Improving the prevention of vascular events after stroke or transient ischemic attack

ISRCTN ISRCTN63816609
DOI https://doi.org/10.1186/ISRCTN63816609
Secondary identifying numbers 9026
Submission date
17/05/2012
Registration date
17/05/2012
Last edited
12/02/2018
Recruitment status
No longer recruiting
Overall study status
Completed
Condition category
Circulatory System
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Record updated in last year

Plain English summary of protocol

Not provided at time of registration

Contact information

Mrs Nicola Wedge
Scientific

Royal Devon & Exeter Hospital
Barrack Road
Exeter
EX2 5DW
United Kingdom

Email nicola.wedge@rdeft.nhs.uk

Study information

Study designRandomised interventional prevention process of care trial
Primary study designInterventional
Secondary study designRandomised controlled trial
Study setting(s)GP practice
Study typePrevention
Participant information sheet Not available in web format, please use the contact details to request a patient information sheet
Scientific titleIMproving 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
Study acronymIMPROVE
Study objectivesOur 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.
Ethics approval(s)ref: 10/H0106/46
Health condition(s) or problem(s) studiedStroke
InterventionSecondary Prevention algorithm, Nurse Independent Prescriber-led, care pathway-based secondary vascular risk factor management.
Intervention typeOther
Primary outcome measureAmbulatory 12-hour daytime systolic blood pressure measured at 6 months
Secondary outcome measuresNo secondary outcome measures
Overall study start date04/01/2011
Completion date09/09/2011

Eligibility

Participant type(s)Patient
Age groupAdult
Lower age limit18 Years
SexBoth
Target number of participantsPlanned Sample Size: 30
Key inclusion criteria1. 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
Key exclusion criteria1. 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
Date of first enrolment04/01/2011
Date of final enrolment09/09/2011

Locations

Countries of recruitment

  • England
  • United Kingdom

Study participating centre

Royal Devon & Exeter Hospital
Exeter
EX2 5DW
United Kingdom

Sponsor information

Royal Devon and Exeter Foundation Trust (UK)
Hospital/treatment centre

Royal Devon & Exeter Hospital
Barrack Road
Exeter
EX2 5DW
England
United Kingdom

Phone +44 (0)1392 411611
Email abc@email.com
Website http://www.rdehospital.nhs.uk/
ROR logo "ROR" https://ror.org/03085z545

Funders

Funder type

Government

NIHR Research for Patient Benefit Programme (UK)

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryNot provided at time of registration
Publication and dissemination planNot provided at time of registration
IPD sharing plan

Study outputs

Output type Details Date created Date added Peer reviewed? Patient-facing?
HRA research summary 28/06/2023 No No

Editorial Notes

12/02/2018: No publications found, verifying study status with principal investigator.