Evaluation of the Asthma Management Program to Promote Activity for Students in Schools (Asthma-PASS)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 452
- 试验地点
- 1
- 主要终点
- Change in the number of Symptom free days (SFDs)
研究概览
简要总结
Physical activity (PA) is an important component of asthma management in children. Studies show that PA is associated with decreased severity of asthma symptoms, as well as improved disease control and quality of life. However, urban minority children with asthma face barriers to PA on multiple levels.The goal of this research project is to evaluate whether a multifaceted school-based intervention that addresses key barriers to physical activity reduces asthma morbidity among urban schoolchildren with asthma.
详细描述
Investigators will conduct a cluster-randomized controlled trial with eligible children with persistent or uncontrolled asthma from 60 Bronx schools. Schools will be randomly assigned to either (1) the Asthma-PASS intervention or an asthma management (AM) comparison group. Both groups will participate in an existing classroom-based daily activity program. Enrollment will occur over 4 consecutive school years with 4-8 schools joining the study each year. The investigators will assess the effectiveness of Asthma-PASS in reducing asthma morbidity and improving PA as well as additional clinical and functional outcomes. The investigators will also identify potential mediators and moderators of the intervention effect. They will evaluate the process of intervention implementation by applying the Reach, Effectiveness, Adoption, Implementation, and Maintenance (RE-AIM) framework. The RE-AIM framework is a public health tool used for planning and evaluating programs to improve translation from research into practice and ensure sustainability in real-world settings.
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
- None
入排标准
- 年龄范围
- 4 Years 至 12 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Physician-diagnosed asthma (based on parent report with validation from the child's physician)
- •Intermittent asthma (but with a report of asthma symptoms, such as coughing, wheezing, chest tightness, mucus/phlegm or shortness of breath, in the past 12 months)
- •Mild persistent or more severe asthma based on prescribed controller medication (currently well-controlled) but with a report of asthma symptoms (as specified above) within the past 12 months [well-controlled due to taking controller medications in the past 12 months and without asthma symptoms (as specified above) within the past 12 months will qualify]
- •Mild persistent or more severe asthma, or asthma that is uncontrolled despite therapy (based on age-specific guidelines)
- •Attending pre-kindergarten through 5th grade in NYC (primarily Bronx) schools and also schools in lower Hudson Valley
- •Parent is able to speak and understand either English or Spanish
- •Consent from the primary caregiver, caregiver permission for child participation as well as assent from the child (for age 7 and above)
排除标准
- •No access to a phone to conduct follow-up surveys
- •Family plans to leave the school or city in less than 6 months
- •The child has other significant medical conditions, such as congenital heart disease, cystic fibrosis, or other chronic lung disease
- •Child is unable to participate in routine physical education (PE) classes as per physician-completed sports participation form
- •Children in foster care or other situations in which consent cannot be obtained from a guardian
- •Child is a participant in a concurrent asthma intervention study
研究组 & 干预措施
Asthma-PASS Intervention
Collaboration with PCPs to optimize management. Community Health Worker (CHW) to ensure PCP plan is followed. Two asthma education sessions with children/caregivers focusing on self-efficacy and physical activity promotion. Promotion of asthma awareness in school. School personnel training in asthma
干预措施: Asthma-PASS (Behavioral)
Asthma-PASS Intervention
Collaboration with PCPs to optimize management. Community Health Worker (CHW) to ensure PCP plan is followed. Two asthma education sessions with children/caregivers focusing on self-efficacy and physical activity promotion. Promotion of asthma awareness in school. School personnel training in asthma
干预措施: Child/Caregiver Education session (Behavioral)
Asthma Management Comparison Group
Includes two sessions of basic asthma education and PCP notification of child's asthma severity level.
干预措施: Basic Asthma Management (AM) (Behavioral)
Asthma Management Comparison Group
Includes two sessions of basic asthma education and PCP notification of child's asthma severity level.
干预措施: Child/Caregiver Education session (Behavioral)
结局指标
主要结局
Change in the number of Symptom free days (SFDs)
时间窗: Baseline, 3, 6, 9, and 12 months
Change from baseline in the number of SFDs will be assessed. Caregivers will report the number of days their child experienced no symptoms of asthma (defined as 24 hours with no coughing, wheezing, chest tightness, or shortness of breath) over the prior 14 day period. Symptom diaries provided as part of the study will be used to assist with recall. The trial will be successful if the intervention demonstrates a significantly greater improvement over time on SFDs at any of the 4 post-baseline assessments.
次要结局
- Physical activity(Baseline, 3, 6 and 9 months)