N/A
Completed N=255
Telephone Delivered Behavioral Skills Intervention for Blacks With T2DM
Type 2 Diabetes Mellitus · Diabetes Mellitus, Adult-Onset · Diabetes Mellitus, Non-Insulin-Dependent · Diabetes Mellitus, Noninsulin Dependent
Source: ClinicalTrials.gov NCT00929838 ↗
Enrolled (actual)
255
Serious AEs
0.0%
Results posted
Apr 2019
Primary outcomePrimary: Hemoglobin A1c (HbA1c) at 12 Months Post Randomization — 9.3; 9.2; 9.2; 9.5 percentage of glycosylated hemoglobin
Summary
Blacks or African Americans have greater risk of and are more likely to die from type 2 diabetes (T2DM). Major barriers to effective diabetes care for Blacks include poor diabetes knowledge, self-management skills, empowerment, and perceived control. Few prior studies have tested interventions to address these barriers 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 by testing the efficacy of separate and combined telephone-delivered, diabetes knowledge and motivation/behavioral skills training intervention in high risk Blacks with poorly controlled T2DM. The findings of this study, if successful, will provide new information on how to improve quality of care for diabetes in ethnic minorities and reduce the disproportionate burden of diabetes complications and deaths in this population.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Hemoglobin A1c (HbA1c) at 12 Months Post Randomization |
9.3; 9.2; 9.2; 9.5 | — |
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT00929838). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.