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

• ClinicalTrials.gov Identifier: NCT01651117
• Recruitment Status: Completed
• First Posted: July 26, 2012
• Results First Posted: September 12, 2019
• Last Update Posted: October 30, 2019
• Sponsor: VA Office of Research and Development
• Information provided by (Responsible Party): VA Office of Research and Development

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Type 2 Diabetes Mellitus	Behavioral: Peer Mentoring	Not Applicable

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.

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 480 participants
• Allocation: Randomized
• Intervention Model: Sequential Assignment
• Masking: Single (Investigator)
• Primary Purpose: Treatment
• Official Title: Using Peer Mentors to Support PACT Team Efforts to Improve Diabetes Control
• Actual Study Start Date: September 1, 2012
• Actual Primary Completion Date: March 21, 2018
• Actual Study Completion Date: October 8, 2018

Arms and Interventions

Arm	Intervention/treatment
No Intervention: Usual Care; 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).
Experimental: 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.	Behavioral: Peer Mentoring; Patients will receive peer mentoring.
Experimental: 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.	Behavioral: Peer Mentoring; Patients will receive peer mentoring.

Outcome Measures

Primary Outcome Measures :

1. Change in Glucose Control (Stage 1: Usual Care v. Peer Mentoring) [ Time Frame: 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)
2. Change in Glucose Control (Stage 2: Usual Care v. Mentees) [ Time Frame: 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)
3. Change in Glucose Control (Stage 2: Non-mentors v. Mentors) [ Time Frame: 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 Outcome Measures :

1. Change in Direct LDL Blood Levels [ Time Frame: 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)
2. Change in Systolic Blood Pressure [ Time Frame: 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)
3. Change in Diabetes Quality of Life Score [ Time Frame: 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)
4. Change in Depression Symptoms [ Time Frame: 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)
5. Change in Glucose Control [ Time Frame: 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)
6. Change in Direct LDL Blood Levels [ Time Frame: Baseline to 12 months ]
   Measured by change in Direct LDL blood levels, adjusted for baseline LDL and patient random effect. LDL is measured as mg/dL. Values of the change variable (difference of 2 levels) can be positive or negative. Negative change, which shows better outcome, occurs when the 12 month LDL is lower than the baseline LDL. (Change = final measure - initial measure)
7. Change in Systolic Blood Pressure [ Time Frame: Baseline to 12 months ]
   Measured by change in systolic Blood Pressure, adjusting for baseline blood pressure and patient random effect. Systolic BP is measured as mmHG. Values of the change variable (difference of 2 levels) can be positive or negative. Negative change, which shows better outcome, occurs when the 12 month BP is lower than the baseline BP. (Change = final measure - initial measure)
8. Change in Diabetes Quality of Life [ Time Frame: 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)
9. Change in Depression Symptoms [ Time Frame: Baseline to 12 months ]
   As measured by change in the Patient Health Questionnaire-2, adjusted for baseline score and patient random effects. The PHQ score is calculated by summing 2 4-point 0-3 Likert scale questions, and ranges from 0 to 6, with lower score indicating lower depression. Values of the change variable can be positive or negative. Negative change, which shows better outcome, occurs when the 12 month PHQ is lower than the baseline PHQ. (Change = final measure - initial measure)
10. Change in Direct LDL Blood Levels (Stage 2: Usual Care v. Mentees) [ Time Frame: 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)
11. Change in Systolic Blood Pressure (Stage 2: Usual Care v. Mentee) [ Time Frame: 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)
12. Change in Diabetes Quality of Life (Stage 2: Usual Care v. Mentee) [ Time Frame: 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)
13. Change in Depression Symptoms (Stage 2: Usual Care v. Mentees) [ Time Frame: 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)
14. Change in Glucose Control (Stage 2: Usual Care v. Mentees) [ Time Frame: 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)
15. Change in Direct LDL Blood Levels (Stage 2: Usual Care v. Mentees) [ Time Frame: Baseline to 12 months ]
    Measured by change in Direct LDL blood levels, adjusted for baseline LDL and patient random effect. LDL is measured as mg/dL. Values of the change variable (difference of 2 levels) can be positive or negative. Negative change, which shows better outcome, occurs when the 12 month LDL is lower than the baseline LDL. (Change = final measure - initial measure)
16. Change in Systolic Blood Pressure (Stage 2: Usual Care v. Mentee) [ Time Frame: Baseline to 12 months ]
    Measured by change in systolic Blood Pressure, adjusting for baseline blood pressure and patient random effect. Systolic BP is measured as mmHG. Values of the change variable (difference of 2 levels) can be positive or negative. Negative change, which shows better outcome, occurs when the 12 month BP is lower than the baseline BP. (Change = final measure - initial measure)
17. Change in Diabetes Quality of Life (Stage 2: Usual Care v. Mentee) [ Time Frame: 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)
18. Change in Depression Symptoms (Stage 2: Usual Care v. Mentees) [ Time Frame: Baseline to 12 months ]
    As measured by change in the Patient Health Questionnaire-2, adjusted for baseline score and patient random effects. The PHQ score is calculated by summing 2 4-point 0-3 Likert scale questions, and ranges from 0 to 6, with lower score indicating lower depression. Values of the change variable can be positive or negative. Negative change, which shows better outcome, occurs when the 12 month PHQ is lower than the baseline PHQ. (Change = final measure - initial measure)
19. Change in Direct LDL Blood Levels (Stage 2: Non-mentors v. Mentors) [ Time Frame: 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)
20. Change in Systolic Blood Pressure (Stage 2: Non-mentors v. Mentors) [ Time Frame: 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)
21. Change in Diabetes Quality of Life (Stage 2: Non-mentors v. Mentors) [ Time Frame: 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)
22. Change in Depression Symptoms (Stage 2: Non-mentors v. Mentors) [ Time Frame: 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)
23. Change in Glucose Control (Stage 2: Non-mentors v. Mentors) [ Time Frame: 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)
24. Change in Direct LDL Blood Levels (Stage 2: Non-mentors v. Mentors) [ Time Frame: Baseline to 12 months ]
    Measured by change in Direct LDL blood levels, adjusted for baseline LDL and patient random effect. LDL is measured as mg/dL. Values of the change variable (difference of 2 levels) can be positive or negative. Negative change, which shows better outcome, occurs when the 12 month LDL is lower than the baseline LDL. (Change = final measure - initial measure)
25. Change in Systolic Blood Pressure (Stage 2: Non-mentors v. Mentors) [ Time Frame: Baseline to 12 months ]
    Measured by change in systolic Blood Pressure, adjusting for baseline blood pressure and patient random effect. Systolic BP is measured as mmHG. Values of the change variable (difference of 2 levels) can be positive or negative. Negative change, which shows better outcome, occurs when the 12 month BP is lower than the baseline BP. (Change = final measure - initial measure)
26. Change in Diabetes Quality of Life (Stage 2: Non-mentors v. Mentors) [ Time Frame: 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)
27. Change in Depression Symptoms (Stage 2: Non-mentors v. Mentors) [ Time Frame: Baseline to 12 months ]
    As measured by change in the Patient Health Questionnaire-2, adjusted for baseline score and patient random effects. The PHQ score is calculated by summing 2 4-point 0-3 Likert scale questions, and ranges from 0 to 6, with lower score indicating lower depression. Values of the change variable can be positive or negative. Negative change, which shows better outcome, occurs when the 12 month PHQ is lower than the baseline PHQ. (Change = final measure - initial measure)

