Trial Outcomes & Findings for Using Peer Mentors to Support PACT Team Efforts to Improve Diabetes Control (NCT NCT01651117)

NCT ID: NCT01651117

Last Updated: 2019-10-30

Results Overview

Measured by change in HbA1c, adjusted for baseline HbA1c and patient random effects. HbA1c is measured as a percent. Values of the change variable (difference of 2 percentages) can be positive or negative. Negative change, which shows better outcome, occurs when the 6 month HBA1c is lower than the baseline HbA1c. (Change = final measure - initial measure)

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 480 participants
• Primary outcome timeframe: Baseline to 6 months
• Results posted on: 2019-10-30

Participant Flow

Participant milestones

Measure	Stage 1 Usual Care Poorly controlled diabetics randomized to no intervention will complete planned surveys, and blood draws (baseline, 6 months, and 12 months).	Stage 1 Peer Mentoring Poorly controlled diabetics randomized to intervention will be mentored for 6 months by a veteran who was once in poor control but is now in good control. For stage 2, they will then be further randomized to either becoming a mentor for 6 months or having no other additional active intervention. All participants in this arm will be evaluated in person at baseline, 6 months, 12 months, and 18 months.	Stage 2 Usual Care Poorly controlled diabetics randomized to stage 2 no intervention will complete planned surveys, and blood draws (baseline, 6 months, and 12 months).	Stage 2 Peer Mentoring FFM (From Former Mentee) Poorly controlled diabetics randomized to stage 2 intervention will be mentored by the former mentee for 6 months and will be followed in person for an additional 6 months after the completion of the active intervention.
Overall Study STARTED	156	205	49	70
Overall Study COMPLETED	154	202	47	68
Overall Study NOT COMPLETED	2	3	2	2

Reasons for withdrawal

Measure	Stage 1 Usual Care Poorly controlled diabetics randomized to no intervention will complete planned surveys, and blood draws (baseline, 6 months, and 12 months).	Stage 1 Peer Mentoring Poorly controlled diabetics randomized to intervention will be mentored for 6 months by a veteran who was once in poor control but is now in good control. For stage 2, they will then be further randomized to either becoming a mentor for 6 months or having no other additional active intervention. All participants in this arm will be evaluated in person at baseline, 6 months, 12 months, and 18 months.	Stage 2 Usual Care Poorly controlled diabetics randomized to stage 2 no intervention will complete planned surveys, and blood draws (baseline, 6 months, and 12 months).	Stage 2 Peer Mentoring FFM (From Former Mentee) Poorly controlled diabetics randomized to stage 2 intervention will be mentored by the former mentee for 6 months and will be followed in person for an additional 6 months after the completion of the active intervention.
Overall Study Death	2	3	2	2

Baseline Characteristics

Using Peer Mentors to Support PACT Team Efforts to Improve Diabetes Control

Baseline characteristics by cohort

Measure	Stage 1 Usual Care n=154 Participants Poorly controlled diabetics randomized to no intervention will complete planned surveys, and blood draws (baseline, 6 months, and 12 months).	Stage 1 Peer Mentoring n=202 Participants Poorly controlled diabetics randomized to intervention will be mentored for 6 months by a veteran who was once in poor control but is now in good control. For stage 2, they will then be further randomized to either becoming a mentor for 6 months or having no other additional active intervention. All participants in this arm will be evaluated in person at baseline, 6 months, 12 months, and 18 months.	Stage 2 Usual Care n=47 Participants Poorly controlled diabetics randomized to stage 2 no intervention will complete planned surveys, and blood draws (baseline, 6 months, and 12 months).	Stage 2 Peer Mentoring FFM (From Former Mentee) n=68 Participants Poorly controlled diabetics randomized to stage 2 intervention will be mentored by the former mentee for 6 months and will be followed in person for an additional 6 months after the completion of the active intervention.	Total n=471 Participants Total of all reporting groups
Age, Continuous	60.6 years STANDARD_DEVIATION 7.4 • n=5 Participants	59.6 years STANDARD_DEVIATION 7.9 • n=7 Participants	62.3 years STANDARD_DEVIATION 6.8 • n=5 Participants	62.3 years STANDARD_DEVIATION 6.9 • n=4 Participants	60.6 years STANDARD_DEVIATION 7.5 • n=21 Participants
Sex: Female, Male Female	8 Participants n=5 Participants	7 Participants n=7 Participants	0 Participants n=5 Participants	2 Participants n=4 Participants	17 Participants n=21 Participants
Sex: Female, Male Male	146 Participants n=5 Participants	195 Participants n=7 Participants	47 Participants n=5 Participants	66 Participants n=4 Participants	454 Participants n=21 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	11 Participants n=5 Participants	11 Participants n=7 Participants	4 Participants n=5 Participants	1 Participants n=4 Participants	27 Participants n=21 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	143 Participants n=5 Participants	191 Participants n=7 Participants	43 Participants n=5 Participants	67 Participants n=4 Participants	444 Participants n=21 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants
Race/Ethnicity, Customized White	40 Participants n=5 Participants	50 Participants n=7 Participants	9 Participants n=5 Participants	20 Participants n=4 Participants	119 Participants n=21 Participants
Race/Ethnicity, Customized Black	93 Participants n=5 Participants	136 Participants n=7 Participants	37 Participants n=5 Participants	45 Participants n=4 Participants	311 Participants n=21 Participants
Race/Ethnicity, Customized Multiple Race	2 Participants n=5 Participants	5 Participants n=7 Participants	0 Participants n=5 Participants	3 Participants n=4 Participants	10 Participants n=21 Participants
Race/Ethnicity, Customized Other Race	19 Participants n=5 Participants	11 Participants n=7 Participants	1 Participants n=5 Participants	0 Participants n=4 Participants	31 Participants n=21 Participants
Region of Enrollment United States	154 Participants n=5 Participants	202 Participants n=7 Participants	47 Participants n=5 Participants	68 Participants n=4 Participants	471 Participants n=21 Participants
Baseline HbA1c	9.8 percent STANDARD_DEVIATION 1.6 • n=5 Participants	9.3 percent STANDARD_DEVIATION 1.6 • n=7 Participants	9.7 percent STANDARD_DEVIATION 2.0 • n=5 Participants	9.2 percent STANDARD_DEVIATION 1.7 • n=4 Participants	9.5 percent STANDARD_DEVIATION 1.7 • n=21 Participants

