Enhancing Children's and Parents' Asthma Management
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 292
- 试验地点
- 2
- 主要终点
- Absenteeism, End of Study
研究概览
简要总结
Asthma is the most common chronic childhood illness and disproportionately affects children who are ethnic minorities and poor. Few studies of childhood asthma have been conducted with children who live in rural areas or have included Mexican American children in their samples. This study builds on the original R01NR007770 with findings that demonstrated the intervention could improve children's asthma self-management, asthma knowledge, metered dose inhaler skill, asthma severity, and parents' asthma management and access to care. In this competing continuation, the investigators added a third arm to the current research design with schools randomized into either an in-school asthma intervention, an in-school attention-control intervention, or an alternate intervention-delivery format of a single 5.5-hour asthma day camp. The tri-ethnic sample will be composed of 320 Mexican-American, African-American, and White rural school-aged children (grades 2-5) who have asthma and their parents. In addition, the investigators propose adding a non-invasive measure of chronic airway inflammation (exhaled nitric oxide) to assess the impact of changes in asthma management on airway inflammation. Families will be followed for a full year with data collection at baseline and at 1-month, 4-months, and 7-months after the intervention to assess improvement in children's asthma morbidity, asthma severity, airway inflammation, family asthma management and quality of life. Hypotheses (H): Children in the Camp-Workshop group and the School-Home group will demonstrate equivalent improvements, but greater improvements than the Attention-Control group in:(H1.1) their asthma severity and airway inflammation from the Time 1 assessment when compared to Time 4 assessment; (H1.2) office visits, ED visits, and hospitalizations for asthma, and absenteeism for the study year (Time 4) when compared to the pre-study year (Time 1); and (H1.4) Parents in the intervention arms will demonstrate sustained improvements in asthma caregiver's quality of life (QOL0 from the pre-study year (Time 1) to the end of the study year (Time 4) measurement, when compared to the Attention-Control group.
详细描述
Families are recruited at the beginning of the school year (Time 1, October-November); parents consent and child assent obtained and baseline data collected in fall. The intervention is provided in December-January. Follow-up data are collected at February (Time 2), April (Time 3), and August (Time 4).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 6 Years 至 13 Years（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •parent reports the child has a diagnosis of asthma made by a medical provider;
- •has had asthma symptoms in the previous 12 months;
- •speaks either English or Spanish.
排除标准
- •has a significant co-morbidity that would preclude participation in classes (e.g., severe cerebral palsy, oxygen dependent conditions)
结局指标
主要结局
Absenteeism, End of Study
时间窗: 12 months
(Days absent/days enrolled)x100 = absenteeism. Using data provided by the school district at the end of the study year.
Quality of Life, End of Study
时间窗: 12 months
Self reported asthma-related quality of life. Outcome data were collected at end of study (Time 4). The Pediatric Asthma Quality of Life scale. Minimum score 23 to maximum score of 115. A higher score indicates worse quality of life. Mean scale scores are computed.
Number of Days Hospitalized, During Study Year
时间窗: 12 months
Number of days hospitalized for asthma. Data were obtained from parent report at the second, third, and fourth data collection point. The number of hospitalization days were summed for a total number at the end of the 12 months.
Emergency Department Visits, Study Year
时间窗: 12 months
Number of visits to Emergency Department for asthma. Data is obtained from parents at three time points (time 2, 3, and 4) and summed for total number of visits to the emergency department for asthma during the study year.
Absenteeism Pre-study Year
时间窗: 12 months before baseline
(Days absent/days enrolled)x100 = absenteeism. Using data for the 12 months prior to study enrollment as the pre-study year. Data is provided by the participating school districts.
Number of Days in Hospital for Asthma, Pre-Study Year
时间窗: 12 months before baseline
Number of days hospitalized for asthma. Data is obtained from parents for the pre-study year for the previous 12 months.
Number of Asthma Hospital Stays, During Study Year
时间窗: 12 months
Number of hospital admissions for asthma. Data were obtained from parent report at the second, third, and fourth data collection point. The number of hospitalizations were summed for a total number at the end of the 12 months.
Emergency Department Visits, Pre-study Year
时间窗: 12 months before baseline
Number of visits to Emergency Department for asthma. Data is obtained from parents for the pre-study year for the previous 12 months.
Quality of Life, Pre-study Year
时间窗: 12 months before baseline
Self reported asthma-related quality of life. Data were collected at study enrollment (time 1). The Pediatric Asthma Quality of Life scale. Minimum score 23 to maximum score of 115. A higher score indicates worse quality of life. Mean scale scores are computed.
Number of Asthma Hospitalizations Pre-Study Year
时间窗: 12 months before baseline
Number of times hospitalized for asthma. Data is obtained from parents for the pre-study year for the previous 12 months.
次要结局
- Asthma Self-management, Time 4(Time 4, at 12 months)
- Home Asthma Management, Time 4, End of Study(Time 4 at 12 months)
- Metered Dose Inhaler Skill, Time 4(Time 4 at 12 months)
- Medication Adherence, Time 4(Time 4 at 12 months)
- Asthma Self-management, Time 3(Time 3 at 9 months)
- Asthma Self-management, Time 2(Time 2 at 5 months)
- Asthma Self-management, Time 1, Baseline(Time 1, baseline)
- Home Asthma Management, Time 1, Baseline(Time 1, baseline)
- Home Asthma Management, Time 2.(Time 2 at 5 months)
- Home Asthma Management, Time 3(Time 3 at 9 months)
- Metered Dose Inhaler Skill, Time 3(Time 3 at 9 months)
- Metered Dose Inhaler Skill, Time 2(Time 2 at 5 months)
- Metered Dose Inhaler Skill, Time 1(Time 1 at baseline)
- Medication Adherence, Time 1(Time 1 at baseline)
- Medication Adherence, Time 2(Time 2 at 5 months)
- Medication Adherence, Time 3(Time 3 at 9 months)