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 designRandomised controlled trial
Primary study designInterventional
Secondary study designRandomised controlled trial
Study setting(s)Other
Study typePrevention
Participant information sheet Not available in web format, please use the contact details below to request a patient information sheet
Scientific titleTo improve adherence to secondary prevention strategies in a high risk stroke population: a randomised controlled trial
Study acronymIRAIS
Study objectivesImproving 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) studiedStroke
InterventionTotal 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 typeOther
Primary outcome measure1. 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 measuresRisk score reduction through lifestyle modification at 3 month follow-up
Overall study start date01/05/2010
Completion date01/06/2010

Eligibility

Participant type(s)Patient
Age groupAdult
Lower age limit18 Years
SexBoth
Target number of participants238
Key inclusion criteria1. 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 criteriaPatients unlikely to survive or be able to attend for the 3 month follow-up consultation
Date of first enrolment01/05/2010
Date of final enrolment01/06/2010

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 logo "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 shareNo
IPD sharing plan summaryNot provided at time of registration
Publication and dissemination planNot provided at time of registration
IPD sharing plan

Editorial Notes

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