Abstract
BackgroundAn estimated 1 in 3 American adults will have diabetes by the year 2050. Nationally, South Carolina ranks 10th in cases of diagnosed diabetes compared to other states. In adults, type 2 diabetes (T2DM) accounts for approximately 90-95% of all diagnosed cases of diabetes. Clinically, provider and health system factors account for < 10% of the variance in major diabetes outcomes including hemoglobin A1c (HbA1c), lipid control, and resource use. Use of telemonitoring systems offer new opportunities to support patients with T2DM while waiting to be seen by their health care providers at actual office visits. A variety of interventions testing the efficacy of telemedicine interventions have been conducted, but the outcomes have yielded equivocal results, emphasizing the shortage of controlled, randomized trials in this area. This study provides a unique opportunity to address this gap in the literature by optimizing two strategies that have been shown to improve glycemic control, while simultaneously implementing clinical outcomes measures, using a sufficient sample size, and offering health care delivery to rural, underserved and low income communities with T2DM who are seen at Federally Qualified Health Centers (FQHCs) in coastal South Carolina.MethodsWe describe a four-year prospective, randomized clinical trial, which will test the effectiveness of technology-assisted case management in low income rural adults with T2DM. Two-hundred (200) male and female participants, 18 years of age or older and with an HbA1c ≥ 8%, will be randomized into one of two groups: (1) an intervention arm employing the innovative FORA system coupled with nurse case management or (2) a usual care group. Participants will be followed for 6-months to ascertain the effect of the interventions on glycemic control. Our primary hypothesis is that among indigent, rural adult patients with T2DM treated in FQHC's, participants randomized to the technology-assisted case management intervention will have significantly greater reduction in HbA1c at 6 months of follow-up compared to usual care.DiscussionResults from this study will provide important insight into the effectiveness of technology-assisted case management intervention (TACM) for optimizing diabetes care in indigent, rural adult patients with T2DM treated in FQHC's.Trial RegistrationNational Institutes of Health Clinical Trials Registry (http://ClinicalTrials.gov identifier# NCT01373489
Highlights
IntroductionSouth Carolina ranks 10th in cases of diagnosed diabetes compared to other states
An estimated 1 in 3 American adults will have diabetes by the year 2050
This paper describes the rationale, study aims and objectives, and research design and methods of an ongoing four-year, randomized clinical trial testing the effectiveness of technology-assisted case management intervention (TACM) using the FORA 2-in-1 and Telehealth System for diabetes in Federally Qualified Community Health Centers (FQHCs)
Summary
South Carolina ranks 10th in cases of diagnosed diabetes compared to other states. Type 2 diabetes (T2DM) accounts for approximately 90-95% of all diagnosed cases of diabetes. This study provides a unique opportunity to address this gap in the literature by optimizing two strategies that have been shown to improve glycemic control, while simultaneously implementing clinical outcomes measures, using a sufficient sample size, and offering health care delivery to rural, underserved and low income communities with T2DM who are seen at Federally Qualified Health Centers (FQHCs) in coastal South Carolina. In 2007, 1.6 million new cases of diabetes were diagnosed in individuals 20 years of age and older [2]. South Carolina ranks 10th in cases of diagnosed diabetes compared to other states [3]. 1089 deaths are attributed to diabetes, and 100,000-160,000 individuals are thought to be undiagnosed and affected by diabetes [3]
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