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Telephone Based Management of Hyperlipidemia

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01212159
First Posted: September 30, 2010
Last Update Posted: September 25, 2015
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Merck Sharp & Dohme Corp.
Information provided by (Responsible Party):
Alfred A Bove, MD, PhD, Temple University
  Purpose
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.

Condition Intervention Phase
Hyperlipidemia Device: Self Monitoring Lipid Analyzer Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Telephone Based Management of Hyperlipidemia Utilizing a Self Monitoring Testing Device

Further study details as provided by Alfred A Bove, MD, PhD, Temple University:

Primary Outcome Measures:
  • LDL Level Change From Baseline [ Time Frame: baseline to 6 months ]
    Comparison of serum LDL level between control and intervention subjects


Secondary Outcome Measures:
  • 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.

  • 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.


Enrollment: 70
Study Start Date: November 2010
Study Completion Date: August 2015
Primary Completion Date: July 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
No Intervention: 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
Experimental: Self Monitoring Lipid Analyzer
Self measured blood lipids using a home lipidometer, and telephone reporting of data to the clinical center.
Device: 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.
Other Name: Cardiochek

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).
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • LDL > 130mg/dl

Exclusion Criteria:

  • Pregnant patients
  • liver disease
  • allergic reaction to statins
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01212159


Locations
United States, Pennsylvania
Temple University Hospital
Philadelphia, Pennsylvania, United States, 19140
Sponsors and Collaborators
Temple University
Merck Sharp & Dohme Corp.
  More Information

Responsible Party: Alfred A Bove, MD, PhD, Emeritus Professor of Medicine, Temple University
ClinicalTrials.gov Identifier: NCT01212159     History of Changes
Other Study ID Numbers: 12832
First Submitted: September 28, 2010
First Posted: September 30, 2010
Results First Submitted: August 11, 2015
Results First Posted: September 25, 2015
Last Update Posted: September 25, 2015
Last Verified: September 2015

Keywords provided by Alfred A Bove, MD, PhD, Temple University:
Internet based monitoring system

Additional relevant MeSH terms:
Hyperlipidemias
Hyperlipoproteinemias
Dyslipidemias
Lipid Metabolism Disorders
Metabolic Diseases