Interactive Cholesterol Advisory Tool (ICAT)

August 5, 2015 updated by: Robert Block, University of Rochester

The 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).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed 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.

Study Type

Interventional

Enrollment (Actual)

131

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • New York
      • Rochester, New York, United States, 14607
        • University of Rochester

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Rochester

Investigators

  • Principal Investigator: Robert Block, MD, MPH, University of Rochester

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2012

Primary Completion (Actual)

June 1, 2013

Study Completion (Actual)

June 1, 2013

Study Registration Dates

First Submitted

June 18, 2012

First Submitted That Met QC Criteria

June 26, 2013

First Posted (Estimate)

July 1, 2013

Study Record Updates

Last Update Posted (Estimate)

September 4, 2015

Last Update Submitted That Met QC Criteria

August 5, 2015

Last Verified

August 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 1R44HL097506-01 (U.S. NIH Grant/Contract)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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