Leonard E Egede1,2,3, Joni S Williams4,5,6, Delia C Voronca7, Mulugeta Gebregziabher8, Cheryl P Lynch9,10,11. 1. Department of Medicine, Froedtert and Medical College of Wisconsin, Milwaukee, WI, USA. legede@mcw.edu. 2. Center for Patient Care and Outcomes Research, Medical College of Wisconsin, Milwaukee, WI, USA. legede@mcw.edu. 3. Division of General Internal Medicine, Froedtert and Medical College of Wisconsin, Milwaukee, WI, USA. legede@mcw.edu. 4. Department of Medicine, Froedtert and Medical College of Wisconsin, Milwaukee, WI, USA. 5. Center for Patient Care and Outcomes Research, Medical College of Wisconsin, Milwaukee, WI, USA. 6. Division of General Internal Medicine, Froedtert and Medical College of Wisconsin, Milwaukee, WI, USA. 7. Emmes, Vaccine and Infectious Diseases, Rockville, MD, USA. 8. Department of Public Health Sciences, Medical University of South Carolina, Charleston, SC, USA. 9. Center for Health Disparities Research, Medical University of South Carolina, Charleston, SC, USA. 10. Department of Medicine, Division of General Internal Medicine and Geriatrics, Medical University of South Carolina, Charleston, SC, USA. 11. Health Equity and Rural Outreach Innovation Center, Ralph H. Johnson VA Medical Center, Charleston, SC, USA.
Abstract
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 hemoglobinA1c (HbA1c) levels in African Americans with type 2 diabetes, using a factorial design. DESIGN: 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. INTERVENTION: 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. MAIN MEASURE: The primary outcome was HbA1c at 12 months post-randomization in the intent-to-treat (ITT) population. KEY 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.
RCT Entities:
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. DESIGN: 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. INTERVENTION: 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. MAIN MEASURE: The primary outcome was HbA1c at 12 months post-randomization in the intent-to-treat (ITT) population. KEY 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.
Authors: Rebekah J Walker; Rebecca G Knapp; Clara E Dismuke-Greer; Renee E Walker; Mukoso N Ozieh; Leonard E Egede Journal: Contemp Clin Trials Date: 2020-11-07 Impact factor: 2.226
Authors: Leonard E Egede; Rebekah Walker; Joni S Williams; Rebecca Knapp; Clara Elizabeth Dismuke; Tatiana Davidson; Jennifer A Campbell Journal: BMJ Open Date: 2020-12-22 Impact factor: 2.692
Authors: Lidia García-Pérez; Yolanda Ramallo-Fariña; Laura Vallejo-Torres; Leticia Rodríguez-Rodríguez; Himar González-Pacheco; Beatriz Santos-Hernández; Miguel Angel García-Bello; Ana María Wägner; Montserrat Carmona; Pedro G Serrano-Aguilar Journal: BMJ Open Date: 2022-04-08 Impact factor: 2.692