Asthma in Children
Conditions
Brief summary
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.
Detailed description
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.
Interventions
BEHAVIORALAsthma-PASS
The investigator will collaborate with the student's primary care provider (PCP) by sending a letter via facsimile, and/or e-mail to ensure appropriate medications are prescribed or adjusted and rescue medications are available at school. Community Health Workers (CHWs) will follow up with PCPs as needed to provide reminders about prescriptions for controlled medications and to ensure a medication administration form (MAF) is provided to schools to allow rescue medication administration by nurses. CHWs will work with local pharmacies when possible to have prescribed medications delivered to schools and homes. For students without a PCP, families will be referred to one of Montefiore Medical Center's 20 practices throughout the Bronx. For students without medical insurance or who are unable to go to a Montefiore clinic, New York City Department of Education (NYC DOE) physicians who routinely attend NYC schools will provide medical care and prescribe appropriate medications.
BEHAVIORALBasic Asthma Management (AM)
PCPs and caregivers will be notified that children in the AM group have persistent/uncontrolled asthma that warrants use of guideline-based preventative medications.
BEHAVIORALChild/Caregiver Education session
The investigator will provide in-school child asthma education sessions delivered by trained, bilingual (English-Spanish) Community Health Workers (CHWs) using an established manualized protocol from past and current studies designed to improve knowledge and self-efficacy. Each child will receive two 1-on 1, 20-minute developmentally appropriate educational sessions at school 3-4 weeks apart. Sessions will cover: 1) asthma basics, symptoms and triggers; and 2) medications and correct administration technique. Caregivers will be called after each child session to highlight key points reviewed with the child and answer questions.
Sponsors
Montefiore Medical Center
University of Rochester
Columbia University
National Heart, Lung, and Blood Institute (NHLBI)
Study design
Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
4 Years to 12 Years
Healthy volunteers
No
Inclusion criteria
* 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)
Exclusion criteria
* 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in the number of Symptom free days (SFDs) | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Physical activity | Baseline, 3, 6 and 9 months | Physical activity will be assessed by the number of minutes the child engages in 'moderate-vigorous' physical activity based on measurements taken using the ActiGraph GT3X+ activity monitor, a small, tri-axial micro-electromechanical system (MEMS) based accelerometer. Measurements will be taken over 7 consecutive days at baseline, 3, 6 and 9 months using the activity monitor. Children will wear the monitor on their waist, secured using an elastic belt. The number of minutes the child is in 'moderate-vigorous' physical activity will be summarized by study arm. |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORMarina Reznik, MD, MS
Montefiore Medical Center
Outcome results
None listed