NCT02486913

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
190

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Aug 2015

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 16, 2015

Completed
15 days until next milestone

First Posted

Study publicly available on registry

July 1, 2015

Completed
1 month until next milestone

Study Start

First participant enrolled

August 1, 2015

Completed
2.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2018

Completed
Last Updated

March 6, 2018

Status Verified

February 1, 2017

Enrollment Period

2.4 years

First QC Date

June 16, 2015

Last Update Submit

March 5, 2018

Conditions

Cardiovascular Disease

Keywords

Primary preventionNational Health Service Health Check

Outcome Measures

Primary Outcomes (1)

  • Change in Heart Age

    Change in Heart Age between 1st Health Check and 2nd Health Check three months later

    3 months

Secondary Outcomes (4)

  • Changes in smoking status

    3 months

  • Change in total cholesterol

    3 months

  • Change in systolic blood pressure

    3 months

  • Change in body mass index

    3 months

Study Arms (2)

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

Other: Enhanced Health Check

Interventions

Enhanced Health CheckOTHER

National Health Service Health Check enhanced by risk report

Enhanced Health Check

Eligibility Criteria

Age40 Years - 74 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Adults aged 40-74 years

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Bart's Heart Centre

London, E1A 7BE, United Kingdom

Location

Related Publications (1)

  • 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.

    PMID: 31481364DERIVED

Related Links

MeSH Terms

Conditions

Cardiovascular Diseases

Study Officials

  • Adam D Timmis, MD FRCP

    Queen Mary University of London

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 16, 2015

First Posted

July 1, 2015

Study Start

August 1, 2015

Primary Completion

January 1, 2018

Study Completion

January 1, 2018

Last Updated

March 6, 2018

Record last verified: 2017-02

Locations

GB(1)