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- Klinische proef NCT02768883
Imperial County Asthma CER Project: Respira Sano (Respira Sano)
PCORI - The Imperial County CER Asthma Project
Studie Overzicht
Gedetailleerde beschrijving
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.
Studietype
Inschrijving (Verwacht)
Fase
- Niet toepasbaar
Contacten en locaties
Studie Locaties
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California
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San Diego, California, Verenigde Staten, 92123
- Institute for Behavioral and Community Health at San Diego State University
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Deelname Criteria
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
Accepteert gezonde vrijwilligers
Geslachten die in aanmerking komen voor studie
Beschrijving
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:
Studie plan
Hoe is de studie opgezet?
Ontwerpdetails
- Primair doel: Preventie
- Toewijzing: Gerandomiseerd
- Interventioneel model: Faculteitstoewijzing
- Masker: Enkel
Wapens en interventies
Deelnemersgroep / Arm |
Interventie / Behandeling |
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Experimenteel: 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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Experimenteel: 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.
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Experimenteel: 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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Actieve vergelijker: 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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Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
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Asthma Quality of Life
Tijdsspanne: 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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Medewerkers en onderzoekers
Sponsor
Medewerkers
Onderzoekers
- Hoofdonderzoeker: John P Elder, PhD MPH, San Diego State University Graduate School of Public Health
Studie record data
Bestudeer belangrijke data
Studie start
Primaire voltooiing (Verwacht)
Studie voltooiing (Verwacht)
Studieregistratiedata
Eerst ingediend
Eerst ingediend dat voldeed aan de QC-criteria
Eerst geplaatst (Schatting)
Updates van studierecords
Laatste update geplaatst (Werkelijk)
Laatste update ingediend die voldeed aan QC-criteria
Laatst geverifieerd
Meer informatie
Termen gerelateerd aan deze studie
Trefwoorden
Aanvullende relevante MeSH-voorwaarden
Andere studie-ID-nummers
- SanDiegoSU
Plan Individuele Deelnemersgegevens (IPD)
Bent u van plan om gegevens van individuele deelnemers (IPD) te delen?
Deze informatie is zonder wijzigingen rechtstreeks van de website clinicaltrials.gov gehaald. Als u verzoeken heeft om uw onderzoeksgegevens te wijzigen, te verwijderen of bij te werken, neem dan contact op met register@clinicaltrials.gov. Zodra er een wijziging wordt doorgevoerd op clinicaltrials.gov, wordt deze ook automatisch bijgewerkt op onze website .
Klinische onderzoeken op Respira Sano
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Precera Bioscience, Inc.University of Pittsburgh Medical CenterBeëindigdPsychische aandoeningVerenigde Staten
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Fundacion Clinic per a la Recerca BiomédicaNog niet aan het werven
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ReCode TherapeuticsSano Genetics; ReverbaWervingPrimaire ciliaire dyskinesieVerenigde Staten
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Precera Bioscience, Inc.University of PittsburghIngetrokkenHartfalen, congestiefVerenigde Staten
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The University of Texas Health Science Center,...Prevent Cancer FoundationVoltooidNiet-alcoholische leververvettingVerenigde Staten
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HealthCore-NERINational Heart, Lung, and Blood Institute (NHLBI); Pediatric Heart NetworkVoltooidHartafwijkingen, aangeborenVerenigde Staten, Canada