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

This study is currently recruiting participants. (see Contacts and Locations)
Verified July 2016 by VA Office of Research and Development
Sponsor:
Information provided by (Responsible Party):
VA Office of Research and Development
ClinicalTrials.gov Identifier:
NCT01651117
First received: July 24, 2012
Last updated: July 8, 2016
Last verified: July 2016

July 24, 2012
July 8, 2016
September 2012
December 2017   (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
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
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
698
June 2018
December 2017   (final data collection date for primary outcome measure)

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
Both
30 Years to 75 Years   (Adult, Senior)
No
Contact: Tanisha N Dicks, MBA BS Tanisha.Dicks@va.gov
Contact: Jennifer C Gutierrez, MA BA (215) 823-5800 ext 3873 jennifer.gutierrez@va.gov
United States
 
NCT01651117
IIR 12-407
No
Yes
Data will be made available upon request of the PI
VA Office of Research and Development
VA Office of Research and Development
Not Provided
Principal Investigator: Judith A. Long, MD Philadelphia VA Medical Center, Philadelphia, PA
VA Office of Research and Development
July 2016

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