PRIMARY outcome

Timeframe: Baseline to 6 months

Measured by change in HbA1c, adjusted for baseline HbA1c and patient random effects. HbA1c is measured as a percent. Values of the change variable (difference of 2 percentages) can be positive or negative. Negative change, which shows better outcome, occurs when the 6 month HBA1c is lower than the baseline HbA1c. (Change = final measure - initial measure)

Outcome measures

Measure	Stage 1 Usual Care n=154 Participants Poorly controlled diabetics randomized to no interventions will complete planned surveys, and blood draws (baseline, 6 months, and 12 months).	Stage 1 Peer Mentoring n=202 Participants Poorly controlled diabetics randomized to intervention will be mentored for 6 months by a veteran who was once in poor control but is now in good control.
Change in Glucose Control (Stage 1: Usual Care v. Peer Mentoring)	-0.1978 percent Interval -0.4567 to 0.0611	-0.5246 percent Interval -0.7554 to -0.2939

PRIMARY outcome

Timeframe: Baseline to 6 months

Measured by change in HbA1c, adjusted for baseline HbA1c and patient random effects. HbA1c is measured as a percent. Values of the change variable (difference of 2 percentages) can be positive or negative. Negative change, which shows better outcome, occurs when the 6 month HBA1c is lower than the baseline HbA1c. (Change = final measure - initial measure)

Outcome measures

Measure	Stage 1 Usual Care n=47 Participants Poorly controlled diabetics randomized to no interventions will complete planned surveys, and blood draws (baseline, 6 months, and 12 months).	Stage 1 Peer Mentoring n=68 Participants Poorly controlled diabetics randomized to intervention will be mentored for 6 months by a veteran who was once in poor control but is now in good control.
Change in Glucose Control (Stage 2: Usual Care v. Mentees)	-0.4587 percent Interval -1.0223 to 0.1049	0.0772 percent Interval -0.4159 to 0.5703

PRIMARY outcome

Timeframe: Baseline to 6 months

Population: After 6 month of Stage 1, patients who were randomized to receive mentoring in Stage 1 were further randomized to either become a mentor in Stage 2 (Stage 2 Mentor) or to not become a mentor in Stage 2 (Stage 2 Non-mentor). Note that only those who had a 6-month follow-up visits for Stage 1 could be randomized to Stage 2 (139 participants).

Measured by change in HbA1c, adjusted for baseline HbA1c and patient random effects. HbA1c is measured as a percent. Values of the change variable (difference of 2 percentages) can be positive or negative. Negative change, which shows better outcome, occurs when the 6 month HBA1c is lower than the baseline HbA1c. (Change = final measure - initial measure)

Outcome measures

Measure	Stage 1 Usual Care n=69 Participants Poorly controlled diabetics randomized to no interventions will complete planned surveys, and blood draws (baseline, 6 months, and 12 months).	Stage 1 Peer Mentoring n=70 Participants Poorly controlled diabetics randomized to intervention will be mentored for 6 months by a veteran who was once in poor control but is now in good control.
Change in Glucose Control (Stage 2: Non-mentors v. Mentors)	0.3156 percent Interval -0.0733 to 0.7045	0.1449 percent Interval -0.2421 to 0.5319

SECONDARY outcome

Timeframe: Baseline to 6 months

Measured by change in Direct LDL blood levels, adjusted for baseline LDL and patient random effect. LDL is measured as mg/dL. Values of the change variable (difference of 2 levels) can be positive or negative. Negative change, which shows better outcome, occurs when the 6 month LDL is lower than the baseline LDL. (Change = final measure - initial measure)

Outcome measures

Measure	Stage 1 Usual Care n=154 Participants Poorly controlled diabetics randomized to no interventions will complete planned surveys, and blood draws (baseline, 6 months, and 12 months).	Stage 1 Peer Mentoring n=202 Participants Poorly controlled diabetics randomized to intervention will be mentored for 6 months by a veteran who was once in poor control but is now in good control.
Change in Direct LDL Blood Levels	-2.0793 mg/dL Interval -6.5786 to 2.4199	-4.3098 mg/dL Interval -8.3135 to -0.3061

SECONDARY outcome

Timeframe: Baseline to 6 months

Measured by change in systolic Blood Pressure, adjusting for baseline blood pressure and patient random effect. Systolic BP is measured as mmHG. Values of the change variable (difference of 2 levels) can be positive or negative. Negative change, which shows better outcome, occurs when the 6 month BP is lower than the baseline BP. (Change = final measure - initial measure)

Outcome measures

Measure	Stage 1 Usual Care n=154 Participants Poorly controlled diabetics randomized to no interventions will complete planned surveys, and blood draws (baseline, 6 months, and 12 months).	Stage 1 Peer Mentoring n=202 Participants Poorly controlled diabetics randomized to intervention will be mentored for 6 months by a veteran who was once in poor control but is now in good control.
Change in Systolic Blood Pressure	-3.4477 mmHG Interval -6.2332 to -0.6623	-0.8695 mmHG Interval -3.4789 to 1.7399

SECONDARY outcome

Timeframe: Baseline to 6 months

Change in Diabetes Distress Scale, adjusted for baseline score and patient random effects. The DDS score is calculated by averaging 2 5-point Likert scale questions, and ranges from 1 to 5, where lower means less distress. Values of the change variable can be positive or negative. Negative change, which shows better outcome, occurs when the 6 month DDS is lower than the baseline DDS. (Change = final measure - initial measure)

Outcome measures

Measure	Stage 1 Usual Care n=154 Participants Poorly controlled diabetics randomized to no interventions will complete planned surveys, and blood draws (baseline, 6 months, and 12 months).	Stage 1 Peer Mentoring n=202 Participants Poorly controlled diabetics randomized to intervention will be mentored for 6 months by a veteran who was once in poor control but is now in good control.
Change in Diabetes Quality of Life Score	0.0159 score on a scale Interval -0.1443 to 0.1761	-0.0371 score on a scale Interval -0.2036 to 0.1294

SECONDARY outcome

Timeframe: Baseline to 6 months

As measured by change in the Patient Health Questionnaire-2, adjusted for baseline score and patient random effects. The PHQ score is calculated by summing 2 4-point 0-3 Likert scale questions, and ranges from 0 to 6, with lower score indicating lower depression. Values of the change variable can be positive or negative. Negative change, which shows better outcome, occurs when the 6 month PHQ is lower than the baseline PHQ. (Change = final measure - initial measure)

