Trial Outcomes & Findings for Million Veteran Program Return of Actionable Results (NCT NCT04178122)
NCT ID: NCT04178122
Last Updated: 2025-10-16
Results Overview
Change in LDL-C after 6 months.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
112 participants
Primary outcome timeframe
6 months
Results posted on
2025-10-16
Participant Flow
Recruitment began on February 27, 2020. 459 MVP participants with a suspected FH-associated variant were recruited and assessed for eligibility.
347 participants were excluded from randomization due to: not meeting inclusion criteria, unable to contact, declined to participate, lost to follow up, withdrew, or deceased.
Participant milestones
| Measure |
Immediate Results
Participants in the Immediate Results arm will receive their genetic testing results from a genetic counselor at baseline following randomization.
|
Delayed Results
Participants in the Delayed Results arm will receive their genetic testing results from a genetic counselor 6 months after randomization.
|
|---|---|---|
|
Overall Study
STARTED
|
55
|
57
|
|
Overall Study
COMPLETED
|
49
|
43
|
|
Overall Study
NOT COMPLETED
|
6
|
14
|
Reasons for withdrawal
| Measure |
Immediate Results
Participants in the Immediate Results arm will receive their genetic testing results from a genetic counselor at baseline following randomization.
|
Delayed Results
Participants in the Delayed Results arm will receive their genetic testing results from a genetic counselor 6 months after randomization.
|
|---|---|---|
|
Overall Study
Withdrawal by Subject
|
1
|
1
|
|
Overall Study
Death
|
2
|
0
|
|
Overall Study
Did not complete testing
|
3
|
13
|
Baseline Characteristics
Million Veteran Program Return of Actionable Results
Baseline characteristics by cohort
| Measure |
Immediate Results
n=55 Participants
Participants in the Immediate Results arm will receive their genetic testing results from a genetic counselor at baseline following randomization.
|
Delayed Results
n=57 Participants
Participants in the Delayed Results arm will receive their genetic testing results from a genetic counselor 6 months after randomization.
|
Total
n=112 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
66.7 Years
STANDARD_DEVIATION 14.1 • n=5 Participants
|
65.2 Years
STANDARD_DEVIATION 12.6 • n=7 Participants
|
65.9 Years
STANDARD_DEVIATION 13.3 • n=5 Participants
|
|
Sex: Female, Male
Female
|
11 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
18 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
44 Participants
n=5 Participants
|
50 Participants
n=7 Participants
|
94 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 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
|
12 Participants
n=5 Participants
|
19 Participants
n=7 Participants
|
31 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
39 Participants
n=5 Participants
|
33 Participants
n=7 Participants
|
72 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
2 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
4 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
10 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
51 Participants
n=5 Participants
|
50 Participants
n=7 Participants
|
101 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
LDL-C
|
114.4 mg/dL
n=5 Participants
|
104.7 mg/dL
n=7 Participants
|
109.5 mg/dL
n=5 Participants
|
PRIMARY outcome
Timeframe: 6 monthsChange in LDL-C after 6 months.
Outcome measures
| Measure |
Immediate Results
n=55 Participants
Participants in the Immediate Results arm will receive their genetic testing results from a genetic counselor at baseline following randomization.
|
Delayed Results
n=57 Participants
Participants in the Delayed Results arm will receive their genetic testing results from a genetic counselor 6 months after randomization.
|
|---|---|---|
|
LDL-C Change
|
-8.0 mg/dL
Standard Deviation 32.3
|
2.4 mg/dL
Standard Deviation 28.9
|
SECONDARY outcome
Timeframe: 6 monthsThe number of participants meeting clinically significant LDL-C targets (\< 100mg/dL for primary prevention and \<70 mg/dL for secondary prevention) at 6 months.
Outcome measures
| Measure |
Immediate Results
n=55 Participants
Participants in the Immediate Results arm will receive their genetic testing results from a genetic counselor at baseline following randomization.
|
Delayed Results
n=57 Participants
Participants in the Delayed Results arm will receive their genetic testing results from a genetic counselor 6 months after randomization.
|
|---|---|---|
|
LDL-C Target
|
15 Participants
|
14 Participants
|
SECONDARY outcome
Timeframe: 6 monthsThe number of participants with an intensification of lipid-lowering pharmacotherapy, a composite outcome including prescription of new monotherapy, dose escalation of existing pharmacotherapy, and addition of one or more medications to existing pharmacotherapy.
