科技辅助个案管理对低收入 2 型糖尿病患者的效果（TACM-DM）：一项随机对照试验的研究方案。

Effectiveness of technology-assisted case management in low income adults with type 2 diabetes (TACM-DM): study protocol for a randomized controlled trial.

机构信息

Center for Disease Prevention and Health Interventions for Diverse Populations, Ralph H, Johnson Veterans Affairs Medical Center, 109 Bee Street, Charleston, South Carolina 29401, USA.

出版信息

Trials. 2011 Oct 20;12:231. doi: 10.1186/1745-6215-12-231.

DOI:10.1186/1745-6215-12-231

PMID:22014122

原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC3219699/

Abstract

BACKGROUND

An 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.

METHODS

We 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.

DISCUSSION

Results 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 REGISTRATION

National Institutes of Health Clinical Trials Registry (http://ClinicalTrials.gov identifier# NCT01373489.

摘要

背景

到 2050 年，预计美国成年人中有 1/3 将患有糖尿病。在全国范围内，南卡罗来纳州的确诊糖尿病病例数在各州中排名第 10。在成年人中，2 型糖尿病（T2DM）约占所有确诊糖尿病病例的 90-95%。临床研究表明，医疗服务提供者和医疗系统因素仅占主要糖尿病结果（包括糖化血红蛋白（HbA1c）、血脂控制和资源使用）差异的<10%。使用远程监测系统为 T2DM 患者提供了新的机会，使他们在等待医疗保健提供者在实际就诊时，可以得到支持。已经进行了各种测试远程医疗干预效果的干预措施，但结果却产生了模棱两可的结果，这强调了在该领域缺乏对照、随机试验的不足。本研究通过优化两种策略为解决这一文献空白提供了独特的机会，这两种策略已被证明可以改善血糖控制，同时实施临床结果测量，使用足够的样本量，并为南卡罗来纳州沿海地区的农村、服务不足和低收入社区的 T2DM 患者提供医疗服务，这些患者在合格的联邦健康中心（FQHC）就诊。

方法

我们描述了一项为期四年的前瞻性、随机临床试验，该试验将测试技术辅助病例管理在低收入农村 T2DM 成年患者中的有效性。200 名年龄在 18 岁及以上且糖化血红蛋白（HbA1c）≥8%的男性和女性参与者将随机分为两组：（1）干预组采用创新的 FORA 系统联合护士病例管理，或（2）常规护理组。将对参与者进行为期 6 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，在接受合格的联邦健康中心治疗的贫困农村成年 T2DM 患者中，与常规护理相比，随机分配到技术辅助病例管理干预组的参与者在 6 个月的随访中 HbA1c 的降低幅度显著更大。