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
Conditions
Keywords
cardiovascular disease, cholesterol
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.
Interventions
OTHERInteractive Cholesterol Advisory Tool
using the virtual clinician computer program for cholesterol information and education.
OTHERStudy physician visits
In-person individual visits with a study physician to give information on cholesterol
Sponsors
University of Rochester
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| LDL-C in All ICAT Group Participants Versus Non-ICAT Group Participants | 9 months |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Low Risk, No ICAT Low risk, not randomized to use the Interactive Cholesterol Advisory Tool, no study physician visits | 50 |
| Low Risk, ICAT Low risk, randomized to use the Interactive Cholesterol Advisory Tool, no study physician visits
Interactive Cholesterol Advisory Tool: using the virtual clinician computer program for cholesterol information and education. | 50 |
| Moderate Risk, no ICAT Moderate risk, study physician visits, and not randomized to use the Interactive Cholesterol Advisory Tool
Study physician visits: In-person individual visits with a study physician to give information on cholesterol | 12 |
| Moderate Risk, ICAT Moderate risk, study physician visits, and randomized to use the Interactive Cholesterol Advisory Tool
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 | 11 |
| Low Risk, ICAT, and Study Physician Low risk, assigned to use the Interactive Cholesterol Advisory Tool, and study physician visits | 8 |
| Total | 131 |
Baseline characteristics
| Characteristic | Low Risk, No ICAT | Low Risk, ICAT | Moderate Risk, no ICAT | Moderate Risk, ICAT | Low Risk, ICAT, and Study Physician | Total |
|---|---|---|---|---|---|---|
| Age, Continuous | 48.5 years STANDARD_DEVIATION 11.9 | 46.6 years STANDARD_DEVIATION 13.5 | 53.3 years STANDARD_DEVIATION 9.7 | 57.7 years STANDARD_DEVIATION 8.8 | 51.4 years STANDARD_DEVIATION 13 | 49.0 years STANDARD_DEVIATION 12.1 |
| LDL Cholesterol | 125.5 mg/dL STANDARD_DEVIATION 31.4 | 123.3 mg/dL STANDARD_DEVIATION 32.5 | 130.4 mg/dL STANDARD_DEVIATION 37.8 | 121.2 mg/dL STANDARD_DEVIATION 41.7 | 129.9 mg/dL STANDARD_DEVIATION 38.2 | 125.7 mg/dL STANDARD_DEVIATION 33.4 |
| Region of Enrollment United States | 50 participants | 50 participants | 12 participants | 11 participants | 8 participants | 131 participants |
| Sex: Female, Male Female | 38 Participants | 33 Participants | 5 Participants | 3 Participants | 7 Participants | 86 Participants |
| Sex: Female, Male Male | 12 Participants | 17 Participants | 7 Participants | 8 Participants | 1 Participants | 45 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk | EG004 affected / at risk |
|---|---|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — | — / — | — / — |
| other Total, other adverse events | 0 / 50 | 0 / 50 | 0 / 12 | 0 / 11 | 0 / 8 |
| serious Total, serious adverse events | 0 / 50 | 0 / 50 | 0 / 12 | 0 / 11 | 0 / 8 |
Outcome results
Primary
LDL-C in All ICAT Group Participants Versus Non-ICAT Group Participants
Time frame: 9 months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Low Risk, No ICAT | LDL-C in All ICAT Group Participants Versus Non-ICAT Group Participants | 126.2 mg/dL | Standard Deviation 32.3 |
| Low Risk, ICAT | LDL-C in All ICAT Group Participants Versus Non-ICAT Group Participants | 126.0 mg/dL | Standard Deviation 28.8 |
| Moderate Risk, no ICAT | LDL-C in All ICAT Group Participants Versus Non-ICAT Group Participants | 103.2 mg/dL | Standard Deviation 35.1 |
| Moderate Risk, ICAT | LDL-C in All ICAT Group Participants Versus Non-ICAT Group Participants | 107.7 mg/dL | Standard Deviation 32.3 |
| Low Risk, ICAT, and Study Physician | LDL-C in All ICAT Group Participants Versus Non-ICAT Group Participants | 107.0 mg/dL | Standard Deviation 45.7 |
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.
Time frame: 9 months
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Low Risk, No ICAT | Number of Participants Who Adhered to Medication Prescribed as Self Reported at 9 Months | 2 participants |
| Low Risk, ICAT | Number of Participants Who Adhered to Medication Prescribed as Self Reported at 9 Months | 1 participants |
| Moderate Risk, no ICAT | Number of Participants Who Adhered to Medication Prescribed as Self Reported at 9 Months | 9 participants |
| Moderate Risk, ICAT | Number of Participants Who Adhered to Medication Prescribed as Self Reported at 9 Months | 7 participants |
| Low Risk, ICAT, and Study Physician | Number of Participants Who Adhered to Medication Prescribed as Self Reported at 9 Months | 0 participants |