Type 2 Diabetes MellitusNCT01651117

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

A study testing Peer Mentoring in people with Type 2 Diabetes Mellitus, run by VA Office of Research and Development at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

Search all trials

Trial summary

Who is it for?: Ages 30 to 75 years
Conditions the study is for: Type 2 Diabetes Mellitus
What is being tested?: Peer Mentoring
Type of treatment: Lifestyle or therapy programme
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 480 participants
Where: 1 siteUnited States
Study dates: 1 Sep 2012to 8 Oct 2018
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 30 to 75 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

United States1 site

Corporal Michael J. Crescenz VA Medical Center, Philadelphia, PA
Philadelphia, Pennsylvania, 19104

Other trials in United States

About this study

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.

Read the 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.

Conditions: Type 2 Diabetes Mellitus
Being tested: Peer Mentoring
Keywords: Diabetes Mellitus, Mentors, Glucose control, Hemoglobin A, Glycosylated, Randomized Controlled Trial, Veterans
Medical subject headings: Diabetes Mellitus, Type 2, Diabetes Mellitus

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Peer MentoringBehavioural
Patients will receive peer mentoring.

Study groups in NCT01651117
Study group	Role	What they receive
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. Receives: 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. Receives: Behavioral: Peer Mentoring

What is being measured

The primary outcome is the main question the study is designed to answer.

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)
Measured: 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)
Measured: 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)
Measured: Baseline to 6 months

Secondary outcomes (27)

