search
Back to results

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

Primary Purpose

Asthma

Status
Unknown status
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Respira Sano
Sponsored by
San Diego State University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Asthma focused on measuring Childhood asthma, Latino

Eligibility Criteria

6 Years - 17 Years (Child)All SexesDoes not accept healthy volunteers

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:

Sites / Locations

  • Institute for Behavioral and Community Health at San Diego State University

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Experimental

Experimental

Active Comparator

Arm Label

Clinic + Home + Community

Clinic + Community

Home + Community

Community only

Arm Description

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.

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.

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.

Community Intervention = exposure to air quality flag program; 3 rotating messages distributed via TV, radio, posters, public presentations, website, Facebook.

Outcomes

Primary Outcome Measures

Asthma Quality of Life
http://qol.thoracic.org/sections/instruments/ae/pages/juniper.html

Secondary Outcome Measures

Full Information

First Posted
May 9, 2016
Last Updated
July 12, 2017
Sponsor
San Diego State University
Collaborators
Patient-Centered Outcomes Research Institute
search

1. Study Identification

Unique Protocol Identification Number
NCT02768883
Brief Title
Imperial County Asthma CER Project: Respira Sano
Acronym
Respira Sano
Official Title
PCORI - The Imperial County CER Asthma Project
Study Type
Interventional

2. Study Status

Record Verification Date
July 2017
Overall Recruitment Status
Unknown status
Study Start Date
February 2014 (undefined)
Primary Completion Date
December 31, 2017 (Anticipated)
Study Completion Date
December 31, 2017 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
San Diego State University
Collaborators
Patient-Centered Outcomes Research Institute

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Asthma
Keywords
Childhood asthma, Latino

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Factorial Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
400 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Clinic + Home + Community
Arm Type
Experimental
Arm Description
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.
Arm Title
Clinic + Community
Arm Type
Experimental
Arm Description
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.
Arm Title
Home + Community
Arm Type
Experimental
Arm Description
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.
Arm Title
Community only
Arm Type
Active Comparator
Arm Description
Community Intervention = exposure to air quality flag program; 3 rotating messages distributed via TV, radio, posters, public presentations, website, Facebook.
Intervention Type
Behavioral
Intervention Name(s)
Respira Sano
Intervention Description
The intervention is all three components: clinic + home + community.
Primary Outcome Measure Information:
Title
Asthma Quality of Life
Description
http://qol.thoracic.org/sections/instruments/ae/pages/juniper.html
Time Frame
1 year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
6 Years
Maximum Age & Unit of Time
17 Years
Accepts Healthy Volunteers
No
Eligibility 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:
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
John P Elder, PhD MPH
Organizational Affiliation
San Diego State University Graduate School of Public Health
Official's Role
Principal Investigator
Facility Information:
Facility Name
Institute for Behavioral and Community Health at San Diego State University
City
San Diego
State/Province
California
ZIP/Postal Code
92123
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Imperial County Asthma CER Project: Respira Sano

We'll reach out to this number within 24 hrs