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Risk factor management in survivors of stroke: a double-blind, cluster-randomized, controlled trial

Authors

  • Amanda G. Thrift,

    Corresponding author
    1. Stroke and Ageing Research Centre (STARC), Department of Medicine, Southern Clinical School, Monash Medical Centre, Monash University, Clayton, Vic., Australia
    2. National Stroke Research Institute, Florey Neurosciences, Heidelberg, Vic., Australia
    • Correspondence: Amanda G. Thrift, Epidemiology and Prevention Unit, Stroke and Ageing Research Centre (STARC), Department of Medicine, Southern Clinical School, Monash Medical Centre, Monash University, Level 1/43-51 Kanooka Grove, Clayton, Vic. 3168, Australia.

      E-mail: amanda.thrift@monash.edu

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  • Velandai K. Srikanth,

    1. Stroke and Ageing Research Centre (STARC), Department of Medicine, Southern Clinical School, Monash Medical Centre, Monash University, Clayton, Vic., Australia
    2. Menzies Research Institute, Tasmania, Hobart, Tas., Australia
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  • Mark R. Nelson,

    1. Menzies Research Institute, Tasmania, Hobart, Tas., Australia
    2. Department Epidemiology and Preventive Medicine, Monash University, Melbourne, Vic., Australia
    3. School of Medicine, University of Tasmania, Hobart, Tas., Australia
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  • Joosup Kim,

    1. Stroke and Ageing Research Centre (STARC), Department of Medicine, Southern Clinical School, Monash Medical Centre, Monash University, Clayton, Vic., Australia
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  • Sharyn M. Fitzgerald,

    1. Department Epidemiology and Preventive Medicine, Monash University, Melbourne, Vic., Australia
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  • Richard P. Gerraty,

    1. Department of Medicine, Epworth Healthcare, Monash University, Richmond, Vic., Australia
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  • Christopher F. Bladin,

    1. Department of Neurosciences, Box Hill Hospital, Box Hill, Vic., Australia
    2. Department of Medicine, Box Hill Hospital, Monash University, Box Hill, Vic., Australia
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  • Thanh G. Phan,

    1. Stroke and Ageing Research Centre (STARC), Department of Medicine, Southern Clinical School, Monash Medical Centre, Monash University, Clayton, Vic., Australia
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  • Dominique A. Cadilhac

    1. Stroke and Ageing Research Centre (STARC), Department of Medicine, Southern Clinical School, Monash Medical Centre, Monash University, Clayton, Vic., Australia
    2. National Stroke Research Institute, Florey Neurosciences, Heidelberg, Vic., Australia
    3. Department of Medicine (Austin Health), The University of Melbourne, Heidelberg, Vic., Australia
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  • 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.

Abstract

Background

Comprehensive community care has the potential to improve risk factor management of patients with stroke or transient ischaemic attack.

Aim

The primary aim is to determine the effectiveness of an individualized management program on risk factor management for patients discharged from hospital after stroke.

Design

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.

Intervention Details

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.

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