Contact information
Type
Scientific
Primary contact
Mrs Nicola Wedge
ORCID ID
Contact details
Royal Devon & Exeter Hospital
Barrack Road
Exeter
EX2 5DW
United Kingdom
-
nicola.wedge@rdeft.nhs.uk
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
9026
Study information
Scientific title
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
Acronym
IMPROVE
Study hypothesis
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 persons risk factors will be better controlled, and their risk of another stroke is reduced. We will check on peoples 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.
Ethics approval
ref: 10/H0106/46
Study design
Randomised interventional prevention process of care trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
GP practices
Trial type
Prevention
Patient information sheet
Not available in web format, please use the contact details to request a patient information sheet
Condition
Stroke
Intervention
Secondary Prevention algorithm, Nurse Independent Prescriber-led, care pathway-based secondary vascular risk factor management.
Intervention type
Other
Phase
Not Applicable
Drug names
Primary outcome measures
Ambulatory 12-hour daytime systolic blood pressure measured at 6 months
Secondary outcome measures
No secondary outcome measures
Overall trial start date
04/01/2011
Overall trial end date
09/09/2011
Reason abandoned
Eligibility
Participant inclusion criteria
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
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
Planned Sample Size: 30
Participant exclusion criteria
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
Recruitment start date
04/01/2011
Recruitment end date
09/09/2011
Locations
Countries of recruitment
United Kingdom
Trial participating centre
Royal Devon & Exeter Hospital
Exeter
EX2 5DW
United Kingdom
Sponsor information
Organisation
Royal Devon and Exeter Foundation Trust (UK)
Sponsor details
Royal Devon & Exeter Hospital
Barrack Road
Exeter
EX2 5DW
United Kingdom
+44 (0)1392 411611
abc@email.com
Sponsor type
Hospital/treatment centre
Website
Funders
Funder type
Government
Funder name
NIHR Research for Patient Benefit Programme (UK)
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