CClinicalTrials.gg
Status unknownNCT02768883Respira SanoUpdated Jul 17, 2017

Imperial County Asthma CER Project: Respira Sano

An interventional study of Respira Sano in Asthma, sponsored by San Diego State University. Status unknown at 1 site in United States. Open to participants aged 6 Years to 17 Years. Per ClinicalTrials.gov, last updated 2017-07-17.

Sponsored by San Diego State University · Not applicable, Interventional, and Prevention

The sponsor has not verified this record recently (last verified Jul 2017), so the status shown — last known as Active, not recruiting — may be out of date.
Phase
Not applicable
Study type
Interventional
Enrollment
400
Allocation
Randomized
Ages
6 Years to 17 Years
Sex
All
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Study 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

Read the 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.

02

Conditions studied

  • Asthma

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Keywords

  • Childhood asthma
  • Latino
03

In context

Asthma

3,921 studies on the registry are indexed under Asthma; 507 are open to participants now.

This study's planned enrollment of 400 is above the median of 83 across 2,752 interventional studies indexed under Asthma.

Browse Asthma studies →

Lead sponsor

San Diego State University is the lead sponsor of 145 studies on the registry; 41 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
6 Years to 17 Years
Sexes eligible
All
Accepts healthy volunteers
No

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

Exclusion Criteria:

05

Study design

Phase
Not applicable
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Factorial assignment
Masking
Single (Outcomes assessor)
Enrollment
400 participants (estimated)

Study arms

  • 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

  • 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

  • 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

  • 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

Interventions

  • BehavioralRespira Sano

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

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What researchers measure

Primary outcomes

  1. Asthma Quality of Life

    http://qol.thoracic.org/sections/instruments/ae/pages/juniper.html

    Time frame: 1 year

07

Study locations

1 site
  • Institute for Behavioral and Community Health at San Diego State University
    San Diego, California 92123, United States
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References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 17, 2017, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT02768883
Lead sponsor
San Diego State University
Collaborators
Patient-Centered Outcomes Research Institute
Responsible party
John Elder (Distinguished Professor of Public Health; and Adjunct Professor of Family and Preventive Medicine, UCSD, San Diego State University) — Principal investigator
First posted
May 11, 2016
Start date
Feb 2014
Primary completion
Dec 31, 2017 (estimated)
Completion
Dec 31, 2017 (estimated)
Last update
Jul 17, 2017

Study contacts

John P Elder, PhD MPH
principal investigator · San Diego State University Graduate School of Public Health

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Jul 2017. You cannot join it, but the record below documents what was studied.

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