Type 2 Diabetes Mellitus
Conditions
Keywords
Diabetes Mellitus, Mentors, Glucose control, Hemoglobin A, Glycosylated, Randomized Controlled Trial, Veterans
Brief summary
The purpose of this study is to test the effectiveness of a peer mentor model in a mixed race population of poorly controlled diabetic Veterans. Also, the study aims to assess the effects of becoming a mentor on those who originally were mentees. It is expected that participants in the peer mentoring arms (Arm 2 and 3) will have improved glucose control regardless of race or ethnicity at the end of the intervention.
Detailed description
The primary objectives of this study are: (1) test the long-term effectiveness of a peer mentor model on improving glucose control, blood pressure, LDL levels, diabetes mellitus quality of life, and depression scores in a mixed race population of poorly controlled diabetic Veterans; (2) test the effectiveness of using former peer mentees as peer mentors as a means of creating a self-sustaining program; and (3) and test the effects of becoming a mentor on those who were originally mentees given a growing literature that being a mentor is good for your health. Secondary objectives include: (1) in those randomized to being a mentee, explore mentor characteristics associated with improved HbA1c. This study will be a prospective randomized controlled trial. Outcomes to be measured include glycosylated hemoglobin, blood pressure, direct LDL, diabetes quality of life and depression. The trial has two phases. In phase one, patients with poorly controlled diabetes are randomized to usual care or receiving peer mentoring. In phase two, poorly controlled diabetics are randomized to usual care or receiving peer mentoring from former mentees. Former mentees from phase 1 are also randomized such that they will have a 50% chance of becoming a mentor.
Interventions
BEHAVIORALPeer Mentoring
Patients will receive peer mentoring.
Sponsors
VA Office of Research and Development
Study design
Allocation
RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT
Masking
SINGLE (Investigator)
Eligibility
Sex/Gender
ALL
Age
30 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
Inclusion Criteria: * All participants must have a diagnosis of Type 2 diabetics. * Diabetes began after age 30 * Mentees: Have an HbA1c \> 8% on 2 different occasions in the course of 24 months, with at least one measure within 3 months of enrollment * Mentors for Phase 1: Had an HbA1c of \> 8% in the past 3 years and an HbA1c \< (or equal to) 7.5% within 3 months of enrollment * Mentors for Phase 2: Former mentee
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Glucose Control (Stage 1: Usual Care v. Peer Mentoring) | 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) |
| Change in Glucose Control (Stage 2: Usual Care v. Mentees) | 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) |
| Change in Glucose Control (Stage 2: Non-mentors v. Mentors) | 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) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in Depression Symptoms | 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) |
| Change in Glucose Control | 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) |
| Change in Diabetes Quality of Life | 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) |
| Change in Direct LDL Blood Levels (Stage 2: Usual Care v. Mentees) | 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) |
| Change in Systolic Blood Pressure (Stage 2: Usual Care v. Mentee) | 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) |
| Change in Diabetes Quality of Life (Stage 2: Usual Care v. Mentee) | 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) |
| Change in Direct LDL Blood Levels | 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) |
| Change in Glucose Control (Stage 2: Usual Care v. Mentees) | 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) |
| Change in Direct LDL Blood Levels (Stage 2: Non-mentors v. Mentors) | 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) |
| Change in Systolic Blood Pressure (Stage 2: Non-mentors v. Mentors) | 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) |
| Change in Diabetes Quality of Life (Stage 2: Non-mentors v. Mentors) | 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) |
| Change in Depression Symptoms (Stage 2: Non-mentors v. Mentors) | 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) |
| Change in Glucose Control (Stage 2: Non-mentors v. Mentors) | 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) |
| Change in Depression Symptoms (Stage 2: Usual Care v. Mentees) | 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) |
| Change in Systolic Blood Pressure | 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) |
| Change in Diabetes Quality of Life Score | 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) |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Stage 1 Usual Care Poorly controlled diabetics randomized to no intervention will complete planned surveys, and blood draws (baseline, 6 months, and 12 months). | 154 |
| 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. | 202 |
