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Asthma Patient Education in the Emergency Room

2013年6月7日 更新者:Hospital for Special Surgery, New York

Trial of Asthma Patient Education in the Emergency Room

The objective of this randomized trial is to assess the effectiveness of an intervention involving education, self-efficacy, and social support in improving quality of life outcomes among 296 adult asthma patients treated in the emergency room. The main outcome will be a comparison of within-patient change in quality of life between enrollment and 8 weeks. Secondary objectives will be to assess the effectiveness of the intervention in decreasing the need for rescue inhaled beta agonists, in improving peak flow meter rates, and in decreasing the number of days lost from work or school due to asthma. These outcomes will be measured again at 16 weeks to determine if benefits are sustained. Additional outcomes at 16 weeks and 1 year will be to assess the effectiveness of the intervention in decreasing urgent resource utilization for asthma and cost effectiveness.

研究概览

详细说明

BACKGROUND:

Many urban asthma emergency room patients lack effective self-management. Most current training programs are administered in outpatient settings and have low attendance rates for emergency room patients. There is a great need to develop effective programs that can be easily administered in the emergency room for patients who, in many cases, are not present in other settings to receive education. This proposal builds on preliminary studies and is tailored to provide emergency room patients with basic education during "a teachable moment" when they may be most receptive to asthma information.

DESIGN NARRATIVE:

Patients will be recruited from two New York City urban emergency rooms or inpatient settings and randomized to the intervention or control groups. Intervention patients will receive a protocol focusing on asthma self-management, education, self-efficacy, and social support, with telephone reinforcement for 8 weeks. Control patients will receive standard emergency room education about asthma.

研究类型

介入性

注册 (预期的)

296

阶段

  • 不适用

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

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 至 95年 (成人、年长者)

接受健康志愿者

有资格学习的性别

全部

描述

Inclusion Criteria:

  • Patients will be eligible if they are 18 years of age or older
  • Fluent in English
  • Have a known diagnosis of asthma
  • Will receive treatment for asthma during the current hospitalization or emergency room visit.

Exclusion Criteria:

  • Cognitive deficits
  • Other pulmonary diseases or severe comorbidity
  • Do not have out-patient access to a telephone

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

  • 主要用途:治疗
  • 分配:随机化
  • 介入模型:并行分配
  • 屏蔽:单身的

武器和干预

参与者组/臂
干预/治疗
实验性的:1
Intervention participants will receive information focusing on asthma self-management, education, self-efficacy, and social support while in the hospital emergency room. Telephone reinforcement will occur for 8 weeks following study entry.
The intervention involves enhancing asthma education, asthma self-efficacy and asthma-related social support and is administered during a single in-person session in the ED (or hospital for admitted patients) followed by telephone reinforcement.
有源比较器:2
Participants in the control group will receive standard emergency room education about asthma.
Participants will receive standard emergency room education about asthma.

研究衡量的是什么?

主要结果指标

结果测量
大体时间
Quality of life
大体时间:Measured at 8 weeks
Measured at 8 weeks

次要结果测量

结果测量
大体时间
Rescue inhaled beta agonist use
大体时间:Measured at 8 weeks
Measured at 8 weeks
Peak flow meter rates
大体时间:Measured at 8 weeks
Measured at 8 weeks
Number of days lost from work or school due to asthma
大体时间:Measured at 8 weeks
Measured at 8 weeks
Decreasing urgent resource utilization for asthma
大体时间:Measured at 16 weeks and 1 year
Measured at 16 weeks and 1 year
Cost effectiveness
大体时间:Measured at 16 weeks and 1 year
Measured at 16 weeks and 1 year

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

  • 学习椅:Carol A. Mancuso, MD、Hospital for Special Surgery, New York

出版物和有用的链接

负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。

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

2005年1月1日

初级完成 (实际的)

2010年2月1日

研究完成 (实际的)

2010年2月1日

研究注册日期

首次提交

2005年5月6日

首先提交符合 QC 标准的

2005年5月6日

首次发布 (估计)

2005年5月9日

研究记录更新

最后更新发布 (估计)

2013年6月10日

上次提交的符合 QC 标准的更新

2013年6月7日

最后验证

2013年6月1日

更多信息

与本研究相关的术语

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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