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Charleston, South Carolina 29425


Purpose:

The purpose of this study is to test the usefulness of an intervention that combines technology with diabetes education and skills training. This study has been designed specifically for African Americans with poorly controlled type 2 diabetes.


Study summary:

African Americans (AA) with type 2 diabetes (T2DM) have higher prevalence of diabetes, poorer metabolic control (i.e. poorer blood glucose, blood pressure, and lipid control), and greater risk for complications and death compared to White Americans. Hemoglobin A1c (HbA1c) is the primary marker for glycemic control and is a strong independent predictor of development of complications and increased mortality in T2DM. Key self-care behaviors that influence glycemic control (and HbA1c) include diet, physical activity, self-monitoring of blood glucose and medication adherence. Systematic review of multiple randomized clinical trials (RCTs) show that self-care interventions that include diabetes education and skills training are effective in improving metabolic control in diabetes. Recent findings indicate that patients with diabetes, especially ethnic minority patients, prefer telephone-delivered diabetes education to group visits or internet-based education. Multiple RCTs have documented the effectiveness of telephone-delivered self-care interventions in T2DM. Preliminary data from our group also suggest that a culturally-tailored telephone-delivered diabetes education and skills training intervention is an effective strategy to improve metabolic control in AA patients with T2DM. This study provides a unique opportunity to address gaps in the literature by testing the efficacy of a technology-intensified diabetes education/skills training (TIDES) intervention in AAs with poorly controlled T2DM. The long-term goal of the project is to identify effective strategies to improve metabolic control and hence reduce diabetes complications and mortality rates in AAs with T2DM.


Criteria:

Inclusion Criteria: - Age ≥21 years - Clinical diagnosis of T2DM and HbA1c ≥8% at the screening visit - Self-identified as AA - Subject must be willing to use the FORA monitoring system for 12 months - Subjects must be able to communicate in English - Subjects must have access to a telephone (landline for data uploads) for the study period Exclusion Criteria: - Mental confusion on interview suggesting significant dementia - Participation in other diabetes clinical trials - Alcohol or drug abuse/dependency - Active psychosis or acute mental disorder - Life expectancy <12 months


NCT ID:

NCT02088658


Primary Contact:

Principal Investigator
Leonard E Egede, MD, MS
Medical University of South Carolina


Backup Contact:

N/A


Location Contact:

Charleston, South Carolina 29425
United States



There is no listed contact information for this specific location.

Site Status: N/A


Data Source: ClinicalTrials.gov

Date Processed: January 21, 2020

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