Multi-clinic Action Trial to Control Hyperglycemia & Hypertension

控制高血糖的多临床行动试验

• 批准号: 8630802
• 负责人: Steven K. Rothschild
• 金额: $ 64.04万
• 依托单位: RUSH UNIVERSITY MEDICAL CENTER
• 依托单位国家: 美国
• 财政年份: 2014
• 资助国家: 美国
• 起止时间: 2014-01-15 至 2018-12-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/8630802
• 关键词: Accident and Emergency department; Address; Adoption; Advocate; African American; Attention; Behavior; Behavior Therapy; Behavioral; Blood Pressure; Clinic; Clinic Visits; Clinical Management; Communication; Communities; Community Health; Control Groups; Costs and Benefits; Diabetes Mellitus; Diet; Diet Monitoring; Educational Curriculum; Effectiveness; Enrollment; Ethnic Origin; Federally Qualified Health Center; Food; Frequencies; Glucose; Glycosylated hemoglobin A; Goals; Hispanic Americans; Hispanics; Home environment; Hospitalization; Hyperglycemia; Hypertension; Institute of Medicine (U.S.); Intervention; Latino; Lipids; Measures; Mediating; Medical; Mexican Americans; Minority; Modeling; Non-Insulin-Dependent Diabetes Mellitus; Not Hispanic or Latino; Online Systems; Organ; Participant; Patients; Persons; Pharmaceutical Preparations; Phase; Physical activity; Physicians; Population; Primary Health Care; Process; Protocols documentation; Provider; Publications; Questionnaires; Race; Randomized; Randomized Controlled Trials; Relative (related person); Reporting; Research; Risk; Risk Factors; Safety; Savings; Self Management; Staging; Testing; Time; Treatment Protocols; Update; Work; arm; blood pressure regulation; clinically significant; community based participatory research; community setting; cost; diabetes control; effectiveness trial; efficacy trial; evidence base; experience; follow-up; glycemic control; health disparity; implementation trial; improved; pressure; programs; public health relevance; social; trend

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.

摘要：与非西班牙裔白人相比，西班牙裔和非裔美国人患有 2 型糖尿病 风险因素（血糖、血压、血脂）的控制率较低，而终末器官的控制率较高 并发症。为了解决这些差异，需要新的初级保健模式。社区的使用 卫生工作者 (CHW) 已被提倡作为一种方法，初步研究结果已得到证实 令人鼓舞。 MATCH 随机对照试验测试了行为自我管理的影响 由社区卫生工作者在社区环境中在参与者家中提供为期两年的辅导。这 严格的 III 期疗效试验表明，MATCH 干预可有效产生 墨西哥裔美国人的糖化血红蛋白持续改善。干预参与者 第 1 年末，手臂的 A1c 水平平均较基线降低 0.48 (p=0.021)，甚至 随机化两年后下降幅度更大，为 0.72 (p=0.005)；注意力对照组没有表现出 改变。尽管平均动脉血压在一年时相对于对照组有所改善，但这种改善是 不持续。拟议的 MATCH2 研究（控制高血糖和糖尿病的多临床行动试验） 高血压）将测试基于 MATCH 协议的优化干预措施，其中 CHW 将 融入三个城市安全诊所的初级保健团队。基于社区的参与性研究 方法将用于使社区卫生工作者的干预适应临床环境，并提高社区卫生工作者的能力 有效地与不同种族/民族的健康差异人群合作。基于网络的通信 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信息。干预课程有 也得到了加强，强调自我监控、饮食和身体活动，并更加重视 血压和血糖。随机对照试验将测试这种优化的干预措施与较低的干预措施相比是否 强度小组教育计划，可以降低血红蛋白 A1c 水平（具体目标 1）和血液 未受控制的糖尿病患者（基线时 A1c > 7.0）在 18 个月时的血压（目标 2）。跟进 干预完成后六个月将评估任何成果的可持续性（目标 3）。使用 将寻求更精确的饮食测量（食物频率问卷）和身体活动（加速测量） 识别介导血糖和血液显着改善的中间行为和过程 MATCH CHW 干预中的压力控制（目标 4）。最后，所有费用均由项目方和项目方承担 参与者将被记录下来，以便评估成本和收益（目标 5）。通过构建和 加强 MATCH 干预，本研究的总体目标是为多中心奠定基础 有效性试验，以确定 CHW 模型在减少健康方面的外部有效性和可复制性 差异。