Outcome measures

Measure	Stage 1 Usual Care n=154 Participants Poorly controlled diabetics randomized to no interventions will complete planned surveys, and blood draws (baseline, 6 months, and 12 months).	Stage 1 Peer Mentoring n=202 Participants Poorly controlled diabetics randomized to intervention will be mentored for 6 months by a veteran who was once in poor control but is now in good control.
Change in Depression Symptoms	-0.0502 score on a scale Interval -0.2792 to 0.1788	-0.0389 score on a scale Interval -0.2561 to 0.1782

SECONDARY outcome

Timeframe: Baseline to 12 months

Measured by change in HbA1c, adjusted for baseline HbA1c and patient random effects. HbA1c is measured as a percent. Values of the change variable (difference of 2 percentages) can be positive or negative. Negative change, which shows better outcome, occurs when the 12 month HBA1c is lower than the baseline HbA1c. (Change = final measure - initial measure)

Outcome measures

Measure	Stage 1 Usual Care n=154 Participants Poorly controlled diabetics randomized to no interventions will complete planned surveys, and blood draws (baseline, 6 months, and 12 months).	Stage 1 Peer Mentoring n=202 Participants Poorly controlled diabetics randomized to intervention will be mentored for 6 months by a veteran who was once in poor control but is now in good control.
Change in Glucose Control	-0.2643 percent Interval -0.5263 to -0.0024	-0.2818 percent Interval -0.5311 to -0.0326

SECONDARY outcome

Timeframe: Baseline to 12 months

Measured by change in Direct LDL blood levels, adjusted for baseline LDL and patient random effect. LDL is measured as mg/dL. Values of the change variable (difference of 2 levels) can be positive or negative. Negative change, which shows better outcome, occurs when the 12 month LDL is lower than the baseline LDL. (Change = final measure - initial measure)

Outcome measures

Measure	Stage 1 Usual Care n=154 Participants Poorly controlled diabetics randomized to no interventions will complete planned surveys, and blood draws (baseline, 6 months, and 12 months).	Stage 1 Peer Mentoring n=202 Participants Poorly controlled diabetics randomized to intervention will be mentored for 6 months by a veteran who was once in poor control but is now in good control.
Change in Direct LDL Blood Levels	-7.1706 mg/dL Interval -11.7706 to -2.5705	-7.8594 mg/dL Interval -12.4047 to -3.314

SECONDARY outcome

Timeframe: Baseline to 12 months

Measured by change in systolic Blood Pressure, adjusting for baseline blood pressure and patient random effect. Systolic BP is measured as mmHG. Values of the change variable (difference of 2 levels) can be positive or negative. Negative change, which shows better outcome, occurs when the 12 month BP is lower than the baseline BP. (Change = final measure - initial measure)

Outcome measures

Measure	Stage 1 Usual Care n=154 Participants Poorly controlled diabetics randomized to no interventions will complete planned surveys, and blood draws (baseline, 6 months, and 12 months).	Stage 1 Peer Mentoring n=202 Participants Poorly controlled diabetics randomized to intervention will be mentored for 6 months by a veteran who was once in poor control but is now in good control.
Change in Systolic Blood Pressure	-3.7548 mmHG Interval -6.5977 to -0.9118	-2.3274 mmHG Interval -4.9242 to 0.2695

SECONDARY outcome

Timeframe: Baseline to 12 months

Change in Diabetes Distress Scale, adjusted for baseline score and patient random effects. The DDS score is calculated by averaging 2 5-point Likert scale questions, and ranges from 1 to 5, where lower means less distress. Values of the change variable can be positive or negative. Negative change, which shows better outcome, occurs when the 12 month DDS is lower than the baseline DDS. (Change = final measure - initial measure)

Outcome measures

Measure	Stage 1 Usual Care n=154 Participants Poorly controlled diabetics randomized to no interventions will complete planned surveys, and blood draws (baseline, 6 months, and 12 months).	Stage 1 Peer Mentoring n=202 Participants Poorly controlled diabetics randomized to intervention will be mentored for 6 months by a veteran who was once in poor control but is now in good control.
Change in Diabetes Quality of Life	-0.1213 score on a scale Interval -0.2869 to 0.0414	-0.1812 score on a scale Interval -0.3445 to -0.0179

SECONDARY outcome

Timeframe: Baseline to 12 months

As measured by change in the Patient Health Questionnaire-2, adjusted for baseline score and patient random effects. The PHQ score is calculated by summing 2 4-point 0-3 Likert scale questions, and ranges from 0 to 6, with lower score indicating lower depression. Values of the change variable can be positive or negative. Negative change, which shows better outcome, occurs when the 12 month PHQ is lower than the baseline PHQ. (Change = final measure - initial measure)

Outcome measures

Measure	Stage 1 Usual Care n=154 Participants Poorly controlled diabetics randomized to no interventions will complete planned surveys, and blood draws (baseline, 6 months, and 12 months).	Stage 1 Peer Mentoring n=202 Participants Poorly controlled diabetics randomized to intervention will be mentored for 6 months by a veteran who was once in poor control but is now in good control.
Change in Depression Symptoms	-0.1168 score on a scale Interval -0.3472 to 0.1135	-0.1736 score on a scale Interval -0.388 to 0.0407

SECONDARY outcome

Timeframe: Baseline to 6 months

Measured by change in Direct LDL blood levels, adjusted for baseline LDL and patient random effect. LDL is measured as mg/dL. Values of the change variable (difference of 2 levels) can be positive or negative. Negative change, which shows better outcome, occurs when the 6 month LDL is lower than the baseline LDL. (Change = final measure - initial measure)

Outcome measures

Measure	Stage 1 Usual Care n=47 Participants Poorly controlled diabetics randomized to no interventions will complete planned surveys, and blood draws (baseline, 6 months, and 12 months).	Stage 1 Peer Mentoring n=68 Participants Poorly controlled diabetics randomized to intervention will be mentored for 6 months by a veteran who was once in poor control but is now in good control.
Change in Direct LDL Blood Levels (Stage 2: Usual Care v. Mentees)	7.9124 mg/dL Interval -0.6975 to 16.5224	-1.6217 mg/dL Interval -9.2467 to 6.0033

SECONDARY outcome

Timeframe: Baseline to 6 months

Measured by change in systolic Blood Pressure, adjusting for baseline blood pressure and patient random effect. Systolic BP is measured as mmHG. Values of the change variable (difference of 2 levels) can be positive or negative. Negative change, which shows better outcome, occurs when the 6 month BP is lower than the baseline BP. (Change = final measure - initial measure)

