Interactive Cholesterol Advisory Tool

Study Overview
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Brief Summary
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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).

Detailed Description
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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.

Official Title
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The Interactive Cholesterol Advisory Tool

Conditions
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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

Intervention / Treatment
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* Other: Interactive Cholesterol Advisory Tool
* Other: Study physician visits


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Low Risk, No ICAT<br>Low risk, not randomized to use the Interactive Cholesterol Advisory Tool, no study physician visits | |
| Other: Low risk, ICAT<br>Low risk, randomized to use the Interactive Cholesterol Advisory Tool, no study physician visits | Other: Interactive Cholesterol Advisory Tool<br>* using the virtual clinician computer program for cholesterol information and education.<br>|
| Other: Low risk, ICAT, and study physician<br>Low risk, assigned to use the Interactive Cholesterol Advisory Tool, and study physician visits. | Other: Interactive Cholesterol Advisory Tool<br>* using the virtual clinician computer program for cholesterol information and education.<br>Other: Study physician visits<br>* In-person individual visits with a study physician to give information on cholesterol<br>|
| Other: Moderate risk, no ICAT<br>Moderate risk, study physician visits, and not randomized to use the Interactive Cholesterol Advisory Tool | Other: Study physician visits<br>* In-person individual visits with a study physician to give information on cholesterol<br>|
| Other: Moderate risk, ICAT<br>Moderate risk, study physician visits, and randomized to use the Interactive Cholesterol Advisory Tool | Other: Interactive Cholesterol Advisory Tool<br>* using the virtual clinician computer program for cholesterol information and education.<br>Other: Study physician visits<br>* In-person individual visits with a study physician to give information on cholesterol<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| LDL-C in All ICAT Group Participants Versus Non-ICAT Group Participants |  | 9 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 9 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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cardiovascular disease, cholesterol