An interventional study of Virtual Clinician Research Tool (VCRT) and No VCRT, only physician counseling at visits in Elevated Risk of Cardiovascular Disease and Tobacco Dependence, sponsored by University of Rochester. Completed at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2017-02-28.
Sponsored by University of Rochester · Not applicable, Interventional, and Treatment
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.
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.
4,904 studies on the registry are indexed under Cardiovascular Diseases; 920 are open to participants now.
This study's enrollment of 79 is below the median of 100 across 2,738 interventional studies indexed under Cardiovascular Diseases.
Browse Cardiovascular Diseases studies →University of Rochester is the lead sponsor of 715 studies on the registry; 116 are open to participants now.
Of its 56 completed or terminated interventional studies of FDA-regulated products, 44 (79%) have results posted.
Counted across the registry records on this site, refreshed daily.
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.
-
This group will have 2 visits with a study physician in addition to using the VCRT.
Other: Virtual Clinician Research Tool (VCRT)
This group will have 2 visits with study physician only, no VCRT.
Other: No VCRT, only physician counseling at visits
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).
No intervention
Tobacco abstinence or lowered LDL cholesterol
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;
Time frame: 6 months
increase in medication use
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;
Time frame: 6 months
This study is completed, as verified in Feb 2017. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
University of Rochester