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

Sponsor
Queen Mary University of London (Other)
Overall Status
Completed
CT.gov ID
NCT02486913
Collaborator
(none)
190
1
2
29
6.5

Study Details

Study Description

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
  • Other: Enhanced Health Check
N/A

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

Study Type:
Interventional
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 :
Aug 1, 2015
Actual Primary Completion Date :
Jan 1, 2018
Actual Study Completion Date :
Jan 1, 2018

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

  1. Change in Heart Age [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 [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 [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 [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 [3 months]

    Change in body mass index by measurement of height and weight between 1st Health Check and 2nd Health Check three months later.

Eligibility Criteria

Criteria

Ages Eligible for Study:
40 Years to 74 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:
  • Adults aged 40-74 years
Exclusion Criteria:
  • Prior diagnosis of heart disease, stroke, diabetes, kidney disease or dementia

Contacts and Locations

Locations

Site City State Country Postal Code
1 Bart's Heart Centre London United Kingdom E1A 7BE

Sponsors and Collaborators

  • Queen Mary University of London

Investigators

  • Principal Investigator: Adam D Timmis, MD FRCP, Queen Mary University of London

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

Publications

None provided.
Responsible Party:
Queen Mary University of London
ClinicalTrials.gov Identifier:
NCT02486913
Other Study ID Numbers:
  • MCPH1C8R
First Posted:
Jul 1, 2015
Last Update Posted:
Mar 6, 2018
Last Verified:
Feb 1, 2017
Individual Participant Data (IPD) Sharing Statement:
Undecided
Plan to Share IPD:
Undecided
Keywords provided by Queen Mary University of London
Additional relevant MeSH terms:

Study Results

No Results Posted as of Mar 6, 2018