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Asthma in Central Texas Project

2 de abril de 2015 actualizado por: University of Texas at Austin

Enhancing Children's and Parents' Asthma Management

Asthma is the most common chronic childhood illness and disproportionately affects children who are ethnic minorities and poor. Few studies of childhood asthma have been conducted with children who live in rural areas or have included Mexican American children in their samples. This study builds on the original R01NR007770 with findings that demonstrated the intervention could improve children's asthma self-management, asthma knowledge, metered dose inhaler skill, asthma severity, and parents' asthma management and access to care. In this competing continuation, the investigators added a third arm to the current research design with schools randomized into either an in-school asthma intervention, an in-school attention-control intervention, or an alternate intervention-delivery format of a single 5.5-hour asthma day camp. The tri-ethnic sample will be composed of 320 Mexican-American, African-American, and White rural school-aged children (grades 2-5) who have asthma and their parents. In addition, the investigators propose adding a non-invasive measure of chronic airway inflammation (exhaled nitric oxide) to assess the impact of changes in asthma management on airway inflammation. Families will be followed for a full year with data collection at baseline and at 1-month, 4-months, and 7-months after the intervention to assess improvement in children's asthma morbidity, asthma severity, airway inflammation, family asthma management and quality of life. Hypotheses (H): Children in the Camp-Workshop group and the School-Home group will demonstrate equivalent improvements, but greater improvements than the Attention-Control group in:(H1.1) their asthma severity and airway inflammation from the Time 1 assessment when compared to Time 4 assessment; (H1.2) office visits, ED visits, and hospitalizations for asthma, and absenteeism for the study year (Time 4) when compared to the pre-study year (Time 1); and (H1.4) Parents in the intervention arms will demonstrate sustained improvements in asthma caregiver's quality of life (QOL0 from the pre-study year (Time 1) to the end of the study year (Time 4) measurement, when compared to the Attention-Control group.

Descripción general del estudio

Descripción detallada

Families are recruited at the beginning of the school year (Time 1, October-November); parents consent and child assent obtained and baseline data collected in fall. The intervention is provided in December-January. Follow-up data are collected at February (Time 2), April (Time 3), and August (Time 4).

Tipo de estudio

Intervencionista

Inscripción (Actual)

292

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

    • Texas
      • Austin, Texas, Estados Unidos, 78712
        • The University of Texas at Austin

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 13 años (Niño)

Acepta Voluntarios Saludables

Géneros elegibles para el estudio

Todos

Descripción

Inclusion Criteria:

  • parent reports the child has a diagnosis of asthma made by a medical provider;
  • has had asthma symptoms in the previous 12 months;
  • speaks either English or Spanish.

Exclusion Criteria:

  • has a significant co-morbidity that would preclude participation in classes (e.g., severe cerebral palsy, oxygen dependent conditions)

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

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

Armas e Intervenciones

Grupo de participantes/brazo
Intervención / Tratamiento
Experimental: Asthma in-school class
Provided in 16 15-minute sessions (4 hours total didactic time); scheduled 3 sessions/week. The content is provided by trained asthma educators. The Asthma Plan for Kids (AP-K) is a 7-step curriculum for children to use when responding to asthma symptoms. Skills practice with placebo metered dose inhaler (MDI) and peak expiratory flow (PEF) meters with PEF score interpretation. Topics include (a) identifying lung function, asthma warning signs, symptoms, and triggers; (b) learning skills to manage symptoms, including PEF meter score interpretation, communication with adults (e.g. teachers, coaches, family members), medication use and MDI technique; (c) evaluating asthma symptoms and the effectiveness of management; and (d) discussing how to stay active in a safe manner.
Otros nombres:
  • Asthma Plan for Kids
Experimental: Asthma Day Camp
The asthma day camp is provided in a single day session (5.5 hours total) by trained camp staff. The same skills (i.e., placebo metered dose inhaler (MDI) and peak expiratory flow (PEF) meters) and topics [a) identifying lung function, asthma warning signs, symptoms, and triggers; (b) learning skills to manage symptoms, including PEF meter score interpretation, communication with adults (e.g. teachers, coaches, family members), medication use and MDI technique; (c) evaluating asthma symptoms and the effectiveness of management; and (d) discussing how to stay active in a safe manner] are covered as those in the asthma in-school classes.
Comparador falso: Health Promotion in-school class
The mock comparison follows the in-school format of 16 15-minute sessions; scheduled 3 sessions/week. The content is provided by trained health educators and includes skills practice (i.e., handwashing and brushing teeth) and health promotion topics of nutrition, healthy snacks, preventing colds, and safe exercise.

