Individual Risk Awareness Intervention in Stroke

ISRCTN	ISRCTN67999605
DOI	https://doi.org/10.1186/ISRCTN67999605
Secondary identifying numbers	SLAJ2002

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

Room 15, Lab Block 11E
Charing Cross Hospital
Hammersmith
London
W6 8RF
United Kingdom

Phone	+44 (0)20 3313 0677
Email	j.slark@imperial.ac.uk

Study information

Study design	Randomised controlled trial
Primary study design	Interventional
Secondary study design	Randomised controlled trial
Study setting(s)	Other
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	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	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 study start date	01/05/2010
Completion date	01/06/2010

Eligibility

Participant type(s)	Patient
Age group	Adult
Lower age limit	18 Years
Sex	Both
Target number of participants	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

England
United Kingdom

Study participating centre

Charing Cross Hospital

London
W6 8RF
United Kingdom

Sponsor information

Imperial College London (UK)
University/education

c/o Ms Michelle Quaye
Research Governance Manager
London
W6 8RF
England
United Kingdom

Website	http://www3.imperial.ac.uk/
"ROR"	https://ror.org/041kmwe10

Funders

Funder type

Hospital/treatment centre

Imperial College Healthcare NHS Trust (UK) - Hammersmith Hospitals Trustees Research Committee Award

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

Editorial Notes

30/09/2016: No publications found, verifying study status with principal investigator.