Telemedicine Based Management of Hyperlipidemia

This study is currently recruiting participants. (see Contacts and Locations)
Verified May 2014 by Temple University
Sponsor:
Collaborator:
Merck Sharp & Dohme Corp.
Information provided by (Responsible Party):
Alfred Bove, Temple University
ClinicalTrials.gov Identifier:
NCT01212159
First received: September 28, 2010
Last updated: May 11, 2014
Last verified: May 2014
  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
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Telemedicine Based Management of Hyperlipidemia Utilizing a Self Monitoring Testing Device

Resource links provided by NLM:


Further study details as provided by Temple University:

Primary Outcome Measures:
  • Time to LDL goal [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]
    Frequent self monitoring will allow rapid titration of medication compared to standard care


Estimated Enrollment: 100
Study Start Date: November 2010
Estimated Study Completion Date: July 2015
Estimated Primary Completion Date: January 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
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 an interned based system to self record lipid values and will in addition 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) quicker than those randomized to usual care( no device).

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • LDL > 130mg/dl

Exclusion Criteria:

  • Pregnant patients
  • liver disease
  • allergic reaction to statins
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01212159

Contacts
Contact: Francine McGonagle, RN 215-707-5839 francine.mcgonagle@tuhs.temple.edu
Contact: Jennie Wong, RN 215-707-5340 jennie.wong@tuhs.temple.edu

Locations
United States, Pennsylvania
Temple University Hospital Recruiting
Philadelphia, Pennsylvania, United States, 19140
Contact: Arleen Wallen, MBA    215-707-9190    arleen@temple.edu   
Principal Investigator: Sara Sirna, MD         
Sponsors and Collaborators
Temple University
Merck Sharp & Dohme Corp.
  More Information

No publications provided

Responsible Party: Alfred Bove, Emeritus Professor of Medicine, Temple University
ClinicalTrials.gov Identifier: NCT01212159     History of Changes
Other Study ID Numbers: 12832
Study First Received: September 28, 2010
Last Updated: May 11, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by Temple University:
Internet based monitoring system

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

ClinicalTrials.gov processed this record on October 23, 2014