Text Size

Telemedicine Based Management of Hyperlipidemia

The recruitment status of this study is unknown because the information has not been verified recently.
Verified September 2010 by Temple University.
Recruitment status was  Not yet recruiting
Sponsor:
Information provided by:
Temple University
ClinicalTrials.gov Identifier:
NCT01212159
First received: September 28, 2010
Last updated: September 29, 2010
Last verified: September 2010
History of Changes
  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

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: June 2012
Estimated Primary Completion Date: January 2012 (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
No Contacts or Locations Provided
  More Information

No publications provided

Responsible Party: Sara J Sirna, Temple University
ClinicalTrials.gov Identifier: NCT01212159     History of Changes
Other Study ID Numbers: 12832
Study First Received: September 28, 2010
Last Updated: September 29, 2010
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 May 23, 2013