Asthma Educational Intervention on Physical Education Teachers in Primary Schools
试验速览
- 阶段
- 3 期
- 入组人数
- 4,506
- 试验地点
- 2
- 主要终点
- Asthma Control
研究概览
简要总结
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).
详细描述
DESIGN. Single-blind clinical trial with random allocation to the group receiving educational intervention and control group, developed throughout the school year (September 2011 to May 2012). The unit of randomization will be the schools to avoid intracenter contamination of the students during the educational intervention. The units of analysis are the students of schools FIELD OF STUDY. Students aged 10 and 13 years old attending school and Primary Education (CEIP) in Andalusia, a world population of 38,829 students from a total of 728 CEIP. The schools will be recruited through AVERROES tool of the Ministry of Education of the Andalusia
Sample size:
To achieve a power of 90.0% to detect differences in the contrast of the null hypothesis H ₀: μ ₀ = μ ₀ by t-Student test bilaterally for two independent samples, considering that the significance level is 5%, and assuming a mean difference to the quality of life questionnaire between groups of 0.5 and the common standard deviation is 1.10 units, with estimated losses of 15% is necessary to include 129 units in the experimental group Reference and 129 units in the Experimental group, totaling 258 experimental units in the study. Since the prevalence of asthma is approximately 10% in our population, we need to include a total of 2580 students, for a total of 258 students with asthma and other students will be students without asthma who get the outcome measures and compare your average asthma knowledge and attitudes to asthma of all students involved in the study and teaching centers.
INVITATION TO PARTICIPATE:
CEIP will be chosen by randomization by computer, which will be offered to participate. One of the researchers contacted the directors and teachers of Physical Education (MEF) of the sites, explaining the purpose of the study. Upon acceptance to participate, seek the approval of the School Councils to inform parents of students about the study, again requesting consent for their children's participation in the trial.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 10 Years 至 13 Years（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Studying in fifth and sixth year of primary education
排除标准
- •Intellectual deficit to answer questions.
- •Do not to sign the parent informed consent
研究组 & 干预措施
Asthma information for teachers
Information about asthma the Ministry of Education to all schools in the community.
干预措施: Usual Asthma Information for teachers (Other)
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.
干预措施: Educational Program (Behavioral)
结局指标
主要结局
Asthma Control
时间窗: 6 months
Quality of life
时间窗: 6 months
We measure the quality of life through the Pediatric Asthma Quality of Life Questionnaire (Elizabeth Juniper)
次要结局
- Measurement of attitudes toward asthma(6 months)
研究者
Manuel Praena-Crespo
MD, Head Researcher Pediatrics
Fundación Pública Andaluza para la gestión de la Investigación en Sevilla