Individual Risk Awareness Intervention in Stroke
| ISRCTN | ISRCTN67999605 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN67999605 |
| Protocol serial number | SLAJ2002 |
| Sponsor | Imperial College London (UK) |
| Funder | Imperial College Healthcare NHS Trust (UK) - Hammersmith Hospitals Trustees Research Committee Award |
- Submission date
- 05/08/2010
- Registration date
- 13/10/2010
- Last edited
- 30/09/2016
- 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
Miss Julia Slark
Scientific
Scientific
Room 15, Lab Block 11E
Charing Cross Hospital
Hammersmith
London
W6 8RF
United Kingdom
| Phone | +44 (0)20 3313 0677 |
|---|---|
| j.slark@imperial.ac.uk |
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Randomised controlled trial |
| Secondary study design | Randomised controlled trial |
| Study type | Participant information sheet |
| Scientific title | To improve adherence to secondary prevention strategies in a high risk stroke population: a randomised controlled trial |
| Study acronym | IRAIS |
| Study objectives | Improving patients perception of their risk of secondary stroke and heart disease at the time of their first event may improve the likelihood of adherence to secondary prevention strategies such as medication taking and lifestyle modification. |
| Ethics approval(s) | East London Research Ethics Committee, 09/04/2010 |
| Health condition(s) or problem(s) studied | Stroke |
| Intervention | Total participation in the trial for both arms is 3 months or until they have been seen in follow-up once. Both arms will complete a questionnaire collecting demographic information, physiological factors and questions relating to awareness of risk and personal stroke knowledge. The intervention arm receives a 1:1 session for approximately 20 minutes which includes a personalised risk score % for secondary stroke. The control arm receives usual routine practice which involves a 1:1 session with a clinical nurse specialist providing information on stroke. |
| Intervention type | Other |
| Primary outcome measure(s) |
1. Another stroke event in 3 months |
| Key secondary outcome measure(s) |
Risk score reduction through lifestyle modification at 3 month follow-up |
| Completion date | 01/06/2010 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | All |
| Target sample size at registration | 238 |
| Key inclusion criteria | 1. Diagnosis of any stroke 2. Aged 18+ years, either sex 3. Cognitively intact in order to understand future consequences of actions to reduce risk 4. Discharge Stroke Scale score of up to and over 40 |
| Key exclusion criteria | Patients unlikely to survive or be able to attend for the 3 month follow-up consultation |
| Date of first enrolment | 01/05/2010 |
| Date of final enrolment | 01/06/2010 |
Locations
Countries of recruitment
- United Kingdom
- England
Study participating centre
Charing Cross Hospital
London
W6 8RF
United Kingdom
W6 8RF
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? |
|---|---|---|---|---|---|
| Participant information sheet | Participant information sheet | 11/11/2025 | 11/11/2025 | No | Yes |
Editorial Notes
30/09/2016: No publications found, verifying study status with principal investigator.
