The Missouri Health Literacy and Diabetes Communication Initiative

Northwestern University

Status: Completed

Conditions: Diabetes Knowledge

Treatments: Other: Diabetes Guide and Brief Counseling

Study type: Interventional

Funder types: Other

Identifiers

NCT00973830

NU0923013

Details and patient eligibility

About

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).

Enrollment: 667 patients

Sex: All

Ages: 25+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Health Services Research

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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667 participants in 3 patient groups

Carve-In

Experimental group

Description:

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.

Treatment:

Other: Diabetes Guide and Brief Counseling

Carve-Out

Experimental group

Description:

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.

Treatment:

Other: Diabetes Guide and Brief Counseling

Control

No Intervention group

Description:

Patients in this arm receive standard care. They receive no Diabetes Guide or brief counseling sessions