Cardiovascular Diseases Clinical Trial
Official title:
Reducing Risk Factors in Peripheral Arterial Disease
The purpose of this study is to compare a health-counselor mediated telephone counseling intervention to usual care to reduce low density lipoprotein cholesterol (LDL-C) levels in patients with peripheral arterial disease (PAD).
BACKGROUND:
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. Data
show that fully 69 percent of patients with PAD from a non-invasive vascular laboratory in
Chicago did not have the recommended LDL-C level of less than 100 mg/dl. Our data from a
national survey indicate that physicians believe atherosclerotic risk factor treatment is
less important for patients with PAD than for patients with CAD. Our data also 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. Clinical trials such as this
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
DESIGN NARRATIVE:
This randomized, controlled clinical trial will test the ability of a health-counselor
mediated telephone counseling intervention as compared to usual care to reduce LDL-C levels
in patients with PAD. The study involves patients with PAD who have LDL-C levels greater
than 100 mg/dl at baseline identified from non-invasive vascular laboratories in Chicago, IL
and Worcester, MA. For their primary specific aim, the investigators 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 usual
care condition at 12-month follow-up. In their secondary aim, they will determine whether
the telephone counseling intervention increases the proportion of PAD patients with LDL-C
less than 100 mg/dl as compared to the usual care condition at 12-month follow-up. To
identify the mediators of the intervention, in their exploratory aims they 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 the
intervention, as compared to patients in the usual care condition.
;
Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment
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