NCT01323348

Effect of Diabetes Education During Retinal Ophthalmology Visits on Diabetes Control

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 1,875 (actual)
• Sponsor: Jaeb Center for Health Research · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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.

Conditions

• Diabetes
• Diabetic Retinopathy

Interventions

Type	Name	Description
BEHAVIORAL	Diabetes Education	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

Timeline

• Start date: 2011-10-01
• Primary completion: 2014-07-01
• Completion: 2015-01-01
• First posted: 2011-03-25
• Last updated: 2016-08-26

Locations

34 sites across 1 country: United States