Is it feasible, acceptable and motivating to show patients attending a lipid clinical ultrasound images of atheromatous plaque in their carotid arteries?
| ISRCTN | ISRCTN71832219 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN71832219 |
| Secondary identifying numbers | N0051117057 |
- Submission date
- 12/09/2003
- Registration date
- 12/09/2003
- Last edited
- 26/06/2008
- 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
Dr Andrew Iversen
Scientific
Scientific
Brighton & Sussex University Hospitals NHS Trust (RSCH)
Royal Sussex County Hospital
Eastern Road
Brighton
BN2 5BE
United Kingdom
| Phone | +44 01273 696955 |
|---|---|
| andrew.iversen@bsuh.nhs.uk |
Study information
| Study design | Randomised controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Not specified |
| Study type | Not Specified |
| Scientific title | |
| Study objectives | 1. That using portable ultrasound to identify carotid atheroma in patients attending a hospital lipid clinic is feasible and acceptable to patients 2. That images of carotid atheroma motivate patients to engage in behaviours to reduce the risk of cardiovascular disease |
| Ethics approval(s) | Not provided at time of registration |
| Health condition(s) or problem(s) studied | Cardiovascular: Carotid atheroma |
| Intervention | A between subjects design in which 200 patients will be randomly allocated to one of two groups: (1) scanned (2) not scanned. Assuming that ultrasound will detect plaque in 50% of patients, this sample gives sufficient power to detect a medium effect size. Between group comparisons will be of cognitions known to precede behaviour change (ie prescriptions of severity of cardiovascular disease, risk and response efficacy (ie giving up smoking will reduce risk), understanding of the results of the scan, acceptability of the scan and fear. Prevalence of carotid atheroma and recruitment rates will be recorded. |
| Intervention type | Other |
| Primary outcome measure | If successful the results in this study will be used to develop a randomised controlled trial of the impact of imaging carotid atheroma to motivate cardiovascular risk reducing behaviour change. |
| Secondary outcome measures | Not provided at time of registration |
| Overall study start date | 01/09/2002 |
| Completion date | 01/09/2003 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Not Specified |
| Sex | Not Specified |
| Target number of participants | 200 |
| Key inclusion criteria | 200 patients attending a routine lipid clinic. |
| Key exclusion criteria | Not provided at time of registration |
| Date of first enrolment | 01/09/2002 |
| Date of final enrolment | 01/09/2003 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centre
Brighton & Sussex University Hospitals NHS Trust (RSCH)
Brighton
BN2 5BE
United Kingdom
BN2 5BE
United Kingdom
Sponsor information
Department of Health (UK)
Government
Government
Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom
| Website | http://www.doh.gov.uk |
|---|
Funders
Funder type
Government
Brighton and Sussex University Hospitals NHS Trust (UK)
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? |
|---|---|---|---|---|---|
| Abstract results | 01/04/2004 | No | No |
