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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).
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Low Risk, No ICAT | No Intervention | Low risk, not randomized to use the Interactive Cholesterol Advisory Tool, no study physician visits | |
| Low risk, ICAT | Other | Low risk, randomized to use the Interactive Cholesterol Advisory Tool, no study physician visits |
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| Low risk, ICAT, and study physician | Other | Low risk, assigned to use the Interactive Cholesterol Advisory Tool, and study physician visits. |
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| Moderate risk, no ICAT | Other | Moderate risk, study physician visits, and not randomized to use the Interactive Cholesterol Advisory Tool |
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| Moderate risk, ICAT | Other | Moderate risk, study physician visits, and randomized to use the Interactive Cholesterol Advisory Tool |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Interactive Cholesterol Advisory Tool | Other | using the virtual clinician computer program for cholesterol information and education. |
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| Measure | Description | Time Frame |
|---|---|---|
| LDL-C in All ICAT Group Participants Versus Non-ICAT Group Participants | 9 months |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Robert Block, MD, MPH | University of Rochester | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Rochester | Rochester | New York | 14607 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 26297222 | Derived | 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. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Low Risk, No ICAT | Low risk, not randomized to use the Interactive Cholesterol Advisory Tool, no study physician visits |
| FG001 | 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. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| Study physician visits | Other | In-person individual visits with a study physician to give information on cholesterol |
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| 9 months |
| FG002 | 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 |
| FG003 | 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 |
| FG004 | Low Risk, ICAT, and Study Physician | Low risk, assigned to use the Interactive Cholesterol Advisory Tool, and study physician visits |
| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | Low Risk, No ICAT | Low risk, not randomized to use the Interactive Cholesterol Advisory Tool, no study physician visits |
| BG001 | 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. |
| BG002 | 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 |
| BG003 | 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 |
| BG004 | Low Risk, ICAT, and Study Physician | Low risk, assigned to use the Interactive Cholesterol Advisory Tool, and study physician visits |
| BG005 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| LDL Cholesterol | Mean | Standard Deviation | mg/dL |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | LDL-C in All ICAT Group Participants Versus Non-ICAT Group Participants | Posted | Mean | Standard Deviation | mg/dL | 9 months |
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| 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. | Posted | Number | participants | 9 months |
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Data were collected at over 9 months.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Low Risk, No ICAT | Low risk, not randomized to use the Interactive Cholesterol Advisory Tool, no study physician visits | 0 | 50 | 0 | 50 | ||
| EG001 | 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. | 0 | 50 | 0 | 50 | ||
| EG002 | 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 | 0 | 12 | 0 | 12 | ||
| EG003 | 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 | 0 | 11 | 0 | 11 | ||
| EG004 | Low Risk, ICAT, and Study Physician | Low risk, assigned to use the Interactive Cholesterol Advisory Tool, and study physician visits | 0 | 8 | 0 | 8 |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Robert Block, MD, MPH; Clinical Trial Director | University of Rochester | 585-275-3356 | robert_block@urmc.rochester.edu |
| ID | Term |
|---|---|
| D002318 | Cardiovascular Diseases |
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| Male |
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| OG003 | 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 |
| OG004 | Low Risk, ICAT, and Study Physician | Low risk, assigned to use the Interactive Cholesterol Advisory Tool, and study physician visits |
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