Interactive Cholesterol Advisory Tool

Phase 1

Completed

• Conditions: Moderate Risk (10-20% Chance) of Developing Cardiovascular (Heart) Disease Within 10 Years Based on Risk Factors; Low Risk (0-10% Chance) of Developing Cardiovascular Disease Within 10 Years Based on Risk Factors
• Interventions: Other: Study physician visits; Other: Interactive Cholesterol Advisory Tool

• Registration Number: NCT01890031
• Lead Sponsor: University of Rochester

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).

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.

Basic Information
|
Recruitment & Eligibility
|
Study & Design
|
Trial Locations

Study Timeline

• Study Start: 2012-01
• Study First Submitted: 2012-06-18
• Primary Completion: 2013-06
• Study Completion: 2013-06
• Study First Submitted QC: 2013-06-26
• Study First Posted: 2013-07-01
• Results First Submitted: 2015-07-01
• Status Verified: 2015-08
• Results First Submitted QC: 2015-08-05
• Last Update Submitted: 2015-08-05
• Results First Posted: 2015-09-04
• Last Update Posted: 2015-09-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 131

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

Read More

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

Read More

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Moderate risk, no ICAT	Study physician visits	Moderate risk, study physician visits, and not randomized to use the Interactive Cholesterol Advisory Tool
Moderate risk, ICAT	Interactive Cholesterol Advisory Tool	Moderate risk, study physician visits, and randomized to use the Interactive Cholesterol Advisory Tool
Low risk, ICAT, and study physician	Interactive Cholesterol Advisory Tool	Low risk, assigned to use the Interactive Cholesterol Advisory Tool, and study physician visits.
Low risk, ICAT	Interactive Cholesterol Advisory Tool	Low risk, randomized to use the Interactive Cholesterol Advisory Tool, no study physician visits
Low risk, ICAT, and study physician	Study physician visits	Low risk, assigned to use the Interactive Cholesterol Advisory Tool, and study physician visits.
Moderate risk, ICAT	Study physician visits	Moderate risk, study physician visits, and randomized to use the Interactive Cholesterol Advisory Tool

Primary Outcome Measures

Name	Time	Method
LDL-C in All ICAT Group Participants Versus Non-ICAT Group Participants	9 months

Secondary Outcome Measures

Name	Time	Method
Number of Participants Who Adhered to Medication Prescribed as Self Reported at 9 Months	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.

Trial Locations

Locations (1)

University of Rochester; 🇺🇸 Rochester, New York, United States