¿Qué mide el estudio?

Medidas de resultado primarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Absenteeism, End of Study
Periodo de tiempo: 12 months
(Days absent/days enrolled)x100 = absenteeism. Using data provided by the school district at the end of the study year.
12 months
Quality of Life, End of Study
Periodo de tiempo: 12 months
Self reported asthma-related quality of life. Outcome data were collected at end of study (Time 4). The Pediatric Asthma Quality of Life scale. Minimum score 23 to maximum score of 115. A higher score indicates worse quality of life. Mean scale scores are computed.
12 months
Number of Days Hospitalized, During Study Year
Periodo de tiempo: 12 months
Number of days hospitalized for asthma. Data were obtained from parent report at the second, third, and fourth data collection point. The number of hospitalization days were summed for a total number at the end of the 12 months.
12 months
Emergency Department Visits, Study Year
Periodo de tiempo: 12 months
Number of visits to Emergency Department for asthma. Data is obtained from parents at three time points (time 2, 3, and 4) and summed for total number of visits to the emergency department for asthma during the study year.
12 months
Number of Asthma Hospitalizations Pre-Study Year
Periodo de tiempo: 12 months before baseline
Number of times hospitalized for asthma. Data is obtained from parents for the pre-study year for the previous 12 months.
12 months before baseline
Absenteeism Pre-study Year
Periodo de tiempo: 12 months before baseline
(Days absent/days enrolled)x100 = absenteeism. Using data for the 12 months prior to study enrollment as the pre-study year. Data is provided by the participating school districts.
12 months before baseline
Number of Days in Hospital for Asthma, Pre-Study Year
Periodo de tiempo: 12 months before baseline
Number of days hospitalized for asthma. Data is obtained from parents for the pre-study year for the previous 12 months.
12 months before baseline
Number of Asthma Hospital Stays, During Study Year
Periodo de tiempo: 12 months
Number of hospital admissions for asthma. Data were obtained from parent report at the second, third, and fourth data collection point. The number of hospitalizations were summed for a total number at the end of the 12 months.
12 months
Emergency Department Visits, Pre-study Year
Periodo de tiempo: 12 months before baseline
Number of visits to Emergency Department for asthma. Data is obtained from parents for the pre-study year for the previous 12 months.
12 months before baseline
Quality of Life, Pre-study Year
Periodo de tiempo: 12 months before baseline
Self reported asthma-related quality of life. Data were collected at study enrollment (time 1). The Pediatric Asthma Quality of Life scale. Minimum score 23 to maximum score of 115. A higher score indicates worse quality of life. Mean scale scores are computed.
12 months before baseline

