Linking Self-Management and Primary Care for Diabetes

描述（由申请人提供）：迫切需要研究能够转化为糖尿病和其他慢性疾病自我管理实践的行为干预措施。绝大多数糖尿病自我管理研究都是在学术环境下进行的，并没有解决现实世界的应用问题或初级保健实践的挑战和背景。有充分的证据表明，为糖尿病患者提供的预防保健是次优的，并且大多数患者尤其需要在糖尿病自我管理的行为改变方面的帮助。基于目前的文献、理论和我们之前疗效研究的经验教训，本竞争性更新申请将通过改进和实验评估一种实用的、基于计算机（结合互联网和自动电话）的初级保健患者糖尿病自我管理干预来解决这些问题。干预的目的是促进饮食和身体活动的做法，药物服用和患者激活周围的糖尿病护理。在一项有效性研究中，共有425名来自HMO和混合付费机构的初级保健提供者的2型糖尿病患者将被随机分配到以下三种情况之一：(1)加强常规护理；(2)第二代基于理论的社会生态行为干预，最大限度地与初级保健和社区资源联系，并加强人际支持；或者(3)这种干预的完全自动化版本。这两项积极干预措施将分别包括若干创新组成部分，以解决覆盖范围、低健康素养、多种健康行为的改变、参与者持续参与、社会环境支持以及维持/复发预防战略等问题。评估将是全面的，并基于RE-AIM模型的范围、有效性、采用、实施和维护维度。我们将采用新的衡量标准来解决卫生差距、任何不利影响和实施成本等问题。关键结果将包括行为改变（饮食、身体活动和药物服用）和UKPDS多重风险公式，该公式结合了几种心脏病风险因素（糖化血红蛋白、血压、吸烟和血脂）。我们将包括一个复杂的成本和成本效益分析。关键的次要结局和过程测量将包括6个月和12个月随访时糖尿病特异性生活质量、患者激活和感知的社会环境支持。这样一项实际有效性试验的结果，对来自不同实践的初级保健患者的代表性样本进行了研究，并强调了内部和外部效度标准，对行为改变科学和将研究转化为实践都具有重要意义。

DESCRIPTION (provided by applicant): There is a pressing need for research on behavioral interventions capable of being translated into practice for the self-management of diabetes and other chronic illnesses. The vast majority of diabetes self-management research has been conducted in academic settings, and has not addressed real world application issues or the challenges and context of primary care practice. It is well-documented that preventive care provided to diabetes patients is suboptimal, and that most patients are especially in need of assistance with behavior- change aspects of diabetes self-management. Based on the current literature, theory, and lessons from our previous efficacy research, this competing renewal application will address these issues by refining and experimentally evaluating a practical, computer-based (combined Internet and automated telephone) diabetes self-management intervention For primary care patients. The intervention is designed to facilitate dietary and physical activity practices, medication-taking, and patient activation around diabetes care. A total of 425 type 2 diabetes patients from primary care providers in HMO and mixed-payer settings will be randomly assigned to one of three conditions in an effectiveness study: (1) enhanced usual care; (2) a second generation version of our social-ecological, theory- based behavioral intervention to maximize linkage with primary care and community resources, plus enhanced interpersonal support; or (3) an entirely automated version of this intervention. The two active interventions will each include several innovative components to address reach, low health literacy, change in multiple health behaviors, continued participant involvement overtime, social environmental support, and maintenance/relapse prevention strategies. Evaluation will be comprehensive and based on the RE-AIM model dimensions of reach, effectiveness, adoption, implementation, and maintenance. We will employ new metrics to address issues such as health disparities, any adverse effects, and implementation costs. Key outcomes will include behavior change (dietary, physical activity, and medication-taking) and the UKPDS multiple risk formula that combines several heart disease risk factors (HbA1c, blood pressure, smoking, and lipids). We will include a sophisticated cost and cost- effectiveness analysis. Key secondary outcomes and process measures will include diabetes-specific quality of life, patient activation, and perceived social-environmental support at 6- and 12-month follow-ups. The results of such a practical effectiveness trial, conducted with a representative sample of primary care patients from heterogeneous practices, and emphasizing both internal and external validity criteria, has important implications both for the science of behavior change and for translating research to practice.