Welcome
Support Centre
30 September 2014 
Current Controlled Trials - Clinical Trials
Trial registration
Unique identification scheme
International databases
home  |   my details  |   ISRCTN Register  |   mRCT  |   links  |   information  |   news
Introduction
English introduction Introduction en franšais Deutsche einleitung
Introducciˇn espa˝ola Introduzione in italiano
 
Find trials
active registers
mental health register
archived registers
all registers
tips on searching
 
 
Information
about mRCT
mRCT FAQs

DISCLAIMER
The site should not be used to diagnose or treat a health problem. Please consult your doctor.
Terms & conditions

DUPLICATION
Your search result may contain a number of different records for the same trial. This occurs when the same trial is listed in more than one register.

[ ...Back to search results ] [ Print-friendly version ]
Secondary prevention after first stroke
Source of record The Wellcome Trust (UK) - subset of ISRCTN Register
Wellcome Trust reference086921
Other organisations' reference numbersN/A
ISRCTNISRCTN35701810
Title of trial/grant titleSecondary prevention after first stroke
AcronymN/A
Topic/hypothesis/clinical objectivesWe aim to provide proof of concept of the feasibility and utility of implementing cluster randomised trials utilising electronic patient records in a large national primary care database.
Lay summaryNot provided at time of registration
Ethics committee approvalLondon - Surrey Borders Research Ethics Committee approved on the 13th January 2010 (ref: 10/H0806/1)
Disease or conditionStroke
Eligibility criteria - inclusion1. All stroke patients (no age limit, either sex)

2. Registered at the practice for at least three years at the trial start date

3. First diagnosis of stroke recorded in the 24 month period before the trial start date

4. Medical code for stroke is entered during the consultation

5. Patient's electronic medical record includes previous stroke medical codes
Eligibility criteria - exclusionNo eligible patients will be excluded from the analysis, to avoid bias.
Multicentre?Yes
Lead centre if multicentre trialKings College London
Lead centre countryUnited Kingdom
Main country locationUnited Kingdom
Current status of trialOpen
Paediatric?No
Adult?Yes
Senior?No
Patient information material
Start date01/04/2010
End of recruitment date31/10/2010
End of follow-up date31/10/2011
Target recruitment number50 GP practices per group (100 practices in total)
Study designInterventional multicentre clustered randomised trial
Methodology/interventionsA series of electronic prompts will be activated at each consultation by patients with previous stroke, to promote adherence with evidence-based recommendations for secondary prevention of stroke and vascular disease following the National Guidelines (Intercollegiate Stroke Working Party [ICSWP], 2008). The prompts encourage primary care professional adherence with recommended processes of care. The prompts will also provide them with supporting information and links to evidence that supports the recommendations. The decision on whether to follow the treatment suggestions included in the prompt will be at the discretion of the GP. The GP will also be able to terminate display of the prompt at any time. Control practices will continue with usual care. The intervention will be implemented for 12 months at each practice.
Primary outcome(s)Difference in mean systolic blood pressure (BP) between intervention and control groups at 12 months adjusted for pre-intervention mean systolic BP
Secondary outcome(s)Measured at 12 months follow-up:

1. Mean diastolic blood pressure

2. Mean cholesterol concentration

3. Proportion of patients whose eligibility for anticoagulants/antiplatelet drugs is defined

4. Proportion of eligible patients that receive anticoagulant/antiplatelet drugs

5. Prescription adherence with prescribed medicines

6. Occurrence and hospitalisation with vascular events including transient ischaemic attack (TIA)/stroke, myocardial infarction, new-onset angina and mortality
Publications1. 2012 protocol in www.ncbi.nlm.nih.gov/pubmed/23034059
Sources of fundingThe Wellcome Trust (UK) (grant ref: 086921)
Contact name(s)Prof Martin Gulliford
Contact detailsDivision of Primary Care and Public Health

King's College London

6th Floor Capital House

42 Weston Street

London

SE1 3QD

United Kingdom



Tel:

Fax:

Email:martin.gulliford@kcl.ac.uk
Sponsor nameThe Wellcome Trust (UK)
Sponsor detailsGibbs Building

215 Euston Road

London

NW1 2BE

United Kingdom



Tel:

Fax:

Email:contact@wellcome.ac.uk
Further information Further information can be obtained from the lead researcher named above.
Last updated Last updated in mRCT on 3rd September 2013.
Submit your trial protocol
Submit to Trials journal
Follow us on Twitter
© 2014 Current Controlled Trials Ltd. Part of Springer Science+Business Media. | terms & conditions | privacy statement | cookies