Improving Medication Adherence among Underserved Patients with Type 2 Diabetes

描述(申请人提供)：约1/3的糖尿病患者不坚持服药。不服药在患有2型糖尿病(T2 DM)的低收入、种族/民族少数民族中更为常见，是血糖控制不佳、住院、死亡率和更高医疗费用的强有力的独立预测因素。基于理论的依从性促进干预比理论上的、特别的方法更有效，并且是不依从性风险最高的患者所需要的。信息-动机-行为技能(IMB)模型是一个经过验证的理论模型，它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，并应该为糖尿病患者的依从性干预提供信息。此外，广泛可用的技术，如移动电话，提供了一种手段，向广泛的患者提供遵守干预措施，包括低收入、不遵守的风险很高的种族/民族少数群体。这项研究的目标是 使用IMB模型告知移动电话提供的药物依从性促进干预措施的内容和功能，确保干预内容清楚地传达(即，使用简化文本和简单语言)，并评估在联邦合格健康中心(FQHC)接受初级保健的低收入成人T2 DM患者服药依从性和血糖控制的干预效果。具体目标和研究策略包括：(1)改进现有手机递送药物依从性推广的内容和功能，使其与IMB模式和明确的健康沟通策略保持一致，并在评估干预对结果的影响之前，对36名患者进行可用性和可接受性测试；(2)采用随机对照试验，对500名患者在3个月、6个月、12个月和15个月的服药依从性、其他自我护理行为和血糖控制等主观和客观指标进行测试，并检验IMB机制是否对依从性起中介作用，依从性是否对血糖控制起中介作用，健康素养、算术能力、抑郁和/或胰岛素状况是否对干预效果起中介作用；以及(3)通过与干预患者和诊所工作人员开展焦点小组，确定背景对干预接受和有效性的影响，为实施和评估低收入患者提供的移动电话干预提供建议。这项跨学科的研究将极大地提高我们对以下问题的理解：如何解决糖尿病高危患者坚持治疗的社会认知障碍；如何利用移动设备支持高危患者群体；以及如何更好地设计干预措施，以改善对低收入、种族/民族多样化患者以及其他高危群体的服务。从这项工作中获得的知识也可能为减少依从性、血糖控制和其他糖尿病结果方面的差异的干预措施提供信息。

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.