Medidas de resultado secundarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Asthma Self-management, Time 4
Periodo de tiempo: Time 4, at 12 months
Child self-report of asthma preventive and management activities, collected at each of 4 time points. This is the Time 4, final measure. Asthma Inventory for Children, 18-item scale, response scale 1-5, minimum score = 18, maximum score = 65, higher score = more frequent asthma self management behaviors.
Time 4, at 12 months
Home Asthma Management, Time 4, End of Study
Periodo de tiempo: Time 4 at 12 months
Parent report of asthma preventive and treatment activities. Data collected at final study visit, Time 4. Home Asthma Management scale, asthma preventive and asthma treatment behaviors performed by parent, response scale 1-5, scale range 16-70, higher scores = more frequent home asthma management behaviors.
Time 4 at 12 months
Metered Dose Inhaler Skill, Time 4
Periodo de tiempo: Time 4 at 12 months
Observation score of child's skill in using a placebo metered dose inhaler (a teaching inhaler). Observation data recorded by trained data collectors. 8-item scale listing the steps to perform proper inhalation technique. Number of correct steps are summed. Higher score = better skill in using inhaler. Collected at final, time 4 data visit.
Time 4 at 12 months
Medication Adherence, Time 4
Periodo de tiempo: Time 4 at 12 months
Parent report of their child remembering/forgetting to take medications. 4-item scale (forgot to take medicine, was careless in taking medicine, stopped taking medicine due to feeling better, stopped taking medicine due to feeling worse), dichotomous response scale (yes, no), sum of number of yes items. Range 0-4, higher score means worse adherence. Data are collected at final data point, Time 4.
Time 4 at 12 months
Asthma Self-management, Time 3
Periodo de tiempo: Time 3 at 9 months
Child self-report of asthma preventive and management activities, collected at each of 4 time points. This is the Time 3 measure. Asthma Inventory for Children, 18-item scale, response scale 1-5, minimum score = 18, maximum score = 65, higher score = more frequent asthma self management behaviors.
Time 3 at 9 months
Asthma Self-management, Time 2
Periodo de tiempo: Time 2 at 5 months
Child self-report of asthma preventive and management activities, collected at each of 4 time points. This is the Time 2 measure. Asthma Inventory for Children, 18-item scale, response scale 1-5, minimum score = 18, maximum score = 65, higher score = more frequent asthma self management behaviors.
Time 2 at 5 months
Asthma Self-management, Time 1, Baseline
Periodo de tiempo: Time 1, baseline
Child self-report of asthma preventive and management activities, collected at each of 4 time points. This is the baseline, Time 1 measure. Asthma Inventory for Children, 18-item scale, response scale 1-5, minimum score = 18, maximum score = 65, higher score = more frequent asthma self management behaviors.
Time 1, baseline
Home Asthma Management, Time 1, Baseline
Periodo de tiempo: Time 1, baseline
Parent report of asthma preventive and treatment activities. Data are collected at study enrollment, Time 1, baseline visit. Home Asthma Management scale, asthma preventive and asthma treatment behaviors performed by parent, response scale 1-5, scale range 16-70, higher scores = more frequent home asthma management behaviors.
Time 1, baseline
Home Asthma Management, Time 2.
Periodo de tiempo: Time 2 at 5 months
Parent report of asthma preventive and treatment activities. Data collected at the time 2 visit. Home Asthma Management scale, asthma preventive and asthma treatment behaviors performed by parent, response scale 1-5, scale range 16-70, higher scores = more frequent home asthma management behaviors.
Time 2 at 5 months
Home Asthma Management, Time 3
Periodo de tiempo: Time 3 at 9 months
Parent report of asthma preventive and treatment activities. Data collected at third time point (Time 3). Home Asthma Management scale, asthma preventive and asthma treatment behaviors performed by parent, response scale 1-5, scale range 16-70, higher scores = more frequent home asthma management behaviors.
Time 3 at 9 months
Metered Dose Inhaler Skill, Time 3
Periodo de tiempo: Time 3 at 9 months
Observation score of child's skill in using a placebo metered dose inhaler (a teaching inhaler). Observation data recorded by trained data collectors. 8-item scale listing the steps to perform proper inhalation technique. Number of correct steps are summed. Higher score = better skill in using inhaler. Collected at time 3 data visit.
Time 3 at 9 months
Metered Dose Inhaler Skill, Time 2
Periodo de tiempo: Time 2 at 5 months
Observation score of child's skill in using a placebo metered dose inhaler (a teaching inhaler). Observation data recorded by trained data collectors. 8-item scale listing the steps to perform proper inhalation technique. Number of correct steps are summed. Higher score = better skill in using inhaler. Collected at final, time 2 data visit.
Time 2 at 5 months
Metered Dose Inhaler Skill, Time 1
Periodo de tiempo: Time 1 at baseline
Observation score of child's skill in using a placebo metered dose inhaler (a teaching inhaler). Observation data recorded by trained data collectors. 8-item scale listing the steps to perform proper inhalation technique. Number of correct steps are summed. Higher score = better skill in using inhaler. Collected at enrollment visit, Time 1 data visit.
Time 1 at baseline
Medication Adherence, Time 1
Periodo de tiempo: Time 1 at baseline
Parent report of their child remembering/forgetting to take medications. 4-item scale (forgot to take medicine, was careless in taking medicine, stopped taking medicine due to feeling better, stopped taking medicine due to feeling worse), dichotomous response scale (yes, no), sum of number of yes items. Range 0-4, higher score means worse adherence. Data are collected at study enrollment, Time 1.
Time 1 at baseline
Medication Adherence, Time 2
Periodo de tiempo: Time 2 at 5 months
Parent report of their child remembering/forgetting to take medications. 4-item scale (forgot to take medicine, was careless in taking medicine, stopped taking medicine due to feeling better, stopped taking medicine due to feeling worse), dichotomous response scale (yes, no), sum of number of yes items. Range 0-4, higher score means worse adherence. Data are collected at Time 2 visit.
Time 2 at 5 months
Medication Adherence, Time 3
Periodo de tiempo: Time 3 at 9 months
Parent report of their child remembering/forgetting to take medications. 4-item scale (forgot to take medicine, was careless in taking medicine, stopped taking medicine due to feeling better, stopped taking medicine due to feeling worse), dichotomous response scale (yes, no), sum of number of yes items. Range 0-4, higher score means worse adherence. Data are collected at Time 3 visit.
Time 3 at 9 months

