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The Missouri Health Literacy and Diabetes Communication Initiative

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified September 2009 by Northwestern University.
Recruitment status was:  Recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT00973830
First Posted: September 9, 2009
Last Update Posted: September 9, 2009
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Northwestern University
September 8, 2009
September 9, 2009
September 9, 2009
August 2008
April 2010   (Final data collection date for primary outcome measure)
Diabetes knowledge [ Time Frame: 3 months, 1 year ]
Same as current
No Changes Posted
Change in HbA1c reading [ Time Frame: 3 months, 1 year ]
Same as current
Not Provided
Not Provided
 
The Missouri Health Literacy and Diabetes Communication Initiative
The Missouri Health Literacy and Diabetes Communication Initiative

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).

Not Provided
Interventional
Not Provided
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Health Services Research
Diabetes Knowledge
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-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.
    Intervention: Other: Diabetes Guide and Brief Counseling
  • 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.
    Intervention: 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
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Unknown status
1080
July 2010
April 2010   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
25 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT00973830
NU0923013
Not Provided
Not Provided
Not Provided
Michael S. Wolf, PhD, MPH, Northwestern University
Northwestern University
Not Provided
Principal Investigator: Michael S. Wolf, PhD, MPH Northwestern University
Northwestern University
September 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP