Asthma Link for Childhood Asthma
Recruiting in Palo Alto (17 mi)
Age: < 18
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Academic
Recruiting
Sponsor: University of Massachusetts, Worcester
Must be taking: Inhaled corticosteroids
Disqualifiers: Developmental delay, others
No Placebo Group
Approved in 1 Jurisdiction
Trial Summary
What is the purpose of this trial?The goal of this cluster RCT is to determine the effectiveness of Asthma Link, a school supervised asthma therapy program, compared with an educational asthma workbook, in improving asthma symptoms for children with poorly controlled asthma aged 5-14.
Will I have to stop taking my current medications?
The trial does not specify if you need to stop taking your current medications. However, since children must be prescribed a daily inhaled corticosteroid (ICS) for asthma to participate, it seems likely that they will continue with this medication during the trial.
What data supports the effectiveness of the treatment Asthma Link for childhood asthma?
Research shows that school-supervised asthma therapy, like Asthma Link, improves medication adherence and health outcomes for children with asthma. Programs that involve schools, families, and healthcare providers have been successful in managing asthma and reducing school absences due to asthma symptoms.
12345Is the Asthma Link treatment safe for children with asthma?
The Asthma Link program, which involves school-supervised asthma therapy, has been shown to improve health outcomes for children with asthma, but the available research does not specifically address safety concerns. It focuses on improving asthma management and coordination among schools, families, and healthcare providers.
12356How is the Asthma Link treatment different from other asthma treatments?
Asthma Link is unique because it involves school-supervised therapy, where children receive their asthma medication at school, improving adherence and health outcomes. This approach is designed to be sustainable and low-cost, making it easier to adopt in real-world settings compared to traditional home-based treatments.
12678Eligibility Criteria
This trial is for children aged 5-14 with poorly controlled asthma. It's designed to see if a school program called Asthma Link can help manage their symptoms better than an educational workbook.Inclusion Criteria
Child: Meet the eligibility criteria for Asthma Link, Enrolled in Asthma Link (if randomized to the Asthma Link Condition), Able and willing to provide informed assent
I am over 18, speak English or Spanish, and can consent for my child.
Exclusion Criteria
My child cannot give informed assent due to developmental delays.
Trial Timeline
Screening
Participants are screened for eligibility to participate in the trial
2-4 weeks
Treatment
Children receive school-supervised asthma therapy or an educational asthma workbook
6 months
Regular school visits for therapy administration
Follow-up
Participants are monitored for asthma control and medication adherence
6 months
Surveys and assessments at 6 and 12 months
Participant Groups
The study is testing the effectiveness of 'Asthma Link', which involves supervised asthma therapy at school, against just using an educational workbook on asthma care. Children will be randomly placed in one of these two groups.
2Treatment groups
Experimental Treatment
Active Control
Group I: Asthma LinkExperimental Treatment1 Intervention
Practices in the Asthma Link condition will receive brief training on how to identify, refer and arrange for children with poorly controlled asthma to receive school-supervised therapy with the child's school health staff. Participants will receive an educational asthma workbook.
Group II: Enhanced Usual CareActive Control1 Intervention
Practices in the Enhanced Usual Care condition will receive brief training on how to identify and refer the same group of children with poorly controlled asthma and these children will receive an educational asthma workbook.
Asthma Link is already approved in United States for the following indications:
🇺🇸 Approved in United States as Asthma Link for:
- Poorly controlled asthma in children aged 5-14
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
University of Massachusetts Chan Medical SchoolWorcester, MA
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Who Is Running the Clinical Trial?
University of Massachusetts, WorcesterLead Sponsor
National Institutes of Health (NIH)Collaborator
National Heart, Lung, and Blood Institute (NHLBI)Collaborator
References
Alignment of stakeholder agendas to facilitate the adoption of school-supervised asthma therapy. [2021]School-supervised inhaled corticosteroid (ICS) therapy improves pediatric asthma medication adherence, outcomes, and morbidity. However, school-supervised ICS therapy has not been widely adopted into practice. We developed Asthma Link™ as a sustainable, low-cost model of school-supervised asthma therapy, designed for real-world adoption. Initial outcomes of Asthma Link™ demonstrated a significant improvement in health outcomes.
Asthma in Schools: How School-Based Partnerships Improve Pediatric Asthma Care. [2019]Children with asthma experience frequent exacerbations that require careful care coordination among families, clinicians, and schools. Prior studies have shown that children with asthma miss more school each year compared with their healthy peers due to uncontrolled asthma symptoms. Successful school-based asthma programs have built strong partnerships among patients, their families, and clinicians to improve communication and the dissemination of asthma action plans and medications to schools. The widely endorsed School-based Asthma Management Program, consisting of 4 components, provides a comprehensive and expert-supported framework to coordinate care with schools.
Building Bridges for Asthma Care Program: A School-Centered Program Connecting Schools, Families, and Community Health-Care Providers. [2023]Asthma imposes tremendous burden on children, families, and society. Successful management requires coordinated care among children, families, health providers, and schools. Building Bridges for Asthma Care Program, a school-centered program to coordinate care for successful asthma management, was developed, implemented, and evaluated. The program consists of five steps: (1) identify students with asthma; (2) assess asthma risk/control; (3) engage the family and student at risk; (4) provide case management and care coordination, including engagement of health-care providers; and (5) prepare for next school year. Implementation occurred in 28 schools from two large urban school districts in Colorado and Connecticut. Significant improvements were noted in the proportions of students with completed School Asthma Care Plans, a quick-relief inhaler at school, Home Asthma Action/Treatment Plans and inhaler technique (p < .01 for all variables). Building Bridges for Asthma Care was successfully implemented extending asthma care to at-risk children with asthma through engagement of schools, health providers, and families.
Creation and implementation of SAMPRO™: A school-based asthma management program. [2019]Clinicians who care for children with asthma have an obligation to coordinate asthma care with the schools. Aside from routine clinical care of asthmatic children, providers must educate the family and child about the need for an asthma treatment plan in school and support the school nurse meeting the needs of the student requiring school-based asthma care. The following article was developed by multiple stakeholders to address this need. It describes the 4 components of the School-based Asthma Management Program (SAMPRO™). SAMPRO™ details elements necessary for the education of children, families, clinicians, and school-based personnel based on a "circle of support" that would enhance multidirectional communication and promote better care for children with asthma within the school setting.
Incorporating systems-level stakeholder perspectives into the clinical trial design of school-supervised asthma therapy. [2022]Few evidence-based public health interventions are adopted in practice, in part due to a disconnect between the outcomes measured in clinical trials and the outcomes important to stakeholders that determine implementation in real-world practice. AsthmaLink is a school-supervised asthma therapy program which partners pediatric providers, school nurses, and families. To inform the design of a cluster randomized controlled trial of AsthmaLink, we elicited systems-level stakeholder input.
Allergic rhinitis co-morbidity on asthma outcomes in city school children. [2023]School based asthma programs have demonstrated that preventive asthma therapy administered in school reduces asthma morbidity. The burden of co-morbid allergic disease on asthma outcomes in a large school based asthma cohort has been unexplored.
Sustaining school-based asthma interventions through policy and practice change. [2018]Schools are an ideal setting for implementation of asthma interventions for children; however, sustaining school-based programs can be challenging. This study illustrates policy and practice changes brought about through the Childhood Asthma Linkages in Missouri (CALM) program to sustain such programs.
Effectiveness of a modified open airways curriculum. [2015]Open Airways for Schools is an asthma education program that has proven to be effective in decreasing the number of asthma attacks in children and increasing their confidence in self-management. It is taught to 8-11 year olds in six 40-min sessions. Due to financial and scheduling constraints, many schools have difficulty implementing the program. The Tulsa Health Department created a modified version of the program, which is taught in ten 20-min sessions over lunch. The same topics are covered in a different order and fewer activities are utilized. This study aimed to pilot the effectiveness of the modified program.