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Secondary prevention after first stroke
Source of record The Wellcome Trust (UK) - subset of ISRCTN Register
Wellcome Trust reference086921
Other organisations' reference numbersN/A
Title of trial/grant titleSecondary prevention after first stroke
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.
Lead centre if multicentre trialKings College London
Lead centre countryUnited Kingdom
Main country locationUnited Kingdom
Current status of trialOpen
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



United Kingdom



Sponsor nameThe Wellcome Trust (UK)
Sponsor detailsGibbs Building

215 Euston Road



United Kingdom



Further information Further information can be obtained from the lead researcher named above.
Last updated Last updated in mRCT on 3rd September 2013.
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