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.


OBJECTIVE
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 , glycosylated 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 glycosylated 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.


CONCLUSIONS
Given the continued racial disparities in CVD, the proposed study could result in significant contributions to cardiovascular risk reduction in African-American patients.
Powers
Benjamin J
BJ
Center for Health Services Research in Primary Care, Durham VAMC, Durham, NC 27705, USA. ben.powers@duke.edu
King
Joy L
JL
Ali
Robin
R
Alkon
Aviel
A
Bowlby
Lynn
L
Edelman
David
D
Gentry
Pamela
P
Grubber
Janet M
JM
Koropchak
Celine
C
Maciejewski
Matthew L
ML
McCant
Felicia
F
McKoy
Gwendolyn
G
Newell
Michael
M
Oddone
Eugene Z
EZ
Olsen
Maren K
MK
Rose
Cynthia M
CM
Trujillo
Gloria
G
Bosworth
Hayden B
HB
D001741:Black or African American; D001786:Blood Glucose; D001794:Blood Pressure; D002318:Cardiovascular Diseases / Q000097:blood / Q000209:etiology*; D008078:Cholesterol, LDL / Q000097:blood; D003924:Diabetes Mellitus, Type 2 / Q000097:blood / Q000150:complications*; D019468:Disease Management; D006442:Glycated Hemoglobin / Q000032:analysis; D015438:Health Behavior; D054624:Health Status Disparities; D006801:Humans; D006973:Hypertension / Q000209:etiology; D010353:Patient Education as Topic; D010358:Patient Participation; D012107:Research Design; D012307:Risk Factors; D040242:Risk Reduction Behavior; D013599:Systole; D055815:Young Adult
D001786:Blood Glucose; D008078:Cholesterol, LDL; D006442:Glycated Hemoglobin