Change in Direct LDL Blood Levels
Measured by change in Direct LDL blood levels, adjusted for baseline LDL and patient random effect. LDL is measured as mg/dL. Values of the change variable (difference of 2 levels) can be positive or negative. Negative change, which shows better outcome, occurs when the 6 month LDL is lower than the baseline LDL. (Change = final measure - initial measure)
Measured: Baseline to 6 months
Change in Systolic Blood Pressure
Measured by change in systolic Blood Pressure, adjusting for baseline blood pressure and patient random effect. Systolic BP is measured as mmHG. Values of the change variable (difference of 2 levels) can be positive or negative. Negative change, which shows better outcome, occurs when the 6 month BP is lower than the baseline BP. (Change = final measure - initial measure)
Measured: Baseline to 6 months
Change in Diabetes Quality of Life Score
Change in Diabetes Distress Scale, adjusted for baseline score and patient random effects. The DDS score is calculated by averaging 2 5-point Likert scale questions, and ranges from 1 to 5, where lower means less distress. Values of the change variable can be positive or negative. Negative change, which shows better outcome, occurs when the 6 month DDS is lower than the baseline DDS. (Change = final measure - initial measure)
Measured: Baseline to 6 months
Change in Depression Symptoms
As measured by change in the Patient Health Questionnaire-2, adjusted for baseline score and patient random effects. The PHQ score is calculated by summing 2 4-point 0-3 Likert scale questions, and ranges from 0 to 6, with lower score indicating lower depression. Values of the change variable can be positive or negative. Negative change, which shows better outcome, occurs when the 6 month PHQ is lower than the baseline PHQ. (Change = final measure - initial measure)
Measured: Baseline to 6 months
Change in Glucose Control
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 12 month HBA1c is lower than the baseline HbA1c. (Change = final measure - initial measure)
Measured: Baseline to 12 months
Change in Direct LDL Blood Levels
Measured by change in Direct LDL blood levels, adjusted for baseline LDL and patient random effect. LDL is measured as mg/dL. Values of the change variable (difference of 2 levels) can be positive or negative. Negative change, which shows better outcome, occurs when the 12 month LDL is lower than the baseline LDL. (Change = final measure - initial measure)
Measured: Baseline to 12 months
Change in Systolic Blood Pressure
Measured by change in systolic Blood Pressure, adjusting for baseline blood pressure and patient random effect. Systolic BP is measured as mmHG. Values of the change variable (difference of 2 levels) can be positive or negative. Negative change, which shows better outcome, occurs when the 12 month BP is lower than the baseline BP. (Change = final measure - initial measure)
Measured: Baseline to 12 months
Change in Diabetes Quality of Life
Change in Diabetes Distress Scale, adjusted for baseline score and patient random effects. The DDS score is calculated by averaging 2 5-point Likert scale questions, and ranges from 1 to 5, where lower means less distress. Values of the change variable can be positive or negative. Negative change, which shows better outcome, occurs when the 12 month DDS is lower than the baseline DDS. (Change = final measure - initial measure)
Measured: Baseline to 12 months
Change in Depression Symptoms
As measured by change in the Patient Health Questionnaire-2, adjusted for baseline score and patient random effects. The PHQ score is calculated by summing 2 4-point 0-3 Likert scale questions, and ranges from 0 to 6, with lower score indicating lower depression. Values of the change variable can be positive or negative. Negative change, which shows better outcome, occurs when the 12 month PHQ is lower than the baseline PHQ. (Change = final measure - initial measure)
Measured: Baseline to 12 months
Change in Direct LDL Blood Levels (Stage 2: Usual Care v. Mentees)
Measured by change in Direct LDL blood levels, adjusted for baseline LDL and patient random effect. LDL is measured as mg/dL. Values of the change variable (difference of 2 levels) can be positive or negative. Negative change, which shows better outcome, occurs when the 6 month LDL is lower than the baseline LDL. (Change = final measure - initial measure)
Measured: Baseline to 6 months
Change in Systolic Blood Pressure (Stage 2: Usual Care v. Mentee)
Measured by change in systolic Blood Pressure, adjusting for baseline blood pressure and patient random effect. Systolic BP is measured as mmHG. Values of the change variable (difference of 2 levels) can be positive or negative. Negative change, which shows better outcome, occurs when the 6 month BP is lower than the baseline BP. (Change = final measure - initial measure)
Measured: Baseline to 6 months
Change in Diabetes Quality of Life (Stage 2: Usual Care v. Mentee)
Change in Diabetes Distress Scale, adjusted for baseline score and patient random effects. The DDS score is calculated by averaging 2 5-point Likert scale questions, and ranges from 1 to 5, where lower means less distress. Values of the change variable can be positive or negative. Negative change, which shows better outcome, occurs when the 6 month DDS is lower than the baseline DDS. (Change = final measure - initial measure)
Measured: Baseline to 6 months
Change in Depression Symptoms (Stage 2: Usual Care v. Mentees)
As measured by change in the Patient Health Questionnaire-2, adjusted for baseline score and patient random effects. The PHQ score is calculated by summing 2 4-point 0-3 Likert scale questions, and ranges from 0 to 6, with lower score indicating lower depression. Values of the change variable can be positive or negative. Negative change, which shows better outcome, occurs when the 6 month PHQ is lower than the baseline PHQ. (Change = final measure - initial measure)
Measured: 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 12 month HBA1c is lower than the baseline HbA1c. (Change = final measure - initial measure)
Measured: Baseline to 12 months
Change in Direct LDL Blood Levels (Stage 2: Usual Care v. Mentees)
