Technologically Enhanced Coaching: A Program to Improve Diabetes Outcomes (VA-TEC)

This study is currently recruiting participants. (see Contacts and Locations)
Verified September 2014 by Department of Veterans Affairs
Sponsor:
Information provided by (Responsible Party):
Department of Veterans Affairs
ClinicalTrials.gov Identifier:
NCT01855399
First received: May 13, 2013
Last updated: September 4, 2014
Last verified: September 2014
  Purpose

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.


Condition Intervention
Diabetes
Behavioral: Peer Coaching
Behavioral: Computer Decision Aid and Self-Management Support Tool

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Investigator)
Primary Purpose: Health Services Research
Official Title: Technologically Enhanced Coaching (TEC):A Program for Improving Diabetes Outcomes

Resource links provided by NLM:


Further study details as provided by Department of Veterans Affairs:

Primary Outcome Measures:
  • Test the effectiveness of a technology-enhanced peer coaching (TEC) program in improving glucose control relative to peer support alone. [ Time Frame: 12 Month ] [ Designated as safety issue: No ]
    At baseline, 6 months, and 12 months, we will measure patients' A1c. For our "usual care" observed group, we will use CDW data to measure A1c levels. More than 85% of diabetes patients who meet our eligibility criteria receive A1c testing at recommended intervals, which should ensure adequate numbers of patients with follow-up A1c levels in our control sample.


Estimated Enrollment: 348
Study Start Date: September 2014
Estimated Study Completion Date: September 2017
Estimated Primary Completion Date: April 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Coaching with Decision Aid
All participants will be assigned to one of 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 Coaching
All participants will be assigned to one of 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 randomized to both groups 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.
Other Name: Coaching
Behavioral: Computer Decision Aid and Self-Management Support Tool
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.
Other Name: TEC
Active Comparator: Coaching without the Decision Aid
Participants randomized to the control 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
All participants will be assigned to one of 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 randomized to both groups 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.
Other Name: Coaching

Detailed Description:

Peer mentoring and support models have been found in two recent VA Randomized Controlled Trials (RCTs) to be more effective than usual care, financial incentives, and usual nurse care management to improve glycemic control in high-risk Veteran patients with poor glycemic control. Such models are important complements to provision of care by formal health care providers as they provide sustained, flexible between-visit support. Peer supporters and coaches can be trained in effective behavioral approaches to support other Veterans' self-management behaviors. Such supporters, however, necessarily lack the content expertise to help Veterans make informed treatment decisions and set health goals with their health care providers. Accordingly, in a recent study we developed and tested a tailored, interactive computer-based tool with diabetes and medication information embedded in the tool's software that peer coaches and other outreach workers can employ to facilitate discussions with patients. Such tailored, interactive tools have been found to be more effective than generic educational and decision support tools in improving clinical and patient-centered outcomes. Moreover, these tools could enhance the sustainability and effectiveness of coaching programs to better prepare patients to set self-management goals and action plans, and to discuss treatment options with their health care providers. With VA support and input from Veterans, we adapted the tailored, interactive computer-based tool for use with and by Veterans with diabetes. We now propose to incorporate this tool into a peer mentor-led diabetes self-management coaching program among predominantly African American Veterans with poor glycemic control at the Detroit VA, a VA health system with high rates of poor risk factor control among diabetes patients. We propose to evaluate this Technology-Enhanced Coaching (TEC) program. Specifically, we propose to:

Aim 1: Test the effectiveness of a technology-enhanced peer coaching (TEC) program in improving glucose control relative to peer coaching without technology enhancement.

Aim 2: Assess the impact of the intervention on key patient-centered outcomes, including patients' satisfaction and involvement with care, perceived social support, diabetes-specific quality of life, and medication adherence.

Aim 3: Identify patient characteristics associated with engagement in the intervention and mediators and moderators of the intervention's impact on patient outcomes.

In summary, the TEC program builds on the demonstrated strengths of peer support models and of tailored, interactive decision support tools in improving diabetes self-management and outcomes. This study will test incorporation of tailored interactive educational tools into a peer coaching model found in prior VA RCTs to be effective in improving diabetes outcomes.

The tools tested in the proposed intervention will be disseminated for use in other VA sites through a tool kit with training and support materials. Because the intervention addresses barriers to disease management for chronically ill patients, physicians, and case managers, the study may have broader impact on management practices for other chronic illnesses.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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+).

Exclusion Criteria:

  • Using ICD-9 diagnostic codes, we 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.
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01855399

Contacts
Contact: Rebecca A Mase, MSW BA (734) 845-3973 rmase@umich.edu
Contact: M. E. M Heisler, MD MPA michele.heisler@va.gov

Locations
United States, Michigan
VA Ann Arbor Healthcare System Recruiting
Ann Arbor, Michigan, United States, 48113-0170
Contact: Janet G Adams-Watson, MHSA BA    (734) 845-3604    jan.adams-watson@va.gov   
Contact: Julie C Lowery, PhD MHSA    (734) 845-3619    Julie.Lowery@va.gov   
Sub-Investigator: Angela Fagerlin, PhD MA         
Principal Investigator: M. E. Michele Heisler, MD MPA         
Sub-Investigator: Sandeep Vijan, MD MS         
John D. Dingell VA Medical Center, Detroit, MI Recruiting
Detroit, Michigan, United States, 48201
Contact: Martin Bermann, DO    313-250-0426    m.bermann@wayne.edu   
Sponsors and Collaborators
Investigators
Principal Investigator: M. E. Michele Heisler, MD MPA VA Ann Arbor Healthcare System
  More Information

No publications provided

Responsible Party: Department of Veterans Affairs
ClinicalTrials.gov Identifier: NCT01855399     History of Changes
Other Study ID Numbers: IIR 12-412
Study First Received: May 13, 2013
Last Updated: September 4, 2014
Health Authority: United States: Federal Government

Keywords provided by Department of Veterans Affairs:
Peer Support
Self Management
Health Disparities

Additional relevant MeSH terms:
Diabetes Mellitus
Endocrine System Diseases
Glucose Metabolism Disorders
Metabolic Diseases

ClinicalTrials.gov processed this record on October 23, 2014