| 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). | 47 |
| 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. | 68 |
| Total | 471 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 |
|---|---|---|---|---|---|
| Overall Study | Death | 2 | 3 | 2 | 2 |
Baseline characteristics
| Characteristic | Stage 1 Usual Care | Total | Stage 2 Peer Mentoring FFM (From Former Mentee) | Stage 2 Usual Care | Stage 1 Peer Mentoring |
|---|---|---|---|---|---|
| Age, Continuous | 60.6 years STANDARD_DEVIATION 7.4 | 60.6 years STANDARD_DEVIATION 7.5 | 62.3 years STANDARD_DEVIATION 6.9 | 62.3 years STANDARD_DEVIATION 6.8 | 59.6 years STANDARD_DEVIATION 7.9 |
| Baseline HbA1c | 9.8 percent STANDARD_DEVIATION 1.6 | 9.5 percent STANDARD_DEVIATION 1.7 | 9.2 percent STANDARD_DEVIATION 1.7 | 9.7 percent STANDARD_DEVIATION 2 | 9.3 percent STANDARD_DEVIATION 1.6 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 11 Participants | 27 Participants | 1 Participants | 4 Participants | 11 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 143 Participants | 444 Participants | 67 Participants | 43 Participants | 191 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race/Ethnicity, Customized Black | 93 Participants | 311 Participants | 45 Participants | 37 Participants | 136 Participants |
| Race/Ethnicity, Customized Multiple Race | 2 Participants | 10 Participants | 3 Participants | 0 Participants | 5 Participants |
| Race/Ethnicity, Customized Other Race | 19 Participants | 31 Participants | 0 Participants | 1 Participants | 11 Participants |
| Race/Ethnicity, Customized White | 40 Participants | 119 Participants | 20 Participants | 9 Participants | 50 Participants |
| Region of Enrollment United States | 154 Participants | 471 Participants | 68 Participants | 47 Participants | 202 Participants |
| Sex: Female, Male Female | 8 Participants | 17 Participants | 2 Participants | 0 Participants | 7 Participants |
| Sex: Female, Male Male | 146 Participants | 454 Participants | 66 Participants | 47 Participants | 195 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk |
|---|---|---|---|---|
| deaths Total, all-cause mortality | 2 / 156 | 3 / 205 | 2 / 70 | 2 / 49 |
| other Total, other adverse events | 11 / 156 | 38 / 205 | 6 / 70 | 5 / 49 |
| serious Total, serious adverse events | 10 / 156 | 28 / 205 | 12 / 70 | 2 / 49 |
Outcome results
Primary
Change in Glucose Control (Stage 1: Usual Care v. Peer Mentoring)
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)
Time frame: Baseline to 6 months
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Stage 1 Usual Care | Change in Glucose Control (Stage 1: Usual Care v. Peer Mentoring) | -0.1978 percent |
| Stage 1 Peer Mentoring | Change in Glucose Control (Stage 1: Usual Care v. Peer Mentoring) | -0.5246 percent |
p-value: 0.061195% CI: [-0.669, 0.0154]Mixed Models Analysis
Primary
Change in Glucose Control (Stage 2: Non-mentors v. Mentors)
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)
Time frame: 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).
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Stage 1 Usual Care | Change in Glucose Control (Stage 2: Non-mentors v. Mentors) | 0.3156 percent |
| Stage 1 Peer Mentoring | Change in Glucose Control (Stage 2: Non-mentors v. Mentors) | 0.1449 percent |
Primary
Change in Glucose Control (Stage 2: Usual Care v. Mentees)
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)
Time frame: Baseline to 6 months
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Stage 1 Usual Care | Change in Glucose Control (Stage 2: Usual Care v. Mentees) | -0.4587 percent |
| Stage 1 Peer Mentoring | Change in Glucose Control (Stage 2: Usual Care v. Mentees) | 0.0772 percent |
Secondary
Change in Depression Symptoms
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)
Time frame: Baseline to 12 months
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Stage 1 Usual Care | Change in Depression Symptoms | -0.1168 score on a scale |
| Stage 1 Peer Mentoring | Change in Depression Symptoms | -0.1736 score on a scale |
Secondary
Change in Depression Symptoms
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)
Time frame: Baseline to 6 months
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Stage 1 Usual Care | Change in Depression Symptoms | -0.0502 score on a scale |
| Stage 1 Peer Mentoring | Change in Depression Symptoms | -0.0389 score on a scale |
Secondary
Change in Depression Symptoms (Stage 2: Non-mentors v. Mentors)
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)
Time frame: 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).
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Stage 1 Usual Care | Change in Depression Symptoms (Stage 2: Non-mentors v. Mentors) | 0.0609 score on a scale |
| Stage 1 Peer Mentoring | Change in Depression Symptoms (Stage 2: Non-mentors v. Mentors) | -0.0819 score on a scale |
Secondary
Change in Depression Symptoms (Stage 2: Non-mentors v. Mentors)
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)
Time frame: 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).
