Virtual Clinician Research Tool (VCRT)
Creating a Virtual Clinician Research Tool
研究概览
地位
详细说明
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.
研究类型
注册 (实际的)
阶段
- 不适用
联系人和位置
学习地点
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New York
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Rochester、New York、美国、14607
- University of Rochester Medical Center Healthy Living Center
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参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
描述
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.
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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.
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学习计划
研究是如何设计的？
设计细节
- 主要用途：治疗
- 分配：随机化
- 介入模型：并行分配
- 屏蔽：单身的
武器和干预
参与者组/臂 |
干预/治疗 |
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其他：VCRT
This group will have 2 visits with a study physician in addition to using the VCRT.
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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).
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其他：no VCRT
This group will have 2 visits with study physician only, no VCRT.
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No intervention
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研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
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Tobacco abstinence or lowered LDL cholesterol
大体时间：6 months
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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;
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6 months
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
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increase in medication use
大体时间：6 months
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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;
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6 months
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合作者和调查者
调查人员
- 首席研究员：Geoffrey C. Williams, M.D., Ph.D.、University of Rochester
研究记录日期
研究主要日期
学习开始
初级完成 (实际的)
研究完成 (实际的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (估计)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.