Outcome measures

Measure	Stage 1 Usual Care n=47 Participants Poorly controlled diabetics randomized to no interventions will complete planned surveys, and blood draws (baseline, 6 months, and 12 months).	Stage 1 Peer Mentoring n=68 Participants Poorly controlled diabetics randomized to intervention will be mentored for 6 months by a veteran who was once in poor control but is now in good control.
Change in Systolic Blood Pressure (Stage 2: Usual Care v. Mentee)	1.4718 mmHG Interval -3.5255 to 6.4692	0.1876 mmHG Interval -4.0493 to 4.4244

SECONDARY outcome

Timeframe: Baseline to 6 months

Change in Diabetes Distress Scale, adjusted for baseline score and patient random effects. The DDS score is calculated by averaging 2 5-point Likert scale questions, and ranges from 1 to 5, where lower means less distress. Values of the change variable can be positive or negative. Negative change, which shows better outcome, occurs when the 6 month DDS is lower than the baseline DDS. (Change = final measure - initial measure)

Outcome measures

Measure	Stage 1 Usual Care n=47 Participants Poorly controlled diabetics randomized to no interventions will complete planned surveys, and blood draws (baseline, 6 months, and 12 months).	Stage 1 Peer Mentoring n=68 Participants Poorly controlled diabetics randomized to intervention will be mentored for 6 months by a veteran who was once in poor control but is now in good control.
Change in Diabetes Quality of Life (Stage 2: Usual Care v. Mentee)	0.1024 score on a scale Interval -0.204 to 0.4089	-0.4098 score on a scale Interval -0.6816 to -0.138

SECONDARY outcome

Timeframe: Baseline to 6 months

As measured by change in the Patient Health Questionnaire-2, adjusted for baseline score and patient random effects. The PHQ score is calculated by summing 2 4-point 0-3 Likert scale questions, and ranges from 0 to 6, with lower score indicating lower depression. Values of the change variable can be positive or negative. Negative change, which shows better outcome, occurs when the 6 month PHQ is lower than the baseline PHQ. (Change = final measure - initial measure)

Outcome measures

Measure	Stage 1 Usual Care n=47 Participants Poorly controlled diabetics randomized to no interventions will complete planned surveys, and blood draws (baseline, 6 months, and 12 months).	Stage 1 Peer Mentoring n=68 Participants Poorly controlled diabetics randomized to intervention will be mentored for 6 months by a veteran who was once in poor control but is now in good control.
Change in Depression Symptoms (Stage 2: Usual Care v. Mentees)	-0.3186 score on a scale Interval -0.7744 to 0.1373	-0.2627 score on a scale Interval -0.6723 to 0.1469

SECONDARY outcome

Timeframe: Baseline to 12 months

Measured by change in HbA1c, adjusted for baseline HbA1c and patient random effects. HbA1c is measured as a percent. Values of the change variable (difference of 2 percentages) can be positive or negative. Negative change, which shows better outcome, occurs when the 12 month HBA1c is lower than the baseline HbA1c. (Change = final measure - initial measure)

Outcome measures

Measure	Stage 1 Usual Care n=47 Participants Poorly controlled diabetics randomized to no interventions will complete planned surveys, and blood draws (baseline, 6 months, and 12 months).	Stage 1 Peer Mentoring n=68 Participants Poorly controlled diabetics randomized to intervention will be mentored for 6 months by a veteran who was once in poor control but is now in good control.
Change in Glucose Control (Stage 2: Usual Care v. Mentees)	-0.2661 percent Interval -0.8889 to 0.3567	-0.1628 percent Interval -0.6544 to 0.3287

SECONDARY outcome

Timeframe: Baseline to 12 months

Measured by change in Direct LDL blood levels, adjusted for baseline LDL and patient random effect. LDL is measured as mg/dL. Values of the change variable (difference of 2 levels) can be positive or negative. Negative change, which shows better outcome, occurs when the 12 month LDL is lower than the baseline LDL. (Change = final measure - initial measure)

Outcome measures

Measure	Stage 1 Usual Care n=47 Participants Poorly controlled diabetics randomized to no interventions will complete planned surveys, and blood draws (baseline, 6 months, and 12 months).	Stage 1 Peer Mentoring n=68 Participants Poorly controlled diabetics randomized to intervention will be mentored for 6 months by a veteran who was once in poor control but is now in good control.
Change in Direct LDL Blood Levels (Stage 2: Usual Care v. Mentees)	5.0419 mg/dL Interval -4.0961 to 14.1799	-4.9126 mg/dL Interval -12.8131 to 2.9879

SECONDARY outcome

Timeframe: Baseline to 12 months

Measured by change in systolic Blood Pressure, adjusting for baseline blood pressure and patient random effect. Systolic BP is measured as mmHG. Values of the change variable (difference of 2 levels) can be positive or negative. Negative change, which shows better outcome, occurs when the 12 month BP is lower than the baseline BP. (Change = final measure - initial measure)

Outcome measures

Measure	Stage 1 Usual Care n=47 Participants Poorly controlled diabetics randomized to no interventions will complete planned surveys, and blood draws (baseline, 6 months, and 12 months).	Stage 1 Peer Mentoring n=68 Participants Poorly controlled diabetics randomized to intervention will be mentored for 6 months by a veteran who was once in poor control but is now in good control.
Change in Systolic Blood Pressure (Stage 2: Usual Care v. Mentee)	-1.6851 mmHG Interval -6.8849 to 3.5147	1.3877 mmHG Interval -2.7712 to 5.5466

SECONDARY outcome

Timeframe: Baseline to 12 months

Change in Diabetes Distress Scale, adjusted for baseline score and patient random effects. The DDS score is calculated by averaging 2 5-point Likert scale questions, and ranges from 1 to 5, where lower means less distress. Values of the change variable can be positive or negative. Negative change, which shows better outcome, occurs when the 12 month DDS is lower than the baseline DDS. (Change = final measure - initial measure)

Outcome measures

Measure	Stage 1 Usual Care n=47 Participants Poorly controlled diabetics randomized to no interventions will complete planned surveys, and blood draws (baseline, 6 months, and 12 months).	Stage 1 Peer Mentoring n=68 Participants Poorly controlled diabetics randomized to intervention will be mentored for 6 months by a veteran who was once in poor control but is now in good control.
Change in Diabetes Quality of Life (Stage 2: Usual Care v. Mentee)	-0.1299 score on a scale Interval -0.4464 to 0.1866	-0.0246 score on a scale Interval -0.3058 to 0.2567

