Telephone Based Management of Hyperlipidemia

Phase 4

Completed

• Conditions: Hyperlipidemia
• Interventions: Device: Self Monitoring Lipid Analyzer

• Registration Number: NCT01212159
• Lead Sponsor: Temple University

Brief Summary

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

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).

Study Timeline

• Study First Submitted: 2010-09-28
• Study First Submitted QC: 2010-09-29
• Study First Posted: 2010-09-30
• Study Start: 2010-11
• Primary Completion: 2015-07
• Study Completion: 2015-08
• Results First Submitted: 2015-08-11
• Status Verified: 2015-09
• Results First Submitted QC: 2015-09-24
• Last Update Submitted: 2015-09-24
• Results First Posted: 2015-09-25
• Last Update Posted: 2015-09-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 70

Inclusion Criteria

• LDL > 130mg/dl

Exclusion Criteria

• Pregnant patients
• liver disease
• allergic reaction to statins

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Self Monitoring Lipid Analyzer	Self Monitoring Lipid Analyzer	Self measured blood lipids using a home lipidometer, and telephone reporting of data to the clinical center.

Primary Outcome Measures

Name	Time	Method
LDL Level Change From Baseline	baseline to 6 months	Comparison of serum LDL level between control and intervention subjects

Secondary Outcome Measures

Name	Time	Method
Medication Compliance	6 months	Self reported comparison of lipid medication compliance between control and intervention subjects, scale 0-4. Highest compliance value indicated by a score of 4.
LDL Values at Two Week Interval	6 weeks	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.

Trial Locations

Locations (1)

Temple University Hospital; 🇺🇸 Philadelphia, Pennsylvania, United States