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Behavioral Interventions for Control of TB

2015年12月21日 更新者:Columbia University

Behavioral Interventions for Control of Tuberculosis

To compare alternative methods to ensure completion of treatment and preventive therapy for tuberculosis (TB) in inner cities, and to identify the most cost-effective methods to accomplish that. The basis for comparison included adherence rates and cost savings as primary outcomes, and other parameters such as patient satisfaction, development of social networks, and participation in support programs as secondary outcomes.

Two clinical trials were conducted with patients from Harlem. Among those with active disease, a clinic-based surrogate family model was compared to traditional community-based directly observed therapy (DOT). Among those eligible for preventive therapy, a community-based intervention conducted by trained graduates of a TB DOT program (peer workers) was compared to traditional self-administered preventive treatment.

研究概览

详细说明

Tuberculosis was on the decline from the mid 1950s until the mid 1980s; however, the United States is now experiencing a resurgence of tuberculosis. In 1992, approximately 27,000 new cases were reported, an increase of about 20 percent from 1985 to 1992. Not only are tuberculosis cases on the increase, but a serious aspect of the problem is the recent occurence of outbreaks of multidrug resistant (MDR) tuberculosis, which poses an urgent public health problem and requires rapid intervention.

Control programs involve two major components. First, and of highest priority, is to detect persons with active tuberculosis and treat them with effective antituberculosis drugs, which prevents death from tuberculosis and stops the transmission of infection to other persons. Treatment of active tuberculosis involves taking multiple antituberculosis drugs daily or several times weekly for at least six months. Failure to take the medications for the full treatment period may mean that the disease is not cured and may recur. If sufficient medications are not prescribed early and taken regularly, the tuberculosis organism can become resistant to the drugs, and the drug resistant tuberculosis then may be transmitted to other persons. Drug resistant disease is difficult and expensive to treat, and in some cases, cannot be treated with available medications.

The second major goal of control efforts is the detection and treatment of persons who do not have active tuberculosis, but who have latent tuberculosis infection. These people may be at high risk of developing active tuberculosis. The only approved treatment modality for preventive therapy requires treatment daily or twice weekly for a minimum of six months, and many patients do not complete the full course of therapy. Public and patient programs are needed to increase the awareness of the problems associated with tuberculosis control.

The study is part of the NHLBI initiative "Behavioral Interventions for Control of Tuberculosis" . The concept for the initiative originated from the National Institutes of Health Working Group on Health and Behavior. The Request for Applications was released in October, 1994.

研究类型

观察性的

注册 (实际的)

145

联系人和位置

本节提供了进行研究的人员的详细联系信息,以及有关进行该研究的地点的信息。

学习地点

    • New York
      • New York、New York、美国、10023
        • Columbia University

参与标准

研究人员寻找符合特定描述的人,称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

18年 及以上 (成人、年长者)

接受健康志愿者

有资格学习的性别

全部

取样方法

非概率样本

研究人群

Patients with suspected and confirmed TB

描述

Inclusion Criteria:

-Patients with suspected and confirmed TB

Exclusion Criteria:

-Patients that are not a part of the therapy program established at Harlem Hospital, New York City

学习计划

本节提供研究计划的详细信息,包括研究的设计方式和研究的衡量标准。

研究是如何设计的?

设计细节

  • 观测模型:病例对照
  • 时间观点:预期

队列和干预

团体/队列
干预/治疗
Community-based therapy (case)
Community-based directly observed therapy (DOT) - A community-based intervention conducted by trained graduates of a TB directly observed therapy (DOT) program (peer workers)
A community-based intervention conducted by trained graduates of a TB directly observed therapy (DOT) program (peer workers)
其他名称:
  • Community-based DOT
Self-administered treatment (control)
Clinic directly observed therapy (DOT) - Traditional self-administered preventive treatment
A traditional self-administered preventive treatment
其他名称:
  • Clinic DOT

研究衡量的是什么?

主要结果指标

结果测量
措施说明
大体时间
Visit adherence rate
大体时间:At the end of study
Prevalence of suspected and confirmed tuberculosis patients that continued treatment
At the end of study

次要结果测量

结果测量
措施说明
大体时间
Treatment completion rate
大体时间:At end of study
Prevalence of suspected and confirmed tuberculosis patients that completed treatment
At end of study

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

调查人员

  • 首席研究员:Wafaa El-Sadr, MD、University Professor; Director, ICAP, Department of Epidemiology

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查,以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始

1995年9月1日

初级完成 (实际的)

2004年12月1日

研究完成 (实际的)

2015年12月1日

研究注册日期

首次提交

2000年5月25日

首先提交符合 QC 标准的

2000年5月25日

首次发布 (估计)

2000年5月26日

研究记录更新

最后更新发布 (估计)

2015年12月23日

上次提交的符合 QC 标准的更新

2015年12月21日

最后验证

2015年12月1日

更多信息

与本研究相关的术语

其他研究编号

  • CUMC ID unknown (4948)
  • R01HL055751 (美国 NIH 拨款/合同)

计划个人参与者数据 (IPD)

研究数据/文件

药物和器械信息、研究文件

研究美国 FDA 监管的药品

研究美国 FDA 监管的设备产品

在美国制造并从美国出口的产品

此信息直接从 clinicaltrials.gov 网站检索,没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求,请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改,我们的网站上也会自动更新.

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