NCT01855399

Brief Summary

Peer support programs have been demonstrated to improve glycemic control among Veterans with poor control. This program will expand on this success by putting innovative tools in the hands of Veteran diabetes patients. Veteran coaches who have demonstrated effective control of their own diabetes will be trained to use communication skills to guide their peers through a diabetes education and decision aid. This tool, which is an iPad application, draws the patient in by showing them their personal risk and medication information derived from baseline labs and self-reported survey data. The tool encourages interaction by providing choices of materials to view, using audio-visual elements and incorporating a goal-setting process for developing self-management action steps and questions to discuss with their doctor at their next clinic visit. Ongoing weekly contact between the Veterans is supported by a confidential phone system.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
290

participants targeted

Target at P75+ for not_applicable diabetes

Timeline
Completed

Started Sep 2014

Typical duration for not_applicable diabetes

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 13, 2013

Completed
3 days until next milestone

First Posted

Study publicly available on registry

May 16, 2013

Completed
1.3 years until next milestone

Study Start

First participant enrolled

September 9, 2014

Completed
3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 20, 2017

Completed
9 days until next milestone

Study Completion

Last participant's last visit for all outcomes

September 29, 2017

Completed
1.8 years until next milestone

Results Posted

Study results publicly available

July 12, 2019

Completed
Last Updated

July 12, 2019

Status Verified

April 1, 2019

Enrollment Period

3 years

First QC Date

May 13, 2013

Results QC Date

June 28, 2018

Last Update Submit

April 30, 2019

Conditions

Keywords

Peer SupportSelf ManagementHealth Disparities

Outcome Measures

Primary Outcomes (1)

  • Percent Glycosylated Hemoglobin

    Percent glycosylated hemoglobin is measured at baseline, 6 months, and 12 months to test the effectiveness of a technology-enhanced peer coaching (TEC) program in improving glucose control relative to peer support alone.

    6 Month

Study Arms (2)

Peer Coaching + Decision Aid

EXPERIMENTAL

All participants will be assigned to one of up to 87 peer coaches, who also are Detroit VA diabetes patients who previously had poor glycemic control but are currently in good control. After their baseline assessment, participants in both arms will receive information on their lab and blood pressure values and will be randomized to one of the two study arms. Participants in the TEC arm will be scheduled for an initial visit with their coach to review the decision aid, which has incorporated their personal baseline data.

Behavioral: Peer CoachingBehavioral: Decision Aid

Peer Coaching Alone

ACTIVE COMPARATOR

Participants randomized to the 'print materials' group will be scheduled for an initial visit with their coach. The coach will then help them list questions and concerns they wish to discuss with their health care provider, practice raising their questions and concerns and develop an action plan to address barriers to self-management they have identified. During the next six months coaches in both arms will call their assigned peers once a week to provide support for their action steps.

Behavioral: Peer Coaching

Interventions

Peer CoachingBEHAVIORAL

All participants will be assigned to a peer coach, who is a Detroit VA diabetes patient who previously had poor glycemic control but is currently in good control. Participants will receive information on their lab and blood pressure values and will be scheduled for an initial visit with their coach. The coach will then help them list questions and concerns they wish to discuss with their health care provider, practice raising their questions and concerns, and develop an action plan to address barriers to self-management they have identified. During the next six months, coaches will call their assigned peers once a week to provide support for their action steps.

Peer Coaching + Decision AidPeer Coaching Alone
Decision AidBEHAVIORAL

The iDecide tool is designed to present key tailored, evidence-based information on diabetes and diabetes treatments. Importantly for a peer support intervention, all content information will be provided through the tool, with the role of the peer mentor being to assist the participant to go through the program and participate in helping the patient formulate questions and concerns to discuss with their health care provider, to set their own behavioral goals and action steps, and to help the participant practice raising the issues they plan to discuss with their health care provider.

Also known as: TEC
Peer Coaching + Decision Aid

Eligibility Criteria

Age18 Years - 99 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • one hospitalization with a diabetes-related ICD-9 code
  • two outpatient visits with a diabetes-related ICD-9 code
  • at least one prescription for a glucose control medication (insulin or oral agents) or monitoring supplies.
  • \[70\] Potential participants must also have their most recent A1c in the prior 6 months be at least 8.0% if age \< 70 or at least 8.5% if age 70+).

You may not qualify if:

  • Using ICD-9 diagnostic codes, the investigators will exclude patients if they have an active substance abuse disorder or serious psychiatric illness:
  • PTSD
  • bipolar disorder
  • dementia
  • schizophrenia
  • or personality disorders
  • We will then send names of the patients to their primary care providers to identify any patients who they do not recommend inviting to participate in the program.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

VA Ann Arbor Healthcare System, Ann Arbor, MI

Ann Arbor, Michigan, 48105, United States

Location

John D. Dingell VA Medical Center, Detroit, MI

Detroit, Michigan, 48201, United States

Location

Related Publications (1)

  • Turner CD, Lindsay R, Heisler M. Peer Coaching to Improve Diabetes Self-Management Among Low-Income Black Veteran Men: A Mixed Methods Assessment of Enrollment and Engagement. Ann Fam Med. 2021 Nov-Dec;19(6):532-539. doi: 10.1370/afm.2742.

MeSH Terms

Conditions

Diabetes Mellitus

Interventions

Decision Support Techniques

Condition Hierarchy (Ancestors)

Glucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Intervention Hierarchy (Ancestors)

Investigative Techniques

Results Point of Contact

Title
Dr. Michele Heisler
Organization
VA HSRD: CCMR Ann Arbor and University of Michigan Medical School

Study Officials

  • M. E. Michele Heisler, MD MPA

    VA Ann Arbor Healthcare System, Ann Arbor, MI

    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
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Sponsor Type
FED
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 13, 2013

First Posted

May 16, 2013

Study Start

September 9, 2014

Primary Completion

September 20, 2017

Study Completion

September 29, 2017

Last Updated

July 12, 2019

Results First Posted

July 12, 2019

Record last verified: 2019-04

Locations