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ISRCTN
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ISRCTN67999605
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ClinicalTrials.gov identifier
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Public title
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Individual Risk Awareness Intervention in Stroke
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Scientific title
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To improve adherence to secondary prevention strategies in a high risk stroke population: a randomised controlled trial
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Acronym
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IRAIS
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Serial number at source
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SLAJ2002
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Study hypothesis
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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.
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Lay summary
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Ethics approval
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East London Research Ethics Committee approved on the 9th April 2010
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Study design
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Randomised controlled trial
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Countries of recruitment
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United Kingdom
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Disease/condition/study domain
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Stroke
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Participants - inclusion criteria
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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
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Participants - exclusion criteria
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Patients unlikely to survive or be able to attend for the 3 month follow-up consultation
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Anticipated start date
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01/05/2010
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Anticipated end date
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01/06/2010
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Status of trial
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Completed |
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Patient information material
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Not available in web format, please use the contact details below to request a patient information sheet
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Target number of participants
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238
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Interventions
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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.
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Primary outcome measure(s)
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1. Another stroke event in 3 months
2. Evidence of adherence to secondary prevention lifestyle modifications at 3 month follow-up through patient self reporting and physiological testing in the intervention arm compared to the control arm of the randomised controlled trial
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Secondary outcome measure(s)
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Risk score reduction through lifestyle modification at 3 month follow-up
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Sources of funding
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Imperial College Healthcare NHS Trust (UK) - Hammersmith Hospitals Trustees Research Committee Award
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Trial website
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Publications
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Contact name
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Miss
Julia
Slark
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Address
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Room 15, Lab Block 11E
Charing Cross Hospital
Hammersmith
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City/town
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London
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Zip/Postcode
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W6 8RF
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Country
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United Kingdom
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Tel
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+44 (0)20 3313 0677
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Email
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j.slark@imperial.ac.uk
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Sponsor
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Imperial College London (UK)
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Address
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c/o Ms Michelle Quaye
Research Governance Manager
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City/town
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London
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Zip/Postcode
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W6 8RF
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Country
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United Kingdom
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Sponsor website:
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http://www3.imperial.ac.uk/
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Date applied
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05/08/2010
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Last edited
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13/10/2010
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Date ISRCTN assigned
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13/10/2010
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