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

This study is ongoing, but not recruiting participants.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01651117
First Posted: July 26, 2012
Last Update Posted: May 30, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
VA Office of Research and Development
  Purpose
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 Intervention
Type 2 Diabetes Mellitus Behavioral: Peer Mentoring

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Investigator)
Primary Purpose: Treatment
Official Title: Using Peer Mentors to Support PACT Team Efforts to Improve Diabetes Control

Further study details as provided by VA Office of Research and Development:

Primary Outcome Measures:
  • Change in Glucose Control [ Time Frame: Baseline, 6 months, and 12 months and for former mentees 18 months ]
    Measured by change in HbA1c


Secondary Outcome Measures:
  • Blood Pressure [ Time Frame: Baseline, 6 months, 12 months and for former mentees 18 months ]
    Measured by change in Blood Pressure

  • Diabetes Quality of Life [ Time Frame: Baseline, 6 months, 12 months and for former mentees 18 months ]
    Diabetes Distress Scale

  • Depression Symptoms [ Time Frame: Baseline, 6 months, and 12 months and for former mentees 18 months ]
    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 ]
    Measured by change in Direct LDL blood levels


Estimated Enrollment: 698
Actual Study Start Date: September 1, 2012
Estimated Study Completion Date: October 8, 2018
Estimated Primary Completion Date: April 8, 2018 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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

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

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


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

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   30 Years to 75 Years   (Adult, Senior)
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01651117


Locations
United States, Pennsylvania
Philadelphia 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 Philadelphia VA Medical Center, Philadelphia, PA
  More Information

Responsible Party: VA Office of Research and Development
ClinicalTrials.gov Identifier: NCT01651117     History of Changes
Other Study ID Numbers: IIR 12-407
First Submitted: July 24, 2012
First Posted: July 26, 2012
Last Update Posted: May 30, 2017
Last Verified: May 2017
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


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