Williams Joni S, Lynch Cheryl P, Knapp Rebecca G, Egede Leonard E
Division of General Internal Medicine & Geriatrics, Medical University of South Carolina, 135 Rutledge Avenue, Charleston, SC 29425, USA.
Trials. 2014 Nov 25;15:460. doi: 10.1186/1745-6215-15-460.
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.
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.
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.
This study was registered with the National Institutes of Health Clinical Trials Registry on 13 March 2014 (ClinicalTrials.gov identifier# NCT02088658).
与美国白人相比，非裔美国人2型糖尿病（T2DM）的患病率更高，代谢控制较差，并发症和死亡风险更大。患者层面的因素，如糖尿病知识、自我管理技能、赋权和感知控制，在这些种族群体间观察到的结局差异中占比超过90%。有强有力的证据表明，包括电话糖尿病教育和技能培训在内的自我管理干预措施可有效改善糖尿病的代谢控制。与标准护理相比，基于网络的家庭远程监测系统结合积极的护理管理也是降低糖化血红蛋白A1c值的有效方法，并能为患者提供反馈；然而，尚无针对T2DM控制不佳的非裔美国人的研究来探讨基于技术的反馈用于定制或加强糖尿病教育和技能培训的情况。本研究提供了一个填补文献空白的独特机会。
我们描述了一项正在进行的为期4年的随机临床试验，该试验将测试强化技术的糖尿病教育和技能培训（TIDES）干预措施对T2DM控制不佳的非裔美国人的疗效。200名年龄在21岁及以上、糖化血红蛋白A1c水平≥8%的非裔美国男性和女性参与者将被随机分为两组，接受为期12周的电话干预：（1）TIDES干预组或（2）常规护理组。对参与者进行12个月的随访，以确定干预措施对血糖控制的影响。我们的主要假设是，在T2DM控制不佳的非裔美国人中，随机分配到TIDES干预组的患者在随访12个月时糖化血红蛋白A1c的降低幅度将显著大于常规护理组。
本研究结果将补充当前关于如何最佳提供糖尿病教育和技能培训的文献，并为改善代谢控制从而降低T2DM控制不佳的非裔美国人糖尿病并发症和死亡率的有效策略提供重要见解。
本研究于2014年3月13日在美国国立卫生研究院临床试验注册中心注册（ClinicalTrials.gov标识符# NCT02088658）。