Outcome measures
| Measure |
Immediate Results
n=55 Participants
Participants in the Immediate Results arm will receive their genetic testing results from a genetic counselor at baseline following randomization.
|
Delayed Results
n=57 Participants
Participants in the Delayed Results arm will receive their genetic testing results from a genetic counselor 6 months after randomization.
|
|---|---|---|
|
Pharmacotherapy
|
11 Participants
|
5 Participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 6 monthsPopulation: Only the participants in the immediate results arm completed this survey measure.
The number of first-degree relatives having undergone genetic testing at 6 months.
Outcome measures
| Measure |
Immediate Results
n=55 Participants
Participants in the Immediate Results arm will receive their genetic testing results from a genetic counselor at baseline following randomization.
|
Delayed Results
Participants in the Delayed Results arm will receive their genetic testing results from a genetic counselor 6 months after randomization.
|
|---|---|---|
|
Cascade Testing
|
3 Participants
|
0 Participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 6 monthsPopulation: Survey responses fully or partially missing from some participants.
The number of participants reporting healthy lifestyle behaviors (smoking, physical activity, and saturated fat intake) at 6 months, measured by questionnaire responses.
Outcome measures
| Measure |
Immediate Results
n=55 Participants
Participants in the Immediate Results arm will receive their genetic testing results from a genetic counselor at baseline following randomization.
|
Delayed Results
n=57 Participants
Participants in the Delayed Results arm will receive their genetic testing results from a genetic counselor 6 months after randomization.
|
|---|---|---|
|
Lifestyle Behaviors
6-month physical activity · YES, I have been for MORE than 6 months
|
30 Participants
|
27 Participants
|
|
Lifestyle Behaviors
6-month physical activity · YES, I have, but for less than 6 months
|
3 Participants
|
4 Participants
|
|
Lifestyle Behaviors
6-month physical activity · NO, but I intend to in the next 30 days
|
4 Participants
|
6 Participants
|
|
Lifestyle Behaviors
6-month physical activity · NO, but I intend to in the next 6 months
|
6 Participants
|
1 Participants
|
|
Lifestyle Behaviors
6-month physical activity · NO, and I do NOT intend to in the next 6 months
|
7 Participants
|
6 Participants
|
|
Lifestyle Behaviors
6-month saturated fat consumption · YES, I have been for MORE than 6 months
|
23 Participants
|
28 Participants
|
|
Lifestyle Behaviors
6-month saturated fat consumption · YES, I have, but for less than 6 months
|
2 Participants
|
0 Participants
|
|
Lifestyle Behaviors
6-month saturated fat consumption · NO, but I intend to in the next 30 days
|
1 Participants
|
3 Participants
|
|
Lifestyle Behaviors
6-month saturated fat consumption · NO, but I intend to in the next 6 months
|
3 Participants
|
0 Participants
|
|
Lifestyle Behaviors
6-month saturated fat consumption · NO, and I do NOT intend to in the next 6 months
|
19 Participants
|
13 Participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 6 monthsPopulation: Survey responses fully or partially missing from some participants.
Quality of life, measured by the Veterans RAND (distributed by RAND Corporation) 12-item Health Survey (VR-12). Items are scored using an algorithm and summarized into two scores (Physical Component Score and a Mental Component Score) ranging from 0-100, with a higher score indicating better health.
