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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Usual Care | No Intervention | Enrolled in two different time frames. No interventions will be provided to this arm. They will complete planned surveys, and blood draws (baseline, 6 months, and 12 months). | |
| Peer Mentoring | Experimental | 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. |
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| Peer Mentoring FFM (from former mentee) | Experimental | 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Peer Mentoring | Behavioral | Patients will receive peer mentoring. |
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| Measure | Description | Time Frame |
|---|---|---|
| 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) | Baseline to 6 months |
| 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) | Baseline to 6 months |
| 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) | Baseline to 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| 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) | Baseline to 6 months |
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Inclusion Criteria:
Inclusion Criteria:
Exclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Judith A. Long, MD | Corporal Michael J. Crescenz VA Medical Center, Philadelphia, PA | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Corporal Michael J. Crescenz VA Medical Center, Philadelphia, PA | Philadelphia | Pennsylvania | 19104 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 32915236 | Derived | Long JA, Ganetsky VS, Canamucio A, Dicks TN, Heisler M, Marcus SC. Effect of Peer Mentors in Diabetes Self-management vs Usual Care on Outcomes in US Veterans With Type 2 Diabetes: A Randomized Clinical Trial. JAMA Netw Open. 2020 Sep 1;3(9):e2016369. doi: 10.1001/jamanetworkopen.2020.16369. |
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Data will be made available upon request of the PI
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| ID | Title | Description |
|---|---|---|
| FG000 | Stage 1 Usual Care | Poorly controlled diabetics randomized to no intervention will complete planned surveys, and blood draws (baseline, 6 months, and 12 months). |
| FG001 | 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. |
| FG002 | 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). |
| FG003 | 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | Stage 1 Usual Care | Poorly controlled diabetics randomized to no intervention will complete planned surveys, and blood draws (baseline, 6 months, and 12 months). |
| BG001 | Stage 1 Peer Mentoring |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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) | Posted | Mean | 95% Confidence Interval | percent | Baseline to 6 months |
|
Adverse event data were collected for 18 months from baseline.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Usual Care Stage 1 | No interventions will be provided to this arm. They will complete planned surveys, and blood draws (baseline, 6 months, and 12 months). |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Hospitalization | Nervous system disorders | Systematic Assessment | We considered any hospitalization (any participant who had to stay in the hospital overnight due to their condition) an SAE. Therefore, these numbers represent those who were hospitalized as a result of an SAE. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| ED visit | Injury, poisoning and procedural complications | Systematic Assessment | We considered any ED visit (any participant who went to the emergency room due to their condition) an AE. Therefore, these numbers represent those who went to the emergency room as a result of an AE. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Judith A. Long, MD | Corporal Michael J. Crescenz VA Medical Center | 215-898-4311 | judith.long@va.gov |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jan 13, 2016 | Mar 26, 2019 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D003924 | Diabetes Mellitus, Type 2 |
| D003920 | Diabetes Mellitus |
| ID | Term |
|---|---|
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D004700 | Endocrine System Diseases |
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| 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) | Baseline to 6 months |
| 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) | Baseline to 6 months |
| 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) | Baseline to 6 months |
| 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) | Baseline to 12 months |
| 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) | Baseline to 12 months |
| 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) | Baseline to 12 months |
| 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) | Baseline to 12 months |
| 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) | Baseline to 12 months |
| 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) | Baseline to 6 months |
| 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) | Baseline to 6 months |
| 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) | Baseline to 6 months |
| 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) | Baseline to 6 months |
| 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) | Baseline to 12 months |
| 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) | Baseline to 12 months |
| 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) | Baseline to 12 months |
| 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) | Baseline to 12 months |
| 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) | Baseline to 12 months |
| 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) | Baseline to 6 months |
| 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) | Baseline to 6 months |
| 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) | Baseline to 6 months |
| 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) | Baseline to 6 months |
| 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) | Baseline to 12 months |
| 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) | Baseline to 12 months |
| 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) | Baseline to 12 months |
| 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) | Baseline to 12 months |
| 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) | Baseline to 12 months |
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.
| BG002 | 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). |
| BG003 | 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. |
| BG004 | Total | Total of all reporting groups |
| years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race/Ethnicity, Customized | Count of Participants | Participants |
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| Region of Enrollment | Count of Participants | Participants |
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| Baseline HbA1c | Mean | Standard Deviation | percent |
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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.