Eligibility Criteria

• Ages Eligible for Study: 30 Years to 75 Years (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Criteria

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

Exclusion Criteria:

Exclusion Criteria:

• Does not speak English
• Unable to understand consents
• Severe speech impediment
• over the age of 75

Contacts and Locations

Locations

United States, Pennsylvania

Corporal Michael J. Crescenz VA Medical Center, Philadelphia, PA

Philadelphia, Pennsylvania, United States, 19104

Sponsors and Collaborators

VA Office of Research and Development

Investigators

• Principal Investigator: Judith A. Long, MD; Corporal Michael J. Crescenz VA Medical Center, Philadelphia, PA

  Study Documents (Full-Text)

Documents provided by VA Office of Research and Development:

Study Protocol and Statistical Analysis Plan  [PDF] January 13, 2016

More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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.

• Responsible Party: VA Office of Research and Development
• ClinicalTrials.gov Identifier: NCT01651117
• Other Study ID Numbers: IIR 12-407
• First Posted: July 26, 2012
• Results First Posted: September 12, 2019
• Last Update Posted: October 30, 2019
• Last Verified: October 2019

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: Yes
• Plan Description: Data will be made available upon request of the PI

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Product Manufactured in and Exported from the U.S.: No

Keywords provided by VA Office of Research and Development:

Diabetes Mellitus; Mentors; Glucose control; Hemoglobin A, Glycosylated; Randomized Controlled Trial; Veterans

Additional relevant MeSH terms:

Diabetes Mellitus; Diabetes Mellitus, Type 2; Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases