Telephone Delivered Behavioral Skills Intervention for Blacks With T2DM

Blacks (African Americans) with Type 2 diabetes (T2DM) have higher prevalence of diabetes,
poorer metabolic control, and greater risk for complications and death compared to Whites.
Poor outcomes in Blacks with T2DM can be attributed to patient, provider, and health systems
level factors. Provider and health system factors account for <10% of variance in major
diabetes outcomes. Key differences appear to be at the patient level. Of the patient level
factors, consistent differences between Blacks and Whites with T2DM have been found in
diabetes knowledge, self-management skills, empowerment, and perceived control. A variety of
interventions to improve diabetes self-management have been tested including: 1) knowledge
interventions; 2) lifestyle interventions; 3) skills training interventions; and 4) patient
activation and empowerment interventions. Most of these interventions have been tested
individually, but rarely have they been tested in combination, especially among Blacks who
have the greatest burden of diabetes related complications. This study provides a unique
opportunity to address this gap in the literature. Using a 2x2 factorial design, this study
will test the efficacy of separate and combined telephone-delivered, diabetes
knowledge/information and motivation/behavioral skills training intervention in high risk
Blacks with poorly controlled T2DM (HbA1c ≥9%). The primary objective is to test the
separate and combined efficacy of a telephone-delivered diabetes knowledge/information
intervention and motivation/behavioral skills training intervention in improving HbA1c
levels in Blacks with T2DM using a 2x2 factorial design. The secondary objectives are: 1) To
determine whether patients randomized to the telephone-delivered diabetes
knowledge/information intervention, the motivation/behavioral skills training intervention
or the combined intervention will have greater improvement in physical activity, diet,
medication adherence, and self-monitoring of blood glucose at 12 months of follow-up
compared to usual care; and 2) To determine the cost-effectiveness of each telephone
intervention separately, and then in combination. The primary outcome is HbA1c level at 12
months of follow-up. The secondary outcomes are cost-effectiveness of each telephone
intervention separately, and then in combination, and change in physical activity, diet,
medication adherence, and self-monitoring of blood glucose over 12 months of follow-up. The
long-term goal of the project is to achieve improvement in diabetes-related outcomes in this
patient population.

Inclusion Criteria:

- 1) Age ≥18 years

- 2) Clinical diagnosis of T2DM and HbA1c ≥9% at the screening visit

- 3) Self-identified as Black or African American

- 4) Subject must be taking at least one oral medication for diabetes, hypertension, or
hyperlipidemia and must be willing to use the MEMS cap and bottle for 12 months

- 5) Subjects must be able to communicate in English

- 6) Subjects must have access to a telephone (landline or cell phone) for the 12 week
intervention period

Exclusion Criteria:

- 1) Mental confusion on interview suggesting significant dementia

- 2) Participation in other diabetes clinical trials

- 3) Alcohol or drug abuse/dependency

- 4) Active psychosis or acute mental disorder

- 5) Life expectancy <6 months