Back to results

Virtual Clinician Research Tool (VCRT)

Primary Purpose

Elevated Risk of Cardiovascular Disease, Tobacco Dependence

Status

Completed

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

Virtual Clinician Research Tool (VCRT)

No VCRT, only physician counseling at visits

About this trial

This is an interventional treatment trial for Elevated Risk of Cardiovascular Disease

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

University of Rochester Medical Center Healthy Living Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Other

Arm Label

VCRT

no VCRT

Arm Description

This group will have 2 visits with a study physician in addition to using the VCRT.

This group will have 2 visits with study physician only, no VCRT.

Outcomes

Primary Outcome Measures

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;

Secondary Outcome Measures

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;

Full Information

NCT ID

NCT01408758

First Posted

January 17, 2011

Last Updated

February 24, 2017

Sponsor

University of Rochester

Collaborators

National Institute on Drug Abuse (NIDA)

1. Study Identification

Unique Protocol Identification Number

NCT01408758

Brief Title

Virtual Clinician Research Tool

Acronym

VCRT

Official Title

Creating a Virtual Clinician Research Tool

Study Type

Interventional

2. Study Status

Record Verification Date

February 2017

Overall Recruitment Status

Completed

Study Start Date

January 2011 (undefined)

Primary Completion Date

June 2012 (Actual)

Study Completion Date

June 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

University of Rochester

Collaborators

National Institute on Drug Abuse (NIDA)

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Elevated Risk of Cardiovascular Disease, Tobacco Dependence

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

Participant

Allocation

Randomized

Enrollment

79 (Actual)

8. Arms, Groups, and Interventions

Arm Title

VCRT

Arm Type

Other

Arm Description

This group will have 2 visits with a study physician in addition to using the VCRT.

Arm Title

no VCRT

Arm Type

Other

Arm Description

This group will have 2 visits with study physician only, no VCRT.

Intervention Type

Other

Intervention Name(s)

Virtual Clinician Research Tool (VCRT)

Intervention Description

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).

Intervention Type

Other

Intervention Name(s)

No VCRT, only physician counseling at visits

Intervention Description

No intervention

Primary Outcome Measure Information:

Title

Tobacco abstinence or lowered LDL cholesterol

Description

Time Frame

6 months

Secondary Outcome Measure Information:

Title

increase in medication use

Description

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

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

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. -

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Geoffrey C. Williams, M.D., Ph.D.

Organizational Affiliation

University of Rochester

Official's Role

Principal Investigator

Facility Information:

Facility Name

University of Rochester Medical Center Healthy Living Center

City

Rochester

State/Province

New York

ZIP/Postal Code

14607

Country

United States

12. IPD Sharing Statement

Learn more about this trial

Virtual Clinician Research Tool

We'll reach out to this number within 24 hrs