Efficacy of Educational Intervention for Parents of Children With Asthma
31 octobre 2013 mis à jour par: 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
Aperçu de l'étude
Statut
Complété
Les conditions
Intervention / Traitement
Description détaillée
- 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
Type d'étude
Interventionnel
Inscription (Réel)
42
Phase
- N'est pas applicable
Critères de participation
Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.
Critère d'éligibilité
Âges éligibles pour étudier
4 ans à 11 ans (Enfant)
Accepte les volontaires sains
Non
Sexes éligibles pour l'étude
Tout
La description
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 d'étude
Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: Traitement
- Répartition: Randomisé
- Modèle interventionnel: Affectation parallèle
- Masquage: Double
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
|---|---|
|
Aucune intervention: 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
Autres noms:
|
Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Délai |
|---|---|
|
asthma control
Délai: 9 months
|
9 months
|
Collaborateurs et enquêteurs
C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.
Parrainer
Collaborateurs
Les enquêteurs
- Chercheur principal: Blanca ZM master, Universidad Autónoma de San Luis Potosí México
Dates d'enregistrement des études
Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.
Dates principales de l'étude
Début de l'étude
1 février 2012
Achèvement primaire (Réel)
1 octobre 2012
Achèvement de l'étude (Réel)
1 octobre 2013
Dates d'inscription aux études
Première soumission
30 mai 2013
Première soumission répondant aux critères de contrôle qualité
31 octobre 2013
Première publication (Estimation)
8 novembre 2013
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Estimation)
8 novembre 2013
Dernière mise à jour soumise répondant aux critères de contrôle qualité
31 octobre 2013
Dernière vérification
1 octobre 2013
Plus d'information
Termes liés à cette étude
Termes MeSH pertinents supplémentaires
Autres numéros d'identification d'étude
- A-001
- UASLP-001 (Identificateur de registre: UASLP-001)
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