Description Module
The Description Module contains narrative descriptions of the clinical trial, including a brief summary and detailed description. These descriptions provide important information about the study's purpose, methodology, and key details in language accessible to both researchers and the general public.
Description Module path is as follows:
Study -> Protocol Section -> Description Module
Description Module
Ignite Creation Date:
2025-12-24 @ 3:00 PM
Ignite Modification Date:
2025-12-24 @ 3:00 PM
NCT ID:
NCT01447459
Brief 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.
Study:
NCT01447459
Study Brief:
Protocol Section:
NCT01447459