Using Latent Variables And Directly Observed Treatment To Improve The Diagnosis And Management of Depression Among Hemodialysis Patients

利用潜在变量和直接观察治疗来改善血液透析患者抑郁症的诊断和管理

• 批准号: 10112897
• 负责人: DOUGLAS D GUNZLER
• 金额: $ 23.34万
• 依托单位: CASE WESTERN RESERVE UNIVERSITY
• 依托单位国家: 美国
• 财政年份: 2017
• 资助国家: 美国
• 起止时间: 2017-12-05 至 2022-11-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/10112897
• 关键词: Address; Adherence; Aftercare; Antidepressive Agents; Cross-Sectional Studies; Depression screen; Desire for food; Diagnosis; Dialysis patients; Dialysis procedure; Disease remission; Effectiveness; Equation; Feeling; Fluoxetine; Future; Goals; HIV; Health Personnel; Hemodialysis; Medical; Mental Depression; Mental Health; Metabolic; Methods; Modeling; Morbidity - disease rate; Muscle Cramp; Nausea; Patient Self-Report; Patients; Pharmaceutical Preparations; Primary Care Physician; Randomized; Randomized Controlled Trials; Research Personnel; Sleep; Structure; Symptoms; Testing; Tuberculosis; Work; depressive symptoms; evidence base; improved; innovation; instrument; mortality; pill; primary outcome; screening; trial design

Depression is present in about 20-30% of hemodialysis patients and is associated with morbidity and mortality. However, depression is inadequately diagnosed and treated among dialysis patients. This is due in part to the overlap between depressive symptoms (e.g. appetite change, trouble sleeping, feeling tired) and symptoms related to persistent metabolic derangements in hemodialysis patients (e.g. nausea, nocturnal cramps, feeling washed out after treatment). The overlap between depressive symptoms and dialysis-related complications makes it difficult to diagnose and therefore to treat depression. In addition, prescription of antidepressant medication may increase an already high pill burden and result in poor adherence. Moreover, the evidence base to guide depression treatment among hemodialysis patients is limited. In our previous work, we developed methods to use latent variables and structural equation modeling to isolate depressive symptoms. Other investigators have demonstrated that directly observed treatment enhances the effectiveness of tuberculosis and HIV treatment. We now propose a cross-sectional study followed by a randomized controlled trial at 17 dialysis facilities. The cross-sectional study will involve assessments of depressive symptoms (using the PHQ-9 screening instrument) as well as dialysis-related complications. We will then use structural equation modeling to develop and validate a hemodialysis-specific PHQ-9 (hdPHQ-9) that will isolate depressive symptoms. The trial will involve 216 patients with confirmed depression who will be randomly assigned to (a) directly observed weekly antidepressant treatment with fluoxetine or (b) referral to their nephrologists, their primary care physicians, or nearby mental health providers. The primary outcome of the trial will be remission of depression at 12 weeks. The trial results will also be used to compare the responsiveness of the PHQ-9 and the hdPHQ-9. We anticipate that the hdPHQ-9 will be a valid and responsive instrument that will isolate depressive symptoms in hemodialysis patients and ultimately improve the screening and diagnosis of depression. We also expect that directly observed weekly fluoxetine treatment will be an effective way to manage depression among hemodialysis patients. Innovative features of the proposed project include the use of latent variables to address overlap, administration of a long acting weekly antidepressant, directly observed treatment, and a rigorous randomized controlled trial design. The project has the potential not only to improve the diagnosis and management of depression among hemodialysis patients but also to improve their morbidity and mortality. Furthermore, it may serve as a model for future studies to isolate symptoms among overlapping medical conditions.

大约20%-30%的血液透析患者存在抑郁，并与 发病率和死亡率。然而，抑郁症没有得到充分的诊断和治疗。 在透析患者中。这在一定程度上是由于抑郁和抑郁之间的重叠 症状(如食欲改变、睡眠困难、感觉疲倦)和与以下有关的症状 血液透析患者的持续性代谢紊乱(如恶心、夜间活动 抽筋，治疗后感觉疲惫)。抑郁与抑郁之间的重叠 症状和透析相关的并发症使其难以诊断，因此 来治疗抑郁症。此外，抗抑郁药物的处方可能会增加 已经很高的药片负担，导致依从性差。此外，证据基础 指导血液透析患者的抑郁治疗是有限的。在我们之前的 工作中，我们开发了使用潜变量和结构方程建模的方法来 隔离抑郁症状。其他调查人员直接证明了这一点 观察治疗提高了结核病和艾滋病毒治疗的有效性。 我们现在建议进行一项横断面研究，然后在17岁时进行随机对照试验。 透析设施。这项横断面研究将涉及抑郁症的评估。 症状(使用PHQ-9筛查仪)以及与透析相关的 并发症。然后，我们将使用结构方程建模来开发和验证 血液透析特异性PHQ-9(hdPHQ-9)，可隔离抑郁症状。这场审判 将涉及216名确诊为抑郁症的患者，他们将被随机分配到(A) 每周直接观察氟西汀的抗抑郁治疗或(B)转诊至他们的 肾病学家、他们的初级保健医生或附近的精神健康提供者。这个 试验的主要结果将是12周后抑郁症状缓解。这场审判 结果还将用于比较PHQ-9和hdPHQ-9的响应性。 我们预计hdphq-9将是一种有效和灵敏的仪器，将分离出 改善血液透析患者的抑郁症状，最终改善筛查和 抑郁症的诊断。我们还预计每周直接观察氟西汀 治疗将是管理血液透析患者抑郁的有效方法。 拟议项目的创新特点包括使用潜在变量来处理 重叠，给药长效每周抗抑郁药，直接观察 治疗，以及严格的随机对照试验设计。该项目拥有 不仅有潜力改善抑郁症的诊断和管理，而且 不仅是为了改善血液透析患者的发病率和死亡率。此外，它还 可以作为未来研究的模型，在重叠的医学中分离症状 条件。