Telephone Based Management of Hyperlipidemia

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

70 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-11-30

Study Completion Date

2015-08-31

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.

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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).

Conditions

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Hyperlipidemia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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No self monitoring device

Standard or usual care of high LDL including lab lipid profiles after treatment with statin therapy. No device or telemedicine education will be provided

Group Type NO_INTERVENTION

No interventions assigned to this group

Self Monitoring Lipid Analyzer

Self measured blood lipids using a home lipidometer, and telephone reporting of data to the clinical center.

Group Type EXPERIMENTAL

Self Monitoring Lipid Analyzer

Intervention Type DEVICE

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.

Interventions

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Self Monitoring Lipid Analyzer

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.

Intervention Type DEVICE