Effects of Educational Intervention on Long-Term Outcomes of Hospitalized Children With Asthma
Condition: Asthma
MeSH terms: Asthma
Study type: Interventional

Summary: 
      The investigators hypothesize that reinforced asthma education improves long-term outcomes in
      children with asthma.

      Specific Aims and Objectives:

        1. To determine the retention rate of parental knowledge about asthma;

        2. To evaluate the clinical status, quality of life and healthcare costs of children with
           asthma following an educational intervention.
    

Detailed description: 
      This study will be a prospective, randomized (1:1), controlled study assessing clinical
      status, quality of life, healthcare costs and parental retention rate of asthma knowledge for
      children 5 to 12 years old with asthma, following standardized asthma education versus
      standard education with an enhanced reinforcement of education intervention.

      Group A (the intervention group) The caregivers of the subjects enrolled in this group will
      be administered two survey instruments at enrollment (t0), and again via telephone at 2 weeks
      (t1), 1 months (t2), and 3 months (t3) after enrollment. This group will also receive
      reinforced asthma education via telephone at 2 weeks, 1 month, and 3 months after enrollment.

      Group B (the control group) The caregivers of the subjects enrolled in this group will be
      administered two survey instruments at enrollment (t0), and again via telephone at 2 weeks
      (t1), 1 month (t2), and 3 months (t3) after enrollment. This group will not receive
      reinforcing of the asthma education at 2 weeks, 1 month, and 3 months after enrollment.

      The two survey instruments administered to the caregivers (parents/legal guardians) of the
      subjects enrolled in this study consist of:

        1. A validated 16-item questionnaire with multiple-choice answers, assessing asthma
           knowledge, trigger identification and avoidance, referred to as "the Asthma Knowledge
           Quiz" from here on.

        2. A validated 5-item questionnaire with multiple-choice answers, assessing the patient's
           quality of life and asthma control, referred to as "the Quality of Life/Asthma Control
           Test (QOL/ACT) survey" from here on.

      Following enrollment and randomization, the caregiver of each subject will be administered
      the two survey instruments prior to discharge from the hospital.

      At the end of the administration of the phone surveys (i.e. at 2 weeks, 1 month and 3 months
      following enrollment), the study coordinator will provide reinforced asthma education to the
      caregiver via telephone for the subjects enrolled in Group A (the intervention group). The
      reinforced asthma education will be consistent with the asthma education training session
      delivered by the AE before the beginning of the study.

      The survey instruments will be administered to the caregiver by the study coordinator in
      paper form; after completion by the caregiver, the form will be saved in the subject's
      research binder for further data analysis. The PI or the study coordinator will determine the
      score for each item on the surveys, and record the scores in the subject's file, in the
      Asthma Knowledge Quiz Scores/Asthma Knowledge Retention Rates Form, and the Quality of
      Life/Asthma Control Test (QOL/ACT) Scores Form respectively.

      The caregiver of each subject will be administered these two survey instruments again, via
      telephone, by the study coordinator, at 2 weeks, 1 month, and 3 months after enrollment. Each
      item and the multiple-choice answers will be literally read to the parent over the phone, and
      the study coordinator will record the answers to each item on the paper survey forms, which
      will be saved in the subject's binder for further data analysis. The PI or the study
      coordinator will determine the score for each survey, and record the scores in the subject's
      file.

      A variety of statistical techniques will be used to analyze the data. The investigators will
      perform descriptive analyses as well as more analytic work using analysis of variance,
      correlation and multiple regression analysis. The investigators will use the expertise of a
      biostatistician to assist with accurate analysis of our data. The study will be powered to
      detect a significant difference in outcomes between the intervention group (group A) and the
      control group (group B); 25 % reduction in cost an 25% improvement in quality of life scores,
      following reinforced asthma education, with a 95% CI (alpha=0.05, beta=0.2, for a power of
      80%). The investigators will also analyze whether there is a statistically significant
      correlation between the amplitude of the asthma knowledge scores (AKS) and the asthma
      knowledge retention rates (AKRR) on one side and the QOL/ACT scores, functional status and
      asthma related healthcare costs on the other side.
    

Intervention name(s): Reinforced Asthma Education
Intervention type(s): Behavioral
Intervention description(s): Before beginning the actual study, a board-certified Asthma Educator (AE) will prepare and administer an asthma education training session for the study personnel, including the PI, the co-investigators, and the study coordinator. The AE will also make herself available via pager for assistance with questions from the study personnel regarding asthma education.
At the end of the administration of the phone surveys (i.e. at 2 weeks, 1 month and 3 months following enrollment), the study coordinator will provide reinforced asthma education to the caregiver via telephone for the subjects enrolled in Group A (the intervention group). The reinforced asthma education will be consistent with the asthma education training session delivered by the AE before the beginning of the study.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Care Provider)
Primary purpose: Supportive Care
Keywords: Asthma; Asthma Education