- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico NCT00233181
Adherence Intervention for Minority Children With Asthma
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
Descripción detallada
BACKGROUND:
While increased asthma morbidity and mortality have been observed across all ethnicities, results from several studies have found that asthma morbidity has increased disproportionately in low-income African American children. Elementary school-based asthma education programs have shown promise in improving asthma management, and reducing asthma morbidity in this high-risk population, however, the fastest growing asthma risk is associated with children young than six. By elementary age many parents and children with asthma have well-established patterns of inappropriate asthma management that may be difficult to change. To date, no research has examined the impact of early intervention for asthma management in low-income, high-risk children.
DESIGN NARRATIVE:
The primary outcome that the study was designed to evaluate medical record documented emergency care for asthma at the JHPED over the eighteen-month follow-up period.
The secondary outcomes Adherence with asthma therapy based on Medicaid pharmacy claims for asthma medications, other asthma health care (urgent and primary), self-reported medication adherence, barriers to health care, restricted activity, nighttime symptoms, asthma medications, self and family asthma management behaviors, asthma management self-efficacy, functional status, and quality of life.
The study completion date listed in this record was obtained from the "End Date" entered in the Protocol Registration and Results System (PRS) record.
Tipo de estudio
Fase
- No aplica
Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
Acepta Voluntarios Saludables
Géneros elegibles para el estudio
Descripción
- Age 2-12 years.
- A current diagnosis of asthma or reactive airway disease
- Resident of Baltimore City.
- Two or more ED visits at the JHPED for asthma in the past 12 months, or hospitalization for asthma at the JHPED in the past 12 months by parent report.
- Not currently participating in other research studies (participation in previous studies will be noted).
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Tratamiento
- Asignación: Aleatorizado
Colaboradores e Investigadores
Patrocinador
Investigadores
- Cynthia Rand, Johns Hopkins University
Publicaciones y enlaces útiles
Publicaciones Generales
- Paasche-Orlow MK, Riekert KA, Bilderback A, Chanmugam A, Hill P, Rand CS, Brancati FL, Krishnan JA. Tailored education may reduce health literacy disparities in asthma self-management. Am J Respir Crit Care Med. 2005 Oct 15;172(8):980-6. doi: 10.1164/rccm.200409-1291OC. Epub 2005 Aug 4.
- Otsuki M, Eakin MN, Rand CS, Butz AM, Hsu VD, Zuckerman IH, Ogborn J, Bilderback A, Riekert KA. Adherence feedback to improve asthma outcomes among inner-city children: a randomized trial. Pediatrics. 2009 Dec;124(6):1513-21. doi: 10.1542/peds.2008-2961.
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio
Finalización del estudio (Actual)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Estimar)
Actualizaciones de registros de estudio
Última actualización publicada (Estimar)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- 298
- R01HL052013 (Subvención/contrato del NIH de EE. UU.)
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