Technology Intensified Diabetes Education Study in African Americans

Diabetes Mellitus, Type 2 Clinical Trial

— TIDES  

Official title:

Technology Intensified Diabetes Education Study in African Americans With Type 2 Diabetes

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT02088658
• Other study ID #: Pro00015064
• Secondary ID: 1R01DK098529
• Status: Active, not recruiting
• Phase: N/A
• Start date: May 2013
• Est. completion date: December 2024

Study information

• Verified date: March 2024
• Source: Medical College of Wisconsin
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 200
• Est. completion date: December 2024
• Est. primary completion date: December 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 21 Years to 100 Years

Eligibility

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

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Adult-Onset
• Diabetes Mellitus, Non-Insulin-Dependent
• Diabetes Mellitus, Noninsulin Dependent
• Diabetes Mellitus, Type 2
• Diabetes Mellitus, Type II

Intervention

Behavioral:
• Technology Intensified
The intervention is based on the Information-Motivation-Behavioral Skills (IMB) model and provides information, motivation, and behavioral skills training (using motivational enhancement techniques). Patients will be assigned the FORA 2-in-1 Telehealth System and provided glucose test strips to allow testing at least once a day. They will be asked to perform glucose testing and blood pressure measurement using the FORA system once daily. They will be asked to upload the measurements daily as soon as possible after the test is performed. The nurse educators will have access to a secure server to which the uploaded measurements are stored in real time. The glucose and BP readings will be used to tailor and reinforce behavior change during weekly telephone-delivered diabetes education sessions.

Locations

Country	Name	City	State
United States	Medical University of South Carolina	Charleston	South Carolina

Sponsors (3)

Lead Sponsor	Collaborator
Medical College of Wisconsin	Medical University of South Carolina, National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Country where clinical trial is conducted

United States, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Hemoglobin A1c	Hemoglobin A1c (HbA1c): blood specimens will be collected at the screening visit, as well as the 3-months, 6-months, 9-months, and 12-months follow-up visits	12 months post randomization
Secondary	Blood Pressure	Blood pressure measurement: Blood pressure readings will be obtained at baseline, 3-months, 6-months, 9-months, and 12-months, following the American Heart Association guidelines. The device will be programmed to take 3 readings at 2 minute intervals, and give an average of the 3 blood pressure readings.	12 months post randomization
Secondary	Resource Utilization & Cost	Resource Utilization & Cost: Information on hospitalizations, physician/professional visits, and medications will be captured.	12 months post randomization