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Stage 1 Usual Care | Change in Depression Symptoms (Stage 2: Non-mentors v. Mentors) | -0.3314 score on a scale |
| Stage 1 Peer Mentoring | Change in Depression Symptoms (Stage 2: Non-mentors v. Mentors) | -0.1809 score on a scale |
Secondary
Change in Depression Symptoms (Stage 2: Usual Care v. Mentees)
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)
Time frame: Baseline to 6 months
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Stage 1 Usual Care | Change in Depression Symptoms (Stage 2: Usual Care v. Mentees) | -0.3186 score on a scale |
| Stage 1 Peer Mentoring | Change in Depression Symptoms (Stage 2: Usual Care v. Mentees) | -0.2627 score on a scale |
Secondary
Change in Depression Symptoms (Stage 2: Usual Care v. Mentees)
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)
Time frame: Baseline to 12 months
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Stage 1 Usual Care | Change in Depression Symptoms (Stage 2: Usual Care v. Mentees) | -0.4581 score on a scale |
| Stage 1 Peer Mentoring | Change in Depression Symptoms (Stage 2: Usual Care v. Mentees) | -0.0890 score on a scale |
Secondary
Change in Diabetes Quality of Life
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)
Time frame: Baseline to 12 months
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Stage 1 Usual Care | Change in Diabetes Quality of Life | -0.1213 score on a scale |
| Stage 1 Peer Mentoring | Change in Diabetes Quality of Life | -0.1812 score on a scale |
Secondary
Change in Diabetes Quality of Life Score
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)
Time frame: Baseline to 6 months
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Stage 1 Usual Care | Change in Diabetes Quality of Life Score | 0.0159 score on a scale |
| Stage 1 Peer Mentoring | Change in Diabetes Quality of Life Score | -0.0371 score on a scale |
Secondary
Change in Diabetes Quality of Life (Stage 2: Non-mentors v. Mentors)
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)
Time frame: 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).
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Stage 1 Usual Care | Change in Diabetes Quality of Life (Stage 2: Non-mentors v. Mentors) | -0.1896 score on a scale |
| Stage 1 Peer Mentoring | Change in Diabetes Quality of Life (Stage 2: Non-mentors v. Mentors) | -0.3017 score on a scale |
Secondary
Change in Diabetes Quality of Life (Stage 2: Non-mentors v. Mentors)
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)
Time frame: 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).
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Stage 1 Usual Care | Change in Diabetes Quality of Life (Stage 2: Non-mentors v. Mentors) | -0.1006 score on a scale |
| Stage 1 Peer Mentoring | Change in Diabetes Quality of Life (Stage 2: Non-mentors v. Mentors) | -0.1332 score on a scale |
Secondary
Change in Diabetes Quality of Life (Stage 2: Usual Care v. Mentee)
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)
Time frame: Baseline to 12 months
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Stage 1 Usual Care | Change in Diabetes Quality of Life (Stage 2: Usual Care v. Mentee) | -0.1299 score on a scale |
| Stage 1 Peer Mentoring | Change in Diabetes Quality of Life (Stage 2: Usual Care v. Mentee) | -0.0246 score on a scale |
Secondary
Change in Diabetes Quality of Life (Stage 2: Usual Care v. Mentee)
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)
Time frame: Baseline to 6 months
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Stage 1 Usual Care | Change in Diabetes Quality of Life (Stage 2: Usual Care v. Mentee) | 0.1024 score on a scale |
| Stage 1 Peer Mentoring | Change in Diabetes Quality of Life (Stage 2: Usual Care v. Mentee) | -0.4098 score on a scale |
Secondary
Change in Direct LDL Blood Levels
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)
Time frame: Baseline to 12 months
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Stage 1 Usual Care | Change in Direct LDL Blood Levels | -7.1706 mg/dL |
| Stage 1 Peer Mentoring | Change in Direct LDL Blood Levels | -7.8594 mg/dL |
Secondary
Change in Direct LDL Blood Levels
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)
Time frame: Baseline to 6 months
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Stage 1 Usual Care | Change in Direct LDL Blood Levels | -2.0793 mg/dL |
| Stage 1 Peer Mentoring | Change in Direct LDL Blood Levels | -4.3098 mg/dL |
Secondary
Change in Direct LDL Blood Levels (Stage 2: Non-mentors v. Mentors)
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)
Time frame: 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).
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Stage 1 Usual Care | Change in Direct LDL Blood Levels (Stage 2: Non-mentors v. Mentors) | -2.1692 mg/dL |
| Stage 1 Peer Mentoring | Change in Direct LDL Blood Levels (Stage 2: Non-mentors v. Mentors) | -7.4649 mg/dL |
Secondary
Change in Direct LDL Blood Levels (Stage 2: Non-mentors v. Mentors)
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)
Time frame: 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).
