The purpose of this study is to assess whether glycemic control (assessed with HbA1c measurement) in individuals with type 1 or type 2 diabetes can be improved with a point-of-care measurement of HbA1c in the ophthalmologist's office combined with a personalized risk assessment for diabetic retinopathy and other complications of diabetes.
Although each patient with diabetes should be receiving diabetic education as part of their on-going routine medical care, it is likely that such education is delivered with different details and intensity. Motivating a patient with diabetes to become involved in his or her care is of primary importance in achieving better systemic control. Ocular complications from diabetes remain the most common cause of blindness among American adults 20-74 years of age. A recent survey reported that loss of vision is the most feared of all diabetic complications. Thus, it is possible that an educational intervention at an ophthalmology office may have additional impact beyond the current standard of diabetes education at a primary care or diabetologist/endocrinologist office alone. This study will determine whether diabetes education in the ophthalmology office (which includes same-visit feedback of HbA1c levels, combined with standardized education regarding same-visit blood pressure, retinopathy status and overall diabetes education) can improve subsequent HbA1c as compared with current standard care in an ophthalmology office. Materials used in this research setting must be applicable for use in ophthalmology practices. Therefore, the materials and procedures for this study have been developed with the goal of easy translation to this audience.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
NONE
Enrollment
1,875
The intervention will consist of the following at enrollment and at each follow-up visit (but no more frequently than once every 12 weeks): * Measurement of HbA1c in office with immediate feedback * Measurement of blood pressure with immediate feedback * Assessment of retinopathy risk with immediate feedback * Personalized risk assessment reports based on current HbA1c * Brief assessment of patient understanding of key issues with immediate feedback * Supplemental diabetes management educational materials (provided at baseline only) * Feedback to primary care provider * Email reminder to study participants with email access of individualized risk assessment findings
Change in HbA1c
Mean change in HbA1c from baseline to 12 months in intervention versus control for study participants being seen for standard care more frequently than every 12 months
Time frame: 12 Months
Diabetes Care Knowledge
At baseline and at annual visits, study participants in all treatment groups will complete self-assessment questionnaires in order to assess perception of emotional problems frequently reported in type 1 and type 2 diabetes and to measure perceived adherence to diabetes self-care recommendations. At the annual visits, summary statistics will be presented on the responses as appropriate to the distribution and the treatment groups will be compared controlling for baseline responses.
Time frame: 12 Months/24 Months
Blood Pressure
For analyses, systolic and diastolic blood pressure will be converted to an overall mean blood pressure according to the following calculation: diastolic blood pressure + 1/3 (systolic blood pressure - diastolic blood pressure). Blood pressure will be analyzed as the change in the weighted mean blood pressure from baseline to 12 months adjusted for the baseline weighted mean blood pressure. Treatment group comparisons will be made using ANCOVA to adjust for the baseline blood pressure, with GEE to adjust for the correlation within subjects of the same cluster.
Time frame: 12 Months/24 Months
Body Mass Index
Treatment group comparisons will be made using analysis of covariance (ANCOVA) to adjust for the baseline HbA1c, with generalized estimating equations (GEE) to adjust for the correlation within subjects of the same randomization cluster.
Time frame: 12 Months/24 Months
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Loma Linda University Health Care, Dept. of Ophthalmology
Loma Linda, California, United States
California Retina Consultants
Santa Barbara, California, United States
Retina Vitreous Consultants
Fort Lauderdale, Florida, United States
University of Florida College of Med., Department of Ophthalmology
Jacksonville, Florida, United States
Central Florida Retina Institute
Lakeland, Florida, United States
University of Illinois at Chicago Medical Center
Chicago, Illinois, United States
Raj K. Maturi, M.D., P.C.
Indianapolis, Indiana, United States
John-Kenyon American Eye Institute
New Albany, Indiana, United States
Retina and Vitreous Associates of Kentucky
Lexington, Kentucky, United States
Paducah Retinal Center
Paducah, Kentucky, United States
...and 24 more locations