Clinical trial NCT01855399: Technologically Enhanced Coaching: A Program to Improve Diabetes Outcomes
Official title: Technologically Enhanced Coaching (TEC):A Program for Improving Diabetes Outcomes
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Diabetes
Keywords: Peer Support
Self Management
Health Disparities
Lead sponsor: VA Office of Research and Development
Sponsor class: FED
First posted: 2013-05-16
Enrollment: 290
Sex: ALL
Minimum age (years): 18
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

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.

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.

Eligibility 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, 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.

Primary outcomes:
measure: Percent Glycosylated Hemoglobin
timeFrame: 6 Month
Secondary outcomes:
Other outcomes:
Locations:
city: Ann Arbor
country: United States
facility: VA Ann Arbor Healthcare System, Ann Arbor, MI
state: Michigan
city: Detroit
country: United States
facility: John D. Dingell VA Medical Center, Detroit, MI
state: Michigan
Study officials:
affiliation: VA Ann Arbor Healthcare System, Ann Arbor, MI
name: M. E. Michele Heisler, MD MPA
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.