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Stage 1 Usual Care | Change in Direct LDL Blood Levels (Stage 2: Non-mentors v. Mentors) | -1.0938 mg/dL |
| Stage 1 Peer Mentoring | Change in Direct LDL Blood Levels (Stage 2: Non-mentors v. Mentors) | 2.2494 mg/dL |
Secondary
Change in Direct LDL Blood Levels (Stage 2: Usual Care v. Mentees)
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)
Time frame: Baseline to 12 months
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Stage 1 Usual Care | Change in Direct LDL Blood Levels (Stage 2: Usual Care v. Mentees) | 5.0419 mg/dL |
| Stage 1 Peer Mentoring | Change in Direct LDL Blood Levels (Stage 2: Usual Care v. Mentees) | -4.9126 mg/dL |
Secondary
Change in Direct LDL Blood Levels (Stage 2: Usual Care v. Mentees)
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)
Time frame: Baseline to 6 months
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Stage 1 Usual Care | Change in Direct LDL Blood Levels (Stage 2: Usual Care v. Mentees) | 7.9124 mg/dL |
| Stage 1 Peer Mentoring | Change in Direct LDL Blood Levels (Stage 2: Usual Care v. Mentees) | -1.6217 mg/dL |
Secondary
Change in Glucose Control
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)
Time frame: Baseline to 12 months
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Stage 1 Usual Care | Change in Glucose Control | -0.2643 percent |
| Stage 1 Peer Mentoring | Change in Glucose Control | -0.2818 percent |
Secondary
Change in Glucose Control (Stage 2: Non-mentors v. Mentors)
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)
Time frame: 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).
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Stage 1 Usual Care | Change in Glucose Control (Stage 2: Non-mentors v. Mentors) | 0.2396 percent |
| Stage 1 Peer Mentoring | Change in Glucose Control (Stage 2: Non-mentors v. Mentors) | 0.0639 percent |
Secondary
Change in Glucose Control (Stage 2: Usual Care v. Mentees)
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)
Time frame: Baseline to 12 months
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Stage 1 Usual Care | Change in Glucose Control (Stage 2: Usual Care v. Mentees) | -0.2661 percent |
| Stage 1 Peer Mentoring | Change in Glucose Control (Stage 2: Usual Care v. Mentees) | -0.1628 percent |
Secondary
Change in Systolic Blood Pressure
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)
Time frame: Baseline to 12 months
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Stage 1 Usual Care | Change in Systolic Blood Pressure | -3.7548 mmHG |
| Stage 1 Peer Mentoring | Change in Systolic Blood Pressure | -2.3274 mmHG |
Secondary
Change in Systolic Blood Pressure
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)
Time frame: Baseline to 6 months
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Stage 1 Usual Care | Change in Systolic Blood Pressure | -3.4477 mmHG |
| Stage 1 Peer Mentoring | Change in Systolic Blood Pressure | -0.8695 mmHG |
Secondary
Change in Systolic Blood Pressure (Stage 2: Non-mentors v. Mentors)
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)
Time frame: 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).
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Stage 1 Usual Care | Change in Systolic Blood Pressure (Stage 2: Non-mentors v. Mentors) | -3.9453 mmHG |
| Stage 1 Peer Mentoring | Change in Systolic Blood Pressure (Stage 2: Non-mentors v. Mentors) | -0.5611 mmHG |
Secondary
Change in Systolic Blood Pressure (Stage 2: Non-mentors v. Mentors)
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)
Time frame: 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).
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Stage 1 Usual Care | Change in Systolic Blood Pressure (Stage 2: Non-mentors v. Mentors) | -1.6942 mmHG |
| Stage 1 Peer Mentoring | Change in Systolic Blood Pressure (Stage 2: Non-mentors v. Mentors) | -1.0527 mmHG |
Secondary
Change in Systolic Blood Pressure (Stage 2: Usual Care v. Mentee)
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)
Time frame: Baseline to 6 months
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Stage 1 Usual Care | Change in Systolic Blood Pressure (Stage 2: Usual Care v. Mentee) | 1.4718 mmHG |
| Stage 1 Peer Mentoring | Change in Systolic Blood Pressure (Stage 2: Usual Care v. Mentee) | 0.1876 mmHG |
Secondary
Change in Systolic Blood Pressure (Stage 2: Usual Care v. Mentee)
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)
Time frame: Baseline to 12 months
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Stage 1 Usual Care | Change in Systolic Blood Pressure (Stage 2: Usual Care v. Mentee) | -1.6851 mmHG |
| Stage 1 Peer Mentoring | Change in Systolic Blood Pressure (Stage 2: Usual Care v. Mentee) | 1.3877 mmHG |