Improving the prevention of vascular events after stroke or transient ischemic attack
| ISRCTN | ISRCTN63816609 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN63816609 |
| Protocol serial number | 9026 |
| Sponsor | Royal Devon and Exeter Foundation Trust (UK) |
| Funder | NIHR Research for Patient Benefit Programme (UK) |
- 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
Scientific
Royal Devon & Exeter Hospital
Barrack Road
Exeter
EX2 5DW
United Kingdom
| nicola.wedge@rdeft.nhs.uk |
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Randomised interventional prevention process of care trial |
| Secondary study design | Randomised controlled trial |
| Study type | Participant information sheet |
| 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 |
| Study acronym | IMPROVE |
| Study objectives | 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(s) | ref: 10/H0106/46 |
| Health condition(s) or problem(s) studied | Stroke |
| Intervention | Secondary Prevention algorithm, Nurse Independent Prescriber-led, care pathway-based secondary vascular risk factor management. |
| Intervention type | Other |
| Primary outcome measure(s) |
Ambulatory 12-hour daytime systolic blood pressure measured at 6 months |
| Key secondary outcome measure(s) |
No secondary outcome measures |
| Completion date | 09/09/2011 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | All |
| Target sample size at registration | 30 |
| Key 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 |
| Key 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 |
| Date of first enrolment | 04/01/2011 |
| Date of final enrolment | 09/09/2011 |
Locations
Countries of recruitment
- United Kingdom
- England
Study participating centre
Royal Devon & Exeter Hospital
Exeter
EX2 5DW
United Kingdom
EX2 5DW
United Kingdom
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | Not 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 | ||
| Participant information sheet | Participant information sheet | 11/11/2025 | 11/11/2025 | No | Yes |
Editorial Notes
12/02/2018: No publications found, verifying study status with principal investigator.
