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Completed

NCT Number: NCT01890031

Interactive Cholesterol Advisory Tool

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).

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Key information

Conditions

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

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

University of Rochester

Rochester, New York, 14607, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Interactive Cholesterol Advisory Tool

Other

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

Study physician visits

Other

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

Primary outcomes

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

    Time frame: 9 months

Secondary outcomes

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

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

University of Rochester

Other

Registry information

Official study title

The Interactive Cholesterol Advisory Tool

Acronym: ICAT

Important dates

Study start
2012
Primary completion
2013
Study completion
2013
First posted
Jul 1, 2013
Registry last updated
Sep 4, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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