Telephone Based Management of Hyperlipidemia

Temple University

Status and phase: Completed; Phase 4

Conditions: Hyperlipidemia

Treatments: Device: Self Monitoring Lipid Analyzer

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT01212159

12832

Details and patient eligibility

About

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.

Full description

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).

Enrollment: 70 patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• LDL > 130mg/dl

Exclusion criteria

• Pregnant patients
• liver disease
• allergic reaction to statins

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

70 participants in 2 patient groups

No self monitoring device

No Intervention group

Description:

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

Self Monitoring Lipid Analyzer

Experimental group

Description:

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

Treatment:

Device: Self Monitoring Lipid Analyzer