Otras medidas de resultado

Medida de resultado
Medida Descripción
Periodo de tiempo
Lung Inflammation, Time 4
Periodo de tiempo: Time 4 at 12 months
Exhaled breath condensation collected and sent for lab analysis of NO3. Data collected at Time 4 visit. Higher values represent greater airway inflammation.
Time 4 at 12 months
Lung Inflammation, Time 1
Periodo de tiempo: Time 1 at baseline
Exhaled breath condensation collected and sent for lab analysis of NO3. Data collected at Time 1 visit. Higher values represent greater airway inflammation.
Time 1 at baseline
Lung Inflammation, Time 2
Periodo de tiempo: Time 2 at 5 months
Exhaled breath condensation collected and sent for lab analysis of NO3. Data collected at Time 2 visit. Higher values represent greater airway inflammation.
Time 2 at 5 months
Lung Inflammation, Time 3
Periodo de tiempo: Time 3 at 9 months
Exhaled breath condensation collected and sent for lab analysis of NO3. Data collected at Time 3 visit. Higher values represent greater airway inflammation.
Time 3 at 9 months

Colaboradores e Investigadores

Aquí es donde encontrará personas y organizaciones involucradas en este 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

1 de diciembre de 2008

Finalización primaria (Actual)

1 de septiembre de 2013

Finalización del estudio (Actual)

1 de noviembre de 2014

Fechas de registro del estudio

Enviado por primera vez

24 de agosto de 2012

Primero enviado que cumplió con los criterios de control de calidad

30 de agosto de 2012

Publicado por primera vez (Estimar)

31 de agosto de 2012

Actualizaciones de registros de estudio

Última actualización publicada (Estimar)

24 de abril de 2015

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

2 de abril de 2015

Última verificación

1 de abril de 2015

Más información

Términos relacionados con este estudio

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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