Skip to main page content
U.S. flag

An official website of the United States government

Dot gov

The .gov means it’s official.
Federal government websites often end in .gov or .mil. Before sharing sensitive information, make sure you’re on a federal government site.

Https

The site is secure.
The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely.

Access keys NCBI Homepage MyNCBI Homepage Main Content Main Navigation
Randomized Controlled Trial
. 2014 Nov 25:15:460.
doi: 10.1186/1745-6215-15-460.

Technology-Intensified Diabetes Education Study (TIDES) in African Americans with type 2 diabetes: study protocol for a randomized controlled trial

Joni S Williams, Cheryl P Lynch, Rebecca G Knapp, Leonard E Egede  1
Affiliations
Randomized Controlled Trial

Technology-Intensified Diabetes Education Study (TIDES) in African Americans with type 2 diabetes: study protocol for a randomized controlled trial

Joni S Williams et al. Trials. .

Abstract

Background: Compared to American Whites, African Americans have a higher prevalence of type 2 diabetes mellitus (T2DM), experiencing poorer metabolic control and greater risks for complications and death. Patient-level factors, such as diabetes knowledge, self-management skills, empowerment, and perceived control, account for >90% of the variance observed in outcomes between these racial groups. There is strong evidence that self-management interventions that include telephone-delivered diabetes education and skills training are effective at improving metabolic control in diabetes. Web-based home telemonitoring systems in conjunction with active care management are also effective ways to lower glycosylated hemoglobin A1c values when compared to standard care, and provide feedback to patients; however, there are no studies in African Americans with poorly controlled T2DM that examine the use of technology-based feedback to tailor or augment diabetes education and skills training. This study provides a unique opportunity to address this gap in the literature.

Methods: We describe an ongoing 4-year randomized clinical trial, which will test the efficacy of a technology-intensified diabetes education and skills training (TIDES) intervention in African Americans with poorly controlled T2DM. Two hundred male and female AfricanAmerican participants, 21 years of age or older and with a glycosylated hemoglobin A1c level ≥ 8%, will be randomized into one of two groups for 12 weeks of telephone interventions: (1) TIDES intervention group or (2) a usual-care group. Participants will be followed for 12 months to ascertain the effect of the interventions on glycemic control. Our primary hypothesis is that, among African Americans with poorly controlled T2DM, patients randomized to the TIDES intervention will have significantly greater reduction in glycosylated hemoglobin A1c at 12 months of follow-up compared to the usual-care group.

Discussion: Results from this study will add to the current literature examining how best to deliver diabetes education and skills training and provide important insight into effective strategies to improve metabolic control and hence reduce diabetes complications and mortality rates in African Americans with poorly controlled T2DM.

Trial registration: This study was registered with the National Institutes of Health Clinical Trials Registry on 13 March 2014 (ClinicalTrials.gov identifier# NCT02088658).

PubMed Disclaimer

Figures

Figure 1
Figure 1
The FORA TeleHealth System. GSM, Global System for Mobile communications.
Figure 2
Figure 2
The FORA two-in-one blood glucose and blood pressure device (D20).
Figure 3
Figure 3
Installation instructions for the FORA TeleHealth gateway.
Figure 4
Figure 4
Design and study flow.
See this image and copyright information in PMC

References

    1. Centers for Disease Control and Prevention . National Diabetes Statistics Report: Estimates of Diabetes and Its Burden in the United States, 2014. Atlanta, GA: U.S. Department of Health and Human Services; 2014.
    1. National Institute of Diabetes and Digestive and Kidney Diseases . National Diabetes Statistics, 2007 fact sheet. Bethesda, MD: U.S. Department of Health and Human Services, National Institutes of Health; 2008.
    1. Norris SL, Lau J, Smith SJ, Schmid CH, Engelgau MM. Self-management education for adults with type 2 diabetes: a meta-analysis of the effect on glycemic control. Diabetes Care. 2002;25:1159–1171. doi: 10.2337/diacare.25.7.1159. - DOI - PubMed
    1. Sarkar U, Piette JD, Gonzales R, Lessler D, Chew LD, Reilly B, Johnson J, Brunt M, Huang J, Regenstein M, Schillinger D. Preferences for self-management support: findings from a survey of diabetes patients in safety-net health systems. Patient Educ Couns. 2008;70:102–110. doi: 10.1016/j.pec.2007.09.008. - DOI - PMC - PubMed
    1. Weinberger M, Kirkman MS, Samsa GP, Shortliffe EA, Landsman PB, Cowper PA, Simel DL, Feussner JR. A nurse-coordinated intervention for primary care patients with non-insulin-dependent diabetes mellitus: impact on glycemic control and health-related quality of life. J Gen Intern Med. 1995;10:59–66. doi: 10.1007/BF02600227. - DOI - PubMed

Publication types

MeSH terms

Associated data