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| 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) | Posted | Mean | 95% Confidence Interval | percent | Baseline to 6 months |
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| 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) | 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). | Posted | Mean | 95% Confidence Interval | percent | Baseline to 6 months |
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| 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) | Posted | Mean | 95% Confidence Interval | mg/dL | Baseline to 6 months |
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| 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) | Posted | Mean | 95% Confidence Interval | mmHG | Baseline to 6 months |
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| 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) | Posted | Mean | 95% Confidence Interval | score on a scale | Baseline to 6 months |
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| 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) | Posted | Mean | 95% Confidence Interval | score on a scale | Baseline to 6 months |
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| 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) | Posted | Mean | 95% Confidence Interval | percent | Baseline to 12 months |
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| 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) | Posted | Mean | 95% Confidence Interval | mg/dL | Baseline to 12 months |
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| 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) | Posted | Mean | 95% Confidence Interval | mmHG | Baseline to 12 months |
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| 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) | Posted | Mean | 95% Confidence Interval | score on a scale | Baseline to 12 months |
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| 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) | Posted | Mean | 95% Confidence Interval | score on a scale | Baseline to 12 months |
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| 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) | Posted | Mean | 95% Confidence Interval | mg/dL | Baseline to 6 months |
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| 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) | Posted | Mean | 95% Confidence Interval | mmHG | Baseline to 6 months |
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| 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) | Posted | Mean | 95% Confidence Interval | score on a scale | Baseline to 6 months |
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| 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) | Posted | Mean | 95% Confidence Interval | score on a scale | Baseline to 6 months |
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| 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) | Posted | Mean | 95% Confidence Interval | percent | Baseline to 12 months |
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| 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) | Posted | Mean | 95% Confidence Interval | mg/dL | Baseline to 12 months |
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| 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) | Posted | Mean | 95% Confidence Interval | mmHG | Baseline to 12 months |
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| 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) | Posted | Mean | 95% Confidence Interval | score on a scale | Baseline to 12 months |
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| 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) | Posted | Mean | 95% Confidence Interval | score on a scale | Baseline to 12 months |
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| 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) | 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). | Posted | Mean | 95% Confidence Interval | mg/dL | Baseline to 6 months |
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| 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) | 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). | Posted | Mean | 95% Confidence Interval | mmHG | Baseline to 6 months |
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| 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) | 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). | Posted | Mean | 95% Confidence Interval | score on a scale | Baseline to 6 months |
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| 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) | 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). | Posted | Mean | 95% Confidence Interval | score on a scale | Baseline to 6 months |
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| 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) | 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). | Posted | Mean | 95% Confidence Interval | percent | Baseline to 12 months |
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| 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) | 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). | Posted | Mean | 95% Confidence Interval | mg/dL | Baseline to 12 months |
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| 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) | 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). | Posted | Mean | 95% Confidence Interval | mmHG | Baseline to 12 months |
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| 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) | 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). | Posted | Mean | 95% Confidence Interval | score on a scale | Baseline to 12 months |
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| 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) | 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). | Posted | Mean | 95% Confidence Interval | score on a scale | Baseline to 12 months |
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| 2 |
| 156 |
| 10 |
| 156 |
| 11 |
| 156 |
| EG001 | Peer Mentoring | 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. | 3 | 205 | 28 | 205 | 38 | 205 |
| EG002 | Peer Mentoring FFM (From Former Mentee) | 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. | 2 | 70 | 12 | 70 | 6 | 70 |
| EG003 | Usual Care Stage 2 | No interventions will be provided to this arm. They will complete planned surveys, and blood draws (baseline, 6 months, and 12 months). | 2 | 49 | 2 | 49 | 5 | 49 |
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| Hospitalization | General disorders | Systematic Assessment | We considered any hospitalization (any participant who had to stay in the hospital overnight due to their condition) an SAE. Therefore, these numbers represent those who were hospitalized as a result of an SAE. |
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| Hospitalization | Infections and infestations | Systematic Assessment | We considered any hospitalization (any participant who had to stay in the hospital overnight due to their condition) an SAE. Therefore, these numbers represent those who were hospitalized as a result of an SAE. |
