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Interactive Cholesterol Advisory Tool (ICAT)

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ClinicalTrials.gov Identifier: NCT01890031
Recruitment Status : Completed
First Posted : July 1, 2013
Results First Posted : September 4, 2015
Last Update Posted : September 4, 2015
Sponsor:
Information provided by (Responsible Party):

Study Description
Brief Summary:
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).

Condition or disease Intervention/treatment Phase
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 Other: Interactive Cholesterol Advisory Tool Other: Study physician visits Phase 1

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 Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 131 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Official Title: The Interactive Cholesterol Advisory Tool
Study Start Date : January 2012
Primary Completion Date : June 2013
Study Completion Date : June 2013

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
No Intervention: Low Risk, No ICAT
Low risk, not randomized to use the Interactive Cholesterol Advisory Tool, no study physician visits
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.
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
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
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


Outcome Measures

Primary Outcome Measures :
  1. LDL-C in All ICAT Group Participants Versus Non-ICAT Group Participants [ Time Frame: 9 months ]

Secondary Outcome Measures :
  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.


Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01890031


Locations
United States, New York
University of Rochester
Rochester, New York, United States, 14607
Sponsors and Collaborators
University of Rochester
Investigators
Principal Investigator: Robert Block, MD, MPH University of Rochester
More Information

Responsible Party: Robert Block, Professor, University of Rochester
ClinicalTrials.gov Identifier: NCT01890031     History of Changes
Other Study ID Numbers: 1R44HL097506-01 ( U.S. NIH Grant/Contract )
First Posted: July 1, 2013    Key Record Dates
Results First Posted: September 4, 2015
Last Update Posted: September 4, 2015
Last Verified: August 2015

Keywords provided by Robert Block, University of Rochester:
cardiovascular disease
cholesterol

Additional relevant MeSH terms:
Cardiovascular Diseases