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OpenTrials
Completed

NCT Number: NCT01212159

Telephone Based Management of Hyperlipidemia

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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Key information

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Temple University Hospital

Philadelphia, Pennsylvania, 19140, United States

About this study

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).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • LDL > 130mg/dl

Exclusion criteria

  • Pregnant patients
  • liver disease
  • allergic reaction to statins

Treatment and study plan

Self Monitoring Lipid Analyzer

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.

Other names: Cardiochek

Primary outcomes

  1. LDL Level Change From Baseline

    Time frame: baseline to 6 months

    Comparison of serum LDL level between control and intervention subjects

Secondary outcomes

  1. Medication Compliance

    Time frame: 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.

  2. LDL Values at Two Week Interval

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Temple University

Other

Collaborators

  • Merck Sharp & Dohme LLC

Registry information

Official study title

Telephone Based Management of Hyperlipidemia Utilizing a Self Monitoring Testing Device

Important dates

Study start
2010
Primary completion
2015
Study completion
2015
First posted
Sep 30, 2010
Registry last updated
Apr 7, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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