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临床试验/NCT00747201
NCT00747201已完成不适用

Implementing Chronic Care Management for Bipolar Disorder

University of Michigan5 个研究点 分布在 1 个国家目标入组 384 人开始时间: 2009年9月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
384
试验地点
5
主要终点
Quality of Life

研究概览

简要总结

This study will determine if a version of the bipolar care model adapted for a nonresearch audience can improve patient health and correct use of the model in community-based mental health care sites.

详细描述

For the approximately 5.7 million Americans suffering from bipolar disorder, recurring manic and depressive symptoms, psychosis, and a high suicide risk prevent normal functioning and normal interpersonal relationships. Bipolar disorder has a high economic cost, as well, both because care for those with the disorder is expensive and because those suffering from the disorder have difficulty holding jobs. The total cost of bipolar disorder in the United States is estimated to be $45 billion. Part of this economic cost comes from poor quality of care. Only half of bipolar patients receive adequate outpatient care, and only a third receive adequate drug levels and safety monitoring. This can lead to preventable hospitalizations, emergency room use, and deaths.

Often, new results from research can take years or decades to be translated into practice in community mental health care. Even then, new methods can be less effective in practice because there is inadequate understanding of or technical support for these methods. This occurs because research is not presented in enough detail or with enough flexibility to be adapted for community settings.

The Centers for Disease Control and Prevention's (CDC's) Replicating Effective Programs (REP) project is a systematic method of replicating effective behavioral interventions for reducing HIV risk. The REP has three components:

  • Packaging, or adapting, a behavioral treatment so its scientific protocols are in nontechnical, user-friendly language
  • Providing formal training for health care professionals in implementing the package
  • Supporting the use of the package through technical assistance available to individual treatment sites

The REP framework has been effective in extending the availability of HIV behavioral interventions and ensuring proper implementation, but it has never been used for non-HIV-related interventions, nor has it been proven that wider availability of these new interventions improves patient health and quality of life. This study will examine both of these untested areas of the REP framework by packaging a new intervention for bipolar disorder, called the Bipolar Care Model (BCM). Research shows the BCM to be effective in real-world settings and across different ethnic groups. This study will determine if a packaged version of the BCM will be effective across multiple, community-based, mental health settings. Success with the packaged version of the BCM will not only make this particular treatment more available to mental health care providers, but it will create a model for transitioning all research on new behavioral interventions for mental health into effective practice.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Health Services Research
盲法
Single (Outcomes Assessor)

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Currently being seen as a patient at the participating site
  • Active diagnosis or treatment plan for Bipolar I, Bipolar II, or Bipolar not otherwise specified (NOS)

排除标准

  • Serious illness that would prevent participation in the BCM components as indicated by the provider
  • Living in a nursing home or other institution

结局指标

主要结局

Quality of Life

时间窗: Change from Baseline in Quality of Life at 12-months.

次要结局

  • Cost-effectiveness(Measured at 12-months)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Amy M. Kilbourne

Associate Professor

University of Michigan

研究点 (5)

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