Comparison of School-Based Supervised Versus Parental Supervised Asthma Therapy
Condition: Asthma
MeSH terms: Asthma
Study type: Interventional

Summary: 
      1. Develop a simple school-based intervention using school-based supervised asthma therapy
           to increase adherence to asthma medication.

        2. Implement a school-based internet monitoring system within both the school-based
           supervised asthma therapy and parent supervised asthma therapy groups to record asthma
           symptoms, peak flow meter readings, school absences, and usage of rescue medications at
           school.

        3. Randomly assign 250 children from inner-city school systems to either school-based
           supervised asthma therapy or parental supervised asthma therapy.

        4. Compare children assigned to school-based supervised asthma therapy with children
           assigned to parent supervised asthma therapy, in regards to time-averaged proportion
           having at least one exacerbation per month, rescue medication use, peak flow meter
           readings, asthma symptoms, school absences, and asthma self-management knowledge.
    

Detailed description: 
      BACKGROUND:

      Pediatric asthma is a well-documented public health issue in the United States. The impact of
      pediatric asthma can be measured by both health care costs and morbidity. Whereas many
      factors contribute to the high health care costs of asthma, much of the morbidity can be
      directly attributed to lack of adherence to medical treatments. The consequence of
      non-adherence for most individuals with ashtma is exacerbations. Greater numbers of
      exacerbations lead to increased school absenteeism, greater activity limitations, decreased
      quality of life for both parent and child, increased urgent health care use and costs, and
      increased parental days missed at work. Therefore, adherence to treatment is essential for
      proper asthma management and ultimate reductions in morbidity.

      Asthma morbidity, as measured by the number of exacerbations, is largely preventable with
      patient education and optimal treatment. However, it has been demonstrated that patient
      education alone is insufficient to decrease asthma morbidity. Optimal treatment is essential
      to control asthma morbidity. Inhaled corticosteroids offer considerable protection against
      asthma exacerbations. However, only a minority of asthma patients take their inhaled steroids
      as recommended by the National Asthma Education and Prevention Program (NAEPP) guidelines.
      Therefore, the Pediatric Asthma Guidelines recommend development and testing of programs
      (including school-based programs) to increase adherence with therapy.

      Because morbidity is higher in inner-city, low-income, minority children, this study will
      collaborate with several inner-city, low-income, minority school districts to examine the
      effects of school-based supervised asthma therapy.

      DESIGN NARRATIVE:

      This study is a longitudinal two-group trial of the effectiveness of a school-based
      supervised asthma therapy program. Two hundred and fifty children will be randomly assigned
      to one of two groups: school-based supervised asthma therapy or parental supervised asthma
      therapy. The children will be followed for 16 months.
    

Intervention name(s): School-Based Supervised Asthma Therapy
Intervention type(s): Behavioral
Intervention description(s): Child's inhaled steroid use supervised daily at school
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment