Efficacy of Educational Intervention for Parents of Children With Asthma

Asthma Clinical Trial

Official title: 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

Status Completed

Clinical Trial Summary

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

Clinical Trial Description

• 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 ;

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Caregiver, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Asthma

• NCT number: NCT01979224
• Study type: Interventional
• Source: Universidad Autonoma de San Luis Potosí
• Status: Completed
• Phase: N/A
• Start date: February 2012
• Completion date: October 2013