- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT02768883
Imperial County Asthma CER Project: Respira Sano (Respira Sano)
PCORI - The Imperial County CER Asthma Project
Studieoversigt
Detaljeret beskrivelse
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.
Undersøgelsestype
Tilmelding (Forventet)
Fase
- Ikke anvendelig
Kontakter og lokationer
Studiesteder
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California
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San Diego, California, Forenede Stater, 92123
- Institute for Behavioral and Community Health at San Diego State University
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Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
Tager imod sunde frivillige
Køn, der er berettiget til at studere
Beskrivelse
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:
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Forebyggelse
- Tildeling: Randomiseret
- Interventionel model: Faktoriel opgave
- Maskning: Enkelt
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
---|---|
Eksperimentel: 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.
|
Eksperimentel: 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.
|
Eksperimentel: 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.
|
Aktiv komparator: Community only
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.
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
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Asthma Quality of Life
Tidsramme: 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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Samarbejdspartnere og efterforskere
Sponsor
Samarbejdspartnere
Efterforskere
- Ledende efterforsker: John P Elder, PhD MPH, San Diego State University Graduate School of Public Health
Datoer for undersøgelser
Studer store datoer
Studiestart
Primær færdiggørelse (Forventet)
Studieafslutning (Forventet)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Skøn)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Nøgleord
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- SanDiegoSU
Plan for individuelle deltagerdata (IPD)
Planlægger du at dele individuelle deltagerdata (IPD)?
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Fundacion Clinic per a la Recerca BiomédicaIkke rekrutterer endnuRespiratorisk insufficiensSpanien
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Precera Bioscience, Inc.University of PittsburghTrukket tilbage
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The University of Texas Health Science Center,...Prevent Cancer FoundationAfsluttetIkke-alkoholisk fedtleversygdomForenede Stater
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