Measured by change in Direct LDL blood levels, adjusted for baseline LDL and patient random effect. LDL is measured as mg/dL. Values of the change variable (difference of 2 levels) can be positive or negative. Negative change, which shows better outcome, occurs when the 12 month LDL is lower than the baseline LDL. (Change = final measure - initial measure)
Measured: Baseline to 12 months
Change in Systolic Blood Pressure (Stage 2: Usual Care v. Mentee)
Measured by change in systolic Blood Pressure, adjusting for baseline blood pressure and patient random effect. Systolic BP is measured as mmHG. Values of the change variable (difference of 2 levels) can be positive or negative. Negative change, which shows better outcome, occurs when the 12 month BP is lower than the baseline BP. (Change = final measure - initial measure)
Measured: Baseline to 12 months
Change in Diabetes Quality of Life (Stage 2: Usual Care v. Mentee)
Change in Diabetes Distress Scale, adjusted for baseline score and patient random effects. The DDS score is calculated by averaging 2 5-point Likert scale questions, and ranges from 1 to 5, where lower means less distress. Values of the change variable can be positive or negative. Negative change, which shows better outcome, occurs when the 12 month DDS is lower than the baseline DDS. (Change = final measure - initial measure)
Measured: Baseline to 12 months
Change in Depression Symptoms (Stage 2: Usual Care v. Mentees)
As measured by change in the Patient Health Questionnaire-2, adjusted for baseline score and patient random effects. The PHQ score is calculated by summing 2 4-point 0-3 Likert scale questions, and ranges from 0 to 6, with lower score indicating lower depression. Values of the change variable can be positive or negative. Negative change, which shows better outcome, occurs when the 12 month PHQ is lower than the baseline PHQ. (Change = final measure - initial measure)
Measured: Baseline to 12 months
Change in Direct LDL Blood Levels (Stage 2: Non-mentors v. Mentors)
Measured by change in Direct LDL blood levels, adjusted for baseline LDL and patient random effect. LDL is measured as mg/dL. Values of the change variable (difference of 2 levels) can be positive or negative. Negative change, which shows better outcome, occurs when the 6 month LDL is lower than the baseline LDL. (Change = final measure - initial measure)
Measured: Baseline to 6 months
Change in Systolic Blood Pressure (Stage 2: Non-mentors v. Mentors)
Measured by change in systolic Blood Pressure, adjusting for baseline blood pressure and patient random effect. Systolic BP is measured as mmHG. Values of the change variable (difference of 2 levels) can be positive or negative. Negative change, which shows better outcome, occurs when the 6 month BP is lower than the baseline BP. (Change = final measure - initial measure)
Measured: Baseline to 6 months
Change in Diabetes Quality of Life (Stage 2: Non-mentors v. Mentors)
Change in Diabetes Distress Scale, adjusted for baseline score and patient random effects. The DDS score is calculated by averaging 2 5-point Likert scale questions, and ranges from 1 to 5, where lower means less distress. Values of the change variable can be positive or negative. Negative change, which shows better outcome, occurs when the 6 month DDS is lower than the baseline DDS. (Change = final measure - initial measure)
Measured: Baseline to 6 months
Change in Depression Symptoms (Stage 2: Non-mentors v. Mentors)
As measured by change in the Patient Health Questionnaire-2, adjusted for baseline score and patient random effects. The PHQ score is calculated by summing 2 4-point 0-3 Likert scale questions, and ranges from 0 to 6, with lower score indicating lower depression. Values of the change variable can be positive or negative. Negative change, which shows better outcome, occurs when the 6 month PHQ is lower than the baseline PHQ. (Change = final measure - initial measure)
Measured: 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 12 month HBA1c is lower than the baseline HbA1c. (Change = final measure - initial measure)
Measured: Baseline to 12 months
Change in Direct LDL Blood Levels (Stage 2: Non-mentors v. Mentors)
Measured by change in Direct LDL blood levels, adjusted for baseline LDL and patient random effect. LDL is measured as mg/dL. Values of the change variable (difference of 2 levels) can be positive or negative. Negative change, which shows better outcome, occurs when the 12 month LDL is lower than the baseline LDL. (Change = final measure - initial measure)
Measured: Baseline to 12 months
Change in Systolic Blood Pressure (Stage 2: Non-mentors v. Mentors)
Measured by change in systolic Blood Pressure, adjusting for baseline blood pressure and patient random effect. Systolic BP is measured as mmHG. Values of the change variable (difference of 2 levels) can be positive or negative. Negative change, which shows better outcome, occurs when the 12 month BP is lower than the baseline BP. (Change = final measure - initial measure)
Measured: Baseline to 12 months
Change in Diabetes Quality of Life (Stage 2: Non-mentors v. Mentors)
Change in Diabetes Distress Scale, adjusted for baseline score and patient random effects. The DDS score is calculated by averaging 2 5-point Likert scale questions, and ranges from 1 to 5, where lower means less distress. Values of the change variable can be positive or negative. Negative change, which shows better outcome, occurs when the 12 month DDS is lower than the baseline DDS. (Change = final measure - initial measure)
Measured: Baseline to 12 months
Change in Depression Symptoms (Stage 2: Non-mentors v. Mentors)
As measured by change in the Patient Health Questionnaire-2, adjusted for baseline score and patient random effects. The PHQ score is calculated by summing 2 4-point 0-3 Likert scale questions, and ranges from 0 to 6, with lower score indicating lower depression. Values of the change variable can be positive or negative. Negative change, which shows better outcome, occurs when the 12 month PHQ is lower than the baseline PHQ. (Change = final measure - initial measure)
Measured: Baseline to 12 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

