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

This study is currently recruiting participants.
Verified November 2013 by Department of Veterans Affairs
Sponsor:
Information provided by (Responsible Party):
Department of Veterans Affairs ( Philadelphia Veterans Affairs Medical Center )
ClinicalTrials.gov Identifier:
NCT01651117
First received: July 24, 2012
Last updated: November 22, 2013
Last verified: November 2013

July 24, 2012
November 22, 2013
September 2012
December 2016   (final data collection date for primary outcome measure)
Change in Glucose Control [ Time Frame: Baseline, 6 months, and 12 months and for former mentees 18 months ] [ Designated as safety issue: No ]
Measured by change in HbA1c
Change in Glucose Control [ Time Frame: Baseline, 6 months, and 12 months ] [ Designated as safety issue: No ]
Measured by change in HbA1c
Complete list of historical versions of study NCT01651117 on ClinicalTrials.gov Archive Site
  • Blood Pressure [ Time Frame: Baseline, 6 months, 12 months and for former mentees 18 months ] [ Designated as safety issue: No ]
  • Diabetes Quality of Life [ Time Frame: Baseline, 6 months, 12 months and for former mentees 18 months ] [ Designated as safety issue: No ]
    Diabetes Distress Scale
  • Depression Symptoms [ Time Frame: Baseline, 6 months, and 12 months and for former mentees 18 months ] [ Designated as safety issue: No ]
    As measured by the Patient Health Questionnaire-2
  • Direct LDL blood levels [ Time Frame: Baseline, 6 months, and 12 months and for former mentees 18 months ] [ Designated as safety issue: No ]
  • Blood Pressure [ Time Frame: Baseline, 6 months, 12 months ] [ Designated as safety issue: No ]
  • Diabetes Quality of Life [ Time Frame: Baseline, 6 months, 12 months ] [ Designated as safety issue: No ]
    Diabetes Distress Scale
  • Depression Symptoms [ Time Frame: Baseline, 6 months, and 12 months ] [ Designated as safety issue: No ]
    As measured by the Patient Health Questionnaire-2
  • Direct LDL blood levels [ Time Frame: Baseline, 6 months, and 12 months ] [ Designated as safety issue: No ]
Not Provided
Not Provided
 
Using Peer Mentors to Support PACT Team Efforts to Improve Diabetes Control
Using Peer Mentors to Support PACT Team Efforts to Improve Diabetes Control (CEPACT)

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.

Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Investigator)
Primary Purpose: Treatment
Type 2 Diabetes Mellitus
Behavioral: Peer Mentoring

Arm 2: Will receive peer mentoring from diabetic veterans who were once in poor control but are now in good control.

Arm 3: Will receive peer mentoring from former mentees.

  • 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.
    Intervention: Behavioral: 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.
    Intervention: Behavioral: Peer Mentoring
Long JA, Jahnle EC, Richardson DM, Loewenstein G, Volpp KG. Peer mentoring and financial incentives to improve glucose control in African American veterans: a randomized trial. Ann Intern Med. 2012 Mar 20;156(6):416-24.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
600
June 2017
December 2016   (final data collection date for primary outcome measure)

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:

  • Does not speak English
  • Unable to understand consents
  • Severe speech impediment
  • over the age of 75
Both
30 Years to 75 Years
No
Contact: Kirsten M Rogers, BA 215-823-5800 ext 7929 Kirsten.Rogers3@va.gov
Contact: Jennifer Gutierrez, MS 215-823-5800 ext 7147 jennifer.gutierrez@va.gov
United States
 
NCT01651117
IIR 12-407, 01373
Yes
Department of Veterans Affairs ( Philadelphia Veterans Affairs Medical Center )
Philadelphia Veterans Affairs Medical Center
Not Provided
Principal Investigator: Judith A Long, MD Philadelphia Veterans Affairs Medical Center
Department of Veterans Affairs
November 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP