In patients with peripheral arterial disease (PAD), this randomized, controlled clinical trial will test the ability of a telephone-counseling intervention to reduce Low Density Lipoprotein cholesterol (LDL-C) levels as compared to usual care and attention control conditions, respectively. Patients with PAD have a 3 to 4-fold higher risk of cardiovascular morbidity and mortality compared to patients without PAD. Risk of future cardiovascular events is comparable between patients with PAD and coronary artery disease (CAD). While improved atherosclerotic risk factor treatment has reduced cardiovascular morbidity and mortality in patients with CAD, such treatment in patients with PAD remains suboptimal. Intensity of cholesterol-lowering therapy, specifically, is significantly poorer in patients with PAD as compared to CAD. Pilot data collected for this study show that fully 69% of patients with PAD from our non-invasive vascular laboratory in Chicago did not have the recommended LDL-C level of < 100 mg/dl. Our published data show that many patients with PAD are unaware of their increased risk of cardiovascular events and under-appreciate the importance of risk factor treatment in PAD. These findings likely contribute to risk factor under-treatment in patients with PAD. Our data from a national survey also indicate that physicians believe atherosclerotic risk factor treatment is less important for patients with PAD than for patients with CAD. Clinical trials such as the 1 proposed are needed to demonstrate whether PAD risk factors can be reduced. If effective, this clinical trial will also encourage clinicians to adopt the proven intervention to lower cardiovascular risks in patients with PAD. This study involves 420 men and women with PAD who have LDL-C levels > 100 mg/dl at baseline identified from non-invasive vascular laboratories in Chicago, IL and Worcester, MA. For our primary specific aim, we hypothesize that subjects randomized to the intervention condition will achieve a reduction in LDL-C of at least 11.1 mg/dl greater than the reduction in LDL-C for subjects randomized to the attention control and usual care conditions, respectively, at 12-month follow-up. In our secondary aim, we will determine whether the telephone counseling intervention increases the proportion of PAD patients with LDLC < 100 mg/dl as compared to the attention control and usual care conditions, respectively, at 12-month follow-up. To identify the mediators of our intervention, in our exploratory aims we will determine whether patients in the intervention condition achieve greater increases (improvement) in specific behavioral and knowledge and attitude mediators that will be targeted by our intervention, as compared to patients in the attention control and usual care conditions, respectively.

National Institute of Health (NIH)
National Heart, Lung, and Blood Institute (NHLBI)
Research Project (R01)
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Behavioral Medicine, Interventions and Outcomes Study Section (BMIO)
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Fleg, Jerome
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Northwestern University at Chicago
Internal Medicine/Medicine
Schools of Medicine
United States
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