SECONDARY outcome

Timeframe: Baseline to 12 months

As measured by change in the Patient Health Questionnaire-2, adjusted for baseline score and patient random effects. The PHQ score is calculated by summing 2 4-point 0-3 Likert scale questions, and ranges from 0 to 6, with lower score indicating lower depression. Values of the change variable can be positive or negative. Negative change, which shows better outcome, occurs when the 12 month PHQ is lower than the baseline PHQ. (Change = final measure - initial measure)

Outcome measures

Measure	Stage 1 Usual Care n=47 Participants Poorly controlled diabetics randomized to no interventions will complete planned surveys, and blood draws (baseline, 6 months, and 12 months).	Stage 1 Peer Mentoring n=68 Participants Poorly controlled diabetics randomized to intervention will be mentored for 6 months by a veteran who was once in poor control but is now in good control.
Change in Depression Symptoms (Stage 2: Usual Care v. Mentees)	-0.4581 score on a scale Interval -0.9375 to 0.0214	-0.0890 score on a scale Interval -0.5157 to 0.3377

SECONDARY outcome

Timeframe: Baseline to 6 months

Population: After 6 month of Stage 1, patients who were randomized to receive mentoring in Stage 1 were further randomized to either become a mentor in Stage 2 (Stage 2 Mentor) or to not become a mentor in Stage 2 (Stage 2 Non-mentor). Note that only those who had a 6-month follow-up visits for Stage 1 could be randomized to Stage 2 (139 participants).

Measured by change in Direct LDL blood levels, adjusted for baseline LDL and patient random effect. LDL is measured as mg/dL. Values of the change variable (difference of 2 levels) can be positive or negative. Negative change, which shows better outcome, occurs when the 6 month LDL is lower than the baseline LDL. (Change = final measure - initial measure)

Outcome measures

Measure	Stage 1 Usual Care n=69 Participants Poorly controlled diabetics randomized to no interventions will complete planned surveys, and blood draws (baseline, 6 months, and 12 months).	Stage 1 Peer Mentoring n=70 Participants Poorly controlled diabetics randomized to intervention will be mentored for 6 months by a veteran who was once in poor control but is now in good control.
Change in Direct LDL Blood Levels (Stage 2: Non-mentors v. Mentors)	-2.1692 mg/dL Interval -9.0874 to 4.7491	-7.4649 mg/dL Interval -14.2567 to -0.6732

SECONDARY outcome

Timeframe: Baseline to 6 months

Population: After 6 month of Stage 1, patients who were randomized to receive mentoring in Stage 1 were further randomized to either become a mentor in Stage 2 (Stage 2 Mentor) or to not become a mentor in Stage 2 (Stage 2 Non-mentor). Note that only those who had a 6-month follow-up visits for Stage 1 could be randomized to Stage 2 (139 participants).

Measured by change in systolic Blood Pressure, adjusting for baseline blood pressure and patient random effect. Systolic BP is measured as mmHG. Values of the change variable (difference of 2 levels) can be positive or negative. Negative change, which shows better outcome, occurs when the 6 month BP is lower than the baseline BP. (Change = final measure - initial measure)

Outcome measures

Measure	Stage 1 Usual Care n=69 Participants Poorly controlled diabetics randomized to no interventions will complete planned surveys, and blood draws (baseline, 6 months, and 12 months).	Stage 1 Peer Mentoring n=70 Participants Poorly controlled diabetics randomized to intervention will be mentored for 6 months by a veteran who was once in poor control but is now in good control.
Change in Systolic Blood Pressure (Stage 2: Non-mentors v. Mentors)	-1.6942 mmHG Interval -5.6326 to 2.2443	-1.0527 mmHG Interval -5.242 to 3.1366

SECONDARY outcome

Timeframe: Baseline to 6 months

Population: After 6 month of Stage 1, patients who were randomized to receive mentoring in Stage 1 were further randomized to either become a mentor in Stage 2 (Stage 2 Mentor) or to not become a mentor in Stage 2 (Stage 2 Non-mentor). Note that only those who had a 6-month follow-up visits for Stage 1 could be randomized to Stage 2 (139 participants).

Change in Diabetes Distress Scale, adjusted for baseline score and patient random effects. The DDS score is calculated by averaging 2 5-point Likert scale questions, and ranges from 1 to 5, where lower means less distress. Values of the change variable can be positive or negative. Negative change, which shows better outcome, occurs when the 6 month DDS is lower than the baseline DDS. (Change = final measure - initial measure)

Outcome measures

Measure	Stage 1 Usual Care n=69 Participants Poorly controlled diabetics randomized to no interventions will complete planned surveys, and blood draws (baseline, 6 months, and 12 months).	Stage 1 Peer Mentoring n=70 Participants Poorly controlled diabetics randomized to intervention will be mentored for 6 months by a veteran who was once in poor control but is now in good control.
Change in Diabetes Quality of Life (Stage 2: Non-mentors v. Mentors)	-0.1006 score on a scale Interval -0.3213 to 0.1202	-0.1332 score on a scale Interval -0.3574 to 0.091

SECONDARY outcome

Timeframe: Baseline to 6 months

Population: After 6 month of Stage 1, patients who were randomized to receive mentoring in Stage 1 were further randomized to either become a mentor in Stage 2 (Stage 2 Mentor) or to not become a mentor in Stage 2 (Stage 2 Non-mentor). Note that only those who had a 6-month follow-up visits for Stage 1 could be randomized to Stage 2 (139 participants).

