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Published on: February 28, 2013
The Cholesterol, Hypertension, And Glucose Education (CHANGE) study: results from a randomized controlled trial in
Matthew J Crowley1, Benjamin J Powers, Maren K Olsen
1Center for Health Services Research in Primary Care, Durham VAMC, Durham, NC, USA. matthew.crowley@dm.duke.edu
Insights
A nurse telephone intervention improved medication adherence in African Americans with type 2 diabetes but did not significantly lower cardiovascular disease risk factors like blood pressure or cholesterol.
Area of Science:
- Public Health
- Cardiology
- Endocrinology
Background:
- Cardiovascular disease (CVD) and diabetes contribute significantly to mortality disparities in African Americans.
- Evaluating interventions to reduce CVD risk in this population is critical.
Purpose of the Study:
- To assess the impact of a nurse telephone intervention on CVD risk factors in African Americans with type 2 diabetes.
- To determine if the intervention improves systolic blood pressure (SBP), hemoglobin A1c (HbA1c), and low-density lipoprotein cholesterol (LDL-C).
Main Methods:
- 359 African Americans with type 2 diabetes were randomized to usual care or a 12-month nurse telephone intervention.
- Intervention included monthly self-management support and quarterly medication management.
- Coprimary outcomes: changes in SBP, HbA1c, and LDL-C; secondary outcome: medication adherence.
Main Results:
- No significant differences in SBP, HbA1c, or LDL-C between groups.
- Intervention group showed significantly improved self-reported medication adherence (OR 4.4, P = .0008).
- Improved adherence did not translate to better control of primary CVD risk factors.
Conclusions:
- The nurse telephone intervention enhanced medication adherence but did not effectively reduce key CVD risk factors in African Americans with diabetes.
- Further research is required to develop strategies that more effectively impact CVD risk in this demographic.
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.
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