Interactive Cholesterol Advisory Tool (ICAT)

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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

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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