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| Name | Class |
|---|---|
| American Thoracic Society | OTHER |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Virtual Teach-to-Goal (V-TTG) | Experimental | They will be randomized to receive education via a virtual learning module. |
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| standardized brief intervention | Active Comparator | Intervention that mimics usual care to deliver inhaler technique education. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Virtual Teach to Goal | Behavioral | Participants will complete inhaler education on a tablet device. |
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| Measure | Description | Time Frame |
|---|---|---|
| Proportion of participants with effective inhaler use (>75% steps correct) post-intervention with V-TTG versus BI | Inhaler technique will be assessed based on a validated published checklist, which was developed and validated by Dr. Press15 and utilized in my preliminary research with children (see Preliminary Studies). For this primary outcome, we will account for the pre-intervention technique to account for any differences in baseline of the two groups | 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| Number of inhaler technique steps correct pre- and post-V-TTG education | Evaluation of inhaler technique before and after education using validated checklist | At baseline |
| Number of inhaler technique steps correct at 1 month |
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Inclusion Criteria:
Families will be included in the study if:
Exclusion Criteria:
Families will be excluded from the study if:
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| Name | Affiliation | Role |
|---|---|---|
| Anna Volerman, MD | University of Chicago | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Chicago Medicine | Chicago | Illinois | 60637 | United States |
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| Type | Date | Date Unknown |
|---|---|---|
| Release | Apr 14, 2022 | |
| Reset | Jan 18, 2023 |
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| Apr 14, 2022 | Jan 18, 2023 |
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| Brief Instruction | Behavioral | Participants will be read out loud instruction on how to use their inhaler. |
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Evaluation of inhaler technique 1-month after education/baseline session
| 1-month after enrollment |
| Score of Asthma Control Survey | Assessed using validated survey measure | 12-months |
| Score of Asthma Impact | Assessed using validated survey measure | 12-months |
| Score of Caregiver Quality of Life | Assessed using validated survey measure | 12-months |
| Score of Child Asthma Management Self-Efficacy | Assessed using validated survey measure | 12-months |
| Number of healthcare encounters self-reported and EHR-recorded since baseline | Healthcare utilization measured via program-specific questionnaire delivered to parent and child as well as manual review of medical records | 12-months |