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NCT00973830 · ClinicalTrials.gov registry record · NA
The Missouri Health Literacy and Diabetes Communication Initiative
A NA study, sponsored by Northwestern University.
- Completed
- Registry status
- NA
- Development phase
- 667
- Enrollment target
NCT00973830 is a NA study that has completed, run by Northwestern University. The registered enrollment target is 667 participants.
The verdict
NCT00973830, a NA study, has completed, sponsored by Northwestern University.
- COMPLETED
- Registry status
- NA
- Development phase
- 667 participants
- Enrollment target
Study 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).
Interventions
- OTHER Diabetes Guide and Brief Counseling
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 667 participants |
| Start Date | 2008-08 |
| Est. Completion | 2010-07 |
| Phase | NA |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00973830
The ClinicalTrials.gov registry entry for NCT00973830 describes a study currently listed as completed, categorized as NA. The registered enrollment target is 667 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Northwestern University, which has 1,209 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which Diabetes Guide and Brief Counseling is the first listed.
NCT00973830 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT00973830 about?
NCT00973830 is a clinical study titled "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...
What is the current status of trial NCT00973830?
This trial is currently completed. It is a NA study. The enrollment target is 667 participants. The study started on 2008-08. Estimated completion is 2010-07.
What interventions are being tested in trial NCT00973830?
The interventions under investigation include: Diabetes Guide and Brief Counseling (OTHER).
Who is sponsoring clinical trial NCT00973830?
This trial is sponsored by Northwestern University, which has 1,209 total clinical trials registered on ClinicalTrials.gov.
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