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临床试验/NCT00373477
NCT00373477已完成不适用

A Randomized Trial of the Cost Effectiveness of Generalist Care Managers for the Treatment of Depression in Medicaid Recipients

University of North Carolina4 个研究点 分布在 1 个国家目标入组 300 人开始时间: 2003年7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
300
试验地点
4
主要终点
Baseline, 3 and 6-month Patient Health Questionnaire (PHQ9) scores

研究概览

简要总结

This project will enable the investigators to conduct a randomized clinical trial to demonstrate the value of generalist care managers in the treatment of depression in Medicaid patients seen in primary health care practices. Depressed patients will be recruited at two primary care practices in Western North Carolina and randomly assigned to either generalist care management or usual care. Patients in each condition will be assessed at baseline and six months follow-up. Outcomes will include depressive symptoms, level of functioning, and cost-effectiveness measures.

详细描述

Randomized trial among depressed Medicaid patients aged 18 years and older in 2 primary care practices in Western NC comparing an intervention with a GCM to usual care (UC) between July 2003 and February 2005. GCMs, already providing diabetes and asthma services, were further trained and given ongoing supervision to provide algorithm-based depression care to enhance guideline concordant treatment. GCMs provided elements of self-management, decision support, use of information systems, and core care management components.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
None

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

  • scoring 10 or greater on PHQ-9 and primary care physician verification of major depression by clinical exam; and
  • willing to begin or continue antidepressant medication

排除标准

  • bipolar disorder, psychotic symptoms, or active suicidal ideation requiring psychiatric admission (

结局指标

主要结局

Baseline, 3 and 6-month Patient Health Questionnaire (PHQ9) scores

次要结局

  • Baseline and 6-month Short Form (SF)-12 scores, Medicaid claims data; patient perception of treatment by self-report; review of GCM case notes, physician and office staff time study; physician and office staff focus groups

研究者

申办方类型
Other

研究点 (4)

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