Symptom Clusters in Children With Exacerbation-prone Asthma
Palabras clave
Abstracto
Descripción
Asthma symptom control is suboptimal in the majority of children in the United States, despite widespread availability of asthma controller medications and standardized treatment guidelines. While deaths from asthma have declined, 53.7% of children with asthma continue to experience an exacerbation each year and the associated public health burden is substantial.
While the factors responsible for poor asthma symptom control are complex and include limited access to care, poor adherence to preventative asthma medications, and exposures to environmental allergens and irritants such as tobacco smoke, it is also recognized that children with exacerbation-prone asthma are a heterogeneous group with differing clinical outcomes and longitudinal disease trajectories. Symptoms (defined as subjective sensations) can also be quite varied within and among affected children. Whereas some children have persistent, troublesome respiratory symptoms, others have respiratory symptoms only with upper respiratory infections. Mental health symptoms and social health symptoms have been inadequately characterized in this population, but some children with asthma also report depression and anxiety and impaired family functioning and relationships that may further worsen asthma outcomes. However, prior studies are limited by a narrow focus on individual symptoms in isolation. To date, there has been no attempt to identify symptom clusters (defined as two or more concurrent symptoms independent of other clusters) in children with exacerbation-prone asthma.
Poor understanding of symptom clusters is a major shortcoming in asthma symptom science. In other chronic disorders such as cancer, compared with a single symptom, symptom clusters of pain, fatigue, sleep disturbance and mood disturbance significantly worsen patient-reported outcomes of functional status and quality of life. There is also emerging evidence that interventions for one symptom within a cluster (i.e., cognitive-behavioral therapy for pain) reduce the severity of other symptoms within that cluster (i.e., fatigue and sleep disturbance). Because children with exacerbation-prone asthma rarely report a single symptom, greater knowledge of the assessment (and ultimately management) of symptom clusters in these children has the potential to significantly improve individualized treatment and clinical outcomes.
The researchers here propose a 48-week cohort study (N=173) to test the overarching hypothesis that symptom clusters and their associated inflammatory and metabolic pathways predict corticosteroid treatment responsiveness (primary objective outcome) and quality of life (patient-reported secondary outcome) in children 8-17 years with exacerbation-prone asthma.
fechas
Verificado por última vez: | 11/30/2019 |
Primero enviado: | 06/26/2019 |
Inscripción estimada enviada: | 06/26/2019 |
Publicado por primera vez: | 06/27/2019 |
Última actualización enviada: | 12/10/2019 |
Última actualización publicada: | 12/11/2019 |
Fecha de inicio real del estudio: | 11/12/2019 |
Fecha estimada de finalización primaria: | 05/31/2024 |
Fecha estimada de finalización del estudio: | 05/31/2024 |
Condición o enfermedad
Intervención / tratamiento
Drug: Children receiving triamcinolone acetonide
Fase
Grupos de brazos
Brazo | Intervención / tratamiento |
---|---|
Experimental: Children receiving triamcinolone acetonide Pediatric participants with exacerbation-prone asthma will receive an intramuscular injection of triamcinolone acetonide and will be followed for 48 weeks. | Drug: Children receiving triamcinolone acetonide An intramuscular injection of triamcinolone acetonide (1 mg/kg, up to 40 mg maximum) will be administered deep in the gluteal muscle by a trained registered nurse. |
Criterio de elegibilidad
Edades elegibles para estudiar | 8 Years A 8 Years |
Sexos elegibles para estudiar | All |
Acepta voluntarios saludables | si |
Criterios | Inclusion Criteria: - Age 8 to less than 18 years at the enrollment visit - Physician diagnosis of asthma - History of an asthma exacerbation treated with systemic corticosteroids in the previous 12 months Exclusion Criteria: - Previous allergic reaction to systemic corticosteroids - Hepatic, biliary, or renal disease that can interfere with drug metabolism/excretion - Chronic medical disorders that may increase the risk of drug-related injury, including osteogenesis imperfecta (increased risk of fracture with corticosteroids), or Crohn's disease, ulcerative colitis, juvenile rheumatoid arthritis, clotting disorders, or Factor deficiency (increased risk of bleeding with corticosteroid therapy) - Pregnancy - Current smoking - Congenital disorders or deformities of the chest wall, lungs or airways - History of premature birth <35 weeks gestation - Unwillingness to receive triamcinolone - Planning to relocate before study completion |
Salir
Medidas de resultado primarias
1. Change in Asthma Control Questionnaire (ACQ) Score [Baseline, Week 2]
Medidas de resultado secundarias
1. Patient-Reported Outcomes Measurement Information System (PROMIS) Pediatric Asthma Impact Scale (PAIS) [Weeks 16, 32, and 48]