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Telephone Based Management of Hyperlipidemia

Primary Purpose

Hyperlipidemia

Status
Completed
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Self Monitoring Lipid Analyzer
Sponsored by
Temple University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hyperlipidemia focused on measuring Internet based monitoring system

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • LDL > 130mg/dl

Exclusion Criteria:

  • Pregnant patients
  • liver disease
  • allergic reaction to statins

Sites / Locations

  • Temple University Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

No Intervention

Experimental

Arm Label

No self monitoring device

Self Monitoring Lipid Analyzer

Arm Description

Standard or usual care of high LDL including lab lipid profiles after treatment with statin therapy. No device or telemedicine education will be provided

Self measured blood lipids using a home lipidometer, and telephone reporting of data to the clinical center.

Outcomes

Primary Outcome Measures

LDL Level Change From Baseline
Comparison of serum LDL level between control and intervention subjects

Secondary Outcome Measures

Medication Compliance
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
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.

Full Information

First Posted
September 28, 2010
Last Updated
September 24, 2015
Sponsor
Temple University
Collaborators
Merck Sharp & Dohme LLC
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1. Study Identification

Unique Protocol Identification Number
NCT01212159
Brief Title
Telephone Based Management of Hyperlipidemia
Official Title
Telephone Based Management of Hyperlipidemia Utilizing a Self Monitoring Testing Device
Study Type
Interventional

2. Study Status

Record Verification Date
September 2015
Overall Recruitment Status
Completed
Study Start Date
November 2010 (undefined)
Primary Completion Date
July 2015 (Actual)
Study Completion Date
August 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Temple University
Collaborators
Merck Sharp & Dohme LLC

4. Oversight

Data Monitoring Committee
No

5. Study Description

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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hyperlipidemia
Keywords
Internet based monitoring system

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
70 (Actual)

8. Arms, Groups, and Interventions

Arm Title
No self monitoring device
Arm Type
No Intervention
Arm Description
Standard or usual care of high LDL including lab lipid profiles after treatment with statin therapy. No device or telemedicine education will be provided
Arm Title
Self Monitoring Lipid Analyzer
Arm Type
Experimental
Arm Description
Self measured blood lipids using a home lipidometer, and telephone reporting of data to the clinical center.
Intervention Type
Device
Intervention Name(s)
Self Monitoring Lipid Analyzer
Other Intervention Name(s)
Cardiochek
Intervention Description
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.
Primary Outcome Measure Information:
Title
LDL Level Change From Baseline
Description
Comparison of serum LDL level between control and intervention subjects
Time Frame
baseline to 6 months
Secondary Outcome Measure Information:
Title
Medication Compliance
Description
Self reported comparison of lipid medication compliance between control and intervention subjects, scale 0-4. Highest compliance value indicated by a score of 4.
Time Frame
6 months
Title
LDL Values at Two Week Interval
Description
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.
Time Frame
6 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: LDL > 130mg/dl Exclusion Criteria: Pregnant patients liver disease allergic reaction to statins
Facility Information:
Facility Name
Temple University Hospital
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19140
Country
United States

12. IPD Sharing Statement

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Telephone Based Management of Hyperlipidemia

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