Outcome measures
| Measure |
Immediate Results
n=55 Participants
Participants in the Immediate Results arm will receive their genetic testing results from a genetic counselor at baseline following randomization.
|
Delayed Results
n=54 Participants
Participants in the Delayed Results arm will receive their genetic testing results from a genetic counselor 6 months after randomization.
|
|---|---|---|
|
Quality of Life (Veterans RAND Survey)
Physical component: baseline
|
38.32 score on a scale
Standard Deviation 11.05
|
39.08 score on a scale
Standard Deviation 14.47
|
|
Quality of Life (Veterans RAND Survey)
Physical component: 6-month
|
39.10 score on a scale
Standard Deviation 11.44
|
40.58 score on a scale
Standard Deviation 14.14
|
|
Quality of Life (Veterans RAND Survey)
Physical component: change
|
0.78 score on a scale
Standard Deviation 4.45
|
1.5 score on a scale
Standard Deviation 4.83
|
|
Quality of Life (Veterans RAND Survey)
Mental component: baseline
|
47.78 score on a scale
Standard Deviation 13.98
|
49.69 score on a scale
Standard Deviation 12.98
|
|
Quality of Life (Veterans RAND Survey)
Mental component: 6-month
|
47.38 score on a scale
Standard Deviation 14.29
|
49.99 score on a scale
Standard Deviation 12.98
|
|
Quality of Life (Veterans RAND Survey)
Mental component: change
|
-0.403 score on a scale
Standard Deviation 6.29
|
0.31 score on a scale
Standard Deviation 4.66
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 6 monthsMedication adherence at 6 months, measured by the Beliefs About Medicines Questionnaire (BMQ).
Outcome measures
| Measure |
Immediate Results
n=55 Participants
Participants in the Immediate Results arm will receive their genetic testing results from a genetic counselor at baseline following randomization.
|
Delayed Results
n=57 Participants
Participants in the Delayed Results arm will receive their genetic testing results from a genetic counselor 6 months after randomization.
|
|---|---|---|
|
Medication Adherence
Doctors use too many medications · Strongly agree
|
8 Participants
|
6 Participants
|
|
Medication Adherence
Doctors use too many medications · Agree
|
24 Participants
|
14 Participants
|
|
Medication Adherence
Doctors use too many medications · Disagree
|
12 Participants
|
18 Participants
|
|
Medication Adherence
Doctors use too many medications · Strongly disagree
|
1 Participants
|
0 Participants
|
|
Medication Adherence
Doctors use too many medications · Neither agree nor disagree
|
5 Participants
|
7 Participants
|
|
Medication Adherence
Doctors use too many medications · Did not respond/ Missing
|
5 Participants
|
12 Participants
|
|
Medication Adherence
People who take medicines should stop their treatment every now and then · Strongly agree
|
0 Participants
|
0 Participants
|
|
Medication Adherence
People who take medicines should stop their treatment every now and then · Agree
|
3 Participants
|
0 Participants
|
|
Medication Adherence
People who take medicines should stop their treatment every now and then · Disagree
|
30 Participants
|
32 Participants
|
|
Medication Adherence
People who take medicines should stop their treatment every now and then · Strongly disagree
|
16 Participants
|
10 Participants
|
|
Medication Adherence
People who take medicines should stop their treatment every now and then · Neither agree nor disagree
|
1 Participants
|
3 Participants
|
|
Medication Adherence
People who take medicines should stop their treatment every now and then · Did not respond/ Missing
|
5 Participants
|
12 Participants
|
|
Medication Adherence
If doctors have more time with patients they would prescribe fewer medicines · Strongly agree
|
6 Participants
|
2 Participants
|
|
Medication Adherence
If doctors have more time with patients they would prescribe fewer medicines · Agree
|
20 Participants
|
18 Participants
|
|
Medication Adherence
If doctors have more time with patients they would prescribe fewer medicines · Disagree
|
10 Participants
|
15 Participants
|
|
Medication Adherence
If doctors have more time with patients they would prescribe fewer medicines · Strongly disagree
|
3 Participants
|
1 Participants
|
|
Medication Adherence
If doctors have more time with patients they would prescribe fewer medicines · Neither agree nor disagree
|
11 Participants
|
9 Participants
|
|
Medication Adherence
