Clinical trial NCT01890031: Interactive Cholesterol Advisory Tool
Official title: The Interactive Cholesterol Advisory Tool
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: 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
Keywords: cardiovascular disease
cholesterol
Lead sponsor: University of Rochester
Sponsor class: OTHER
First posted: 2013-07-01
Enrollment: 131
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL

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.

Eligibility 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

Primary outcomes:
measure: LDL-C in All ICAT Group Participants Versus Non-ICAT Group Participants
timeFrame: 9 months
Secondary outcomes:
measure: Number of Participants Who Adhered to Medication Prescribed as Self Reported at 9 Months
timeFrame: 9 months
Other outcomes:
Locations:
city: Rochester
country: United States
facility: University of Rochester
state: New York
Study officials:
affiliation: University of Rochester
name: Robert Block, MD, MPH
role: PRINCIPAL_INVESTIGATOR
References:
citation: Block RC, Abdolahi A, Niemiec CP, Rigby CS, Williams GC. Effects of an evidence-based computerized virtual clinician on low-density lipoprotein and non-high-density lipoprotein cholesterol in adults without cardiovascular disease: The Interactive Cholesterol Advisory Tool. Health Informatics J. 2016 Dec;22(4):897-910. doi: 10.1177/1460458215600040. Epub 2015 Aug 21.