Diabetes Mellitus, Type 2 Clinical Trial
— DM-TBSIOfficial title:
Telephone Delivered Behavioral Skills Intervention for Blacks With T2DM
Verified date | June 2021 |
Source | Medical College of Wisconsin |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 256 |
Est. completion date | June 2016 |
Est. primary completion date | June 2016 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
United States | Medical University of South Carolina | Charleston | South Carolina |
Lead Sponsor | Collaborator |
---|---|
Medical College of Wisconsin | National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) |
United States,
Egede LE, Strom JL, Durkalski VL, Mauldin PD, Moran WP. Rationale and design: telephone-delivered behavioral skills interventions for Blacks with Type 2 diabetes. Trials. 2010 Mar 29;11:35. doi: 10.1186/1745-6215-11-35. — View Citation
Egede LE, Williams JS, Voronca DC, Gebregziabher M, Lynch CP. Telephone-Delivered Behavioral Skills Intervention for African American Adults with Type 2 Diabetes: A Randomized Controlled Trial. J Gen Intern Med. 2017 Jul;32(7):775-782. doi: 10.1007/s11606 — View Citation
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---|---|---|---|---|
Primary | Hemoglobin A1c (HbA1c) at 12 Months Post Randomization | 12-months post randomization |
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