Hyperlipidemia
Conditions
Keywords
Internet based monitoring system
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).
Interventions
DEVICESelf 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.
Sponsors
Temple University
Merck Sharp & Dohme LLC
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
* LDL \> 130mg/dl
Exclusion criteria
* Pregnant patients * liver disease * allergic reaction to statins
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| LDL Level Change From Baseline | baseline to 6 months | Comparison of serum LDL level between control and intervention subjects |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Medication Compliance | 6 months | 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 | 6 weeks | 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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 | 14 |
| 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. | 32 |
| Total | 46 |
Baseline characteristics
| Characteristic | No Self Monitoring Device | Total | Self Monitoring Lipid Analyzer |
|---|---|---|---|
| Age, Continuous | 56.8 years STANDARD_DEVIATION 10.6 | 54.6 years STANDARD_DEVIATION 9.9 | 52.5 years STANDARD_DEVIATION 9.3 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 1 Participants | 29 Participants | 28 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 12 Participants | 15 Participants | 3 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 1 Participants | 2 Participants | 1 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 1 Participants | 2 Participants | 1 Participants |
| Race (NIH/OMB) Black or African American | 7 Participants | 26 Participants | 19 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 2 Participants | 2 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 1 Participants | 2 Participants | 1 Participants |
| Race (NIH/OMB) White | 5 Participants | 14 Participants | 9 Participants |
| Region of Enrollment United States | 14 participants | 46 participants | 32 participants |
| Sex: Female, Male Female | 6 Participants | 33 Participants | 27 Participants |
| Sex: Female, Male Male | 8 Participants | 13 Participants | 5 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| other Total, other adverse events | 0 / 26 | 0 / 44 |
| serious Total, serious adverse events | 1 / 26 | 1 / 44 |
Outcome results
Primary
LDL Level Change From Baseline
Comparison of serum LDL level between control and intervention subjects
Time frame: baseline to 6 months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| No Self Monitoring Device | LDL Level Change From Baseline | -63.4 mg/dl | Standard Deviation 35.5 |
| Self Monitoring Lipid Analyzer | LDL Level Change From Baseline | -54.6 mg/dl | Standard Deviation 43.2 |
Comparison: Paired t-test analysis of 6 month change in LDL cholesterol for no monitor and self monitor groups Independent sample t-test to compare ldl change between groupsp-value: 0.391t-test, 2 sided
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.
Time frame: 6 weeks
Population: No self monitoring group had LDL levels only at baseline and 6 months.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Self Monitoring Lipid Analyzer | LDL Values at Two Week Interval | two week | 96.3 mg/dl | Standard Deviation 47.3 |
| Self Monitoring Lipid Analyzer | LDL Values at Two Week Interval | four week | 92.4 mg/dl | Standard Deviation 37 |
| Self Monitoring Lipid Analyzer | LDL Values at Two Week Interval | six week | 118.6 mg/dl | Standard Deviation 37.8 |
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.
Time frame: 6 months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| No Self Monitoring Device | Medication Compliance | 2.4 units on a scale | Standard Deviation 1.1 |
| Self Monitoring Lipid Analyzer | Medication Compliance | 2.4 units on a scale | Standard Deviation 1.2 |