Multi-Clinic Action Trial to Control Hyperglycemia & Hypertension

控制高血糖的多临床行动试验

• 批准号: 9189716
• 负责人: Steven K. Rothschild
• 金额: $ 61.16万
• 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/9189716
• 关键词: Accelerometer; Accident and Emergency department; Address; Adoption; Advocate; African American; Behavior; Behavior Therapy; Behavioral; Blood Pressure; Clinic; Clinic Visits; Clinical; Clinical Management; Communication; Communities; Community Health Aides; Community Trial; Control Groups; Costs and Benefits; Diabetes Mellitus; Diet; 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; Monitor; 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; Reporting; Research; Risk; Risk Factors; Safety; Savings; Self Management; Testing; Time; Treatment Protocols; Update; Work; arm; attentional control; blood pressure regulation; caucasian American; 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

DESCRIPTION (provided by applicant): 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.

描述（由申请人提供）：与非西班牙裔白人相比，西班牙裔和非裔美国人2型糖尿病患者的风险因素（血糖、血压、血脂）控制率较低，终末器官并发症发生率较高。为了解决这些差距，需要新的初级保健模式。使用社区卫生工作者（CHW）一直被提倡作为一种方法，初步的研究结果是令人鼓舞的。MATCH随机对照试验测试了CHW在社区环境中为期两年的参与者家中提供的行为自我管理教练的影响。这项严格的III期疗效试验表明，MATCH干预措施可有效地持续改善墨西哥裔美国人人群的血红蛋白A1 c。干预组的参与者在第1年结束时A1 c水平较基线平均下降0.48（p=0.021），随机分组后两年内下降幅度更大，为0.72（p=0.005）;注意力控制组没有变化。虽然平均动脉血压在一年内相对于对照组有所改善，但这种改善并不持久。拟议的MATCH 2研究（控制高血压和高血压的多诊所行动试验）将测试基于MATCH协议的优化干预措施，其中CHW将被纳入三个城市安全诊所的初级保健团队。将采用基于社区的前瞻性研究方法，使社区卫生工作者的干预措施适应临床环境，并提高社区卫生工作者有效处理不同种族/族裔的健康差异人群的能力。基于网络的通信将允许参与者家中的CHW快速更新诊所中的提供者。干预课程也得到了加强，强调自我监测、饮食和体育活动，并更加重视血压和葡萄糖。随机对照试验将测试这种优化的干预措施，与低强度的团体教育计划相比，是否可以在18个月时降低未受控制的糖尿病患者（基线时A1 c>7.0）的血红蛋白A1 c水平（具体目标1）和血压（目标2）。干预完成后六个月的随访将评估任何收益的可持续性（目标3）。使用更精确的饮食（食物频率问卷）和体力活动（加速度计）测量方法，将寻求确定在MATCH CHW干预中介导血糖和血压控制显著改善的中间行为和过程（目标4）。最后，项目和参与者承担的所有费用都将记录在案，以评估成本和效益（目标5）。通过建立和加强MATCH干预，本研究的总体目标是为多中心有效性试验奠定基础，以确定CHW模型在减少健康差距方面的外部有效性和可复制性。