Condition category
Circulatory System
Date applied
17/05/2012
Date assigned
17/05/2012
Last edited
09/11/2015
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

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 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

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 below 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

http://www.rdehospital.nhs.uk/

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

Publication citations

Additional files

Editorial Notes

09/11/2015: no publications found on PubMed.