Improving Medication Adherence among Underserved Patients with Type 2 Diabetes

描述（由申请人提供）：大约1/3的糖尿病患者不依从药物治疗。不依从性在低收入、少数种族/民族的2型糖尿病（T2 DM）患者中更为常见，是血糖控制不良、住院、死亡率和较高医疗费用的一个强有力的独立预测因素。基于理论的依从性促进干预措施比非理论的、临时的方法更有效，并且对于不依从性风险最高的患者是需要的。一个经过充分验证的理论模型，信息-动机-行为技能（IMB）模型，为艾滋病毒和高血压患者提供了有效的药物依从性促进干预措施，并应告知糖尿病患者的依从性干预措施。此外，广泛使用的技术，如移动的电话，提供了一种向广泛的患者提供依从性干预措施的手段，包括低收入、高不依从风险的种族/少数民族。 这项研究的目的是 使用IMB模型来通知移动的电话递送的药物依从性促进干预的内容和功能，确保干预内容被清楚地传达（即，使用简化的文本和简单的语言），并评估干预措施对在联邦合格卫生中心（FATHCs）接受初级保健的低收入T2 DM成年人的依从性和血糖控制的影响。具体目标和研究策略包括：（1）改进现有的移动的电话传递的药物依从性促进的内容和功能，使其与IMB模型和明确的健康沟通策略一致，并在评估干预措施对结局的影响之前，对36名患者进行可用性和可接受性测试;（2）在两个CIMCs对500名患者进行随机对照试验，以测试干预对3、6、12和15个月时的药物依从性、其他自我护理行为和血糖控制的主观和客观测量的影响，并测试IMB机制是否介导对依从性的干预效果，测试依从性是否介导对血糖控制的干预效果，并测试健康素养、算术能力、抑郁和/或胰岛素状态是否调节干预效果;以及（3）制定实施和评估移动的电话干预措施的建议，通过与干预患者和诊所工作人员进行焦点小组，以确定对干预的接受和有效性的背景影响， 这项跨学科的研究将大大提高我们对以下问题的理解：如何解决高风险糖尿病患者依从性的社会认知障碍;如何利用移动的设备来支持一般的高风险患者人群;以及如何更好地设计干预措施，以改善低收入、种族/民族多样化患者以及其他高风险人群的服务。从这项工作中获得的知识也可以为干预提供信息，以减少依从性，血糖控制和其他糖尿病结局的差异。

DESCRIPTION (provided by applicant): Approximately 1 in 3 persons with diabetes are nonadherent to their medications. Nonadherence is more common among low income, racial/ethnic minorities with type 2 diabetes (T2DM), and is a strong, independent predictor of poor glycemic control, hospitalizations, mortality, and higher healthcare costs. Theory-based adherence promotion interventions are more effective than atheoretical, ad hoc approaches, and are needed for patients at highest risk of nonadherence. A well-validated theoretical model, the Information-Motivation-Behavioral Skills (IMB) model, has informed effective medication adherence promotion interventions for patients with HIV and hypertension, and should inform adherence interventions in diabetes. Moreover, widely available technologies, such as mobile phones, offer a means to deliver adherence interventions to a broad range of patients, including low income, racial/ethnic minorities at high risk of nonadherence. The goal of this research is to use the IMB model to inform the content and functionality of a mobile phone- delivered medication adherence promotion intervention, ensure intervention content is clearly communicated (i.e., uses simplified text and plain language), and evaluate intervention effects on adherence and glycemic control among a low income adults with T2DM receiving primary care at Federally Qualified Health Centers (FQHCs). The Specific Aims and Research Strategy include: (1) improving the content and functionality of an existing mobile phone-delivered medication adherence promotion to be consistent with the IMB model and clear health communication strategies, and testing for usability and acceptability with 36 patients before evaluating the intervention's effect on outcomes; (2) performing a randomized controlled trial with 500 patients at two FQHCs to test the effect of the intervention on subjective and objective measures of medication adherence, other self-care behaviors and glycemic control at 3, 6, 12, and 15 months, and test whether the IMB mechanisms mediate intervention effects on adherence, test whether adherence mediates intervention effects on glycemic control, and test whether health literacy, numeracy, depression, and/or insulin status moderate intervention effects; and (3) develop recommendations for implementing and evaluating mobile phone-delivered interventions for low-income patients by conducting focus groups with intervention patients and clinic staff to identify the contextual influences on acceptance and effectiveness of the intervention. This interdisciplinary research will greatly enhance our understanding of how to address social-cognitive barriers to adherence among high-risk patients with diabetes, how to leverage mobile devices to support high- risk patient populations in general; and how to better design interventions to improve services for low income, racially/ethnically diverse patients, as well as other high-risk groups. Knowledge gained form this work may also inform interventions to reduce disparities in adherence, glycemic control, and other diabetes outcomes.