The Missouri Health Literacy and Diabetes Communication Initiative

Sponsor

Northwestern University (Other)

Overall Status

Completed

CT.gov ID

NCT00973830

Collaborator

(none)

667

Enrollment

Location

Arms

Duration (Months)

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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).

Condition or Disease	Intervention/Treatment	Phase
Diabetes Knowledge	Other: Diabetes Guide and Brief Counseling	N/A

Study Design

Study Type:

Interventional

Actual Enrollment :

667 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Health Services Research

Official Title:

The Missouri Health Literacy and Diabetes Communication Initiative

Study Start Date :

Aug 1, 2008

Actual Primary Completion Date :

Apr 1, 2010

Actual Study Completion Date :

Jul 1, 2010

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Carve-In 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 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).
Experimental: Carve-Out 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 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).
No Intervention: Control Patients in this arm receive standard care. They receive no Diabetes Guide or brief counseling sessions

Arm

Intervention/Treatment

Experimental: Carve-In

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

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).

Experimental: Carve-Out

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

No Intervention: Control

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

Outcome Measures

Primary Outcome Measures

Diabetes knowledge [3 months, 1 year]

Secondary Outcome Measures

Change in HbA1c reading [3 months, 1 year]

Eligibility Criteria

Criteria

Ages Eligible for Study:

25 Years and Older

Sexes Eligible for Study:

All

Accepts 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Northwestern University	Chicago	Illinois	United States	60611

Sponsors and Collaborators

Northwestern University

Investigators

Principal Investigator: Michael S. Wolf, PhD, MPH, Northwestern University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Northwestern University

ClinicalTrials.gov Identifier:

NCT00973830

Other Study ID Numbers:

NU0923013

First Posted:

Sep 9, 2009

Last Update Posted:

Jun 13, 2022

Last Verified:

Jun 1, 2022

Keywords provided by Northwestern University

Changes in HbA1c

Additional relevant MeSH terms:

Diabetes Mellitus

Study Results

No Results Posted as of Jun 13, 2022