Trial Outcomes & Findings for Interactive Cholesterol Advisory Tool (NCT NCT01890031)

Results Overview

Recruitment status

COMPLETED

Study phase

PHASE1

Target enrollment

131 participants

Primary outcome timeframe

9 months

Results posted on

2015-09-04

Participant Flow

Participant milestones

Participant milestones
Measure	Low Risk, No ICAT Low risk, not randomized to use the Interactive Cholesterol Advisory Tool, no study physician visits	Low Risk, ICAT Low risk, randomized to use the Interactive Cholesterol Advisory Tool, no study physician visits Interactive Cholesterol Advisory Tool: using the virtual clinician computer program for cholesterol information and education.	Moderate Risk, no ICAT Moderate risk, study physician visits, and not randomized to use the Interactive Cholesterol Advisory Tool Study physician visits: In-person individual visits with a study physician to give information on cholesterol	Moderate Risk, ICAT Moderate risk, study physician visits, and randomized to use the Interactive Cholesterol Advisory Tool Interactive Cholesterol Advisory Tool: using the virtual clinician computer program for cholesterol information and education. Study physician visits: In-person individual visits with a study physician to give information on cholesterol	Low Risk, ICAT, and Study Physician Low risk, assigned to use the Interactive Cholesterol Advisory Tool, and study physician visits
Overall Study STARTED	50	50	12	11	8
Overall Study COMPLETED	50	50	12	11	8
Overall Study NOT COMPLETED	0	0	0	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Interactive Cholesterol Advisory Tool

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Low Risk, No ICAT n=50 Participants Low risk, not randomized to use the Interactive Cholesterol Advisory Tool, no study physician visits	Low Risk, ICAT n=50 Participants Low risk, randomized to use the Interactive Cholesterol Advisory Tool, no study physician visits Interactive Cholesterol Advisory Tool: using the virtual clinician computer program for cholesterol information and education.	Moderate Risk, no ICAT n=12 Participants Moderate risk, study physician visits, and not randomized to use the Interactive Cholesterol Advisory Tool Study physician visits: In-person individual visits with a study physician to give information on cholesterol	Moderate Risk, ICAT n=11 Participants Moderate risk, study physician visits, and randomized to use the Interactive Cholesterol Advisory Tool Interactive Cholesterol Advisory Tool: using the virtual clinician computer program for cholesterol information and education. Study physician visits: In-person individual visits with a study physician to give information on cholesterol	Low Risk, ICAT, and Study Physician n=8 Participants Low risk, assigned to use the Interactive Cholesterol Advisory Tool, and study physician visits	Total n=131 Participants Total of all reporting groups
Age, Continuous	48.5 years STANDARD_DEVIATION 11.9 • n=99 Participants	46.6 years STANDARD_DEVIATION 13.5 • n=107 Participants	53.3 years STANDARD_DEVIATION 9.7 • n=206 Participants	57.7 years STANDARD_DEVIATION 8.8 • n=7 Participants	51.4 years STANDARD_DEVIATION 13.0 • n=31 Participants	49.0 years STANDARD_DEVIATION 12.1 • n=30 Participants
Sex: Female, Male Female	38 Participants n=99 Participants	33 Participants n=107 Participants	5 Participants n=206 Participants	3 Participants n=7 Participants	7 Participants n=31 Participants	86 Participants n=30 Participants
Sex: Female, Male Male	12 Participants n=99 Participants	17 Participants n=107 Participants	7 Participants n=206 Participants	8 Participants n=7 Participants	1 Participants n=31 Participants	45 Participants n=30 Participants
Region of Enrollment United States	50 participants n=99 Participants	50 participants n=107 Participants	12 participants n=206 Participants	11 participants n=7 Participants	8 participants n=31 Participants	131 participants n=30 Participants
LDL Cholesterol	125.5 mg/dL STANDARD_DEVIATION 31.4 • n=99 Participants	123.3 mg/dL STANDARD_DEVIATION 32.5 • n=107 Participants	130.4 mg/dL STANDARD_DEVIATION 37.8 • n=206 Participants	121.2 mg/dL STANDARD_DEVIATION 41.7 • n=7 Participants	129.9 mg/dL STANDARD_DEVIATION 38.2 • n=31 Participants	125.7 mg/dL STANDARD_DEVIATION 33.4 • n=30 Participants

PRIMARY outcome

Timeframe: 9 months

Outcome measures

Outcome measures
Measure	Low Risk, No ICAT n=50 Participants Low risk, not randomized to use the Interactive Cholesterol Advisory Tool, no study physician visits	Low Risk, ICAT n=50 Participants Low risk, randomized to use the Interactive Cholesterol Advisory Tool, no study physician visits Interactive Cholesterol Advisory Tool: using the virtual clinician computer program for cholesterol information and education.	Moderate Risk, no ICAT n=12 Participants Moderate risk, study physician visits, and not randomized to use the Interactive Cholesterol Advisory Tool Study physician visits: In-person individual visits with a study physician to give information on cholesterol	Moderate Risk, ICAT n=11 Participants Moderate risk, study physician visits, and randomized to use the Interactive Cholesterol Advisory Tool Interactive Cholesterol Advisory Tool: using the virtual clinician computer program for cholesterol information and education. Study physician visits: In-person individual visits with a study physician to give information on cholesterol	Low Risk, ICAT, and Study Physician n=8 Participants Low risk, assigned to use the Interactive Cholesterol Advisory Tool, and study physician visits
LDL-C in All ICAT Group Participants Versus Non-ICAT Group Participants	126.2 mg/dL Standard Deviation 32.3	126.0 mg/dL Standard Deviation 28.8	103.2 mg/dL Standard Deviation 35.1	107.7 mg/dL Standard Deviation 32.3	107.0 mg/dL Standard Deviation 45.7

SECONDARY outcome

Timeframe: 9 months

We will assess adherence (for those who are prescribed a statin in the moderate CVD risk group) by both indirect objective measures and subjective reports. The study design did not include prescription of a cholesterol-lowering medication as per randomization. Participants were prescribed a statin as standard of care based on the participants and physicians agreement. Low risk individuals have less need for medication compared to moderate risk based on the current science.