Interactive Cholesterol Advisory Tool (ICAT)

University of Rochester

Status and phase: Completed; Phase 1

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

Treatments: Other: Interactive Cholesterol Advisory Tool; Other: Study physician visits

Study type: Interventional

Funder types: Other

Identifiers

NCT01890031

1R44HL097506-01

Details and patient eligibility

About

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).

Full description

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.

Enrollment: 131 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

131 participants in 5 patient groups

Low Risk, No ICAT

No Intervention group

Description:

Low risk, not randomized to use the Interactive Cholesterol Advisory Tool, no study physician visits

Low risk, ICAT

Other group

Description:

Low risk, randomized to use the Interactive Cholesterol Advisory Tool, no study physician visits

Treatment:

Other: Interactive Cholesterol Advisory Tool

Low risk, ICAT, and study physician

Other group

Description:

Low risk, assigned to use the Interactive Cholesterol Advisory Tool, and study physician visits.

Treatment:

Other: Study physician visits

Other: Interactive Cholesterol Advisory Tool

Moderate risk, no ICAT

Other group

Description:

Moderate risk, study physician visits, and not randomized to use the Interactive Cholesterol Advisory Tool

Treatment:

Other: Study physician visits

Moderate risk, ICAT

Other group

Description:

Moderate risk, study physician visits, and randomized to use the Interactive Cholesterol Advisory Tool

Treatment:

Other: Study physician visits

Other: Interactive Cholesterol Advisory Tool