Condition category
Circulatory System
Date applied
05/08/2010
Date assigned
13/10/2010
Last edited
30/09/2016
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

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

http://www3.imperial.ac.uk/

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

Publication citations

Additional files

Editorial Notes

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