Diabetes Knowledge
Conditions
Keywords
Changes in HbA1c
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).
Interventions
OTHERDiabetes 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).
Sponsors
Northwestern University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
25 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Diabetes knowledge | 3 months, 1 year |
Secondary
| Measure | Time frame |
|---|---|
| Change in HbA1c reading | 3 months, 1 year |
Countries
United States
Outcome results
None listed