Combined Diabetes Education/Skills Training and Social Needs Resolution Intervention for Older African Americans with Poorly Controlled Type 2 Diabetes (DM Social Needs): Study Protocol for a Randomized Controlled Trial

Background: Approximately 11.3% of the US population has diabetes. The burden of diabetes is higher in older adults and African Americans (AAs), such that 40% of adults aged 50 years and older have diabetes; African Americans are 60% more likely to be diagnosed with diabetes compared to non-Hispanic Whites (NHWs). Structural racism has resulted in fewer economic and educational opportunities for AAs, higher social risks, and unmet basic needs, which result in financial instability, housing instability, food insecurity, and a lack of transportation compared to NHWs. The presence of these unmet basic needs is a driver of poor adherence to diabetes self-management in older AAs. Aim: To test the preliminary efficacy of a nurse case-manager, telephone-delivered intervention that provides foundational diabetes self-management education and skills training, while also addressing and resolving the unmet social needs of older AAs with poorly controlled type 2 diabetes mellitus (T2DM). The primary hypothesis is that older AAs with T2DM randomized to the DM Social Needs intervention will have significantly lower hemoglobin A1C (HbA1C), blood pressure, and LDL levels compared to the usual care arm at 6 months post randomization. Methods: This is a three-year prospective, randomized clinical trial that will enroll 100 AAs aged 50 and older with type 2 diabetes (T2DM) and HbA1C >= 8% into one of the following two groups: (1) a nurse case-manager, telephone-delivered intervention that provides foundational diabetes self-management education and skills training, but also addresses and resolves unmet social needs; or (2) an enhanced usual care group that will receive mailed diabetes education materials. Participants will be followed for 6 months to determine the effect of the intervention on HbA1C, blood pressure, and low-density lipoprotein (LDL) cholesterol levels. Results: Baseline characteristics will be presented by study group, and within- and between-group changes in primary outcomes from baseline to 6 months will be reported. Conclusion: The results from this study will provide insights into the efficacy of a combined diabetes education and skills training and social needs resolution intervention for older African Americans with poorly controlled type 2 diabetes and will inform strategies to improve diabetes outcomes for this vulnerable population.