Secondary prevention after first stroke
| ISRCTN | ISRCTN35701810 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN35701810 |
| Secondary identifying numbers | 086921 |
- Submission date
- 16/03/2010
- Registration date
- 17/03/2010
- Last edited
- 09/06/2014
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Circulatory System
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Plain English summary of protocol
Not provided at time of registration
Contact information
Prof Martin Gulliford
Scientific
Scientific
Division of Primary Care and Public Health
King's College London
6th Floor Capital House
42 Weston Street
London
SE1 3QD
United Kingdom
| martin.gulliford@kcl.ac.uk |
Study information
| Study design | Interventional multicentre clustered randomised trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | GP practice |
| Study type | Prevention |
| Participant information sheet | Not available in web format, please use the contact details below to request a patient information sheet |
| Scientific title | Cluster randomised trial in a Primary Care database: utilising electronic patient records for intervention research into secondary prevention after first stroke |
| Study objectives | We aim to provide proof of concept of the feasibility and utility of implementing cluster randomised trials utilising electronic patient records in a large national primary care database. |
| Ethics approval(s) | London - Surrey Borders Research Ethics Committee approved on the 13th January 2010 (ref: 10/H0806/1) |
| Health condition(s) or problem(s) studied | Stroke |
| Intervention | A series of electronic prompts will be activated at each consultation by patients with previous stroke, to promote adherence with evidence-based recommendations for secondary prevention of stroke and vascular disease following the National Guidelines (Intercollegiate Stroke Working Party [ICSWP], 2008). The prompts encourage primary care professional adherence with recommended processes of care. The prompts will also provide them with supporting information and links to evidence that supports the recommendations. The decision on whether to follow the treatment suggestions included in the prompt will be at the discretion of the GP. The GP will also be able to terminate display of the prompt at any time. Control practices will continue with usual care. The intervention will be implemented for 12 months at each practice. |
| Intervention type | Other |
| Primary outcome measure | Difference in mean systolic blood pressure (BP) between intervention and control groups at 12 months adjusted for pre-intervention mean systolic BP |
| Secondary outcome measures | Measured at 12 months follow-up: 1. Mean diastolic blood pressure 2. Mean cholesterol concentration 3. Proportion of patients whose eligibility for anticoagulants/antiplatelet drugs is defined 4. Proportion of eligible patients that receive anticoagulant/antiplatelet drugs 5. Prescription adherence with prescribed medicines 6. Occurrence and hospitalisation with vascular events including transient ischaemic attack (TIA)/stroke, myocardial infarction, new-onset angina and mortality |
| Overall study start date | 01/04/2010 |
| Completion date | 31/10/2011 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Both |
| Target number of participants | 50 GP practices per group (100 practices in total) |
| Key inclusion criteria | 1. All stroke patients (no age limit, either sex) 2. Registered at the practice for at least three years at the trial start date 3. First diagnosis of stroke recorded in the 24 month period before the trial start date 4. Medical code for stroke is entered during the consultation 5. Patient's electronic medical record includes previous stroke medical codes |
| Key exclusion criteria | No eligible patients will be excluded from the analysis, to avoid bias. |
| Date of first enrolment | 01/04/2010 |
| Date of final enrolment | 31/10/2011 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centre
Division of Primary Care and Public Health
London
SE1 3QD
United Kingdom
SE1 3QD
United Kingdom
Sponsor information
The Wellcome Trust (UK)
Charity
Charity
Gibbs Building
215 Euston Road
London
NW1 2BE
United Kingdom
| contact@wellcome.ac.uk | |
| Website | http://www.wellcome.ac.uk/ |
"ROR" |
https://ror.org/029chgv08 |
Funders
Funder type
Charity
The Wellcome Trust (UK) (grant ref: 086921)
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Protocol article | protocol | 03/10/2012 | Yes | No | |
| Results article | results | 01/07/2014 | Yes | No |
