Contact information
Type
Scientific
Primary contact
Miss Julia Slark
ORCID ID
Contact details
Room 15
Lab Block 11E
Charing Cross Hospital
Hammersmith
London
W6 8RF
United Kingdom
+44 (0)20 3313 0677
j.slark@imperial.ac.uk
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
SLAJ2002
Study information
Scientific title
To improve adherence to secondary prevention strategies in a high risk stroke population: a randomised controlled trial
Acronym
IRAIS
Study hypothesis
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
East London Research Ethics Committee, 09/04/2010
Study design
Randomised controlled trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Other
Trial type
Prevention
Patient information sheet
Not available in web format, please use the contact details below to request a patient information sheet
Condition
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
Phase
Not Applicable
Drug names
Primary outcome measures
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
Secondary outcome measures
Risk score reduction through lifestyle modification at 3 month follow-up
Overall trial start date
01/05/2010
Overall trial end date
01/06/2010
Reason abandoned
Eligibility
Participant 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
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
238
Participant exclusion criteria
Patients unlikely to survive or be able to attend for the 3 month follow-up consultation
Recruitment start date
01/05/2010
Recruitment end date
01/06/2010
Locations
Countries of recruitment
United Kingdom
Trial participating centre
Charing Cross Hospital
London
W6 8RF
United Kingdom
Sponsor information
Organisation
Imperial College London (UK)
Sponsor details
c/o Ms Michelle Quaye
Research Governance Manager
London
W6 8RF
United Kingdom
Sponsor type
University/education
Website
Funders
Funder type
Hospital/treatment centre
Funder name
Imperial College Healthcare NHS Trust (UK) - Hammersmith Hospitals Trustees Research Committee Award
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Results - basic reporting
Publication summary