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| Hospitalization | Musculoskeletal and connective tissue disorders | Systematic Assessment | We considered any hospitalization (any participant who had to stay in the hospital overnight due to their condition) an SAE. Therefore, these numbers represent those who were hospitalized as a result of an SAE. |
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| Hospitalization | Renal and urinary disorders | Systematic Assessment | We considered any hospitalization (any participant who had to stay in the hospital overnight due to their condition) an SAE. Therefore, these numbers represent those who were hospitalized as a result of an SAE. |
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| Hospitalization | Surgical and medical procedures | Systematic Assessment | We considered any hospitalization (any participant who had to stay in the hospital overnight due to their condition) an SAE. Therefore, these numbers represent those who were hospitalized as a result of an SAE. |
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| Hospitalization | Psychiatric disorders | Systematic Assessment | We considered any hospitalization (any participant who had to stay in the hospital overnight due to their condition) an SAE. Therefore, these numbers represent those who were hospitalized as a result of an SAE. |
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| Hospitalization | Immune system disorders | Systematic Assessment | We considered any hospitalization (any participant who had to stay in the hospital overnight due to their condition) an SAE. Therefore, these numbers represent those who were hospitalized as a result of an SAE. |
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| Hospitalization | Injury, poisoning and procedural complications | Systematic Assessment | We considered any hospitalization (any participant who had to stay in the hospital overnight due to their condition) an SAE. Therefore, these numbers represent those who were hospitalized as a result of an SAE. |
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| Hospitalization | Gastrointestinal disorders | Systematic Assessment | We considered any hospitalization (any participant who had to stay in the hospital overnight due to their condition) an SAE. Therefore, these numbers represent those who were hospitalized as a result of an SAE. |
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| Hospitalization | Reproductive system and breast disorders | Systematic Assessment | We considered any hospitalization (any participant who had to stay in the hospital overnight due to their condition) an SAE. Therefore, these numbers represent those who were hospitalized as a result of an SAE. |
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| Hospitalization | Respiratory, thoracic and mediastinal disorders | Systematic Assessment | We considered any hospitalization (any participant who had to stay in the hospital overnight due to their condition) an SAE. Therefore, these numbers represent those who were hospitalized as a result of an SAE. |
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| Hospitalization | Cardiac disorders | Systematic Assessment | We considered any hospitalization (any participant who had to stay in the hospital overnight due to their condition) an SAE. Therefore, these numbers represent those who were hospitalized as a result of an SAE. |
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| Hospitalization | Endocrine disorders | Systematic Assessment | We considered any hospitalization (any participant who had to stay in the hospital overnight due to their condition) an SAE. Therefore, these numbers represent those who were hospitalized as a result of an SAE. |
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| ED visit | Surgical and medical procedures | Systematic Assessment | We considered any ED visit (any participant who went to the emergency room due to their condition) an AE. Therefore, these numbers represent those who went to the emergency room as a result of an AE. |
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| ED visit | Cardiac disorders | Systematic Assessment | We considered any ED visit (any participant who went to the emergency room due to their condition) an AE. Therefore, these numbers represent those who went to the emergency room as a result of an AE. |
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| ED visit | Musculoskeletal and connective tissue disorders | Systematic Assessment | We considered any ED visit (any participant who went to the emergency room due to their condition) an AE. Therefore, these numbers represent those who went to the emergency room as a result of an AE. |
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| ED visit | Skin and subcutaneous tissue disorders | Systematic Assessment | We considered any ED visit (any participant who went to the emergency room due to their condition) an AE. Therefore, these numbers represent those who went to the emergency room as a result of an AE. |
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| ED visit | General disorders | Systematic Assessment | We considered any ED visit (any participant who went to the emergency room due to their condition) an AE. Therefore, these numbers represent those who went to the emergency room as a result of an AE. |
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| ED visit | Renal and urinary disorders | Systematic Assessment | We considered any ED visit (any participant who went to the emergency room due to their condition) an AE. Therefore, these numbers represent those who went to the emergency room as a result of an AE. |
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| ED visit | Infections and infestations | Systematic Assessment | We considered any ED visit (any participant who went to the emergency room due to their condition) an AE. Therefore, these numbers represent those who went to the emergency room as a result of an AE. |
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| ED visit | Respiratory, thoracic and mediastinal disorders | Systematic Assessment | We considered any ED visit (any participant who went to the emergency room due to their condition) an AE. Therefore, these numbers represent those who went to the emergency room as a result of an AE. |
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| ED visit | Reproductive system and breast disorders | Systematic Assessment | We considered any ED visit (any participant who went to the emergency room due to their condition) an AE. Therefore, these numbers represent those who went to the emergency room as a result of an AE. |
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| ED visit | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | Systematic Assessment | We considered any ED visit (any participant who went to the emergency room due to their condition) an AE. Therefore, these numbers represent those who went to the emergency room as a result of an AE. |
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| ED visit | Nervous system disorders | Systematic Assessment | We considered any ED visit (any participant who went to the emergency room due to their condition) an AE. Therefore, these numbers represent those who went to the emergency room as a result of an AE. |
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