A randomized controlled trial to test the efficacy of a diabetes behavioral intervention to prevent memory decline in older blacks/African Americans with diabetes and mild cognitive impairment

Abstract

BackgroundThe prevalence of dementia in Blacks/African Americans (AAs) is almost twice that of Whites. Inequities in access to health care, socioeconomic conditions, and diabetes contribute to this disparity. Poorly controlled diabetes, which is more prevalent in Blacks/AAs, causes microvascular disease and neurodegeneration and increases dementia risk. Improving glycemic control, therefore, may prevent cognitive decline. To address this issue, we developed Diabetes Regulation for Eyesight and Memory (DREAM), a community health worker (CHW)-led behavioral intervention to improve diabetes self-management and thereby prevent cognitive decline. DREAM consists of home-based diabetes education, goal setting, and telehealth visits with a diabetes nurse educator. Exploratory aims will investigate whether APOE genotype moderates and retinal biomarkers mediate treatment effects. This report describes the trial's rationale, methodology, and study procedures. (clinicaltrials.gov identifier NCT04259047). MethodsThis randomized controlled trial will test the efficacy of DREAM to prevent decline in memory (primary outcome) in Blacks/AAs aged 65+ with poorly controlled diabetes and Mild Cognitive Impairment (MCI). Two hundred participants will be randomized to DREAM or an attention control condition, and will receive 11 in-home treatment sessions over two years. Outcome data are collected at 6, 12, 18, and 24 months. The primary outcome is verbal learning as measured by Hopkins Verbal Learning Test (HVLT) Total Recall scores. Participants will have retinal imaging at baseline, 12, and 24 months. ConclusionsThis research aims to prevent cognitive decline in older Blacks/AAs with diabetes and MCI. If successful, this research will preserve health in an underserved population and reduce racial health disparities.