Imperial County Asthma CER Project: Respira Sano (Respira Sano)
PCORI - The Imperial County CER Asthma Project
研究概览
详细说明
Asthma is a prevalent chronic disease in rural and border communities along the U.S.-Mexico border. Among 5-17 year olds, 20.2% have physician-diagnosed asthma compared to 16.2% statewide. Risk factors for poor asthma control are well documented and include ambient air quality, home environmental factors, and exposure to tobacco smoke. Although directionality is not well established, obesity and poverty are related to asthma and are also prevalent in the partner communities. These combined risk factors may explain the elevated rates of emergency department use for asthma among children in Imperial County compared with the state. Comprehensive approaches are needed that recognize and involve the various sectors relevant to asthma control.
Objectives: The Imperial County's Asthma CER project is a family-clinic-community intervention designed to improve asthma control. The objectives of this study are to determine whether this combined approach (family clinic-community) is more effective at promoting asthma control, quality of life and improved lung functioning than a family-community intervention, a clinic-community intervention, or a community only intervention. The ultimate goal is to identify feasible and effective methods for promoting lifelong asthma control.
Methods: This is a 2x2 factorial (family and clinic) study nested within a community intervention. Four hundred children 6-17 years old and a parent/legal guardian will be recruited to participate in the study which includes random assignment to family home visitations or no family home visits. Assignment in the second factor (clinic) will be determined based on whether the child is a patient of the partner clinic (Clínicas de Salud del Pueblo, Inc).
Patient Outcomes: Changes in children's asthma control, quality of life, and lung functioning will be examined.
Partnerships to Facilitate Study: This study is a partnership between an academic/research institute (San Diego State University and the Institute for Behavioral and Community Health) with over 30 years of experience conducting rigorous public health research, a Federally Qualified Health Center (Clínicas de Salud del Pueblo, Inc) with excellent reach and credibility in the partner community, a community-based organization (Comité Cívico del Valle) with extensive experience in promoting asthma control, and a division of the state health department (California Breathing) responsible for asthma control efforts statewide. Combined, they bring expertise in developing and implementing evidenced-based approaches for real world settings to address urgent public health problems. Importantly, they have successfully collaborated in the design, implementation and evaluation of over ten research studies and/or projects within the last ten years.
研究类型
注册 (预期的)
阶段
- 不适用
联系人和位置
学习地点
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California
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San Diego、California、美国、92123
- Institute for Behavioral and Community Health at San Diego State University
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参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
描述
Inclusion Criteria:
- Lives in Imperial County (except cities of Winterhaven, Salton City, Palo Verde)
- Have a child between the ages of 6 - 17 years with asthma
- Speak Spanish or English
- Consider the child to be Latino
Exclusion Criteria:
学习计划
研究是如何设计的?
设计细节
- 主要用途:预防
- 分配:随机化
- 介入模型:阶乘赋值
- 屏蔽:单身的
武器和干预
参与者组/臂 |
干预/治疗 |
---|---|
实验性的:Clinic + Home + Community
Clinic Intervention = 4 clinical visits with provider over 12 months, 4 visits with clinic asthma educator Home Intervention = 4 home visits with community health worker over 2 months, 4 mailers, and 4 phone calls Community Intervention = exposure to air quality flag program; 3 rotating messages distributed via TV, radio, posters, public presentations, website, Facebook. |
The intervention is all three components: clinic + home + community.
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实验性的:Clinic + Community
Clinic Intervention = 4 clinical visits with provider over 12 months, 4 visits with clinic asthma educator Community Intervention = exposure to air quality flag program; 3 rotating messages distributed via TV, radio, posters, public presentations, website, Facebook. |
The intervention is all three components: clinic + home + community.
|
实验性的:Home + Community
Home Intervention = 4 home visits with community health worker over 2 months, 4 mailers, and 4 phone calls Community Intervention = exposure to air quality flag program; 3 rotating messages distributed via TV, radio, posters, public presentations, website, Facebook. |
The intervention is all three components: clinic + home + community.
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有源比较器:Community only
Community Intervention = exposure to air quality flag program; 3 rotating messages distributed via TV, radio, posters, public presentations, website, Facebook.
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The intervention is all three components: clinic + home + community.
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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 |
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Asthma Quality of Life
大体时间:1 year
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http://qol.thoracic.org/sections/instruments/ae/pages/juniper.html
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1 year
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合作者和调查者
调查人员
- 首席研究员:John P Elder, PhD MPH、San Diego State University Graduate School of Public Health
研究记录日期
研究主要日期
学习开始
初级完成 (预期的)
研究完成 (预期的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (估计)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
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.
Respira Sano的临床试验
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Fundacion Clinic per a la Recerca Biomédica尚未招聘
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The University of Texas Health Science Center,...Prevent Cancer Foundation完全的
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HealthCore-NERINational Heart, Lung, and Blood Institute (NHLBI); Pediatric Heart Network完全的