Using Peer Mentors to Support PACT Team Efforts to Improve Diabetes Control
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Enrollment
- 480
- Locations
- 2
- Primary Endpoint
- Change in Glucose Control (Stage 1: Usual Care v. Peer Mentoring)
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Sequential
- Primary Purpose
- Treatment
- Masking
- Single (Investigator)
Eligibility Criteria
- Ages
- 30 Years to 75 Years (Adult, Older Adult)
- Sex
- All
- Accepts 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
Exclusion Criteria
- •Exclusion Criteria:
- •Does not speak English
- •Unable to understand consents
- •Severe speech impediment
- •over the age of 75
Arms & Interventions
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).
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.
Intervention: Peer Mentoring (Behavioral)
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.
Intervention: Peer Mentoring (Behavioral)
Outcomes
Primary Outcomes
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)
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)
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 Outcomes
- Change in Direct LDL Blood Levels(Baseline to 12 months)
- Change in Systolic Blood Pressure(Baseline to 12 months)
- Change in Diabetes Quality of Life Score(Baseline to 6 months)
- Change in Depression Symptoms(Baseline to 12 months)
- Change in Glucose Control(Baseline to 12 months)
- Change in Diabetes Quality of Life(Baseline to 12 months)
- Change in Direct LDL Blood Levels (Stage 2: Usual Care v. Mentees)(Baseline to 12 months)
- Change in Systolic Blood Pressure (Stage 2: Usual Care v. Mentee)(Baseline to 12 months)
- Change in Diabetes Quality of Life (Stage 2: Usual Care v. Mentee)(Baseline to 12 months)
- Change in Depression Symptoms (Stage 2: Usual Care v. Mentees)(Baseline to 12 months)
- Change in Glucose Control (Stage 2: Usual Care v. Mentees)(Baseline to 12 months)
- Change in Direct LDL Blood Levels (Stage 2: Non-mentors v. Mentors)(Baseline to 12 months)
- Change in Systolic Blood Pressure (Stage 2: Non-mentors v. Mentors)(Baseline to 12 months)
- Change in Diabetes Quality of Life (Stage 2: Non-mentors v. Mentors)(Baseline to 12 months)
- Change in Depression Symptoms (Stage 2: Non-mentors v. Mentors)(Baseline to 12 months)
- Change in Glucose Control (Stage 2: Non-mentors v. Mentors)(Baseline to 12 months)