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Web-Based and Tailored Asthma Management Intervention (Puff City) in Teens With Asthma Attending Urban Clinics (PCC)

2017年8月8日 更新者:Dr. Mei Lu、Henry Ford Health System

Pragmatic Randomized Controlled Trial of the Web-Based Asthma Management Intervention (Puff City) in Teens With Asthma Attending Urban Clinics

The purpose of this study is to evaluate the Puff City web-based behavioral intervention of asthma management program in a clinical setting. This study also examines and evaluates the cost and efficiency of patient eligibility determination methods, patient recruitment, study monitoring (compliance with study regimen, participant retention and follow-up), and the collection of clinical endpoints.

研究概览

详细说明

Asthma continues to be a major public health problem in the US with high economic and social costs. Vulnerable ethnic communities are disproportionately affected by asthma as demonstrated by higher morbidity and mortality for these groups. We have completed two school-based, randomized trials of a web-based, computer-tailored asthma management intervention that targets urban teens (Puff City).

The current study, Puff City in the Clinic, will be evaluated as a clinical tool by initiating the web-based behavioral intervention of asthma management in a clinical setting. However, the current paradigm for conducting such a trial is costly with respect to patient recruitment, intervention delivery, and data collection and management. To address these high costs, the study utilizes comparative effectiveness research (CER) pragmatic approaches to design a randomized controlled trial for patient recruitment and determination of eligibility, study monitoring (compliance with study regimen, participant retention and follow-up), and collection of clinical endpoints.

研究类型

介入性

注册 (实际的)

266

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

    • Michigan
      • Detroit、Michigan、美国、48202
        • Henry Ford Health System

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

13年 至 19年 (孩子、成人)

接受健康志愿者

有资格学习的性别

全部

描述

Inclusion Criteria:

  • 13-19 years of age
  • Must be able to provide electronic assent and have consent from a parent/guardian if applicable
  • Diagnosis of asthma by meeting one of the following criteria within the last 12 months:

    • At least one emergency department diagnosis of asthma or
    • At least one acute inpatient encounter with asthma as the principal diagnosis or
    • At least four outpatient visits with an asthma diagnosis and at least 2 asthma medications dispensed or
    • At least four asthma medications dispensed

Exclusion Criteria:

  • Inability to provide informed consent/assent
  • Lack of physician diagnosis of asthma
  • Other co-morbidities that make it impossible for the individual to participate.

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:其他
  • 分配:随机化
  • 介入模型:并行分配
  • 屏蔽:无(打开标签)

武器和干预

参与者组/臂
干预/治疗
实验性的:Tailored asthma management program
Teens randomized to the experimental arm will receive 4 sessions plus a booster of web-based, tailored asthma management.
Web-based, computer-tailored asthma management intervention delivered in 4 sessions, plus a 6 month booster.
有源比较器:Control
Teens in the control group will receive generic, web-based asthma education.
Web-based, generic asthma management intervention delivered in 4 sessions.

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
Asthma Control Test (ACT)
大体时间:12 Months
Comparison of ACT scores at 12 months after the randomization
12 Months

次要结果测量

结果测量
措施说明
大体时间
Asthma Exacerbations/Functional Status
大体时间:12 Months
Comparison of asthma exacerbations (asthma hospitalizations, emergency department visits, or oral corticosteroid dispensing)and functional status(e.g. self report of symptom-days, symptom nights, days of restricted activity, school/work days missed) at 12 months after randomization.
12 Months

其他结果措施

结果测量
措施说明
大体时间
The Cost
大体时间:Up to 12 months
The cost of study intervention will be evaluated: The cost for participant enrollment with Electronic Medical Record (EMR) initiation; data collection and management with/o EMR initiation including assessing the reliability of EMR clinical outcomes/primary endpoints, compared to chart abstraction.
Up to 12 months
The Cost Effectiveness
大体时间:Up to 12 months
The cost effectiveness of Puff City intervention compared to controls without study intervention.
Up to 12 months

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:Christine Joseph, PhD、Henry Ford Health System
  • 首席研究员:Mei Lu, PhD、Henry Ford Health System

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

2013年3月1日

初级完成 (实际的)

2015年5月1日

研究完成 (实际的)

2016年11月1日

研究注册日期

首次提交

2012年12月7日

首先提交符合 QC 标准的

2012年12月27日

首次发布 (估计)

2012年12月28日

研究记录更新

最后更新发布 (实际的)

2017年8月9日

上次提交的符合 QC 标准的更新

2017年8月8日

最后验证

2017年8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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