The Cholesterol, Hypertension, and Glucose Education (CHANGE) study for African Americans with diabetes: Study design and methodology

Background: Cardiovascular disease (CVD) and diabetes account for over one third of the mortality difference between African Americans and white patients. The increased CVD risk in African Americans is due in large part to the clustering of multiple CVD risk factors. Objectives: The current study is aimed at improving CVD outcomes in African-American adults with diabetes by addressing the modifiable risk factors of systolic blood pressure, glycosolated hemoglobin, and low-density lipoprotein cholesterol. Methods: A sample of African American patients with diabetes (N = 400) will receive written education material at baseline and be randomized to one of 2 arms: (1) usual primary care or (2) nurse-administered disease-management intervention combining patient self-management support and provider medication management. The nurse administered intervention is delivered monthly over the telephone. The nurses also interacts with the primary care providers at 3, 6, and 9 months to provide concise patient updates and facilitate changes in medical management. All patients are followed for 12 months after enrollment. The primary outcomes are change in glycosolated hemoglobin, systolic blood pressure, and low-density lipoprotein cholesterol over 12-months. Secondary outcomes include change in overall cardiovascular risk, aspirin use, and health behaviors. Conclusion: Given the continued racial disparities in CVD, the proposed study could result in significant contributions to cardiovascular risk reduction in African-American patients.