Clinical InvestigationDiabetes and MetabolismThe Cholesterol, Hypertension, And Glucose Education (CHANGE) study: Results from a randomized controlled trial in African Americans with diabetes
Section snippets
Background
Individuals with type 2 diabetes have increased risk for cardiovascular disease (CVD), resulting in higher mortality, morbidity, and costs.1, 2, 3 Achieving simultaneous control of multiple CVD risk factors such as diabetes, hypertension, and hyperlipidemia reduces complications among patients with diabetes.4, 5, 6 African Americans are approximately twice as likely as white patients to have ≥3 CVD risk factors7, 8 and to experience higher rates of coronary events, stroke, and mortality.9, 10,
Methods
The CHANGE study (ClinicalTrials.gov Identifier: NCT00815789) randomized African American patients with type 2 diabetes to (1) usual care or (2) a nurse-administered telephone intervention incorporating CVD risk factor self-management education and medication management facilitation. Participants received care at 2 clinics in Durham, NC, where primary care providers (PCPs) including physicians, nurse practitioners, physician assistants, and residents serve significant numbers of African
Baseline characteristics
We randomized 359 patients to usual care (n = 177) or intervention groups (n = 182) (Figure 1). Compared with 870 potentially eligible participants who were not included, randomized patients were more often female (73% vs 66%; P = .02) but did not differ in age; hypertension, coronary artery disease, chronic kidney disease, or congestive heart failure prevalence; or HbA1c, BP, or LDL-C. Table I shows the characteristics of included patients by intervention group and is notable for the 49% of
Discussion
We enrolled a large group of African Americans with diabetes, limited financial resources, and high prevalence of low health literacy for a trial of a nurse-delivered intervention combining patient self-management education and facilitation of medication management. Despite frequent contact with patients/PCPs and good intervention participation, we observed no significant intervention effect on SBP, HbA1c, or LDL-C compared with usual care. Although intervention group patients were
Acknowledgements
Preliminary results were presented at the 35th Annual Society of General Internal Medicine Meeting, Orlando, Florida. May 9-12, 2012. B.J.P. was supported by a VA Career Development Award during this project. M.L.M and H.B.B are supported by VA HSRD Career Scientist Awards, and H.B.B. is supported by an American Heart Association Established Investigator Award. Study funding is described in the Methods section.
The views expressed in this manuscript do not necessarily represent those of the
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RCT reg #NCT00815789.
Darren K. McGuire, MD, MHSc served as guest editor for this article.