Trial Outcomes & Findings for Telephone Based Management of Hyperlipidemia (NCT NCT01212159)
NCT ID: NCT01212159
Last Updated: 2026-04-07
Results Overview
Comparison of serum LDL level between control and intervention subjects
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
70 participants
Primary outcome timeframe
baseline to 6 months
Results posted on
2026-04-07
Participant Flow
Participant milestones
| Measure |
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
|
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.
|
|---|---|---|
|
Overall Study
STARTED
|
26
|
44
|
|
Overall Study
COMPLETED
|
14
|
32
|
|
Overall Study
NOT COMPLETED
|
12
|
12
|
Reasons for withdrawal
| Measure |
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
|
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.
|
|---|---|---|
|
Overall Study
Withdrawal by Subject
|
12
|
12
|
Baseline Characteristics
Telephone Based Management of Hyperlipidemia
Baseline characteristics by cohort
| Measure |
No Self Monitoring Device
n=14 Participants
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
n=32 Participants
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.
|
Total
n=46 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
56.8 years
STANDARD_DEVIATION 10.6 • n=527 Participants
|
52.5 years
STANDARD_DEVIATION 9.3 • n=527 Participants
|
54.6 years
STANDARD_DEVIATION 9.9 • n=1054 Participants
|
|
Sex: Female, Male
Female
|
6 Participants
n=527 Participants
|
27 Participants
n=527 Participants
|
33 Participants
n=1054 Participants
|
|
Sex: Female, Male
Male
|
8 Participants
n=527 Participants
|
5 Participants
n=527 Participants
|
13 Participants
n=1054 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
1 Participants
n=527 Participants
|
28 Participants
n=527 Participants
|
29 Participants
n=1054 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
12 Participants
n=527 Participants
|
3 Participants
n=527 Participants
|
15 Participants
n=1054 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=527 Participants
|
1 Participants
n=527 Participants
|
2 Participants
n=1054 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=527 Participants
|
0 Participants
n=527 Participants
|
0 Participants
n=1054 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=527 Participants
|
1 Participants
n=527 Participants
|
2 Participants
n=1054 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=527 Participants
|
0 Participants
n=527 Participants
|
0 Participants
n=1054 Participants
|
|
Race (NIH/OMB)
Black or African American
|
7 Participants
n=527 Participants
|
19 Participants
n=527 Participants
|
26 Participants
n=1054 Participants
|
|
Race (NIH/OMB)
White
|
5 Participants
n=527 Participants
|
9 Participants
n=527 Participants
|
14 Participants
n=1054 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=527 Participants
|
2 Participants
n=527 Participants
|
2 Participants
n=1054 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=527 Participants
|
1 Participants
n=527 Participants
|
2 Participants
n=1054 Participants
|
|
Region of Enrollment
United States
|
14 participants
n=527 Participants
|
32 participants
n=527 Participants
|
46 participants
n=1054 Participants
|
PRIMARY outcome
Timeframe: baseline to 6 monthsComparison of serum LDL level between control and intervention subjects
Outcome measures
| Measure |
No Self Monitoring Device
n=14 Participants
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
n=32 Participants
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.
|
|---|---|---|
|
LDL Level Change From Baseline
|
-63.4 mg/dl
Standard Deviation 35.5
|
-54.6 mg/dl
Standard Deviation 43.2
|
SECONDARY outcome
Timeframe: 6 monthsSelf reported comparison of lipid medication compliance between control and intervention subjects, scale 0-4. Highest compliance value indicated by a score of 4.
Outcome measures
| Measure |
No Self Monitoring Device
n=14 Participants
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
n=32 Participants
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.
|
|---|---|---|
|
Medication Compliance
|
2.4 units on a scale
Standard Deviation 1.1
|
2.4 units on a scale
Standard Deviation 1.2
|
SECONDARY outcome
Timeframe: 6 weeksPopulation: No self monitoring group had LDL levels only at baseline and 6 months.
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.
Outcome measures
| Measure |
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
|
Self Monitoring Lipid Analyzer
n=32 Participants
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.
|
|---|---|---|
|
LDL Values at Two Week Interval
two week
|
—
|
96.3 mg/dl
Standard Deviation 47.3
|
|
LDL Values at Two Week Interval
four week
|
—
|
92.4 mg/dl
Standard Deviation 37.0
|
|
LDL Values at Two Week Interval
six week
|
—
|
118.6 mg/dl
Standard Deviation 37.8
|
Adverse Events
No Self Monitoring Device
Serious events: 1 serious events
Other events: 0 other events
Deaths: 0 deaths
Self Monitoring Lipid Analyzer
Serious events: 1 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
No Self Monitoring Device
n=26 participants at risk
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
n=44 participants at risk
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.
|
|---|---|---|
|
Musculoskeletal and connective tissue disorders
Motor vehicle accident, minor musculoskeletal injury
|
3.8%
1/26 • Number of events 1
|
0.00%
0/44
|
|
Blood and lymphatic system disorders
Hodgkins lymphoma
|
0.00%
0/26
|
2.3%
1/44 • Number of events 1
|
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place