Elevated Risk of Cardiovascular Disease, Tobacco Dependence
Conditions
Brief summary
The Virtual Clinician Research Tool (VCRT) will use a virtual format to present our National Cholesterol Education Program (Brown, 2004) and the Tobacco Use and Dependence Treatment Clinical Guideline (Fiore et al., 2008) integrated with principles of human motivation from Self-Determination Theory (SDT) for patients with elevated risk for cardiovascular disease from LDL-cholesterol or tobacco dependence.
Detailed description
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.
Interventions
OTHERVirtual Clinician Research Tool (VCRT)
The Virtual Clinician Research Tool (VCRT) will use Self-Determination Theory (SDT) to guide the process or style of how two national guidelines (one for hyperlipidemia, 1 for tobacco dependence)will be operationalized into a virtual format that patients can access online using any internet connected personal computer to develop their plan for change (in this project regarding tobacco or nutrition).
OTHERNo VCRT, only physician counseling at visits
No intervention
Sponsors
National Institute on Drug Abuse (NIDA)
University of Rochester
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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. \-
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Tobacco abstinence or lowered LDL cholesterol | 6 months | 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 receiving standard clinician care; |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| increase in medication use | 6 months | 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; |
Countries
United States
Outcome results
None listed