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Interactive Cholesterol Advisory Tool (ICAT)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
University of Rochester
ClinicalTrials.gov Identifier:
NCT01890031
First received: June 18, 2012
Last updated: July 3, 2013
Last verified: July 2013
  Purpose

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 Intervention 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

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Official Title: The Interactive Cholesterol Advisory Tool

Resource links provided by NLM:


Further study details as provided by University of Rochester:

Primary Outcome Measures:
  • Improvement in LDL-C and HLD-C in all ICAT group participants versus non-ICAT group participants [ Time Frame: 9 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • medication adherence [ Time Frame: 9 months ] [ Designated as safety issue: No ]
    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.MEMS caps will be used to monitor when medication bottles are opened.


Enrollment: 131
Study Start Date: January 2012
Study Completion Date: June 2013
Primary Completion Date: June 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

Responsible Party: University of Rochester
ClinicalTrials.gov Identifier: NCT01890031     History of Changes
Other Study ID Numbers: 1 R44 HL097506-01
Study First Received: June 18, 2012
Last Updated: July 3, 2013
Health Authority: United States: Data and Safety Monitoring Board

Keywords provided by University of Rochester:
cardiovascular disease
cholesterol

Additional relevant MeSH terms:
Cardiovascular Diseases

ClinicalTrials.gov processed this record on November 25, 2014