- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01855399
Technologically Enhanced Coaching: A Program to Improve Diabetes Outcomes (VA-TEC)
Technologically Enhanced Coaching (TEC):A Program for Improving Diabetes Outcomes
Study Overview
Status
Conditions
Intervention / Treatment
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 the investigators 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, the investigators adapted the tailored, interactive computer-based tool for use with and by Veterans with diabetes. The investigators 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. The investigators propose to evaluate this Technology-Enhanced Coaching (TEC) program. Specifically, the investigators 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; and, also test the effectiveness of peer support compared to observed usual care. For the "usual care" observed group, the investigators will use electronic health record data to measure A1c levels.
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.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Michigan
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Ann Arbor, Michigan, United States, 48105
- VA Ann Arbor Healthcare System, Ann Arbor, MI
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Detroit, Michigan, United States, 48201
- John D. Dingell VA Medical Center, Detroit, MI
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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, 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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Health Services Research
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Peer Coaching + Decision Aid
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.
|
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.
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 Names:
|
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Active Comparator: Peer Coaching Alone
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.
|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Percent Glycosylated Hemoglobin
Time Frame: 6 Month
|
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
|
Collaborators and Investigators
Investigators
- Principal Investigator: M. E. Michele Heisler, MD MPA, VA Ann Arbor Healthcare System, Ann Arbor, MI
Publications and helpful links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- IIR 12-412
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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