Telephone Based Management of Hyperlipidemia
1 other identifier
interventional
70
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_4
Started Nov 2010
Longer than P75 for phase_4
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
September 28, 2010
CompletedFirst Posted
Study publicly available on registry
September 30, 2010
CompletedStudy Start
First participant enrolled
November 1, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
August 1, 2015
CompletedResults Posted
Study results publicly available
September 25, 2015
CompletedSeptember 25, 2015
September 1, 2015
4.7 years
September 28, 2010
August 11, 2015
September 24, 2015
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
LDL Level Change From Baseline
Comparison of serum LDL level between control and intervention subjects
baseline to 6 months
Secondary Outcomes (2)
Medication Compliance
6 months
LDL Values at Two Week Interval
6 weeks
Study Arms (2)
No self monitoring device
NO INTERVENTIONStandard or usual care of high LDL including lab lipid profiles after treatment with statin therapy. No device or telemedicine education will be provided
Self Monitoring Lipid Analyzer
EXPERIMENTALSelf measured blood lipids using a home lipidometer, and telephone reporting of data to the clinical center.
Interventions
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.
Eligibility Criteria
You may qualify if:
- LDL \> 130mg/dl
You may not qualify if:
- Pregnant patients
- liver disease
- allergic reaction to statins
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Temple Universitylead
- Merck Sharp & Dohme LLCcollaborator
Study Sites (1)
Temple University Hospital
Philadelphia, Pennsylvania, 19140, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Limitations and Caveats
Recruiting did not reach goal due to change in FDA approval for simvastatin use requiring protocol modification.
Results Point of Contact
- Title
- Alfred A. Bove
- Organization
- Temple University School of Medicine
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Emeritus Professor of Medicine
Study Record Dates
First Submitted
September 28, 2010
First Posted
September 30, 2010
Study Start
November 1, 2010
Primary Completion
July 1, 2015
Study Completion
August 1, 2015
Last Updated
September 25, 2015
Results First Posted
September 25, 2015
Record last verified: 2015-09