Muideen T Olaiya1, Dominique A Cadilhac1, Joosup Kim1, Mark R Nelson1, Velandai K Srikanth1, Richard P Gerraty1, Christopher F Bladin1, Sharyn M Fitzgerald1, Thanh Phan1, Judith Frayne1, Amanda G Thrift2. 1. From the Stroke and Ageing Research, Department of Medicine, School of Clinical Sciences at Monash Health (M.T.O., D.A.C., J.K., V.K.S., T.P., A.G.T.) and Department of Epidemiology and Preventive Medicine (M.R.N., S.M.F.), Monash University, Clayton, Victoria, Australia; Stroke Division, Florey Institute of Neuroscience and Mental Health, Heidelberg, Victoria, Australia (D.A.C., J.K.); Menzies Institute for Medical Research, Hobart, Tasmania, Australia (M.R.N., V.K.S.); Department of Medicine, Epworth Healthcare, Richmond, Victoria, Australia (R.P.G.); Department of Neurosciences, Box Hill Hospital, Victoria, Australia (C.F.B.); and Department of Neurology, Alfred Hospital, Melbourne, Victoria, Australia (J.F.). 2. From the Stroke and Ageing Research, Department of Medicine, School of Clinical Sciences at Monash Health (M.T.O., D.A.C., J.K., V.K.S., T.P., A.G.T.) and Department of Epidemiology and Preventive Medicine (M.R.N., S.M.F.), Monash University, Clayton, Victoria, Australia; Stroke Division, Florey Institute of Neuroscience and Mental Health, Heidelberg, Victoria, Australia (D.A.C., J.K.); Menzies Institute for Medical Research, Hobart, Tasmania, Australia (M.R.N., V.K.S.); Department of Medicine, Epworth Healthcare, Richmond, Victoria, Australia (R.P.G.); Department of Neurosciences, Box Hill Hospital, Victoria, Australia (C.F.B.); and Department of Neurology, Alfred Hospital, Melbourne, Victoria, Australia (J.F.). amanda.thrift@monash.edu.
Abstract
BACKGROUND AND PURPOSE: Many guidelines for secondary prevention of stroke focus on controlling cardiometabolic risk factors. We investigated the effectiveness of a management program for attaining cardiometabolic targets in survivors of stroke/transient ischemic attack. METHODS: Randomized controlled trial of survivors of stroke/transient ischemic attack aged ≥18 years. General practices were randomized to usual care (control) or an intervention comprising specialist review of care plans and nurse education in addition to usual care. The outcome is attainment of pre-defined cardiometabolic targets based on Australian guidelines. Multivariable regression was undertaken to determine efficacy and identify factors associated with attaining targets. RESULTS: Overall, 283 subjects were randomized to the intervention and 280 to controls. Although we found no between-group difference in overall cardiometabolic targets achieved at 12 months, the intervention group more often achieved control of low-density lipoprotein cholesterol (odds ratio, 1.97; 95% confidence interval, 1.18-3.29) than controls. At 24 months, no between-group differences were observed. Medication adherence was ≥80% at follow-up, but uptake of lifestyle/behavioral habits was poor. Older age, being male, being married/living with partner, and having greater functional ability or a history of diabetes mellitus were associated with attaining targets. CONCLUSIONS: The intervention in this largely negative trial only had a detectable effect on attaining target for lipids but not for other factors at 12 months or any factor at 24 months. This limited effect may be attributable to inadequate uptake of behavioral/lifestyle interventions, highlighting the need for new or better approaches to achieve meaningful behavioral change. CLINICAL TRIAL REGISTRATION: URL: http://www.clinicaltrials.gov. Unique identifier: ACTRN12608000166370.
RCT Entities:
BACKGROUND AND PURPOSE: Many guidelines for secondary prevention of stroke focus on controlling cardiometabolic risk factors. We investigated the effectiveness of a management program for attaining cardiometabolic targets in survivors of stroke/transient ischemic attack. METHODS: Randomized controlled trial of survivors of stroke/transient ischemic attack aged ≥18 years. General practices were randomized to usual care (control) or an intervention comprising specialist review of care plans and nurse education in addition to usual care. The outcome is attainment of pre-defined cardiometabolic targets based on Australian guidelines. Multivariable regression was undertaken to determine efficacy and identify factors associated with attaining targets. RESULTS: Overall, 283 subjects were randomized to the intervention and 280 to controls. Although we found no between-group difference in overall cardiometabolic targets achieved at 12 months, the intervention group more often achieved control of low-density lipoprotein cholesterol (odds ratio, 1.97; 95% confidence interval, 1.18-3.29) than controls. At 24 months, no between-group differences were observed. Medication adherence was ≥80% at follow-up, but uptake of lifestyle/behavioral habits was poor. Older age, being male, being married/living with partner, and having greater functional ability or a history of diabetes mellitus were associated with attaining targets. CONCLUSIONS: The intervention in this largely negative trial only had a detectable effect on attaining target for lipids but not for other factors at 12 months or any factor at 24 months. This limited effect may be attributable to inadequate uptake of behavioral/lifestyle interventions, highlighting the need for new or better approaches to achieve meaningful behavioral change. CLINICAL TRIAL REGISTRATION: URL: http://www.clinicaltrials.gov. Unique identifier: ACTRN12608000166370.
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