Telephone Based Management of Hyperlipidemia

Hyperlipidemia Clinical Trial

Official title:

Telephone Based Management of Hyperlipidemia Utilizing a Self Monitoring Testing Device

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01212159
• Other study ID #: 12832
• Status: Completed
• Phase: Phase 4
• First received: September 28, 2010
• Last updated: September 24, 2015
• Start date: November 2010
• Est. completion date: August 2015

Study information

• Verified date: September 2015
• Source: Temple University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 70
• Est. completion date: August 2015
• Est. primary completion date: July 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 80 Years

Eligibility

Inclusion Criteria:

• LDL > 130mg/dl

Exclusion Criteria:

• Pregnant patients

• liver disease

• allergic reaction to statins

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Hyperlipidemia
• Hyperlipidemias

Intervention

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.

Locations

Country	Name	City	State
United States	Temple University Hospital	Philadelphia	Pennsylvania

Sponsors (2)

Lead Sponsor	Collaborator
Temple University	Merck Sharp & Dohme Corp.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	LDL Level Change From Baseline	Comparison of serum LDL level between control and intervention subjects	baseline to 6 months	No
Secondary	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.	6 months	No
Secondary	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.	6 weeks	No