Asthma in Children Clinical Trial
Official title:
An RCT of Virtual Teach-to-Goal Versus Brief Instruction for Children With Asthma in Clinics
This study aims to evaluate the comparative effectiveness of a high-fidelity, low-resource, and feasible model versus a standardized brief intervention that mimics usual care to deliver tailored inhaler technique education to children with asthma via a randomized clinical trial. We have already conducted a trial of V-TTG among elementary school-aged children hospitalized in the inpatient setting and we now aim to test this tool in the outpatient clinic setting among a broader pediatric patient population.
Asthma is the most common chronic childhood condition and has significant adverse consequences. One in 12 United States children has asthma, resulting in 13.4 million missed school days, 1 million emergency department visits, and 140,000 hospitalizations annually. Urban, minority, and underserved youth are disproportionally affected. On Chicago's South Side, one-in-five children have an asthma diagnosis; over half visit an urgent care or emergency department (55%), miss school (51.2%), or require parents to miss work annually due to asthma (56.1%). Effective self-management is crucial to optimize asthma care and improve outcomes. A key barrier to self-management is the improper use of respiratory inhalers, which limits disease control. Better inhaler technique is associated with improved asthma outcomes for children. Assessment and education of inhaler technique are recommended at all healthcare encounters; however, it is limited in practice because it is resource-intensive (both personnel and time) and lacks fidelity. Thus, low-resource interventions that accurately teach inhaler skills are needed to impact pediatric asthma outcomes. Teach-to-Goal (TTG) is a patient-centered strategy that uses tailored rounds of teaching and assessments to ensure mastery of inhaler technique. Studies show it is effective but resource-intensive. A "virtual TTG" (V-TTG) intervention represents an opportunity to deliver inhaler technique education with a high-fidelity, low-resource, and feasible strategy. The module utilizes innovative learning technology with video demonstrations and assessment questions to tailor education to each user; the cycles of assessment and education continues until satisfactory mastery is achieved. Our team developed a V-TTG intervention for adults with demonstrated efficacy. It remains unknown whether this interactive and adaptive module will be feasible and effective in the pediatric population due to varied developmental levels and parental involvement in care. Virtual Teach-to-Goal (V-TTG) holds the potential to improve inhaler technique in children; however, because learning theory indicates children and adults learn differently, the same learning module cannot be utilized. We have already constructed V-TTG for children with feedback from children with asthma, parents, and healthcare professionals. The learning module is tailored for age by using developmentally and age-appropriate vocabulary, concepts, format, and pacing. ;
Status | Clinical Trial | Phase | |
---|---|---|---|
Completed |
NCT04450108 -
Vivatmo Pro™ for Fractional Exhaled Nitric Oxide (FeNO) Monitoring in U.S. Asthmatic Patients
|
N/A | |
Recruiting |
NCT05734261 -
Forced Oscillations Technique During a Metacholine Test in Children
|
N/A | |
Recruiting |
NCT06044051 -
Dynamics of the Upper and Lower Airway Respiratory Microbiomes Associated With Severe Infant Asthma
|
N/A | |
Completed |
NCT04896502 -
Effectiveness of Telemedicine Home Assessments for Identification and Reduction of Asthma Triggers
|
N/A | |
Completed |
NCT03503812 -
Mitigating the Health Effects of Desert Dust Storms Using Exposure-Reduction Approaches
|
N/A | |
Recruiting |
NCT06003569 -
Reducing Asthma Attacks in Disadvantaged School Children With Asthma
|
N/A | |
Not yet recruiting |
NCT05902702 -
Isotonic Saline for Children With Bronchiolitis
|
N/A | |
Not yet recruiting |
NCT05547477 -
Continuous EMG Measurements in Children With Asthma During Sleep
|
||
Completed |
NCT04388098 -
Oral Health Status of Asthmatic Children
|
||
Terminated |
NCT03586544 -
Reducing Exercise-induced Bronchoconstriction in Children With Asthma and Obesity
|
Phase 4 | |
Recruiting |
NCT04821908 -
Consequences of COVID 19 Pandemic on Childhood Asthma
|
||
Not yet recruiting |
NCT03277170 -
Pragmatic RCT of High-dose Oral Montelukast for Moderate and Severe Pediatric Acute Asthma Exacerbations
|
Phase 2 | |
Enrolling by invitation |
NCT06239844 -
Navigating Together for Equitable Asthma Management for Children in Families Who Communicate in Language Other Than English
|
N/A | |
Not yet recruiting |
NCT05974917 -
Serious gaMes as Emerging E-health Interventions for Young People With neurologicaL or rEspiratory disoRders
|
||
Not yet recruiting |
NCT05997784 -
Study of Indoor Air Pollutants and Their Impact in Childhood Health and Wellbeing
|
||
Recruiting |
NCT05366309 -
Performance and Adherence in Children Using Spacers
|
N/A | |
Completed |
NCT05684926 -
COVID-19 Pandemic Asthma Child Telerehabilitation Yoga
|
N/A | |
Recruiting |
NCT04166344 -
A mHealth Intervention to Improve Symptom Control in Children and Adolescents With Difficult-to-control Asthma
|
N/A | |
Completed |
NCT03673618 -
Soluble Corn Fiber Supplementation for Asthma
|
Phase 2 | |
Completed |
NCT03907410 -
The Tailored Adherence Incentives for Childhood Asthma Medications (TAICAM) Trial
|
N/A |