st Health Check and 2nd Health Check three months later 3 months
Secondary 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. 3 months
Secondary 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. 3 months
Secondary 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. 3 months
Secondary 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. 3 months
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