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Imperial County Asthma CER Project: Respira Sano (Respira Sano)

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ClinicalTrials.gov Identifier: NCT02768883
Recruitment Status : Active, not recruiting
First Posted : May 11, 2016
Last Update Posted : July 17, 2017
Sponsor:
Collaborator:
Patient-Centered Outcomes Research Institute
Information provided by (Responsible Party):
John Elder, San Diego State University

Brief Summary:
The immediate goal of the Imperial County CER Asthma project is to identify strategies to improve asthma control among children 0-17 years old and the asthma control behaviors of their families, their health care providers, and the communities in which they live. Our long-term goal is to improve the quality of life of children with asthma and potentially reduce families' economic and social burdens of uncontrolled asthma

Condition or disease Intervention/treatment Phase
Asthma Behavioral: Respira Sano Not Applicable

Detailed Description:

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.


Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 400 participants
Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Prevention
Official Title: PCORI - The Imperial County CER Asthma Project
Study Start Date : February 2014
Estimated Primary Completion Date : December 31, 2017
Estimated Study Completion Date : December 31, 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Asthma

Arm Intervention/treatment
Experimental: 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.

Behavioral: Respira Sano
The intervention is all three components: clinic + home + community.

Experimental: 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.

Behavioral: Respira Sano
The intervention is all three components: clinic + home + community.

Experimental: 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.

Behavioral: Respira Sano
The intervention is all three components: clinic + home + community.

Active Comparator: Community only
Community Intervention = exposure to air quality flag program; 3 rotating messages distributed via TV, radio, posters, public presentations, website, Facebook.
Behavioral: Respira Sano
The intervention is all three components: clinic + home + community.




Primary Outcome Measures :
  1. Asthma Quality of Life [ Time Frame: 1 year ]
    http://qol.thoracic.org/sections/instruments/ae/pages/juniper.html



Information from the National Library of Medicine

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Ages Eligible for Study:   6 Years to 17 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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:


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02768883


Locations
United States, California
Institute for Behavioral and Community Health at San Diego State University
San Diego, California, United States, 92123
Sponsors and Collaborators
San Diego State University
Patient-Centered Outcomes Research Institute
Investigators
Principal Investigator: John P Elder, PhD MPH San Diego State University Graduate School of Public Health

Responsible Party: John Elder, Distinguished Professor of Public Health; and Adjunct Professor of Family and Preventive Medicine, UCSD, San Diego State University
ClinicalTrials.gov Identifier: NCT02768883     History of Changes
Other Study ID Numbers: SanDiegoSU
First Posted: May 11, 2016    Key Record Dates
Last Update Posted: July 17, 2017
Last Verified: July 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by John Elder, San Diego State University:
Childhood asthma
Latino

Additional relevant MeSH terms:
Asthma
Bronchial Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive
Lung Diseases
Respiratory Hypersensitivity
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases