Effective Care Management of Depressed Diabetes Patients

描述（由申请人提供）： 合并2型糖尿病和抑郁症（DM/D）的患者代表了一个庞大且特别脆弱的人群，他们可能无法从有关糖尿病自我护理和增强体力活动重要性的最新知识进展中获益。这项多中心随机有效性试验的目的是评价通过电话提供的阶梯式护理管理干预的影响，以增加不同DM/D患者人群的可及性。该干预措施是基于广泛的流行病学证据，关于抑郁症管理的糖尿病患者的重要性，以及研究表明：（a）抑郁症管理对糖尿病治疗结果的影响;（B）电话护理对糖尿病患者和抑郁症患者的疗效，以及（c）促进体力活动对糖尿病和抑郁症患者多种结局的影响。具体而言，干预措施将有效治疗的组成部分整合到一个手动护理管理模型中，该模型可以提供给大量DM/D患者，并在整个医疗保健系统中一致传播。DM/D患者将随机接受：（1）强化常规护理，包括抑郁症、糖尿病自我护理和促进体力活动的简短教育;或（2）基于电话的阶梯式护理管理，包括药物护理管理（MCM）和/或认知行为治疗（CBT）。MCM模块将使用广泛接受的算法来识别有效的抗抑郁药，确定适当的剂量，并促进依从性。CBT模块基于经证实有效的干预措施，侧重于治疗抑郁症状，促进身体活动（特别是步行），并提高患者与其提供者沟通的有效性。为了最大限度地提高普遍性，参与者将从两个网站，每个网站包括一个基于大学的医疗保健系统和其附属的VA医疗保健系统。强化干预阶段将包括由护士执业作为护理经理和使用手动MCM和CBT协议频繁接触。维持阶段将包括每月电话随访，以监测患者的进展，加强教育信息，并鼓励继续坚持治疗。将在4个月和12个月时测量结果。主要终点将是Hb ALC水平和心血管风险指数。次要终点包括近端干预目标（例如，抑郁症状、体力活动水平和医患关系

DESCRIPTION (provided by applicant): Patients with co-occurring type 2 diabetes and depression (DM/D) represent a large and especially vulnerable population that may not benefit from recent advances in knowledge regarding the importance of diabetes self-care and physical activity enhancement. The purpose of this multi-site randomized effectiveness trial is to evaluate the impact of a stepped care management intervention, delivered via telephone in order to increase access for a diverse population of DM/D patients. The intervention is based on extensive epidemiologic evidence regarding the importance of depression management for diabetes patients, as well as studies demonstrating: (a) the impact of depression management on diabetes treatment outcomes; (b) the efficacy of telephone care for diabetic patients and depressed patients, and (c) the impact of physical activity promotion on multiple outcomes among diabetic and depressed patients. Specifically, the intervention integrates components of efficacious treatments into a manualized care management model that can be delivered to large numbers of DM/D patients and disseminated consistently across health care systems. DM/D patients will be randomized to either: (1) enhanced usual care consisting of brief education regarding depression, diabetes self-care, and physical activity promotion; or (2) telephone-based, stepped care management that includes medication care management (MCM) and/or cognitive behavioral therapy (CBT). The MCM module will use a widely accepted algorithm to identify effective antidepressant agents, determine appropriate doses, and promote adherence. The CBT module is based on interventions with proven efficacy and focuses on the treatment of depressive symptoms, the promotion of physical activity (specifically walking), and increasing patients' effectiveness in communicating with their providers. In order to maximize generalizability, participants will be drawn from two sites, each consisting of a university-based health care system and its affiliated VA health care system. The intensive intervention phase will consist of frequent contacts by a nurse practitioner serving as a care manager and using manualized MCM and CBT protocols. The maintenance phase will consist of monthly telephone follow-up to monitor patients' progress, reinforce educational messages, and provide encouragement for continued treatment adherence. Outcomes will be measured at four- and 12-months. Primary endpoints will be Hb ALC levels and a cardiovascular risk index. Secondary endpoints include proximal intervention targets (e.g., depressive symptoms, physical activity levels, and provider-patient