Condition category
Circulatory System
Date applied
06/02/2006
Date assigned
15/03/2006
Last edited
27/11/2015
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Prof Margaret Thorogood

ORCID ID

Contact details

Warwick Medical School
Gibbet Hill Road
Coventry
CV4 7AL
United Kingdom
+44 (0)2476 574509
margaret.thorogood@warwick.ac.uk

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N/A

Study information

Scientific title

A randomised controlled trial of automated electronic feedback to reduce the cardiovascular risk of individuals in general practice - the e-Nudge trial

Acronym

Study hypothesis

Primary research question: can an automated system of electronic feedback (e-Nudge) reduce the incidence of cardiovascular events in high-risk patients in general practice, compared to usual care?

Ethics approval

Approved by the Warwickshire Local Research Ethics Committee, on 06/09/2005, reference number: 05/Q2803/85

Study design

Randomised controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

GP practices

Trial type

Prevention

Patient information sheet

Condition

Cardiovascular disease and diabetes

Intervention

A system of automatically generated alerts and electronic reminders versus usual care

Intervention type

Other

Phase

Not Specified

Drug names

Primary outcome measures

Cardiovascular event rates

Secondary outcome measures

Proportion of individuals at high cardiovascular risk

Overall trial start date

01/03/2006

Overall trial end date

28/02/2009

Reason abandoned

Eligibility

Participant inclusion criteria

General practices in Warwickshire and Coventry using appropriate clinical software

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

Up to 26 practices

Participant exclusion criteria

Practices at which the principal investigator undertakes clinical practice

Recruitment start date

01/03/2006

Recruitment end date

28/02/2009

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Warwick Medical School
Coventry
CV4 7AL
United Kingdom

Sponsor information

Organisation

University of Warwick

Sponsor details

Gibbet Hill Road
Coventry
CV4 7AL
United Kingdom

Sponsor type

University/education

Website

Funders

Funder type

University/education

Funder name

Department of Health PhD Studentship from Warwick Medical School

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

2006 protocol in http://www.ncbi.nlm.nih.gov/pubmed/16646967
2010 results in http://www.ncbi.nlm.nih.gov/pubmed/20353659

Publication citations

  1. Holt TA, Thorogood M, Griffiths F, Munday S, Protocol for the 'e-Nudge trial': a randomised controlled trial of electronic feedback to reduce the cardiovascular risk of individuals in general practice [ISRCTN64828380]., Trials, 2006, 7, 11, doi: 10.1186/1745-6215-7-11.

Additional files

Editorial Notes

27/11/2015: Publication references added.