Study for Asthma Education in Primary Schools
NCT01607749 · Status: UNKNOWN · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 4506
Last updated 2012-06-19
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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