Study for Asthma Education in Primary Schools
Asthma Educational Intervention on Physical Education Teachers in Primary Schools
1 other identifier
interventional
4,506
1 country
2
Brief 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).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3 asthma
Started Nov 2011
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
November 1, 2011
CompletedFirst Submitted
Initial submission to the registry
November 23, 2011
CompletedFirst Posted
Study publicly available on registry
May 30, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2012
CompletedStudy Completion
Last participant's last visit for all outcomes
July 1, 2013
CompletedJune 19, 2012
June 1, 2012
8 months
November 23, 2011
June 17, 2012
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Quality of life
We measure the quality of life through the Pediatric Asthma Quality of Life Questionnaire (Elizabeth Juniper)
6 months
Asthma Control
6 months
Secondary Outcomes (1)
Measurement of attitudes toward asthma
6 months
Study Arms (2)
Educational Program
EXPERIMENTALStudents in the intervention schools learn the educational program "Asthma, Sport and Health" in three sessions during a period of 6 weeks. The content of the educational program has been published elsewhere.
Asthma information for teachers
NO INTERVENTIONInformation about asthma the Ministry of Education to all schools in the community.
Interventions
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.
Common asthma information for teachers
Eligibility Criteria
You may qualify if:
- Studying in fifth and sixth year of primary education
You may not qualify if:
- Intellectual deficit to answer questions.
- Do not to sign the parent informed consent
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (2)
Centro de Salud La Candelaria
Seville, Andalusia, 41006, Spain
Universidad Pablo de Olavide
Seville, Andalusia, Spain
Related Publications (1)
Praena-Crespo M, Aquino-Llinares N, Fernandez-Truan JC, Castro-Gomez L, Segovia-Ferrera C; GESA network. Asthma education taught by physical education teachers at grade schools: A randomised cluster trial. Allergol Immunopathol (Madr). 2017 Jul-Aug;45(4):375-386. doi: 10.1016/j.aller.2016.10.022. Epub 2017 Mar 18.
PMID: 28318759DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Manuel Praena-Crespo, PhD
Centro de Salud La Candelaria. Sevilla. Servicio Andaluz de Salud
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- MD, Head Researcher Pediatrics
Study Record Dates
First Submitted
November 23, 2011
First Posted
May 30, 2012
Study Start
November 1, 2011
Primary Completion
July 1, 2012
Study Completion
July 1, 2013
Last Updated
June 19, 2012
Record last verified: 2012-06