Telephone Based Management of Hyperlipidemia

Study Overview
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Brief Summary
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The purpose of the study is to demonstrate that systematic self measurement of blood lipids reduces LDL cholesterol more effectively than standard care. The hypothesis is that cholesterol lowering medication adherence will be improved with self monitoring and reporting of frequent blood lipids and the percentage of patients achieving LDL goal will be greater than without home monitoring.

Detailed Description
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The study utilizes a telephone reporting system to self report lipid values and provide educational counseling regarding lifestyle modification methods to reduce cardiovascular risk. Study patients will be randomized to receive a home monitoring device and will be instructed on its use. Generic simvastatin will be given to reduce LDL levels in all groups. It is the hypothesis that those study patients receiving a home device will reach target LDL (goal LDL) more frequently than those randomized to usual care( no device).

Official Title
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Telephone Based Management of Hyperlipidemia Utilizing a Self Monitoring Testing Device

Conditions
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Hyperlipidemia

Intervention / Treatment
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* Device: Self Monitoring Lipid Analyzer


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: LDL > 130mg/dl Exclusion Criteria: Pregnant patients liver disease allergic reaction to statins

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: No self monitoring device<br>Standard or usual care of high LDL including lab lipid profiles after treatment with statin therapy. No device or telemedicine education will be provided | |
| Experimental: Self Monitoring Lipid Analyzer<br>Self measured blood lipids using a home lipidometer, and telephone reporting of data to the clinical center. | Device: Self Monitoring Lipid Analyzer<br>* The device is similar to a glucometer- Utilizing a lancet a small amount of blood is collected in a capillary tube and placed on a hand held monitor that records lipid values.<br>* Other names: Cardiochek;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| LDL Level Change From Baseline | Comparison of serum LDL level between control and intervention subjects | baseline to 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Medication Compliance | Self reported comparison of lipid medication compliance between control and intervention subjects, scale 0-4. Highest compliance value indicated by a score of 4. | 6 months | 
| LDL Values at Two Week Interval | Participant in the self monitored arm reported LDL every two weeks. LDL goal for treatment was 100 mg/dl and subjects were followed every two weeks to observe mean LDL values. | 6 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Internet based monitoring system