Study for Asthma Education in Primary Schools

NCT01607749 · Status: UNKNOWN · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 4506

Last updated 2012-06-19

No results posted yet for this study

Summary

Undertake a study of educational intervention in primary schools in Andalusia

HYPOTHESIS:

There are differences in quality of life associated with asthma (as measured by the questionnaire PAQLQ) and the level of asthma control in students with asthma aged 11 and 12 years who receive an educational intervention with their peers without asthma versus those receiving standard information in schools.

OBJECTIVES: To compare the control of asthma symptoms, quality of life in asthma and asthma knowledge among a group receiving an educational intervention delivered by specialist teachers of physical education (MEEF) in Primary Schools (CEIP) and control.

MÉTODOS group: Randomized controlled single-blind.

POPULATION: Students of 11 and 12 years old in Andalusia

Sample size: 258 children / children with asthma for a mean contrast (alpha error of 3.4%. 80% power, a confidence level of 95% considering 20% loss. 2580 students will be enrolled prevalence of asthma 10%) . Conglomerates of the CEIP in urban, rural, public and private-reached.

INTERVENTION: Training MEEF with the educational program "Sports and Health Asthma and subsequent delivery, then the students MEEF are 5th and 6th grade ( 3 sessions). CONTROL: The standard instruction in schools. OUTCOME VARIABLES: Quality of life (Juniper) and "control del asthma en niños"(CAN) in asthmatics, Knowledge (NAKQ questionnaire) and attitudes toward asthma (all students and teachers). Pre-intervention (T0), post-intervention at 5-6 months (T1)

Independent variables: Sex, suffering or not asthma, intervention / control, type CEIP.

STATISTICAL ANALYSIS: Comparison of continuous variables: T Students (If normal distribution) "Mann-Whitney (If non-normal distribution). To study qualitative variables chi-square test (normal distribution) and Kruskal-Wallis ( no-normal distribution).

Conditions

Interventions

BEHAVIORAL

Educational Program

Schools in the intervention group received the educational program "Asthma, Sport and Health", as validated by our group. This program will be taught to students in three lessons with equipment designed and developed by the research group to be taught within the curriculum of physical education subject. Teachers of physical education specialists responsible for the project at each center will receive the training curriculum for use in a training seminar for a school day by researchers from the health of our group. Once familiar with the educational package of three sessions taught his students and fellow faculty (on different days for teachers and students) within 15-30 days.

OTHER

Usual Asthma Information for teachers

Common asthma information for teachers

Sponsors & Collaborators

  • Fundación Pública Andaluza para la gestión de la Investigación en Sevilla

    lead OTHER

Principal Investigators

  • Manuel Praena-Crespo, PhD · Centro de Salud La Candelaria. Sevilla. Servicio Andaluz de Salud

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
10 Years
Max Age
13 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2011-11-30
Primary Completion
2012-07-31
Completion
2013-07-31

Countries

  • Spain

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01607749 on ClinicalTrials.gov