Study for Asthma Education in Primary Schools
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Purpose
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).
| Condition | Intervention | Phase |
|---|---|---|
|
Asthma |
Behavioral: Educational Program Other: Usual Asthma Information for teachers |
Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Single Blind (Subject) Primary Purpose: Treatment |
| Official Title: | Asthma Educational Intervention on Physical Education Teachers in Primary Schools |
- Quality of life [ Time Frame: 6 months ] [ Designated as safety issue: No ]We measure the quality of life through the Pediatric Asthma Quality of Life Questionnaire (Elizabeth Juniper)
- Asthma Control [ Time Frame: 6 months ] [ Designated as safety issue: No ]
- Measurement of attitudes toward asthma [ Time Frame: 6 months ] [ Designated as safety issue: No ]
| Enrollment: | 4506 |
| Study Start Date: | November 2011 |
| Estimated Study Completion Date: | July 2013 |
| Estimated Primary Completion Date: | July 2012 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: Educational Program
Students 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.
|
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. |
|
No Intervention: Asthma information for teachers
Information about asthma the Ministry of Education to all schools in the community.
|
Other: Usual Asthma Information for teachers
Common asthma information for teachers
|
Show Detailed Description Eligibility| Ages Eligible for Study: | 10 Years to 13 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
- Studying in fifth and sixth year of primary education
Exclusion Criteria:
- Intellectual deficit to answer questions.
- Do not to sign the parent informed consent
Contacts and Locations| Spain | |
| Centro de Salud La Candelaria | |
| Sevilla, Andalucía, Spain, 41006 | |
| Universidad Pablo de Olavide | |
| Sevilla, Andalucía, Spain | |
| Principal Investigator: | Manuel Praena-Crespo, PhD | Centro de Salud La Candelaria. Sevilla. Servicio Andaluz de Salud |
More Information
Additional Information:
No publications provided
| Responsible Party: | Manuel Praena-Crespo, MD, Head Researcher Pediatrics, Fundación Pública Andaluza para la gestión de la Investigación en Sevilla |
| ClinicalTrials.gov Identifier: | NCT01607749 History of Changes |
| Other Study ID Numbers: | GESA |
| Study First Received: | November 23, 2011 |
| Last Updated: | June 17, 2012 |
| Health Authority: | Spain: Ethics Committee |
Keywords provided by Fundación Pública Andaluza para la gestión de la Investigación en Sevilla:
|
Asthma Control Quality of life Children Asthma education |
Additional relevant MeSH terms:
|
Asthma Bronchial Diseases Respiratory Tract Diseases Lung Diseases, Obstructive Lung Diseases |
Respiratory Hypersensitivity Hypersensitivity, Immediate Hypersensitivity Immune System Diseases |
ClinicalTrials.gov processed this record on May 23, 2013