School-Based Preventive Asthma Care Technology: A Trial Using a Novel Technology to Improve Adherence (SB-PACT)
31 de diciembre de 2013 actualizado por: Jill Halterman, University of Rochester
School-Based Preventive Asthma Care Technology: A Randomized Control Trial Using a Novel Technology to Improve Adherence
The goal of this new translational project is to test the feasibility and effectiveness of implementing school-based directly observed therapy of preventive asthma medications in a real-world setting, using state-of-the-art web-based technology for systematic screening, electronic report generation, and communication between nurses, caregivers, and primary care providers.
With the use of a novel method to improve adherence and subsequently reduce morbidity, the investigators hypothesize that this novel adaptation of school-based asthma care will; 1) be feasible and acceptable among this population and among school and community stakeholders, and 2) yield reduced asthma morbidity (symptom-free days, absenteeism, and emergency room / urgent care use for asthma care).
The investigators anticipate that enhancing preventive healthcare for young urban children with asthma through partnerships with the schools using a novel technology will yield improved health, prevention of suffering, decreased absenteeism from school, and reduced healthcare costs.
Descripción general del estudio
Tipo de estudio
Intervencionista
Inscripción (Actual)
99
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
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New York
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Rochester, New York, Estados Unidos, 14642
- Univeristy of Rochester
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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 10 años (Niño)
Acepta Voluntarios Saludables
No
Géneros elegibles para el estudio
Todos
Descripción
Inclusion Criteria (all 4 criteria must be met):
- Physician-diagnosed asthma (based on parent report).
Persistent asthma (criteria based on NHLBI guidelines). Any 1 of the following:
- An average of >2 days per week with asthma symptoms
- >2 days per week with rescue medication use
- >2 days per month with nighttime symptoms
- ≥2 episodes of asthma during the past year that have required systemic corticosteroids
- Age ≥3 and ≤10 years.
- Attending school in participating Rochester City School District preschools or elementary schools.
Exclusion Criteria:
- Inability to speak and understand English. (*Parents unable to read will be eligible, and all instruments will be given verbally.)
- No access to a working phone for follow-up surveys (either at the subject's home or an easily accessible alternate phone number).
- Family planning to leave the school district within fewer than 6 months.
- The child having other significant medical conditions, including congenital heart disease, cystic fibrosis, or other chronic lung disease, that could interfere with the assessment of asthma-related measures.
- Children in foster care or other situations in which consent cannot be obtained from a guardian.
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 |
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Experimental: School-Based Medication Group
For children assigned to the School-Based Medication group, an asthma coordinator will send the child's primary care physician a report indicating the child's asthma symptoms, and will recommend that the child receive a preventive asthma medication at school.
If the child's doctor agrees, the preventive asthma medication will be delivered to the child's school and to his/her home by a local pharmacy.
The child's school nurse will begin directly observed therapy of the preventive asthma medication at school, and will routinely assess the child's asthma symptoms throughout the school year.
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For children assigned to the School-Based Medication group, an asthma coordinator will send the child's primary care physician a report indicating the child's asthma symptoms, and will recommend that the child receive a preventive asthma medication at school.
If the child's doctor agrees, the preventive asthma medication will be delivered to the child's school and to his/her home by a local pharmacy.
The child's school nurse begin directly observed therapy of the preventive asthma medication at school, and will routinely assess the child's asthma symptoms throughout the school year.
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Sin intervención: Usual Care Group
Children in the Usual Care group will not receive preventive medications delivered at school.
These children will continue to receive all of their asthma care from their parents and primary care physicians.
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Average Number of Symptom-free Days Over 14 Days; (Symptom-free Days Are Averaged Over 4 Bi-monthly Follow-ups)
Periodo de tiempo: Average number of days, over 2 weeks, throughout the school year
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The primary outcome is asthma morbidity between groups.
We will measure asthma morbidity by looking at the average number of symptom-free days, over 2 weeks, at each bi-monthly follow-up time point over the school year.
Number of days without asthma symptoms will be reported by the child's caregiver.
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Average number of days, over 2 weeks, throughout the school year
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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Cost Effectiveness
Periodo de tiempo: one year
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We will evaluate the cost effectiveness to implement and sustain the web-based system in schools.
We will review the cost of the intervention using three main categories of costs; programmatic costs (costs of initiating and running the program), productivity costs, and medical costs estimated at the individual child level.
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one year
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Feasibility and Acceptability
Periodo de tiempo: one year
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We will conduct interviews with parents and school nurses to evaluate whether this new program is feasible and acceptable among this population.
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one year
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Colaboradores e Investigadores
Aquí es donde encontrará personas y organizaciones involucradas en este estudio.
Patrocinador
Colaboradores
Investigadores
- Investigador principal: Jill S. Halterman, MD, MPH, University of Rochester
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.
Publicaciones Generales
- Halterman JS, Sauer J, Fagnano M, Montes G, Fisher S, Tremblay P, Tajon R, Butz A. Working toward a sustainable system of asthma care: development of the School-Based Preventive Asthma Care Technology (SB-PACT) trial. J Asthma. 2012 May;49(4):395-400. doi: 10.3109/02770903.2012.669441. Epub 2012 Mar 28.
- Halterman JS, Fagnano M, Montes G, Fisher S, Tremblay P, Tajon R, Sauer J, Butz A. The school-based preventive asthma care trial: results of a pilot study. J Pediatr. 2012 Dec;161(6):1109-15. doi: 10.1016/j.jpeds.2012.05.059. Epub 2012 Jul 10.
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 agosto de 2010
Finalización primaria (Actual)
1 de agosto de 2011
Finalización del estudio (Actual)
1 de agosto de 2012
Fechas de registro del estudio
Enviado por primera vez
16 de abril de 2010
Primero enviado que cumplió con los criterios de control de calidad
3 de agosto de 2010
Publicado por primera vez (Estimar)
4 de agosto de 2010
Actualizaciones de registros de estudio
Última actualización publicada (Estimar)
17 de febrero de 2014
Última actualización enviada que cumplió con los criterios de control de calidad
31 de diciembre de 2013
Última verificación
1 de diciembre de 2013
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- 32479
- 1RC1HL099432-01 (Subvención/contrato del NIH de EE. UU.)
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