If doctors have more time with patients they would prescribe fewer medicines · Did not respond/ Missing
|
5 Participants
|
12 Participants
|
|
Medication Adherence
Doctors place too much trust in medicines · Strongly agree
|
7 Participants
|
3 Participants
|
|
Medication Adherence
Doctors place too much trust in medicines · Agree
|
22 Participants
|
17 Participants
|
|
Medication Adherence
Doctors place too much trust in medicines · Disagree
|
12 Participants
|
15 Participants
|
|
Medication Adherence
Doctors place too much trust in medicines · Strongly disagree
|
3 Participants
|
0 Participants
|
|
Medication Adherence
Doctors place too much trust in medicines · Neither agree nor disagree
|
6 Participants
|
10 Participants
|
|
Medication Adherence
Doctors place too much trust in medicines · Did not respond/ Missing
|
5 Participants
|
12 Participants
|
|
Medication Adherence
Medicines do more harm than good · Strongly agree
|
2 Participants
|
1 Participants
|
|
Medication Adherence
Medicines do more harm than good · Agree
|
6 Participants
|
3 Participants
|
|
Medication Adherence
Medicines do more harm than good · Disagree
|
24 Participants
|
25 Participants
|
|
Medication Adherence
Medicines do more harm than good · Strongly disagree
|
10 Participants
|
9 Participants
|
|
Medication Adherence
Medicines do more harm than good · Neither agree nor disagree
|
8 Participants
|
7 Participants
|
|
Medication Adherence
Medicines do more harm than good · Did not respond/ Missing
|
5 Participants
|
12 Participants
|
|
Medication Adherence
Most medicines are addictive · Strongly agree
|
1 Participants
|
1 Participants
|
|
Medication Adherence
Most medicines are addictive · Agree
|
6 Participants
|
5 Participants
|
|
Medication Adherence
Most medicines are addictive · Disagree
|
33 Participants
|
32 Participants
|
|
Medication Adherence
Most medicines are addictive · Strongly disagree
|
6 Participants
|
6 Participants
|
|
Medication Adherence
Most medicines are addictive · Neither agree nor disagree
|
4 Participants
|
1 Participants
|
|
Medication Adherence
Most medicines are addictive · Did not respond/ Missing
|
5 Participants
|
12 Participants
|
|
Medication Adherence
All medicines are poisons · Strongly agree
|
1 Participants
|
0 Participants
|
|
Medication Adherence
All medicines are poisons · Agree
|
0 Participants
|
0 Participants
|
|
Medication Adherence
All medicines are poisons · Disagree
|
34 Participants
|
28 Participants
|
|
Medication Adherence
All medicines are poisons · Strongly disagree
|
14 Participants
|
16 Participants
|
|
Medication Adherence
All medicines are poisons · Neither agree nor disagree
|
1 Participants
|
1 Participants
|
|
Medication Adherence
All medicines are poisons · Did not respond/ Missing
|
5 Participants
|
12 Participants
|
|
Medication Adherence
Natural remedies are safer than medicines · Strongly agree
|
2 Participants
|
2 Participants
|
|
Medication Adherence
Natural remedies are safer than medicines · Agree
|
11 Participants
|
5 Participants
|
|
Medication Adherence
Natural remedies are safer than medicines · Disagree
|
14 Participants
|
20 Participants
|
|
Medication Adherence
Natural remedies are safer than medicines · Strongly disagree
|
7 Participants
|
3 Participants
|
|
Medication Adherence
Natural remedies are safer than medicines · Neither agree nor disagree
|
16 Participants
|
15 Participants
|
|
Medication Adherence
Natural remedies are safer than medicines · Did not respond/ Missing
|
5 Participants
|
12 Participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 6-month6-month smoking status
Outcome measures
| Measure |
Immediate Results
n=50 Participants
Participants in the Immediate Results arm will receive their genetic testing results from a genetic counselor at baseline following randomization.
|
Delayed Results
n=44 Participants
Participants in the Delayed Results arm will receive their genetic testing results from a genetic counselor 6 months after randomization.
|
|---|---|---|
|
Smoking Status
Never smoked
|
15 Participants
|
23 Participants
|
|
Smoking Status
Quit > 6 months
|
30 Participants
|
16 Participants
|
|
Smoking Status
Quit within 6 months
|
1 Participants
|
2 Participants
|
|
Smoking Status
Current smoker
|
4 Participants
|
3 Participants
|
Adverse Events
Immediate Results
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Delayed Results
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place