Virtual Clinician Research Tool

Hypercholesterolemia and tobacco use interact to increase cardiovascular disease (USDHHS
1990; 2004). Smoking is a cause of metabolic syndrome and diabetes (Eliasson, 2003; Hu et
al., 2001; Weitzman et al., 2005). Smokers live on average 13 years less than non-smokers
(USDHHS, 2004), and tobacco remains the number one health threat in the United States
(Mokdad, Marks, Stroup, & Gerberding, 2004). The Public Health Service (PHS) has published a
Guideline for Tobacco Dependence Treatment (Fiore, 2000; Fiore et al., 2008).
Hypercholesterolemia is a major risk for cardiovascular disease, and effective treatment
with lifestyle and medications lower the risk of cardiovascular events including sudden
death, myocardial infarction, and stroke. The National Cholesterol Education Program (NCEP)
has published clinical guidelines for its management (Brown, 2004). These include
recommendations for therapeutic lifestyle change and medications.

The specific aims of the proposed work are: first, to determine abstinence from tobacco at
6-months and lower LDL-cholesterol from baseline to 6-months for patients assigned the VCRT
in addition to the clinician compared to those just receiving clinician care; second, to
test for increase in medication use (number of days of medication use-for tobacco dependence
mediations and for statin medications for cholesterol) for those receiving the VCRT +
clinician; third, to examine the self-determination process model, expanded to include
autonomous motivation and perceived competence for medication adherence and actual adherence
to promote maintained abstinence and lower LDL-cholesterol.

Inclusion Criteria:

Inclusion Criteria Tobacco Dependence: Subjects must be currently smoking at least 5
cigarettes per day in the past month, and have smoked 100 cigarettes in their lifetime to
qualify for the tobacco VCRT; and will be eligible regardless of their desire to stop
smoking.

B. Inclusion Criteria Cholesterol. Subjects must have moderate or moderately high risk for
coronary artery disease defined by NCEP (two or more of the following risk factors (male
age > 45 years, female >55, HDL-C <40 mg/dl, active smoking, family history of CHD age <
55 years male or age < 65 years female) and the average of two LDL-cholesterols > 100
mg/dl, or the average of two non-HDL cholesterols of 130 mg/dl. Participants will be
eligible regardless of desire to lower their cholesterol.

Exclusion Criteria:

Exclusion Criteria Tobacco and Cholesterol: Participants will be excluded if they are
pregnant or lactating, have a psychotic disorder, are unable to make decisions about
medications for themselves, are too sick to participate, or have a life expectancy of less
than 12 months (e.g., advanced cancer). Participants will be excluded from the tobacco
portion of the trial if they have suicidal ideation (score of 1 or more on the suicidal
thought or self harm question in the Patient Health Questionnaire (PHQ) 9). Participants
will be excluded from the cholesterol portion of the trial if they have had a heart attack
or a stroke, if they have diabetes mellitus, aortic aneurysm, peripheral vascular disease,
or chronic kidney disease. They will also be excluded if they are already taking a statin
medication to lower their cholesterol. They will be excluded if they are unable to take
any of the statin medications due to allergy or adverse reaction in the past (before the
study starts). They will be excluded from both cholesterol and tobacco portions of study
if they do not speak or write English. Participants will be excluded if they do not have
access to a personal computer at home (Mac or PC) with broadband internet access (such as
cable modem or digital subscriber line [DSL] and Firefox, Internet Explorer 7 (or higher),
or Safari browser software.