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Evaluation of the Delay in Asthma Diagnosis in Children From the Lodz Region

6 de febrero de 2013 actualizado por: Iwona Stelmach, Medical University of Lodz

Evaluation of the Delay in Asthma Diagnosis in Children From the Lodz Region After the Program for Prevention of Allergic Diseases

The aim of the research is to assess the duration of a delay in asthma diagnosis in children after the Program for Prevention of Allergic Diseases. Risk factors for delayed diagnosis of asthma in children will also be assessed. This study will answer the question of whether this ratio depends on the time, which indirectly proves that it can be changed by local intervention programs. Prove lasting effects of the Program may contribute to planning further local interventions focused on improving medical care for patients with bronchial asthma in the Lodz region, and reduce social costs associated with this disease.

Descripción general del estudio

Estado

Terminado

Condiciones

Descripción detallada

The object of this study is asthma, the most common chronic childhood disease. The disease has become epidemic in developed countries and also in Poland. The percentage of children suffering from bronchial asthma in Lodz is one of the highest in the country (8.5%. Bronchial asthma in children of Lodz is a real challenge not only for doctors but also for public health professionals. This study is to assess the long-term effects of innovation on a national scale Prevention Program of Allergic Diseases, which was carried out in 2000-2003 in the region of Lodz. This Program has given many positive effects, most of all, improvement in the diagnosis of allergic diseases, availability of medical specialists and reduction the number of hospitalizations because of the disease exacerbation.

The aim of the research is to assess the duration of a delay in asthma diagnosis in children after the Program for Prevention of Allergic Diseases. Risk factors for delayed diagnosis of asthma in children will also be assessed. This study will answer the question of whether this ratio depends on the time, which indirectly proves that it can be changed by local intervention programs. Prove lasting effects of the Program may contribute to planning further local interventions focused on improving medical care for patients with bronchial asthma in the Lodz region, and reduce social costs associated with this disease.

Subject of study are patients under 18 age, with newly diagnosed asthma, who were under care in Allergy Clinic in Copernicus Hospital in Lodz in 2004-2009. Selected clinic is the largest pediatric allergy center in the region and was also the largest center participating in the Program for Prevention of Allergic Diseases and the only center, which analyzed the delay in asthma diagnosis among patients. Children's medical documentation will be analyzed as far as following data were concerned: demographic data, anthropometric parameters, information about family history of atopic diseases, asthma symptoms (cough, dyspnoea, wheezing, reducing physical activity, and recurrent respiratory infections) and symptoms of other atopic diseases in both the current and in the past. In addition, information will be collected on the child's family situation, housing conditions and the presence of animals in the house. Data obtained from the children's medical documentation will be supplemented by telephone interview conducted with parents of the child. The group of patients with underdiagnosed asthma will be classified as children who experienced frequent wheezing (at least 4 episodes per year) and 1 major criterium (positive family history of allergic diseases or symptoms of atopic as infants) or two smaller criteria (symptoms of food allergies, the increased number of eosinophilic cells in the peripheral blood or wheezing without infection). For each child the time from appearance of asthma symptoms (according to the API - asthma predictive index) to diagnose the disease by a specialist will be set. This time will be defined as duration of undiagnosed asthma. Due to the fact that the delay in asthma diagnosis is dependent on the patient's age, the analysis will be carried out in four groups separated on the basis of the upper and lower quartiles of respondents age.

Tipo de estudio

De observación

Inscripción (Actual)

907

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

      • Lodz, Polonia, 93-513
        • Department of Social and Preventive Medicine, Medical University of Lodz, Poland, Department of Pediatrics and Allergy, N. Copernicus Hospital, Medical University of Lodz, Poland

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 18 años (Niño, Adulto)

Acepta Voluntarios Saludables

No

Géneros elegibles para el estudio

Todos

Método de muestreo

Muestra de probabilidad

Población de estudio

patients under 18 age, with newly diagnosed asthma,

Descripción

Inclusion Criteria:

  • patients under 18 age, with newly diagnosed asthma

Exclusion Criteria:

  • patients under 18 age, without newly diagnosed asthma

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

  • Modelos observacionales: Grupo
  • Perspectivas temporales: Retrospectivo

Cohortes e Intervenciones

Grupo / Cohorte
Intervención / Tratamiento
asthmatic children
patients under 18 age, with newly diagnosed asthma
medical documentation analysis supplemented by telephone interview conducted with parents of the child

¿Qué mide el estudio?

Medidas de resultado primarias

Medida de resultado
Medida Descripción
Periodo de tiempo
duration of a delay in asthma diagnosis in children
Periodo de tiempo: 5 years
The duration of a delay in asthma diagnosis in children after the Program for Prevention of Allergic Diseases
5 years

Colaboradores e Investigadores

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

Investigadores

  • Silla de estudio: Włodzimierz Stelmach, MD, PhD, Department of Social and Preventive Medicine, Medical University of Lodz, Poland
  • Director de estudio: Iwona Stelmach, MD,PhD,Prof., Department of Pediatrics and Allergy, N. Copernicus Hospital, Medical University of Lodz, Poland
  • Investigador principal: Ewa Bąk, Master of Sc, Department of Social and Preventive Medicine, Medical University of Lodz, Poland

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 marzo de 2010

Finalización primaria (Actual)

1 de febrero de 2011

Finalización del estudio (Actual)

1 de febrero de 2011

Fechas de registro del estudio

Enviado por primera vez

9 de marzo de 2010

Primero enviado que cumplió con los criterios de control de calidad

9 de marzo de 2010

Publicado por primera vez (Estimar)

10 de marzo de 2010

Actualizaciones de registros de estudio

Última actualización publicada (Estimar)

7 de febrero de 2013

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

6 de febrero de 2013

Última verificación

1 de febrero de 2013

Más información

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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