Trial Outcomes & Findings for Telephone Based Management of Hyperlipidemia (NCT NCT01212159)

NCT ID: NCT01212159

Last Updated: 2015-09-25

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: 2015-09-25

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=5 Participants	52.5 years STANDARD_DEVIATION 9.3 • n=7 Participants	54.6 years STANDARD_DEVIATION 9.9 • n=5 Participants
Sex: Female, Male Female	6 Participants n=5 Participants	27 Participants n=7 Participants	33 Participants n=5 Participants
Sex: Female, Male Male	8 Participants n=5 Participants	5 Participants n=7 Participants	13 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	1 Participants n=5 Participants	28 Participants n=7 Participants	29 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	12 Participants n=5 Participants	3 Participants n=7 Participants	15 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	1 Participants n=5 Participants	1 Participants n=7 Participants	2 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Asian	1 Participants n=5 Participants	1 Participants n=7 Participants	2 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	7 Participants n=5 Participants	19 Participants n=7 Participants	26 Participants n=5 Participants
Race (NIH/OMB) White	5 Participants n=5 Participants	9 Participants n=7 Participants	14 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	2 Participants n=7 Participants	2 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	1 Participants n=5 Participants	1 Participants n=7 Participants	2 Participants n=5 Participants
Region of Enrollment United States	14 participants n=5 Participants	32 participants n=7 Participants	46 participants n=5 Participants

PRIMARY outcome

Timeframe: baseline to 6 months

Comparison 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 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.

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 weeks

Population: 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

Alfred A. Bove

Temple University School of Medicine

Phone: 215-707-9259

Email: alfred.bove@tuhs.temple.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place