Study for Asthma Education in Primary Schools

The recruitment status of this study is unknown because the information has not been verified recently.
Verified June 2012 by Fundación Pública Andaluza para la gestión de la Investigación en Sevilla.
Recruitment status was  Active, not recruiting
Sponsor:
Information provided by (Responsible Party):
Manuel Praena-Crespo, Fundación Pública Andaluza para la gestión de la Investigación en Sevilla
ClinicalTrials.gov Identifier:
NCT01607749
First received: November 23, 2011
Last updated: June 17, 2012
Last verified: June 2012
  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

Resource links provided by NLM:


Further study details as provided by Fundación Pública Andaluza para la gestión de la Investigación en Sevilla:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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
Criteria

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01607749

Locations
Spain
Centro de Salud La Candelaria
Sevilla, Andalucía, Spain, 41006
Universidad Pablo de Olavide
Sevilla, Andalucía, Spain
Sponsors and Collaborators
Fundación Pública Andaluza para la gestión de la Investigación en Sevilla
Investigators
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 October 19, 2014