Conflicts of interest: Dr Phan has received honoraria for presentations given for Bayer. None of the other authors have any conflicts of interest to declare.
Risk factor management in survivors of stroke: a double-blind, cluster-randomized, controlled trial
Article first published online: 11 DEC 2012
© 2012 The Authors. International Journal of Stroke © 2012 World Stroke Organization
International Journal of Stroke
Volume 9, Issue 5, pages 652–657, July 2014
How to Cite
Thrift, A. G., Srikanth, V. K., Nelson, M. R., Kim, J., Fitzgerald, S. M., Gerraty, R. P., Bladin, C. F., Phan, T. G. and Cadilhac, D. A. (2014), Risk factor management in survivors of stroke: a double-blind, cluster-randomized, controlled trial. International Journal of Stroke, 9: 652–657. doi: 10.1111/j.1747-4949.2012.00933.x
- Issue published online: 9 JUN 2014
- Article first published online: 11 DEC 2012
- Manuscript Accepted: 16 JUL 2012
- Manuscript Received: 17 JAN 2012
- multicenter cluster-randomized controlled trial;
- risk factor management;
- secondary prevention
Comprehensive community care has the potential to improve risk factor management of patients with stroke or transient ischaemic attack.
The primary aim is to determine the effectiveness of an individualized management program on risk factor management for patients discharged from hospital after stroke.
Multicentre, cluster-randomized, controlled trial, with clusters by general practice. Participants are randomized to receive intervention or control after a baseline assessment undertaken after discharge from hospital. The general practice they attend is marked as an intervention or control accordingly. All subsequent participants attending those practices are automatically assigned as intervention or control. Baseline and all outcome assessments, including an analysis of risk factors, are undertaken by assessors blinded to patient randomization.
Based on the results of blinded assessments, the individualized management program group will receive targeted advice on how to manage their risk factors using a standardized, evidence-based template to communicate ‘ideal’ management with their general practitioner. In addition, patients randomized to the individualized management program group will receive counselling and education about stroke risk factor management by an intervention study nurse. Individualized management programs will be reviewed at three-months, six-months, 12 months, and 18 months after stroke, at which times they will be modified if appropriate. Stroke risk management will be evaluated using changes in the Framingham cardiovascular risk score. Analysis will be on an intention-to-treat basis using analysis of covariance or generalized linear model to adjust for baseline risk score and other relevant confounding factors.