Telephone-Delivered Behavioral Skills Intervention for African American Adults with Type 2 Diabetes: A Randomized Controlled Trial.
BACKGROUND
Diabetes disproportionately affects African Americans and is associated with poorer outcomes. Self-management is important for glycemic control; however, evidence in African Americans is limited.


OBJECTIVE
To assess the efficacy of a combined telephone-delivered education and behavioral skills intervention (TBSI) in reducing hemoglobin A1c (HbA1c) levels in African Americans with type 2 diabetes, using a factorial design.


METHODS
This is a four-year randomized clinical trial, using a 2 x 2 factorial design.: Participants: African American adults ≥18 years) with poorly controlled type 2 diabetes (HbA1c ≥9%) were randomly assigned to one of four groups: 1) knowledge only, 2) skills only, 3) combined knowledge and skills (TBSI), or 4) control group.


METHODS
All participants received 12 telephone-delivered 30-min intervention sessions specific to their assigned group. Participants were assessed at baseline and 3, 6, and 12 months.


METHODS
The primary outcome was HbA1c at 12 months post-randomization in the intent-to-treat (ITT) population.


RESULTS
Two hundred fifty-five participants were randomly assigned to the four groups. Based on the ITT population after multiple imputation, the analysis of covariance with baseline HbA1c as the covariate showed that HbA1c at 12 months for the intervention groups did not differ significantly from that of the control group (knowledge: 0.49, p = 0.123; skills: 0.23, p = 0.456; combined: 0.48, p = 0.105). Absolute change from baseline at 12 months for all treatment arms was 0.6. Longitudinal mixed effects analysis showed that, on average, there was a significant decline in HbA1c over time for all treatment groups (-0.07, p < 0.001). However, the rates of decline for the intervention groups were not significantly different from that of the control group (knowledge: 0.06, p = 0.052; skills: 0.02, p = 0.448; combined: 0.05, p = 0.062). Results from per-protocol populations were similar.


CONCLUSIONS
For African Americans with poorly controlled type 2 diabetes, combined education and skills training did not achieve greater reductions in glycemic control (i.e., HbA1c levels) at 12 months compared to the control group, education alone, or skills training alone. This trial is registered with ClinicalTrials.gov, identifier no. NCT00929838.
Department of Medicine, Froedtert and Medical College of Wisconsin, Milwaukee, WI, USA. legede@mcw.edu.|Center for Patient Care and Outcomes Research, Medical College of Wisconsin, Milwaukee, WI, USA. legede@mcw.edu.|Division of General Internal Medicine, Froedtert and Medical College of Wisconsin, Milwaukee, WI, USA. legede@mcw.edu.
Leonard E
LE
Egede
Department of Medicine, Froedtert and Medical College of Wisconsin, Milwaukee, WI, USA.|Center for Patient Care and Outcomes Research, Medical College of Wisconsin, Milwaukee, WI, USA.|Division of General Internal Medicine, Froedtert and Medical College of Wisconsin, Milwaukee, WI, USA.
Joni S
JS
Williams
Emmes, Vaccine and Infectious Diseases, Rockville, MD, USA.
Delia C
DC
Voronca
Department of Public Health Sciences, Medical University of South Carolina, Charleston, SC, USA.
Mulugeta
M
Gebregziabher
Center for Health Disparities Research, Medical University of South Carolina, Charleston, SC, USA.|Department of Medicine, Division of General Internal Medicine and Geriatrics, Medical University of South Carolina, Charleston, SC, USA.|Health Equity and Rural Outreach Innovation Center, Ralph H. Johnson VA Medical Center, Charleston, SC, USA.
Cheryl P
CP
Lynch
D000293:Adolescent; D000328:Adult; D001741:Black or African American / Q000523:psychology*; D000368:Aged; D003924:Diabetes Mellitus, Type 2 / Q000097:blood / Q000523:psychology* / Q000628:therapy*; D005260:Female; D038321:Glycemic Index / Q000502:physiology; D015438:Health Behavior; D007722:Health Knowledge, Attitudes, Practice; D006801:Humans; D008297:Male; D008875:Middle Aged; D010353:Patient Education as Topic / Q000379:methods*; D016037:Single-Blind Method; D017216:Telemedicine / Q000379:methods*; D055815:Young Adult