The Missouri Health Literacy and Diabetes Communication Initiative

NCT00973830 | Completed

• 1 other identifier: NU0923013
• Study Type: interventional
• Target: 667
• Locations: 1 country
• Sites: 1

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).

Conditions

Diabetes Knowledge

Keywords

Changes in HbA1c

Outcome Measures

Primary Outcomes (1)

• Diabetes knowledge

  3 months, 1 year

Secondary Outcomes (1)

• Change in HbA1c reading

  3 months, 1 year

Study Arms (3)

Carve-In

EXPERIMENTAL

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

Carve-Out

EXPERIMENTAL

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

Control

NO INTERVENTION

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

Interventions

Diabetes Guide and Brief Counseling OTHER

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).

Carve-In; Carve-Out

Eligibility Criteria

• Age: 25 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Uncontrolled diabetes patients (defined as HbA1c 6.0 or greater).
• years or older
• English or Spanish speaking

You may not qualify if:

• Uncorrectable hearing or visual impairment
• Moderate to severe cognitive deficits

Sponsors & Collaborators

• Northwestern University: lead

Study Sites (1)

Northwestern University

Chicago, Illinois, 60611, United States

Location

Study Officials

• Michael S. Wolf, PhD, MPH

  Northwestern University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 8, 2009
• First Posted: September 9, 2009
• Study Start: August 1, 2008
• Primary Completion: April 1, 2010
• Study Completion: July 1, 2010
• Last Updated: June 13, 2022

Record last verified: 2022-06

Locations

US (1)