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

NCT01651117 | Completed Results

• 1 other identifier: IIR 12-407
• Study Type: interventional
• Target: 480
• Locations: 1 country
• Sites: 1

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.

Conditions

Type 2 Diabetes Mellitus

Keywords

Diabetes Mellitus; Mentors; Glucose control; Hemoglobin A, Glycosylated; Randomized Controlled Trial; Veterans

Outcome Measures

Primary Outcomes (3)

• Change in Glucose Control (Stage 1: Usual Care v. Peer Mentoring)

  Measured by change in HbA1c, adjusted for baseline HbA1c and patient random effects. HbA1c is measured as a percent. Values of the change variable (difference of 2 percentages) can be positive or negative. Negative change, which shows better outcome, occurs when the 6 month HBA1c is lower than the baseline HbA1c. (Change = final measure - initial measure)

  Baseline to 6 months

• Change in Glucose Control (Stage 2: Usual Care v. Mentees)

  Measured by change in HbA1c, adjusted for baseline HbA1c and patient random effects. HbA1c is measured as a percent. Values of the change variable (difference of 2 percentages) can be positive or negative. Negative change, which shows better outcome, occurs when the 6 month HBA1c is lower than the baseline HbA1c. (Change = final measure - initial measure)

  Baseline to 6 months

• Change in Glucose Control (Stage 2: Non-mentors v. Mentors)

  Measured by change in HbA1c, adjusted for baseline HbA1c and patient random effects. HbA1c is measured as a percent. Values of the change variable (difference of 2 percentages) can be positive or negative. Negative change, which shows better outcome, occurs when the 6 month HBA1c is lower than the baseline HbA1c. (Change = final measure - initial measure)

  Baseline to 6 months

Secondary Outcomes (27)

• Change in Direct LDL Blood Levels

  Baseline to 6 months

• Change in Systolic Blood Pressure

  Baseline to 6 months

• Change in Diabetes Quality of Life Score

  Baseline to 6 months

• Change in Depression Symptoms

  Baseline to 6 months

• Change in Glucose Control

  Baseline to 12 months

Study Arms (3)

Usual Care

NO INTERVENTION

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).

Peer Mentoring

EXPERIMENTAL

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

Peer Mentoring FFM (from former mentee)

EXPERIMENTAL

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

Interventions

Peer Mentoring BEHAVIORAL

Patients will receive peer mentoring.

Peer Mentoring; Peer Mentoring FFM (from former mentee)

Eligibility Criteria

• Age: 30 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Does not speak English
• Unable to understand consents
• Severe speech impediment
• over the age of 75

Sponsors & Collaborators

• VA Office of Research and Development: lead

Study Sites (1)

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

Philadelphia, Pennsylvania, 19104, United States

Location

Related Publications (1)

• 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.

  PMID: 32915236 DERIVED

MeSH Terms

Conditions

Diabetes Mellitus, Type 2; Diabetes Mellitus

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Results Point of Contact

• Title: Judith A. Long, MD
• Organization: Corporal Michael J. Crescenz VA Medical Center

judith.long@va.gov

215-898-4311

Study Officials

• Judith A. Long, MD

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

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: FED
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 24, 2012
• First Posted: July 26, 2012
• Study Start: September 1, 2012
• Primary Completion: March 21, 2018
• Study Completion: October 8, 2018
• Last Updated: October 30, 2019
• Results First Posted: September 12, 2019

Record last verified: 2019-10

Data Sharing

• IPD Sharing: Will share

Locations

US (1)