Clinical trial NCT02088658: Technology Intensified Diabetes Education Study in African Americans
Official title: Technology Intensified Diabetes Education Study in African Americans With Type 2 Diabetes
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Diabetes Mellitus, Type 2
Diabetes Mellitus, Adult-Onset
Diabetes Mellitus, Non-Insulin-Dependent
Diabetes Mellitus, Noninsulin Dependent
Diabetes Mellitus, Type II
Keywords: Diabetes Mellitus, Type 2
Diabetes Mellitus, Adult-Onset
Diabetes Mellitus, Non-Insulin-Dependent
Diabetes Mellitus, Noninsulin Dependent
Diabetes Mellitus, Type II
African Americans
Blacks
non-Hispanic Blacks
Randomized Control Trial
Controlled Clinical Trial
Behavioral Research
Behavioral Medicine
Lead sponsor: State University of New York at Buffalo
Sponsor class: OTHER
Collaborators: name: Medical University of South Carolina
name: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
First posted: 2014-03-17
Enrollment: 200
Sex: ALL
Minimum age (years): 21
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.

Detailed description: 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.

Eligibility 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

Primary outcomes:
measure: Hemoglobin A1c
timeFrame: 12 months post randomization
Secondary outcomes:
measure: Blood Pressure
timeFrame: 12 months post randomization
measure: Resource Utilization & Cost
timeFrame: 12 months post randomization
Other outcomes:
Locations:
city: Charleston
country: United States
facility: Medical University of South Carolina
state: South Carolina
Study officials:
affiliation: Medical College of Wisconsin
name: Leonard E Egede, MD, MS
role: PRINCIPAL_INVESTIGATOR
References:
citation: Williams JS, Lynch CP, Knapp RG, Egede LE. Technology-Intensified Diabetes Education Study (TIDES) in African Americans with type 2 diabetes: study protocol for a randomized controlled trial. Trials. 2014 Nov 25;15:460. doi: 10.1186/1745-6215-15-460.