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.
|Study Design:||Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Telephone Based Management of Hyperlipidemia Utilizing a Self Monitoring Testing Device|
- LDL Level Change From Baseline [ Time Frame: baseline to 6 months ] [ Designated as safety issue: No ]Comparison of serum LDL level between control and intervention subjects
- Medication Compliance [ Time Frame: 6 months ] [ Designated as safety issue: No ]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 ] [ Designated as safety issue: No ]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.
|Study Start Date:||November 2010|
|Study Completion Date:||August 2015|
|Primary Completion Date:||July 2015 (Final data collection date for primary outcome measure)|
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
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).
Please refer to this study by its ClinicalTrials.gov identifier: NCT01212159
|United States, Pennsylvania|
|Temple University Hospital|
|Philadelphia, Pennsylvania, United States, 19140|