Efficacy of Educational Intervention for Parents of Children With Asthma
31 de octubre de 2013 actualizado por: Blanca Nohemí Zamora Mendoza, Universidad Autonoma de San Luis Potosí
Efficacy of Educational Intervention for Parents of Children With Asthma in 4-11 Years and Their Impact on the Control Children as Measured by ACT. Randomized Controlled Clinical
Introduction.
Asthma is a chronic inflammatory disorder of the airways, identified by airflow obstruction.
Unfortunately only 2.4% of American asthmatics meet internationally recommended criteria for control.
The lack of knowledge in parents of asthmatic children has been a direct result of minimum or no control at all, so the educational programs need to be assessed in terms of improvement of the control.
Target.
To determine whether an educational intervention aimed at parents of asthmatic children 4 to 11 years improved clinical control measured by Test Childhood Asthma Control.
Material and Methods.
Randomized controlled clinical trial in 42 patients randomly divided into two groups that were evaluated in the same time knowledge and control of asthma, a measurement was performed at baseline and monthly for nine months.
The experimental group attended an educational intervention for individual reinforcements through this period, the control group was only monitored
Descripción general del estudio
Estado
Terminado
Condiciones
Intervención / Tratamiento
Descripción detallada
- Recruitment of patients that attended hospital's emergency gate due to asthma issues, and phone calls to regular physicians patients.
- Once recruited all parents of patients were asked to participate in the study where their children will be evaluated on an asthma control and asked informed consent
- The clinical history, spirometry and / or basal peak flow Diagnostic concordance
- With the collected data was performed a database clinical history, ACT score, FEV1 and PEF, results of each patient and personal data for future location, the base was used for the concordance of diagnosis.
- Once the sample that met the selection criteria were formed experimental and control groups at random using "R Project Statistical Computing" 2.12.2 version performed by the statistical
- The experimental group was invited to participate in educational sessions two hours at week in just one month and monthly individual reinforcements through the evaluation period.
- Educational sessions were based on the Global Initiative for Asthma (GINA), Guía Española para el Manejo del Asma (GEMA) And Concenso Mexicano de Asma.
- Those measurements were performed by an external partner or educators or the attending physician performed to avoid biased results.
The monthly ACT and peak flow of the attending physician were blinded
variables:
- educational intervention, with and without intervention
- asthma control: measured by infant ACT
- time: 0 to 9 months
- sex: female or male
- Age: 4 to 11 years
Tipo de estudio
Intervencionista
Inscripción (Actual)
42
Fase
- No aplica
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
4 años a 11 años (Niño)
Acepta Voluntarios Saludables
No
Géneros elegibles para el estudio
Todos
Descripción
Eligibility Criteria
- Children 4-11 years with diagnosed asthma with parents attending the outpatient pediatric pneumology and pediatric emergency because of acute asthma in General Hospital de Soledad.
- Patients with a baseline score less than 27 points in childhood ACT
- Patients with Government Health Insurance. (to ensure access to medication and medical care)
- Parents who can read and write
- Parents willing and able to participate
- Parents who do not belong or have been part of an educational program on asthma by asthma clinic.
Exclusion Criteria
- Parents with children having other comorbidities that prevent or hinder proper control of asthma, such as Cerebral Palsy, (PCI) psychomotor retardation, psychiatric Sd. Down, congenital malformations, which alter the chest wall, obesity, nasal polyp.
Elimination criteria
- Parents who fail to attend 50% of the sessions given (since it does not allow parents to acquire sufficient knowledge to significantly improve the control of asthma as GEMA educational guidance)
- Patients and parents who decide not to continue in the project.
- Patients who develop pulmonary comorbidities over a month of evolution and lung tissue affecting significantly, as syncytial respiratory virus, pneumonia, tuberculosis, and asthma control difficulties.
- Patients who leave or do not take the prescribed treatment by physician for a month.
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: Doble
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
|
Sin intervención: treatment and routine counseling
Parents attend regular consultation and receive regular medical guidance
|
educational sessions once a week two hours for a month and later educational reinforcement and monitoring asthma control monthly for nine months
Otros nombres:
|
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Periodo de tiempo |
|---|---|
|
asthma control
Periodo de tiempo: 9 months
|
9 months
|
Colaboradores e Investigadores
Aquí es donde encontrará personas y organizaciones involucradas en este estudio.
Patrocinador
Colaboradores
Investigadores
- Investigador principal: Blanca ZM master, Universidad Autónoma de San Luis Potosí México
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 febrero de 2012
Finalización primaria (Actual)
1 de octubre de 2012
Finalización del estudio (Actual)
1 de octubre de 2013
Fechas de registro del estudio
Enviado por primera vez
30 de mayo de 2013
Primero enviado que cumplió con los criterios de control de calidad
31 de octubre de 2013
Publicado por primera vez (Estimar)
8 de noviembre de 2013
Actualizaciones de registros de estudio
Última actualización publicada (Estimar)
8 de noviembre de 2013
Última actualización enviada que cumplió con los criterios de control de calidad
31 de octubre de 2013
Última verificación
1 de octubre de 2013
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- A-001
- UASLP-001 (Identificador de registro: UASLP-001)
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