Interactive Cholesterol Advisory Tool

University of Rochester131 enrolled

Overview

The purpose of this study is to show that we can effectively deliver health information and education, online, via computer regarding cholesterol. This computer program is called the Interactive Cholesterol Advisory Tool (ICAT).

Participants will be recruited and categorized based on screening labs into 1 of 2 groups: Low or moderate risk of developing cardiovascular disease within 10 years based on risk factors. The low risk group will be advised to take the blood test results furnished by the study to their primary care doctor to discuss managing cholesterol. The moderate risk group will see the study physician for 4 visits about high cholesterol. Both groups complete a total of 4 blood draws over 9 months. Both groups will be randomized at consent into 2 groups: 1 who uses the Interactive Cholesterol Advisory Tool (ICAT) and 1 that does not use the ICAT. Because recruitment goals for the low risk group were met, a third group was created: low risk who both the study physician for 4 visits about high cholesterol and use the ICAT.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Masking

NONE

Enrollment

131

Conditions

Low Risk (0-10% Chance) of Developing Cardiovascular Disease Within 10 Years Based on Risk Factors Moderate Risk (10-20% Chance) of Developing Cardiovascular (Heart) Disease Within 10 Years Based on Risk Factors

Interventions

Interactive Cholesterol Advisory ToolOTHER

using the virtual clinician computer program for cholesterol information and education.

Study physician visitsOTHER

In-person individual visits with a study physician to give information on cholesterol

Eligibility

Sex: ALLMin age: 18 YearsHealthy volunteers:

Medical Language ↔ Plain English

Inclusion Criteria: * Fluency in English, * Willing to come in for 1-5 visits, * Low and moderate CVD risk. * Having access to a computer with internet connection Exclusion Criteria: * CVD diagnosis or CVD equivalent, * Psychosis, terminal illness, * Pregnancy, * Current statin use if assigned to the low risk group * Liver disease, * Peripheral Vascular Disease, * Diabetes Mellitus, * Abdominal Aortic Aneurism, * Cerebral Vascular Disease * Triglyceride level above 500 mg/dl * Uncorrected hypothyroidism

Locations (1)

University of Rochester

Rochester, New York, United States

Outcomes

Primary Outcomes

LDL-C in All ICAT Group Participants Versus Non-ICAT Group Participants

Time frame: 9 months

Secondary Outcomes

Number of Participants Who Adhered to Medication Prescribed as Self Reported at 9 Months

We will assess adherence (for those who are prescribed a statin in the moderate CVD risk group) by both indirect objective measures and subjective reports. The study design did not include prescription of a cholesterol-lowering medication as per randomization. Participants were prescribed a statin as standard of care based on the participants and physicians agreement. Low risk individuals have less need for medication compared to moderate risk based on the current science.

Time frame: 9 months

Data from ClinicalTrials.gov

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