Improving Diabetes Medication, Adherence and Outcomes

描述(由申请人提供)： 2型糖尿病的代谢控制及其并发症的预防与血糖等因素的管理密切相关。药物和生活方式的改变是大多数自我管理计划不可或缺的部分；然而，坚持下去仍然是一个巨大的挑战。许多患者HbA1c、血压和血脂值异常，发生并发症的风险更大。这项建议是为了评估一种量身定制的电话干预的有效性和成本，以促进参加工会/雇主赞助的健康福利计划的中老年2型糖尿病患者的依从性。目标人群包括健康计划数据库中说英语和西班牙语的个人。该提案的具体目的是检验以下假设：1)与标准护理干预相比，定制电话干预将显著改善服药依从性；以及2)与标准护理干预相比，定制电话干预将显著改善HbA1c测量的代谢控制。目标2a是探索如何将药物依从性的行为改变与饮食和体力活动的生活方式改变联系起来。目标3是对电话干预与标准护理进行成本评估。研究设计为随机、对照、掩蔽干预试验，个体是抽样、分配和分析的单位。在评估资格并通过电话获得同意后，患者将按性别和语言偏好(英语或西班牙语)随机接受电话干预或标准护理。研究结果将是根据药学记录和代谢控制(HbA1c)衡量的用药依从性。共有556名2型糖尿病患者将被随机分组，这将提供80%的能力来检测HbA1c至少0.3%的统计显著差异，并提供超过95%的能力来检测处方处方中的差异。电话调查将提供有关自我护理行为的数据，包括饮食和锻炼、风险认知和抑郁症状。将使用标准化方法收集成本数据。研究结果将为实施实用的护士管理干预措施提供信息，以改善不同的中老年2型糖尿病患者的用药依从性和代谢控制，同时将用药依从性的变化与改变饮食和体力活动的生活方式联系起来。

DESCRIPTION (provided by applicant): Metabolic control of type 2 diabetes and prevention of its complications are related to management of blood glucose and other factors. Medication and lifestyle modifications are integral to most self-management plans; however, adherence remains a great challenge. Many patients have abnormal HbA1c, blood pressure and lipid values, and are at greater risk for complications. This proposal is to evaluate the effectiveness and costs of a tailored, telephone intervention to promote adherence in middle-aged and older adults with type 2 diabetes who are members of a union/employer-sponsored health benefit plan. The target population includes English-and Spanish-speaking individuals from the health plan database. Specific aims of the proposal are to test the hypotheses that 1) a tailored telephone intervention will significantly improve medication adherence compared to a standard care intervention; and 2) a tailored telephone intervention will significantly improve metabolic control measured by HbA1c compared to the standard care intervention. Aim 2a is to explore ways to link behavior change for medication adherence with lifestyle modification for diet and physical activity. Aim 3 is to conduct cost evaluations for the telephone intervention vs. standard care. The study design is a randomized, controlled intervention trial with masking; the individual is the unit of sampling, assignment and analysis. After eligibility is assessed and consent is obtained by telephone, patients will be randomized by gender and language preference (English or Spanish) to either the telephone intervention or standard care. Study outcomes will be medication adherence as measured from pharmacy records and metabolic control (HbA1c). A total of 556 patients with type 2 diabetes will be randomized, which will provide 80 percent power to detect a statistically significant difference in HbA1c of at least 0.3 percent, and over 95 percent power to detect a difference in filled prescriptions. Telephone surveys will provide data on self-care behaviors including diet and exercise, risk perceptions, and depressive symptoms. Cost data will be collected using standardized methods. Study results will inform implementation of practical, nurse-managed interventions to improve medication adherence and metabolic control in diverse, middle-aged and older, type 2 diabetes patients, while linking changes in medication adherence to lifestyle modification for diet and physical activity.