Effect of Diabetes Education During Retinal Ophthalmology Visits on Diabetes Control

Jaeb Center for Health Research

Status and phase: Completed; Phase 3

Conditions: Diabetes; Diabetic Retinopathy

Treatments: Behavioral: Diabetes Education

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT01323348

DRCR.net-Protocol M

Details and patient eligibility

About

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.

Full 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.

Enrollment: 1,875 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Age >18 years

2. Diagnosis of type 1 or type 2 diabetes mellitus

   Any one of the following will be considered to be sufficient evidence that diabetes is present:

   • Current regular use of insulin for the treatment of diabetes
   • Current regular use of oral anti-hyperglycemia agents for the treatment of diabetes
   • Documented diabetes by American Diabetes Associate and/or World Health Organization criteria

3. Routine care follow-up is yearly or more frequent

4. English or Spanish speaking

5. Able and willing to provide informed consent

6. Willing to complete 24 months of study follow up

Exclusion criteria

1. Known HbA1c (patient report or available records at time of enrollment) <7.5% within prior 6 months
2. Active participation in any type of intervention study
3. Initiation of insulin treatment within 3 months from date of enrollment
4. Prior complete panretinal photocoagulation or prior diabetes-related vitrectomy in both eyes
5. Advanced visual acuity loss in both eyes which prohibits ability to read study materials (tested as needed with reading test using materials in appropriate size script)
6. Significant renal disease including use of erythropoietin (Procrit, Epogen, Eprex) or a history of chronic renal failure requiring dialysis or kidney transplant

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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1,875 participants in 2 patient groups

Diabetes Educational Intervention

Experimental group

Description:

Study participants in the intervention group will receive a diabetes management educational intervention at baseline and at follow-up visits. For those on an annual follow-up schedule, educational intervention will take place at baseline and 12 months. For those whose standard care involves more frequent, than annual, visits the educational intervention will take place no more than once every 12 weeks.

Treatment:

Behavioral: Diabetes Education

Standard Care

No Intervention group

Description:

Usual care