1 Sep 20128 Oct 2018

First posted26 Jul 2012 (estimated)
Study start1 Sep 2012
Primary completion21 Mar 2018
Study completion8 Oct 2018

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (1)Papers the sponsor has linked to this study.
Other trials for Type 2 Diabetes MellitusStudies of the same condition, open and under way.
More trials run by VA Office of Research and DevelopmentThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Sequential
Masking: Single blind
Who is masked: Investigator
Enrolment: 480 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01651117
Sponsor's protocol ID: IIR 12-407
Status last verified: Oct 2019
First submitted: 24 Jul 2012
Last updated: 30 Oct 2019
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: Yes: Data will be made available upon request of the PI

Publications

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.
PubMed 32915236

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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Study at a glance

From the registry record, last updated by the sponsor on 30 Oct 2019. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Using Peer Mentors to Support PACT Team Efforts to Improve Diabetes Control
ClinicalTrials.gov ID: NCT01651117
Acronym / sponsor ID: IIR 12-407
Conditions: Type 2 Diabetes Mellitus
Keywords: Diabetes Mellitus, Mentors, Glucose control, Hemoglobin A, Glycosylated, Randomized Controlled Trial, Veterans
Study type: Interventional
Recruitment status: Completed
Enrolment: 480 participants (actual)
Lead sponsor: VA Office of Research and DevelopmentUS federal agency
Study start: 1 Sep 2012 (actual)
Primary completion: 21 Mar 2018 (actual)
Study completion: 8 Oct 2018 (actual)
First posted: 26 Jul 2012 (estimated)
Results: Posted 12 Sep 2019

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

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.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Sequential
Masking: Single blind (investigator)
Number of arms: 3

Arm	Type	Receives
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	Behavioral: Peer MentoringParticipants 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.
Peer Mentoring FFM (from former mentee)	Experimental	Behavioral: Peer MentoringParticipants 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.

Who may qualify

Ages: 30 to 75 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (5 listed)

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

Key exclusion criteria (4 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Peer MentoringPatients will receive peer mentoring.	Behavioural	Peer Mentoring, Peer Mentoring FFM (from former mentee)

Primary outcome

Change in Glucose Control (Stage 1: Usual Care v. Peer Mentoring)
Time frame: Baseline to 6 months
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)
Change in Glucose Control (Stage 2: Usual Care v. Mentees)
Time frame: Baseline to 6 months
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)
Change in Glucose Control (Stage 2: Non-mentors v. Mentors)
Time frame: Baseline to 6 months
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)

27 secondary outcomes

Change in Direct LDL Blood Levels
Time frame: Baseline to 6 months
Change in Systolic Blood Pressure
Time frame: Baseline to 6 months
Change in Diabetes Quality of Life Score
Time frame: Baseline to 6 months
Change in Depression Symptoms
Time frame: Baseline to 6 months
Change in Glucose Control
Time frame: Baseline to 12 months
Change in Direct LDL Blood Levels
Time frame: Baseline to 12 months
Change in Systolic Blood Pressure
Time frame: Baseline to 12 months
Change in Diabetes Quality of Life
Time frame: Baseline to 12 months
Change in Depression Symptoms
Time frame: Baseline to 12 months
Change in Direct LDL Blood Levels (Stage 2: Usual Care v. Mentees)
Time frame: Baseline to 6 months
Change in Systolic Blood Pressure (Stage 2: Usual Care v. Mentee)
Time frame: Baseline to 6 months
Change in Diabetes Quality of Life (Stage 2: Usual Care v. Mentee)
Time frame: Baseline to 6 months
Change in Depression Symptoms (Stage 2: Usual Care v. Mentees)
Time frame: Baseline to 6 months
Change in Glucose Control (Stage 2: Usual Care v. Mentees)
Time frame: Baseline to 12 months
Change in Direct LDL Blood Levels (Stage 2: Usual Care v. Mentees)
Time frame: Baseline to 12 months
Change in Systolic Blood Pressure (Stage 2: Usual Care v. Mentee)
Time frame: Baseline to 12 months
Change in Diabetes Quality of Life (Stage 2: Usual Care v. Mentee)
Time frame: Baseline to 12 months
Change in Depression Symptoms (Stage 2: Usual Care v. Mentees)
Time frame: Baseline to 12 months
Change in Direct LDL Blood Levels (Stage 2: Non-mentors v. Mentors)
Time frame: Baseline to 6 months
Change in Systolic Blood Pressure (Stage 2: Non-mentors v. Mentors)
Time frame: Baseline to 6 months
Change in Diabetes Quality of Life (Stage 2: Non-mentors v. Mentors)
Time frame: Baseline to 6 months
Change in Depression Symptoms (Stage 2: Non-mentors v. Mentors)
Time frame: Baseline to 6 months
Change in Glucose Control (Stage 2: Non-mentors v. Mentors)
Time frame: Baseline to 12 months
Change in Direct LDL Blood Levels (Stage 2: Non-mentors v. Mentors)
Time frame: Baseline to 12 months
Change in Systolic Blood Pressure (Stage 2: Non-mentors v. Mentors)
Time frame: Baseline to 12 months
Change in Diabetes Quality of Life (Stage 2: Non-mentors v. Mentors)
Time frame: Baseline to 12 months
Change in Depression Symptoms (Stage 2: Non-mentors v. Mentors)
Time frame: Baseline to 12 months