As measured by change in the Patient Health Questionnaire-2, adjusted for baseline score and patient random effects. The PHQ score is calculated by summing 2 4-point 0-3 Likert scale questions, and ranges from 0 to 6, with lower score indicating lower depression. Values of the change variable can be positive or negative. Negative change, which shows better outcome, occurs when the 6 month PHQ is lower than the baseline PHQ. (Change = final measure - initial measure)

Outcome measures

Measure	Stage 1 Usual Care n=69 Participants Poorly controlled diabetics randomized to no interventions will complete planned surveys, and blood draws (baseline, 6 months, and 12 months).	Stage 1 Peer Mentoring n=70 Participants Poorly controlled diabetics randomized to intervention will be mentored for 6 months by a veteran who was once in poor control but is now in good control.
Change in Depression Symptoms (Stage 2: Non-mentors v. Mentors)	-0.3314 score on a scale Interval -0.6916 to 0.0288	-0.1809 score on a scale Interval -0.5454 to 0.1837

SECONDARY outcome

Timeframe: Baseline to 12 months

Population: After 6 month of Stage 1, patients who were randomized to receive mentoring in Stage 1 were further randomized to either become a mentor in Stage 2 (Stage 2 Mentor) or to not become a mentor in Stage 2 (Stage 2 Non-mentor). Note that only those who had a 6-month follow-up visits for Stage 1 could be randomized to Stage 2 (139 participants).

Measured by change in HbA1c, adjusted for baseline HbA1c and patient random effects. HbA1c is measured as a percent. Values of the change variable (difference of 2 percentages) can be positive or negative. Negative change, which shows better outcome, occurs when the 12 month HBA1c is lower than the baseline HbA1c. (Change = final measure - initial measure)

Outcome measures

Measure	Stage 1 Usual Care n=69 Participants Poorly controlled diabetics randomized to no interventions will complete planned surveys, and blood draws (baseline, 6 months, and 12 months).	Stage 1 Peer Mentoring n=70 Participants Poorly controlled diabetics randomized to intervention will be mentored for 6 months by a veteran who was once in poor control but is now in good control.
Change in Glucose Control (Stage 2: Non-mentors v. Mentors)	0.2396 percent Interval -0.1853 to 0.6645	0.0639 percent Interval -0.3306 to 0.4585

SECONDARY outcome

Timeframe: Baseline to 12 months

Population: After 6 month of Stage 1, patients who were randomized to receive mentoring in Stage 1 were further randomized to either become a mentor in Stage 2 (Stage 2 Mentor) or to not become a mentor in Stage 2 (Stage 2 Non-mentor). Note that only those who had a 6-month follow-up visits for Stage 1 could be randomized to Stage 2 (139 participants).

Measured by change in Direct LDL blood levels, adjusted for baseline LDL and patient random effect. LDL is measured as mg/dL. Values of the change variable (difference of 2 levels) can be positive or negative. Negative change, which shows better outcome, occurs when the 12 month LDL is lower than the baseline LDL. (Change = final measure - initial measure)

Outcome measures

Measure	Stage 1 Usual Care n=69 Participants Poorly controlled diabetics randomized to no interventions will complete planned surveys, and blood draws (baseline, 6 months, and 12 months).	Stage 1 Peer Mentoring n=70 Participants Poorly controlled diabetics randomized to intervention will be mentored for 6 months by a veteran who was once in poor control but is now in good control.
Change in Direct LDL Blood Levels (Stage 2: Non-mentors v. Mentors)	-1.0938 mg/dL Interval -8.3514 to 6.1637	2.2494 mg/dL Interval -4.7631 to 9.2619

SECONDARY outcome

Timeframe: Baseline to 12 months

Population: After 6 month of Stage 1, patients who were randomized to receive mentoring in Stage 1 were further randomized to either become a mentor in Stage 2 (Stage 2 Mentor) or to not become a mentor in Stage 2 (Stage 2 Non-mentor). Note that only those who had a 6-month follow-up visits for Stage 1 could be randomized to Stage 2 (139 participants).

Measured by change in systolic Blood Pressure, adjusting for baseline blood pressure and patient random effect. Systolic BP is measured as mmHG. Values of the change variable (difference of 2 levels) can be positive or negative. Negative change, which shows better outcome, occurs when the 12 month BP is lower than the baseline BP. (Change = final measure - initial measure)

Outcome measures

Measure	Stage 1 Usual Care n=69 Participants Poorly controlled diabetics randomized to no interventions will complete planned surveys, and blood draws (baseline, 6 months, and 12 months).	Stage 1 Peer Mentoring n=70 Participants Poorly controlled diabetics randomized to intervention will be mentored for 6 months by a veteran who was once in poor control but is now in good control.
Change in Systolic Blood Pressure (Stage 2: Non-mentors v. Mentors)	-3.9453 mmHG Interval -8.1308 to 0.2401	-0.5611 mmHG Interval -4.7598 to 3.6375

SECONDARY outcome

Timeframe: Baseline to 12 months

Population: After 6 month of Stage 1, patients who were randomized to receive mentoring in Stage 1 were further randomized to either become a mentor in Stage 2 (Stage 2 Mentor) or to not become a mentor in Stage 2 (Stage 2 Non-mentor). Note that only those who had a 6-month follow-up visits for Stage 1 could be randomized to Stage 2 (139 participants).

Change in Diabetes Distress Scale, adjusted for baseline score and patient random effects. The DDS score is calculated by averaging 2 5-point Likert scale questions, and ranges from 1 to 5, where lower means less distress. Values of the change variable can be positive or negative. Negative change, which shows better outcome, occurs when the 12 month DDS is lower than the baseline DDS. (Change = final measure - initial measure)

Outcome measures

Measure	Stage 1 Usual Care n=69 Participants Poorly controlled diabetics randomized to no interventions will complete planned surveys, and blood draws (baseline, 6 months, and 12 months).	Stage 1 Peer Mentoring n=70 Participants Poorly controlled diabetics randomized to intervention will be mentored for 6 months by a veteran who was once in poor control but is now in good control.
Change in Diabetes Quality of Life (Stage 2: Non-mentors v. Mentors)	-0.1896 score on a scale Interval -0.4311 to 0.0519	-0.3017 score on a scale Interval -0.5475 to -0.0559

SECONDARY outcome

Timeframe: Baseline to 12 months

Population: After 6 month of Stage 1, patients who were randomized to receive mentoring in Stage 1 were further randomized to either become a mentor in Stage 2 (Stage 2 Mentor) or to not become a mentor in Stage 2 (Stage 2 Non-mentor). Note that only those who had a 6-month follow-up visits for Stage 1 could be randomized to Stage 2 (139 participants).

