Clinical trial NCT01651117: Using Peer Mentors to Support PACT Team Efforts to Improve Diabetes Control
Official title: Using Peer Mentors to Support PACT Team Efforts to Improve Diabetes Control
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Type 2 Diabetes Mellitus
Keywords: Diabetes Mellitus
Mentors
Glucose control
Hemoglobin A, Glycosylated
Randomized Controlled Trial
Veterans
Lead sponsor: VA Office of Research and Development
Sponsor class: FED
First posted: 2012-07-26
Enrollment: 480
Sex: ALL
Minimum age (years): 30
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SEQUENTIAL
Primary purpose: TREATMENT

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.

Eligibility 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

Primary outcomes:
measure: Change in Glucose Control (Stage 1: Usual Care v. Peer Mentoring)
timeFrame: Baseline to 6 months
measure: Change in Glucose Control (Stage 2: Usual Care v. Mentees)
timeFrame: Baseline to 6 months
measure: Change in Glucose Control (Stage 2: Non-mentors v. Mentors)
timeFrame: Baseline to 6 months
Secondary outcomes:
measure: Change in Direct LDL Blood Levels
timeFrame: Baseline to 6 months
measure: Change in Systolic Blood Pressure
timeFrame: Baseline to 6 months
measure: Change in Diabetes Quality of Life Score
timeFrame: Baseline to 6 months
measure: Change in Depression Symptoms
timeFrame: Baseline to 6 months
measure: Change in Glucose Control
timeFrame: Baseline to 12 months
measure: Change in Direct LDL Blood Levels
timeFrame: Baseline to 12 months
measure: Change in Systolic Blood Pressure
timeFrame: Baseline to 12 months
measure: Change in Diabetes Quality of Life
timeFrame: Baseline to 12 months
measure: Change in Depression Symptoms
timeFrame: Baseline to 12 months
measure: Change in Direct LDL Blood Levels (Stage 2: Usual Care v. Mentees)
timeFrame: Baseline to 6 months
measure: Change in Systolic Blood Pressure (Stage 2: Usual Care v. Mentee)
timeFrame: Baseline to 6 months
measure: Change in Diabetes Quality of Life (Stage 2: Usual Care v. Mentee)
timeFrame: Baseline to 6 months
measure: Change in Depression Symptoms (Stage 2: Usual Care v. Mentees)
timeFrame: Baseline to 6 months
measure: Change in Glucose Control (Stage 2: Usual Care v. Mentees)
timeFrame: Baseline to 12 months
measure: Change in Direct LDL Blood Levels (Stage 2: Usual Care v. Mentees)
timeFrame: Baseline to 12 months
measure: Change in Systolic Blood Pressure (Stage 2: Usual Care v. Mentee)
timeFrame: Baseline to 12 months
measure: Change in Diabetes Quality of Life (Stage 2: Usual Care v. Mentee)
timeFrame: Baseline to 12 months
measure: Change in Depression Symptoms (Stage 2: Usual Care v. Mentees)
timeFrame: Baseline to 12 months
measure: Change in Direct LDL Blood Levels (Stage 2: Non-mentors v. Mentors)
timeFrame: Baseline to 6 months
measure: Change in Systolic Blood Pressure (Stage 2: Non-mentors v. Mentors)
timeFrame: Baseline to 6 months
measure: Change in Diabetes Quality of Life (Stage 2: Non-mentors v. Mentors)
timeFrame: Baseline to 6 months
measure: Change in Depression Symptoms (Stage 2: Non-mentors v. Mentors)
timeFrame: Baseline to 6 months
measure: Change in Glucose Control (Stage 2: Non-mentors v. Mentors)
timeFrame: Baseline to 12 months
measure: Change in Direct LDL Blood Levels (Stage 2: Non-mentors v. Mentors)
timeFrame: Baseline to 12 months
measure: Change in Systolic Blood Pressure (Stage 2: Non-mentors v. Mentors)
timeFrame: Baseline to 12 months
measure: Change in Diabetes Quality of Life (Stage 2: Non-mentors v. Mentors)
timeFrame: Baseline to 12 months
measure: Change in Depression Symptoms (Stage 2: Non-mentors v. Mentors)
timeFrame: Baseline to 12 months
Other outcomes:
Locations:
city: Philadelphia
country: United States
facility: Corporal Michael J. Crescenz VA Medical Center, Philadelphia, PA
state: Pennsylvania
Study officials:
affiliation: Corporal Michael J. Crescenz VA Medical Center, Philadelphia, PA
name: Judith A. Long, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.