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Telephone Coaches to Improve Control of Asthma in Children ( PARTNER) Study) (PARTNER)

1 de octubre de 2018 actualizado por: Jane Garbutt, MD, Washington University School of Medicine

Parents, Pediatricians, and Telephone Coaches Partner to Improve Control of Asthma

Parents of children with asthma must work with their child's pediatrician to ensure that their child's asthma is managed well. Asthma coaches are one way to facilitate and support the relationship between parents and pediatricians. This study will evaluate whether access to a 12-month telephone asthma coaching program for parents is an effective way to improve asthma outcomes in children.

Descripción general del estudio

Estado

Terminado

Condiciones

Descripción detallada

Asthma is the most common long-term disease among children. Each year, most children with asthma will have at least one asthma exacerbation, experience asthma symptoms on approximately 100 days, and miss 4 days of school because of asthma. Surveys of primary care physicians (PCPs) and asthma patients have indicated that asthma care is episodic, effective asthma controller medications are underused, and few PCPs provide self-management education or support for parents of children with asthma. Previous research showed that when an asthma coach worked with parents of children from low-income, urban neighborhoods, there were multiple benefits: improved self-management behaviors, reduced asthma hospitalizations, and improved rates of follow-up with a PCP after an emergency department visit for asthma symptoms. In this study, researchers will evaluate the effectiveness of an asthma coach program in a larger, general asthma population. Trained asthma coaches will work with parents of children with asthma to provide education about the goals of asthma care, and they will encourage and facilitate an active partnership between the family and PCP to enhance asthma care and improve self-management behaviors. Study researchers will then evaluate the effectiveness of this program at improving asthma control and quality of life among children with asthma. The cost effectiveness of the program will also be analyzed.

This study will enroll pediatricians and parents of children between 5 and 12 years old who have persistent asthma. Pediatricians will be randomly assigned to either the asthma coach program or usual care. All pediatricians will receive access to the Education in Quality Improvement for Pediatric Practice (eQIPP) module for asthma care provided by the American Academy of Pediatrics. They will also receive articles about effective doctor-parent communication on asthma and asthma billing practices. In addition, pediatricians taking part in the asthma coach program will attend two meetings to learn about asthma coaching and how the program can be implemented into their practice. For 12 months, an asthma coach will work directly with the parents of children who see doctors participating in the asthma coaching group. Telephone calls with the asthma coach will be arranged at times convenient for the parent and will occur anywhere between once a week to once a month. At Months 12 and 24, about 40 parents of children in each pediatrician's practice will participate in telephone interviews and their children's medical charts will be reviewed to assess asthma control, asthma-related quality of life factors, and urgent care events.

Tipo de estudio

Intervencionista

Inscripción (Actual)

984

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

    • Missouri
      • Saint Louis, Missouri, Estados Unidos, 63110
        • Washington University School of Medicine

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

3 años a 12 años (Niño)

Acepta Voluntarios Saludables

No

Géneros elegibles para el estudio

Todos

Descripción

Inclusion Criteria for Pediatricians:

  • Affiliated with St. Louis Children's Hospital and/or Washington University in St. Louis
  • Provides asthma care for at least 40 asthmatic children from the target population

Inclusion Criteria for Parents:

  • Has a child who is between 3 and 12 years old with persistent asthma and who is cared for by a study pediatrician

Exclusion Criteria for Pediatricians:

  • Spends less than 50% of their time in general pediatrics
  • Is an asthma specialist (allergist or pulmonary specialist)
  • Another physician in their practice is participating in the study

Exclusion Criteria for Parents:

  • Their asthmatic child is less than 3 years old or is 13 years or older at the time of study entry
  • Their child has not had a physician diagnosis of asthma before study entry
  • Their child has a significant comorbid condition
  • Cannot speak English
  • Does not have a phone

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: Tratamiento
  • Asignación: Aleatorizado
  • Modelo Intervencionista: Asignación paralela
  • Enmascaramiento: Único

Armas e Intervenciones

Grupo de participantes/brazo
Intervención / Tratamiento
Experimental: 1
Pediatricians and parents of children with asthma will participate in the asthma coaching program.
Parents will have access to an asthma coach for 12 months. Telephone calls between parents and coaches will occur anywhere from once a week to once a month.
Comparador activo: 2
Children of parents enrolled in the study will receive usual asthma care from their pediatrician.
Children of parents enrolled in the study will receive the normal asthma care that their pediatricians usually provide.

¿Qué mide el estudio?

Medidas de resultado primarias

Medida de resultado
Periodo de tiempo
Asthma control
Periodo de tiempo: Measured at Months 12 and 24
Measured at Months 12 and 24
Asthma-related quality of life
Periodo de tiempo: Measured at Months 12 and 24
Measured at Months 12 and 24
Urgent care events
Periodo de tiempo: Measured at Months 12 and 24
Measured at Months 12 and 24

Medidas de resultado secundarias

Medida de resultado
Periodo de tiempo
Adherence to guideline-recommended asthma maintenance care behaviors
Periodo de tiempo: Measured at Months 12 and 24
Measured at Months 12 and 24
Cost effectiveness
Periodo de tiempo: Measured at Months 12 and 24
Measured at Months 12 and 24

Colaboradores e Investigadores

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

Investigadores

  • Investigador principal: Robert Strunk, MD, Washington University School of Medicine
  • Investigador principal: Jane M. Garbutt, MB, ChB, Washington University School of Medicine

Publicaciones y enlaces útiles

La persona responsable de ingresar información sobre el estudio proporciona voluntariamente estas publicaciones. Estos pueden ser sobre cualquier cosa relacionada con el estudio.

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 (Actual)

1 de agosto de 2008

Finalización primaria (Actual)

3 de mayo de 2013

Finalización del estudio (Actual)

3 de mayo de 2014

Fechas de registro del estudio

Enviado por primera vez

10 de marzo de 2009

Primero enviado que cumplió con los criterios de control de calidad

10 de marzo de 2009

Publicado por primera vez (Estimar)

12 de marzo de 2009

Actualizaciones de registros de estudio

Última actualización publicada (Actual)

3 de octubre de 2018

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

1 de octubre de 2018

Última verificación

1 de octubre de 2018

Más información

Términos relacionados con este estudio

Otros números de identificación del estudio

  • 634
  • R01HL072919 (Subvención/contrato del NIH de EE. UU.)
  • R01HL072919-06 (Subvención/contrato del NIH de EE. UU.)

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. .

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