As measured by change in the Patient Health Questionnaire-2, adjusted for baseline score and patient random effects. The PHQ score is calculated by summing 2 4-point 0-3 Likert scale questions, and ranges from 0 to 6, with lower score indicating lower depression. Values of the change variable can be positive or negative. Negative change, which shows better outcome, occurs when the 12 month PHQ is lower than the baseline PHQ. (Change = final measure - initial measure)

Outcome measures

Measure	Stage 1 Usual Care n=69 Participants Poorly controlled diabetics randomized to no interventions will complete planned surveys, and blood draws (baseline, 6 months, and 12 months).	Stage 1 Peer Mentoring n=70 Participants Poorly controlled diabetics randomized to intervention will be mentored for 6 months by a veteran who was once in poor control but is now in good control.
Change in Depression Symptoms (Stage 2: Non-mentors v. Mentors)	0.0609 score on a scale Interval -0.3251 to 0.447	-0.0819 score on a scale Interval -0.4716 to 0.3077

Adverse Events

Usual Care Stage 1

Serious events: 10 serious events

Other events: 11 other events

Deaths: 2 deaths

Peer Mentoring

Serious events: 28 serious events

Other events: 38 other events

Deaths: 3 deaths

Peer Mentoring FFM (From Former Mentee)

Serious events: 12 serious events

Other events: 6 other events

Deaths: 2 deaths

Usual Care Stage 2

Serious events: 2 serious events

Other events: 5 other events

Deaths: 2 deaths

Serious adverse events

Measure	Usual Care Stage 1 n=156 participants at risk No interventions will be provided to this arm. They will complete planned surveys, and blood draws (baseline, 6 months, and 12 months).	Peer Mentoring n=205 participants at risk Participants in this arm will be mentored for 6 months by a veteran who was once in poor control but is now in good control. They will then be further randomized to either becoming a mentor for 6 months or having no other additional active intervention. All participants in this arm will be evaluated in person at baseline, 6 months, 12 months, and 18 months.	Peer Mentoring FFM (From Former Mentee) n=70 participants at risk Participants in this arm will be mentored by the former mentee for 6 months and will be followed in person for an additional 6 months after the completion of the active intervention.	Usual Care Stage 2 n=49 participants at risk No interventions will be provided to this arm. They will complete planned surveys, and blood draws (baseline, 6 months, and 12 months).
Nervous system disorders Hospitalization	1.9% 3/156 • Number of events 3 • Adverse event data were collected for 18 months from baseline.	1.5% 3/205 • Number of events 3 • Adverse event data were collected for 18 months from baseline.	2.9% 2/70 • Number of events 2 • Adverse event data were collected for 18 months from baseline.	0.00% 0/49 • Adverse event data were collected for 18 months from baseline.
General disorders Hospitalization	2.6% 4/156 • Number of events 4 • Adverse event data were collected for 18 months from baseline.	7.3% 15/205 • Number of events 15 • Adverse event data were collected for 18 months from baseline.	4.3% 3/70 • Number of events 4 • Adverse event data were collected for 18 months from baseline.	2.0% 1/49 • Number of events 1 • Adverse event data were collected for 18 months from baseline.
Infections and infestations Hospitalization	1.9% 3/156 • Number of events 3 • Adverse event data were collected for 18 months from baseline.	1.5% 3/205 • Number of events 3 • Adverse event data were collected for 18 months from baseline.	0.00% 0/70 • Adverse event data were collected for 18 months from baseline.	0.00% 0/49 • Adverse event data were collected for 18 months from baseline.
Musculoskeletal and connective tissue disorders Hospitalization	0.00% 0/156 • Adverse event data were collected for 18 months from baseline.	0.00% 0/205 • Adverse event data were collected for 18 months from baseline.	0.00% 0/70 • Adverse event data were collected for 18 months from baseline.	0.00% 0/49 • Adverse event data were collected for 18 months from baseline.
Renal and urinary disorders Hospitalization	0.64% 1/156 • Number of events 1 • Adverse event data were collected for 18 months from baseline.	2.4% 5/205 • Number of events 5 • Adverse event data were collected for 18 months from baseline.	0.00% 0/70 • Adverse event data were collected for 18 months from baseline.	0.00% 0/49 • Adverse event data were collected for 18 months from baseline.
Surgical and medical procedures Hospitalization	0.64% 1/156 • Number of events 1 • Adverse event data were collected for 18 months from baseline.	0.98% 2/205 • Number of events 2 • Adverse event data were collected for 18 months from baseline.	1.4% 1/70 • Number of events 1 • Adverse event data were collected for 18 months from baseline.	2.0% 1/49 • Number of events 1 • Adverse event data were collected for 18 months from baseline.
Psychiatric disorders Hospitalization	0.00% 0/156 • Adverse event data were collected for 18 months from baseline.	0.49% 1/205 • Number of events 1 • Adverse event data were collected for 18 months from baseline.	1.4% 1/70 • Number of events 3 • Adverse event data were collected for 18 months from baseline.	2.0% 1/49 • Number of events 1 • Adverse event data were collected for 18 months from baseline.
Immune system disorders Hospitalization	0.00% 0/156 • Adverse event data were collected for 18 months from baseline.	1.5% 3/205 • Number of events 3 • Adverse event data were collected for 18 months from baseline.	0.00% 0/70 • Adverse event data were collected for 18 months from baseline.	0.00% 0/49 • Adverse event data were collected for 18 months from baseline.
Injury, poisoning and procedural complications Hospitalization	0.00% 0/156 • Adverse event data were collected for 18 months from baseline.	0.98% 2/205 • Number of events 2 • Adverse event data were collected for 18 months from baseline.	0.00% 0/70 • Adverse event data were collected for 18 months from baseline.	0.00% 0/49 • Adverse event data were collected for 18 months from baseline.
Gastrointestinal disorders Hospitalization	0.00% 0/156 • Adverse event data were collected for 18 months from baseline.	0.98% 2/205 • Number of events 2 • Adverse event data were collected for 18 months from baseline.	0.00% 0/70 • Adverse event data were collected for 18 months from baseline.	0.00% 0/49 • Adverse event data were collected for 18 months from baseline.
Reproductive system and breast disorders Hospitalization	0.00% 0/156 • Adverse event data were collected for 18 months from baseline.	0.49% 1/205 • Number of events 1 • Adverse event data were collected for 18 months from baseline.	0.00% 0/70 • Adverse event data were collected for 18 months from baseline.	0.00% 0/49 • Adverse event data were collected for 18 months from baseline.
Respiratory, thoracic and mediastinal disorders Hospitalization	0.00% 0/156 • Adverse event data were collected for 18 months from baseline.	0.49% 1/205 • Number of events 1 • Adverse event data were collected for 18 months from baseline.	0.00% 0/70 • Adverse event data were collected for 18 months from baseline.	0.00% 0/49 • Adverse event data were collected for 18 months from baseline.
Cardiac disorders Hospitalization	0.00% 0/156 • Adverse event data were collected for 18 months from baseline.	2.9% 6/205 • Number of events 8 • Adverse event data were collected for 18 months from baseline.	7.1% 5/70 • Number of events 9 • Adverse event data were collected for 18 months from baseline.	2.0% 1/49 • Number of events 1 • Adverse event data were collected for 18 months from baseline.
Endocrine disorders Hospitalization	0.64% 1/156 • Number of events 1 • Adverse event data were collected for 18 months from baseline.	0.00% 0/205 • Adverse event data were collected for 18 months from baseline.	0.00% 0/70 • Adverse event data were collected for 18 months from baseline.	2.0% 1/49 • Number of events 1 • Adverse event data were collected for 18 months from baseline.