Results and safety

Results posted to the registry on 12 Sep 2019, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Stage 1 Usual Care	156	154
Stage 1 Peer Mentoring	205	202
Stage 2 Usual Care	49	47
Stage 2 Peer Mentoring FFM (From Former Mentee)	70	68

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

Time frame: Baseline to 6 months. Mean (95% Confidence Interval). Unit: percent

Measure	Stage 1 Usual Care n = 154	Stage 1 Peer Mentoring n = 202
Value	-0.1978 (-0.4567 to 0.0611)	-0.5246 (-0.7554 to -0.2939)

Stage 1 Usual Care vs Stage 1 Peer Mentoring: Mean Difference (Final Values): -0.3268 (95% CI -0.6690 to 0.0154), p = 0.0611, Mixed Models Analysis

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

Time frame: Baseline to 6 months. Mean (95% Confidence Interval). Unit: percent

Measure	Stage 2 Usual Care n = 47	Stage 2 Peer Mentoring FFM (From Former Mentee) n = 68
Value	-0.4587 (-1.0223 to 0.1049)	0.0772 (-0.4159 to 0.5703)

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

Time frame: Baseline to 6 months. Mean (95% Confidence Interval). Unit: percent

Measure	Stage 2 Non-mentor n = 69	Stage 2 Mentor n = 70
Value	0.3156 (-0.0733 to 0.7045)	0.1449 (-0.2421 to 0.5319)

Population analysed: After 6 month of Stage 1, patients who were randomized to receive mentoring in Stage 1 were further randomized to either become a mentor in Stage 2 (Stage 2 Mentor) or to not become a mentor in Stage 2 (Stage 2 Non-mentor). Note that only those who had a 6-month follow-up visits for Stage 1 could be randomized to Stage 2 (139 participants).

27 secondary outcomes are reported in the full results.

Adverse events

Time frame: Adverse event data were collected for 18 months from baseline.. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Usual Care Stage 1	10 of 156 (6.4%)	11 of 156 (7.1%)	2 of 156
Peer Mentoring	28 of 205 (13.7%)	38 of 205 (18.5%)	3 of 205
Peer Mentoring FFM (From Former Mentee)	12 of 70 (17.1%)	6 of 70 (8.6%)	2 of 70
Usual Care Stage 2	2 of 49 (4.1%)	5 of 49 (10.2%)	2 of 49

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 30 Oct 2019.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 32915236Long 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.
Individual participant dataSharing planned: Yes. Data will be made available upon request of the PI

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Judith A. Long, MD principal investigator

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

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing Peer Mentoring in people with Type 2 Diabetes Mellitus, run by VA Office of Research and Development at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 30 Oct 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 12 Sep 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in Glucose Control (Stage 1: Usual Care v. Peer Mentoring) (time frame: Baseline to 6 months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01651117, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Oct 2019.