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Enhancing Diagnosis and Prevention of Cardiovascular Disease in Newham by Integrated Use of Electronic Health Records

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ClinicalTrials.gov Identifier: NCT02486913
Recruitment Status : Completed
First Posted : July 1, 2015
Last Update Posted : March 6, 2018
Sponsor:
Information provided by (Responsible Party):
Queen Mary University of London

Brief 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.

Condition or disease Intervention/treatment Phase
Cardiovascular Disease Other: Enhanced Health Check Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 190 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Enhancing the Diagnosis and Prevention of Cardiovascular Disease in Newham by Integrated Use of Electronic Health Records
Study Start Date : August 2015
Actual Primary Completion Date : January 1, 2018
Actual Study Completion Date : January 1, 2018

Arm Intervention/treatment
No Intervention: Conventional Health Check
Patients undergoing conventional National Health Service Health Check
Experimental: Enhanced Health Check
Patients undergoing National Health Service Health Check enhanced by risk report
Other: Enhanced Health Check
National Health Service Health Check enhanced by risk report




Primary Outcome Measures :
  1. Change in Heart Age [ Time Frame: 3 months ]
    Change in Heart Age between 1st Health Check and 2nd Health Check three months later


Secondary Outcome Measures :
  1. Changes in smoking status [ Time Frame: 3 months ]
    Changes in smoking status (number smoked per day) by direct patient enquiry between 1st Health Check and 2nd Health Check three months later.

  2. Change in total cholesterol [ Time Frame: 3 months ]
    Changes in total blood cholesterol (mmol/L) by serum sampling between 1st Health Check and 2nd Health Check three months later.

  3. Change in systolic blood pressure [ Time Frame: 3 months ]
    Change in systolic blood pressure (mmHg) by direct measurement using an inflatable cuff between 1st Health Check and 2nd Health Check three months later.

  4. Change in body mass index [ Time Frame: 3 months ]
    Change in body mass index by measurement of height and weight between 1st Health Check and 2nd Health Check three months later.



Information from the National Library of Medicine

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Ages Eligible for Study:   40 Years to 74 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Adults aged 40-74 years

Exclusion Criteria:

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02486913


Locations
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United Kingdom
Bart's Heart Centre
London, United Kingdom, E1A 7BE
Sponsors and Collaborators
Queen Mary University of London
Investigators
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Principal Investigator: Adam D Timmis, MD FRCP Queen Mary University of London
Additional Information:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Queen Mary University of London
ClinicalTrials.gov Identifier: NCT02486913    
Other Study ID Numbers: MCPH1C8R
First Posted: July 1, 2015    Key Record Dates
Last Update Posted: March 6, 2018
Last Verified: February 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Keywords provided by Queen Mary University of London:
Primary prevention
National Health Service Health Check
Additional relevant MeSH terms:
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Cardiovascular Diseases