Trial record 5 of 27 for:    Open Studies | "Health Literacy"

The Missouri Health Literacy and Diabetes Communication Initiative

The recruitment status of this study is unknown because the information has not been verified recently.
Verified September 2009 by Northwestern University.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
Northwestern University
ClinicalTrials.gov Identifier:
NCT00973830
First received: September 8, 2009
Last updated: NA
Last verified: September 2009
History: No changes posted
  Purpose

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 Intervention
Diabetes Knowledge
Other: Diabetes Guide and Brief Counseling

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Health Services Research
Official Title: The Missouri Health Literacy and Diabetes Communication Initiative

Resource links provided by NLM:


Further study details as provided by Northwestern University:

Primary Outcome Measures:
  • Diabetes knowledge [ Time Frame: 3 months, 1 year ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Change in HbA1c reading [ Time Frame: 3 months, 1 year ] [ Designated as safety issue: No ]

Estimated Enrollment: 1080
Study Start Date: August 2008
Estimated Study Completion Date: July 2010
Estimated Primary Completion Date: April 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   25 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00973830

Contacts
Contact: Stacy C. Bailey, MPH (312) 503-5586 stacy-bailey@northwestern.edu
Contact: Anjali Pandit, MPH (312) 503-5597 a-pandit@northwestern.edu

Locations
United States, Illinois
Northwestern University Recruiting
Chicago, Illinois, United States, 60611
Contact: Stacy Bailey, MPH    312-503-5586    stacy-bailey@northwestern.edu   
Sponsors and Collaborators
Northwestern University
Investigators
Principal Investigator: Michael S. Wolf, PhD, MPH Northwestern University
  More Information

No publications provided

Responsible Party: Michael S. Wolf, PhD, MPH, Northwestern University
ClinicalTrials.gov Identifier: NCT00973830     History of Changes
Other Study ID Numbers: NU0923013
Study First Received: September 8, 2009
Last Updated: September 8, 2009
Health Authority: United States: Institutional Review Board

Keywords provided by Northwestern University:
Changes in HbA1c

Additional relevant MeSH terms:
Diabetes Mellitus
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases

ClinicalTrials.gov processed this record on August 20, 2014