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

NCT ID: NCT01651117

Last Updated: 2019-10-30

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

View full results

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

480 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-09-01

Study Completion Date

2018-10-08

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Type 2 Diabetes Mellitus

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

SEQUENTIAL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Investigators

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

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).

Group Type NO_INTERVENTION

No interventions assigned to this group

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.

Group Type EXPERIMENTAL

Peer Mentoring

Intervention Type BEHAVIORAL

Patients will receive peer mentoring.

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.

Group Type EXPERIMENTAL

Peer Mentoring

Intervention Type BEHAVIORAL

Patients will receive peer mentoring.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Peer Mentoring

Patients will receive peer mentoring.

Intervention Type BEHAVIORAL

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

30 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

VA Office of Research and Development

FED

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Judith A. Long, MD

Role: PRINCIPAL_INVESTIGATOR

Corporal Michael J. Crescenz VA Medical Center, Philadelphia, PA

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Corporal Michael J. Crescenz VA Medical Center, Philadelphia, PA

Philadelphia, Pennsylvania, United States

Site Status

Countries

Review the countries where the study has at least one active or historical site.

United States

References

Explore related publications, articles, or registry entries linked to this study.

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.

Reference Type DERIVED
PMID: 32915236 (View on PubMed)

Provided Documents

Download supplemental materials such as informed consent forms, study protocols, or participant manuals.

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

IIR 12-407

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Genetic Testing for Type 2 Diabetes
NCT01060540 COMPLETED NA
Peer Support Dyads in Churches
NCT03463941 COMPLETED NA