Elsevier

American Heart Journal

Volume 166, Issue 1, July 2013, Pages 179-186.e2
American Heart Journal

Clinical Investigation
Diabetes and Metabolism
The Cholesterol, Hypertension, And Glucose Education (CHANGE) study: Results from a randomized controlled trial in African Americans with diabetes

https://doi.org/10.1016/j.ahj.2013.04.004Get rights and content

Background

Cardiovascular disease (CVD) and diabetes account for one-third of the mortality difference between African American and white patients. We evaluated the effect of a CVD risk reduction intervention in African Americans with diabetes.

Methods

We randomized 359 African Americans with type 2 diabetes to receive usual care or a nurse telephone intervention. The 12-month intervention provided monthly self-management support and quarterly medication management facilitation. Coprimary outcomes were changes in systolic blood pressure (SBP), hemoglobin A1c (HbA1c), and low-density lipoprotein cholesterol (LDL-C) over 12 months. We estimated between-intervention group differences over time using linear mixed-effects models. The secondary outcome was self-reported medication adherence.

Results

The sample was 72% female; 49% had low health literacy, and 37% had annual income <$10,000. Model-based estimates for mean baseline SBP, HbA1c, and LDL-C were 136.8 mm Hg (95% CI 135.0-138.6), 8.0% (95% CI 7.8-8.2), and 99.1 mg/dL (95% CI 94.7-103.5), respectively. Intervention patients received 9.9 (SD 3.0) intervention calls on average. Primary providers replied to 76% of nurse medication management facilitation contacts, 18% of these resulted in medication changes. There were no between-group differences over time for SBP (P = .11), HbA1c (P = .66), or LDL-C (P = .79). Intervention patients were more likely than those receiving usual care to report improved medication adherence (odds ratio 4.4, 95% CI 1.8-10.6, P = .0008), but adherent patients did not exhibit relative improvement in primary outcomes.

Conclusions

This intervention improved self-reported medication adherence but not CVD risk factor control among African Americans with diabetes. Further research is needed to determine how to maximally impact CVD risk factors in African American patients.

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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    Darren K. McGuire, MD, MHSc served as guest editor for this article.

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