Effects of Educational Intervention on Long-Term Outcomes of Hospitalized Children With Asthma
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 144
- 试验地点
- 2
- 主要终点
- Asthma Knowledge Scores (AKS)
研究概览
简要总结
The investigators hypothesize that reinforced asthma education improves long-term outcomes in children with asthma.
Specific Aims and Objectives:
- To determine the retention rate of parental knowledge about asthma;
- To evaluate the clinical status, quality of life and healthcare costs of children with asthma following an educational intervention.
详细描述
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:
- 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.
- 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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Single (Care Provider)
入排标准
- 年龄范围
- 5 Years 至 12 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Children age 5-12 years (eligible on or after the 5th birthday, until the day before the 13th birthday);
- •Hospitalized at Norton Children's Hospital (KCH) for asthma;
- •Physician diagnosis of asthma (ICD-9 codes 493.00, 493.01, 493.02, 493.10, 493.11, 493.12, 493.90, 493.91, 493.92);
- •Completion of asthma education (standard of care);
- •Ability of parent/legal guardian to give informed consent/research authorization, as evidenced by signing the Informed Consent Form (ICF) approved by the University of Louisville (UofL) IRB;
- •Ability of subject to give informed assent for subjects equal to or older than 7 years of age, as evidenced by signing the Informed Assent Form (IAF) approved by UofL IRB.
排除标准
- •Previous enrollment in either group of this study.
研究组 & 干预措施
Reinforced Education
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.
干预措施: Reinforced Asthma Education (Behavioral)
No Reinforced Education
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.
结局指标
主要结局
Asthma Knowledge Scores (AKS)
时间窗: 3 months
The Asthma Knowledge Quiz will be administered. The higher the score (AKS), the better the knowledge of the caregiver regarding asthma, symptom recognition, trigger identification and avoidance, and medication administration. The PI or the study coordinator will calculate AKSt0, AKSt1, AKSt2, and AKSt3 (enrollment, 1 week, 2 weeks and 3 months, respectively) for each caregiver enrolled in the study. These scores will be recorded in the Asthma Knowledge Quiz Score/Asthma Knowledge Retention Rates Form for each individual subject.
次要结局
- Quality of Life/Asthma Control Test Scores (QOL/ACT Scores)(At enrollment; 2 weeks, 1 month and 3 months after enrollment)
- Asthma Knowledge Retention Rates (AKRR)(2 weeks, 1 month, and 3 months after the initial educational intervention)
- Functional Status(Enrollment; 2 weeks, 1 month and 3 months after enrollment)
- Asthma-related healthcare costs(6 months after enrollment)
研究者
Tania Condurache
Associate Professor
University of Louisville