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ISRCTN
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ISRCTN63816609
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DOI
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10.1186/ISRCTN63816609
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ClinicalTrials.gov identifier
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EudraCT number
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Public title
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IMproving the PRevention Of Vascular Events after stroke or transient ischemic attack
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Scientific title
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IMproving the PRevention Of Vascular Events after stroke or transient ischemic attack: a randomised controlled pilot trial of nurse independent prescriber-led care pathway-based risk factor management
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Acronym
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IMPROVE
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Serial number at source
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9026
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Study hypothesis
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Our pilot trial will be trying to improve the treatment of risk factors like blood pressure after a mini-stroke. The trial will compare ‘usual care’ (having your risk factors treated the way they are at the moment, usually by visits to the GP with an approach that puts treatment in the hands of a new type of nurse, who will prescribe treatment according to a specially-designed plan called a ‘care pathway’. We are hoping this will mean that the person’s risk factors will be better controlled, and their risk of another stroke is reduced. We will check on people’s blood pressure using an automatic arm cuff during normal activities – an ‘ambulatory monitor’, which gives a more reliable result than measurements taken in the clinic. After six months and again after a year we will compare the effects of treatment between ‘usual care’ and the new approach, to see if one is better than the other.
Any treatment is only effective if people can stick with it, and we know that a lot of people on prescribed drugs give up taking them for various reasons. In this trial people will get the chance to tell the researchers the good and bad things about taking part, and whether the new type of nurse-led care pathway worked for them. This is important so that we can understand the things that would help people to stay on treatment. If our pilot is successful, we will go ahead with a larger study.
More details can be found at http://public.ukcrn.org.uk/Search/StudyDetail.aspx?StudyID=9026
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Lay summary
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Not provided at time of registration
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Ethics approval
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ref: 10/H0106/46
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Study design
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Randomised interventional prevention process of care trial
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Countries of recruitment
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United Kingdom
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Disease/condition/study domain
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Stroke
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Participants - inclusion criteria
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1. Clinical diagnosis of transient ischemic attack (TIA) or stroke within one month
2. Patient is living at home at time of recruitment
3. Ag e> 18 years
4. systolic blood pressure (SBP) > 140 mmHg measured at time of diagnosis of stroke or TIA
5. Registered with ageneral practitioner (GP) in one of the two pilot clusters (Exete and East Devon)
6. Ability to attend for follow-up visits
7. Given iInformed consent
8. Male or female participants
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Participants - exclusion criteria
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1. Severe dementia or aphasia
2. Significant co-morbidity likely to jeopardise ability to complete the trial e.g. malignancy, severe heart failure
3. Current participation in other trials
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Anticipated start date
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04/01/2011
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Anticipated end date
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09/09/2011
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Status of trial
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Completed |
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Patient information material
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Not available in web format, please use the contact details below to request a patient information sheet
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Target number of participants
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Planned Sample Size: 30
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Interventions
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Secondary Prevention algorithm, Nurse Independent Prescriber-led, care pathway-based secondary vascular risk factor management.
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Primary outcome measure(s)
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Ambulatory 12-hour daytime systolic blood pressure measured at 6 months
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Secondary outcome measure(s)
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No secondary outcome measures
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Sources of funding
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NIHR Research for Patient Benefit Programme (UK)
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Trial website
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Publications
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Contact name
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Mrs
Nicola
Wedge
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Address
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Royal Devon & Exeter Hospital
Barrack Road
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City/town
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Exeter
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Zip/Postcode
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EX2 5DW
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Country
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United Kingdom
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Email
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nicola.wedge@rdeft.nhs.uk
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Sponsor
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Royal Devon and Exeter Foundation Trust (UK)
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Address
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Royal Devon & Exeter Hospital
Barrack Road
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City/town
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Exeter
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Zip/Postcode
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EX2 5DW
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Country
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United Kingdom
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Tel
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+44 (0)1392 411611
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Email
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Sponsor website:
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http://www.rdehospital.nhs.uk/
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Date applied
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17/05/2012
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Last edited
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17/05/2012
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Date ISRCTN assigned
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17/05/2012
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