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

12 de julio de 2017 actualizado por: John Elder, San Diego State University

PCORI - The Imperial County CER Asthma Project

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

Descripción general del estudio

Estado

Desconocido

Condiciones

Intervención / Tratamiento

Descripción detallada

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.

Tipo de estudio

Intervencionista

Inscripción (Anticipado)

400

Fase

  • No aplica

Contactos y Ubicaciones

Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.

Ubicaciones de estudio

    • California
      • San Diego, California, Estados Unidos, 92123
        • Institute for Behavioral and Community Health at San Diego State University

Criterios de participación

Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.

Criterio de elegibilidad

Edades elegibles para estudiar

6 años a 17 años (Niño)

Acepta Voluntarios Saludables

No

Géneros elegibles para el estudio

Todos

Descripción

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:

Plan de estudios

Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.

¿Cómo está diseñado el estudio?

Detalles de diseño

  • Propósito principal: Prevención
  • Asignación: Aleatorizado
  • Modelo Intervencionista: Asignación factorial
  • Enmascaramiento: Único

Armas e Intervenciones

Grupo de participantes/brazo
Intervención / Tratamiento
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.

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.

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.

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

¿Qué mide el estudio?

Medidas de resultado primarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Asthma Quality of Life
Periodo de tiempo: 1 year
http://qol.thoracic.org/sections/instruments/ae/pages/juniper.html
1 year

Colaboradores e Investigadores

Aquí es donde encontrará personas y organizaciones involucradas en este estudio.

Investigadores

  • Investigador principal: John P Elder, PhD MPH, San Diego State University Graduate School of Public Health

Fechas de registro del estudio

Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados ​​por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.

Fechas importantes del estudio

Inicio del estudio

1 de febrero de 2014

Finalización primaria (Anticipado)

31 de diciembre de 2017

Finalización del estudio (Anticipado)

31 de diciembre de 2017

Fechas de registro del estudio

Enviado por primera vez

9 de mayo de 2016

Primero enviado que cumplió con los criterios de control de calidad

10 de mayo de 2016

Publicado por primera vez (Estimar)

11 de mayo de 2016

Actualizaciones de registros de estudio

Última actualización publicada (Actual)

17 de julio de 2017

Última actualización enviada que cumplió con los criterios de control de calidad

12 de julio de 2017

Última verificación

1 de julio de 2017

Más información

Términos relacionados con este estudio

Plan de datos de participantes individuales (IPD)

¿Planea compartir datos de participantes individuales (IPD)?

NO

Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .

Ensayos clínicos sobre Respira Sano

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