Multi-clinic Action Trial to Control Hyperglycemia & Hypertension

摘要：与非西班牙裔白人相比，西班牙裔和非洲裔美国人患有2型糖尿病 风险因素(血糖、血压、血脂)的控制率较低，终末器官的控制率较高 并发症。为了解决这些差距，需要新的初级保健模式。社区的使用 卫生工作者(CHW)一直被倡导作为一种方法，初步研究结果已经 令人鼓舞。匹配型随机对照试验检验了行为自我管理的影响 在社区环境中，社区妇女会在参与者的家中进行为期两年的辅导。这 严格的III期疗效试验表明，比赛干预在产生 墨西哥裔美国人中血红蛋白A1c的持续改善。参与干预的人 ARM的A1c水平在第一年末比基线平均下降了0.48%(p=0.021)，平均水平为 随机化两年后下降0.72更大(p=0.005)；注意对照组无 变化。虽然平均动脉压在一年时比对照组有所改善，但这种改善是 不成立。拟议的MATCH2研究(控制高血糖和 高血压)将测试建立在匹配协议基础上的优化干预，其中CHWS将 整合到三个城市安全诊所的初级保健团队。基于社区的参与式研究 将采用方法使CHW干预适应临床环境，提高CHW的能力 与不同种族/民族的健康差距人群有效合作。基于Web的通信 将允许参与者家中的社区卫生工作者快速更新诊所的提供者。干预课程有 也得到了加强，强调自我监测、饮食和体力活动，并更加重视 血压和血糖。RCT将测试这种优化的干预措施是否与较低的 强度团体教育计划，可降低血红蛋白A1c水平(特定目标1)，并可降低血液 未控制糖尿病患者18个月时的血压(目标2)(基线时为A1C&GT；7.0)。跟进 干预完成后六个月将评估任何收益的可持续性(目标3)。使用 将寻求对饮食(食物频率问卷)和体力活动(加速计)进行更精确的测量 确定调节血糖和血液显著改善的中间行为和过程 配对CHW干预中的压力控制(目标4)。最后，该计划和 参与者将被记录下来，以评估成本和收益(目标5)。通过在和基础上构建 加强比赛干预，为多中心搭建舞台是本次研究的总目标 用于确定CHW模型在降低健康方面的外部有效性和可重复性的有效性试验 差距。

ABSTRACT: Compared to non-Hispanic whites, Hispanics and African Americans with type 2 diabetes experience lower rates of control of risk factors (glucose, blood pressure, lipids), and higher rates of end-organ complications. To address these disparities, new models of primary care are needed. The use of Community Health Workers (CHWs) has been advocated as one approach, and preliminary research findings have been encouraging. The MATCH randomized controlled trial tested the impact of behavioral self-management coaching delivered in participants' homes by CHWs over a two-year period in a community setting. This rigorous Phase III efficacy trial demonstrated that the MATCH intervention was effective in producing a sustained improvement in Hemoglobin A1c in a Mexican-American population. Participants in the intervention arm had a mean reduction of A1c levels of 0.48 from baseline at the end of year 1 (p=0.021) and an even greater decrease of 0.72 two years post-randomization (p=0.005); the attention control group showed no change. Although mean arterial blood pressure improved relative to control at one year, this improvement was not sustained. The proposed MATCH2 Study (The Multi-clinic Action Trial to Control Hyperglycemia and Hypertension) will test an optimized intervention building on the MATCH protocol in which CHWs will be integrated into the primary care team at three urban safety clinics. A Community Based Participatory Research approach will be used to adapt the CHW intervention to the clinic setting, and to enhance the ability of CHWs to work effectively with health disparity populations of different races/ethnicities. Web-based communications will allow CHWs in participants' homes to rapidly update providers in the clinic. The intervention curriculum has also been strengthened, emphasizing self-monitoring, diet, and physical activity, with increased emphasis on blood pressure as well as glucose. The RCT will test if this optimized intervention, compared to a lower intensity group educational program, can reduce both Hemoglobin A1c levels (Specific Aim 1), and blood pressure (Aim 2) at eighteen months in persons with uncontrolled diabetes (A1c >7.0 at baseline). Follow-up six months after the completion of the intervention will evaluate the sustainability of any gains (Aim 3). Use of more precise measures of diet (food frequency questionnaires) and physical activity (accelerometry) will seek to identify intermediate behaviors and processes that mediate significant improvements in glycemic and blood pressure control in the MATCH CHW intervention (Aim 4). Finally, all costs borne by both the program and the participant will be documented, in order to evaluate costs and benefits (Aim 5). By building on and strengthening the MATCH intervention, the overarching goal of this study is to set the stage for a multi-center effectiveness trial to determine the external validity and replicability of the CHW model in reducing health disparities.