Effect of Behavioral Intervention on Dilated Fundus Examination Rates in Older African American Individuals With Diabetes Mellitus: A Randomized Clinical Trial

Abstract

Importance: African American individuals are at high risk of diabetes mellitus and diabetic retinopathy but have suboptimal rates of dilated fundus examinations (DFEs). Early intervention is crucial for the prevention of diabetic retinopathy in this high-risk population.

Objective: To test the efficacy of behavioral activation for diabetic retinopathy prevention on rates of DFEs in older African American individuals with diabetes mellitus.

Design, setting, and participants: Masked randomized clinical trial at 2 urban medical centers from October 1, 2010, to May 31, 2014. Participants included 206 African American individuals 65 years and older with diabetes mellitus who had not obtained a DFE in the preceding 12 months.

Interventions: Participants were randomized to either behavioral activation for diabetic retinopathy prevention, a behavioral intervention designed to provide education, facilitate identifying and addressing health care barriers, and promote goal setting to improve rates of DFEs, or supportive therapy, a control condition.

Main outcomes and measures: The primary outcome was medical documentation of a DFE at 6 months' follow-up. Secondary outcomes included the Risk Perceptions and Risk Knowledge Survey of Diabetes Mellitus, Diabetes Self-Care Inventory, Patient Health Questionnaire 9, and National Eye Institute Vision Function Questionnaire 25 scores and hemoglobin A1c levels.

Results: More participants in the behavioral activation for diabetic retinopathy prevention group (87.9%) obtained a DFE compared with those in the supportive therapy group (34.1%) by the 6-month follow-up assessment (P < .001). Overall, participants in the behavioral activation for diabetic retinopathy prevention group were 2.5 times more likely to obtain a DFE compared with those in the supportive therapy group (risk ratio = 2.58; 95% CI, 1.91-3.48; P < .001). The intervention had no short-term effect on secondary outcomes of hemoglobin A1c levels, depression, or the Risk Perceptions and Risk Knowledge Survey of Diabetes Mellitus or National Eye Institute Vision Function Questionnaire 25 composite scores; however, both groups had improved adherence to diabetes mellitus self-care behaviors from baseline to 6-month follow-up.

Conclusions and relevance: Behavioral activation for diabetic retinopathy prevention significantly increased rates of DFEs in older African American individuals with diabetes mellitus. Behavioral interventions may have the potential to positively affect screening for diabetic retinopathy in at-risk populations.

Trial registration: clinicaltrials.gov Identifier: NCT01179555.