The Missouri Health Literacy and Diabetes Communication Initiative

Study Overview
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Brief Summary
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Objective: to evaluate the efficacy of the American College of Physicians Foundation (ACPF) Diabetes Guide (Living with Diabetes: An Everyday Guide for You and Your Family) to improve diabetes self-management. Study Sites: Nine Federally-qualified health centers or safety-net clinics at three sites in Missouri. Sites are urban (St. Louis), midsize (Columbia) and rural (Kirksville). Three FQHCs or safety net clinics are located at each of the sites. Methods Overview and Design: A randomized controlled trial will be conducted. Patients will be recruited from identified health centers. As the intervention itself is directed to the clinic and not patient, the clinics will be randomly assigned to either 1) usual care (no treatment), 2) Carve-In - patients receive the Diabetes Guide and clinic staff follow-up and work with patients to create and complete action plans or 3)Carve-Out - patients receive the Diabetes Guide and a diabetes educator in Chicago follows up and works with patients to create and complete action plans. Recruited subjects will be administered a baseline assessment, and 3-month and 1-year follow-up assessments. Sample: The investigators will recruit a total of 1,080 patients (n=120 per clinic) anticipating 80 percent retention through both follow-up assessments (final estimated number of patients = 720). Eligibility to participate will be defined as patients 1) ages 30 and older (to better represent disease distribution), 2) English or Spanish-speaking, 3) a confirmed (by chart) diagnosis of uncontrolled diabetes (HBA1c 7.0 or more).

Official Title
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The Missouri Health Literacy and Diabetes Communication Initiative

Conditions
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Diabetes Knowledge

Intervention / Treatment
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* Other: Diabetes Guide and Brief Counseling


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Uncontrolled diabetes patients (defined as HbA1c 6.0 or greater). 25 years or older English or Spanish speaking Exclusion Criteria: Uncorrectable hearing or visual impairment Moderate to severe cognitive deficits

Ages Eligible for Study
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Minimum Age: 25 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Health Services Research
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Carve-In<br>Patients in this arm are given the Diabetes Guide and engage in six sessions of brief counseling with a nurse or medical assistant from their clinic. Counseling focuses on behavioral changes patients can make to improve their diabetes. | Other: Diabetes Guide and Brief Counseling<br>* If in one of the intervention arms, patients will receive a Diabetes Guide (a patient-friendly guide to help patients make healthy changes to improve their diabetes). The Diabetes Guide includes a brief counseling component, to be conducted with clinic staff (Carve-In) or an outside diabetes educator (Carve-Out).<br>|
| Experimental: Carve-Out<br>Patients in this arm are given the Diabetes Guide and engage in six sessions of brief counseling over-the-phone with a diabetes health educator stationed in Chicago, IL. Counseling focuses on behavioral changes patients can make to improve their diabetes. | Other: Diabetes Guide and Brief Counseling<br>* If in one of the intervention arms, patients will receive a Diabetes Guide (a patient-friendly guide to help patients make healthy changes to improve their diabetes). The Diabetes Guide includes a brief counseling component, to be conducted with clinic staff (Carve-In) or an outside diabetes educator (Carve-Out).<br>|
| No Intervention: Control<br>Patients in this arm receive standard care. They receive no Diabetes Guide or brief counseling sessions | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Diabetes knowledge |  | 3 months, 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in HbA1c reading |  | 3 months, 1 year | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Changes in HbA1c