Interactive Cholesterol Advisory Tool

Low Risk (0-10% Chance) of Developing Cardiovascular Disease Within 10 Years Based on Risk Factors Clinical Trial

— ICAT  

Official title:

The Interactive Cholesterol Advisory Tool

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01890031
• Other study ID #: 1R44HL097506-01
• Status: Completed
• Phase: Phase 1
• First received: June 18, 2012
• Last updated: August 5, 2015
• Start date: January 2012
• Est. completion date: June 2013

Study information

• Verified date: August 2015
• Source: University of Rochester
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Data and Safety Monitoring Board
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 131
• Est. completion date: June 2013
• Est. primary completion date: June 2013
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label

Related Conditions & MeSH terms

• Cardiovascular Diseases
• 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

Intervention

Other:
• Interactive Cholesterol Advisory Tool
using the virtual clinician computer program for cholesterol information and education.
• Study physician visits
In-person individual visits with a study physician to give information on cholesterol

Locations

Country	Name	City	State
United States	University of Rochester	Rochester	New York

Sponsors (1)

Lead Sponsor	Collaborator
University of Rochester

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	LDL-C in All ICAT Group Participants Versus Non-ICAT Group Participants		9 months	No
Secondary	Number of Participants Who Adhered to Medication Prescribed as Self Reported at 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	No