Other adverse events

Measure	Usual Care Stage 1 n=156 participants at risk No interventions will be provided to this arm. They will complete planned surveys, and blood draws (baseline, 6 months, and 12 months).	Peer Mentoring n=205 participants at risk Participants in this arm will be mentored for 6 months by a veteran who was once in poor control but is now in good control. They will then be further randomized to either becoming a mentor for 6 months or having no other additional active intervention. All participants in this arm will be evaluated in person at baseline, 6 months, 12 months, and 18 months.	Peer Mentoring FFM (From Former Mentee) n=70 participants at risk Participants in this arm will be mentored by the former mentee for 6 months and will be followed in person for an additional 6 months after the completion of the active intervention.	Usual Care Stage 2 n=49 participants at risk No interventions will be provided to this arm. They will complete planned surveys, and blood draws (baseline, 6 months, and 12 months).
Injury, poisoning and procedural complications ED visit	1.9% 3/156 • Number of events 3 • Adverse event data were collected for 18 months from baseline.	3.4% 7/205 • Number of events 8 • Adverse event data were collected for 18 months from baseline.	4.3% 3/70 • Number of events 3 • Adverse event data were collected for 18 months from baseline.	2.0% 1/49 • Number of events 1 • Adverse event data were collected for 18 months from baseline.
Surgical and medical procedures ED visit	1.9% 3/156 • Number of events 3 • Adverse event data were collected for 18 months from baseline.	2.0% 4/205 • Number of events 6 • Adverse event data were collected for 18 months from baseline.	2.9% 2/70 • Number of events 2 • Adverse event data were collected for 18 months from baseline.	4.1% 2/49 • Number of events 2 • Adverse event data were collected for 18 months from baseline.
Cardiac disorders ED visit	0.64% 1/156 • Number of events 1 • Adverse event data were collected for 18 months from baseline.	0.00% 0/205 • Adverse event data were collected for 18 months from baseline.	0.00% 0/70 • Adverse event data were collected for 18 months from baseline.	0.00% 0/49 • Adverse event data were collected for 18 months from baseline.
Musculoskeletal and connective tissue disorders ED visit	0.64% 1/156 • Number of events 1 • Adverse event data were collected for 18 months from baseline.	0.49% 1/205 • Number of events 1 • Adverse event data were collected for 18 months from baseline.	0.00% 0/70 • Adverse event data were collected for 18 months from baseline.	0.00% 0/49 • Adverse event data were collected for 18 months from baseline.
Skin and subcutaneous tissue disorders ED visit	1.3% 2/156 • Number of events 2 • Adverse event data were collected for 18 months from baseline.	0.49% 1/205 • Number of events 1 • Adverse event data were collected for 18 months from baseline.	0.00% 0/70 • Adverse event data were collected for 18 months from baseline.	0.00% 0/49 • Adverse event data were collected for 18 months from baseline.
General disorders ED visit	0.64% 1/156 • Number of events 1 • Adverse event data were collected for 18 months from baseline.	10.2% 21/205 • Number of events 26 • Adverse event data were collected for 18 months from baseline.	0.00% 0/70 • Adverse event data were collected for 18 months from baseline.	4.1% 2/49 • Number of events 2 • Adverse event data were collected for 18 months from baseline.
Renal and urinary disorders ED visit	0.64% 1/156 • Number of events 1 • Adverse event data were collected for 18 months from baseline.	0.00% 0/205 • Adverse event data were collected for 18 months from baseline.	0.00% 0/70 • Adverse event data were collected for 18 months from baseline.	0.00% 0/49 • Adverse event data were collected for 18 months from baseline.
Infections and infestations ED visit	0.00% 0/156 • Adverse event data were collected for 18 months from baseline.	2.0% 4/205 • Number of events 5 • Adverse event data were collected for 18 months from baseline.	0.00% 0/70 • Adverse event data were collected for 18 months from baseline.	2.0% 1/49 • Number of events 1 • Adverse event data were collected for 18 months from baseline.
Respiratory, thoracic and mediastinal disorders ED visit	0.00% 0/156 • Adverse event data were collected for 18 months from baseline.	1.5% 3/205 • Number of events 5 • Adverse event data were collected for 18 months from baseline.	1.4% 1/70 • Number of events 1 • Adverse event data were collected for 18 months from baseline.	0.00% 0/49 • Adverse event data were collected for 18 months from baseline.
Reproductive system and breast disorders ED visit	0.00% 0/156 • Adverse event data were collected for 18 months from baseline.	0.98% 2/205 • Number of events 2 • Adverse event data were collected for 18 months from baseline.	0.00% 0/70 • Adverse event data were collected for 18 months from baseline.	0.00% 0/49 • Adverse event data were collected for 18 months from baseline.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) ED visit	0.00% 0/156 • Adverse event data were collected for 18 months from baseline.	0.49% 1/205 • Number of events 1 • Adverse event data were collected for 18 months from baseline.	0.00% 0/70 • Adverse event data were collected for 18 months from baseline.	0.00% 0/49 • Adverse event data were collected for 18 months from baseline.
Nervous system disorders ED visit	0.00% 0/156 • Adverse event data were collected for 18 months from baseline.	0.49% 1/205 • Number of events 1 • Adverse event data were collected for 18 months from baseline.	0.00% 0/70 • Adverse event data were collected for 18 months from baseline.	0.00% 0/49 • Adverse event data were collected for 18 months from baseline.

Additional Information

Judith A. Long, MD

Corporal Michael J. Crescenz VA Medical Center

Phone: 215-898-4311

Email: judith.long@va.gov

Results disclosure agreements

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