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| Name | Class |
|---|---|
| Merck Sharp & Dohme LLC | INDUSTRY |
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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.
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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| No self monitoring device | No Intervention | 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 Monitoring Lipid Analyzer | Experimental | Self measured blood lipids using a home lipidometer, and telephone reporting of data to the clinical center. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Self Monitoring Lipid Analyzer | Device | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| LDL Level Change From Baseline | Comparison of serum LDL level between control and intervention subjects | baseline to 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| LDL Values at Two Week Interval |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Temple University Hospital | Philadelphia | Pennsylvania | 19140 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | 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 |
| FG001 | Self Monitoring Lipid Analyzer | Self measured blood lipids using a home lipidometer, and telephone reporting of data to the clinical center. 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | 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 |
| BG001 | Self Monitoring Lipid Analyzer |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | LDL Level Change From Baseline | Comparison of serum LDL level between control and intervention subjects | Posted | Mean | Standard Deviation | mg/dl | baseline to 6 months |
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Motor vehicle accident, minor musculoskeletal injury | Musculoskeletal and connective tissue disorders | MVA | Non-systematic Assessment | Subject seen in emergency department after MVA, analgesic therapy prescribed for 4 days. |
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Recruiting did not reach goal due to change in FDA approval for simvastatin use requiring protocol modification.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Alfred A. Bove | Temple University School of Medicine | 215-707-9259 | alfred.bove@tuhs.temple.edu |
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| ID | Term |
|---|---|
| D006949 | Hyperlipidemias |
| ID | Term |
|---|---|
| D050171 | Dyslipidemias |
| D052439 | Lipid Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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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 |
Self measured blood lipids using a home lipidometer, and telephone reporting of data to the clinical center.
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.
| BG002 | Total | Total of all reporting groups |
| years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| 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. | Posted | Mean | Standard Deviation | units on a scale | 6 months |
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| 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. | No self monitoring group had LDL levels only at baseline and 6 months. | Posted | Mean | Standard Deviation | mg/dl | 6 weeks |
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| 1 |
| 26 |
| 0 |
| 26 |
| EG001 | Self Monitoring Lipid Analyzer | Self measured blood lipids using a home lipidometer, and telephone reporting of data to the clinical center. 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. | 1 | 44 | 0 | 44 |
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| Hodgkins lymphoma | Blood and lymphatic system disorders | lymphoma | Systematic Assessment | Subject noted to have lymphadenopathy during study period. Evaluation by hematology diagnosed Hodgkin's lymphoma and instituted therapy. Subject withdrew from study before completion. |
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| Title | Measurements |
|---|---|
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