Effective Care Management of Depressed Diabetes Patients

描述(由申请人提供)： 同时患有2型糖尿病和抑郁症(DM/D)的患者是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加强体力活动重要性的最新知识进步中受益。这项多点随机有效性试验的目的是评估通过电话提供的分级护理管理干预的影响，以增加不同人群的DM/D患者的机会。这项干预措施基于广泛的流行病学证据，这些证据表明抑郁症管理对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)对糖尿病患者和抑郁症患者进行电话护理的效果；以及(C)促进体力活动对糖尿病和抑郁症患者的多种结果的影响。具体地说，干预措施将有效治疗的组成部分整合到一个可以提供给大量DM/D患者并在卫生保健系统中持续传播的手动护理管理模式中。DM/D患者将被随机分为两组：(1)增强型日常护理，包括有关抑郁症、糖尿病自我护理和促进体力活动的简短教育；或(2)基于电话的分级护理管理，包括药物护理管理(MCM)和/或认知行为疗法(CBT)。MCM模块将使用被广泛接受的算法来识别有效的抗抑郁药物，确定适当的剂量，并促进依从性。CBT模块基于已被证明有效的干预措施，重点是治疗抑郁症状，促进体力活动(特别是步行)，并提高患者与提供者沟通的有效性。为了最大限度地推广，参与者将从两个地点抽调，每个地点都包括一个以大学为基础的保健系统及其附属的退伍军人保健系统。密集干预阶段将由一名护士作为护理经理进行频繁接触，并使用手册的MCM和CBT方案。维护阶段将包括每月电话随访，以监测患者的进展，强化教育信息，并鼓励继续坚持治疗。结果将在4个月和12个月时进行衡量。主要终点将是Hb、ALC水平和心血管风险指数。次要终端包括近端干预目标(例如，抑郁症状、体力活动水平和提供者-患者

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