Asthma Control Study

Study Overview
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Brief Summary
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The Digital Health Tool for Parental Management of Childhood Asthma -- Impact on Asthma Control Test Scores Study is a 16 week, prospective, intent-to-treat, 2-arm randomized controlled trial that aims to evaluate the impact of the Tueo Health program on asthma control as indicated by change in baseline and study end (week 16) score on the Childhood Asthma Control Test score (ages 6- under 12 years) and the Asthma Control Test (ages 12-17 years) in children with uncontrolled asthma as the primary study objective.

Official Title
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Digital Health Tool for Parental Management of Childhood Asthma -- Impact on Asthma Control Test Scores

Conditions
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Childhood Asthma

Intervention / Treatment
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* Behavioral: Tueo Program


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Parent has a child who is > 6 and < 17.5 years old Parent reports child has a diagnosis of asthma Child takes daily asthma controller medication Child has used rescue inhaler (e.g.albuterol, ProAir, etc) or nebulizer at least 2 times per week in the past 4 weeks Child sleeps on a toddler, single, or double bed by themselves Child will live in the same home for the majority of the next 16 weeks Parent is > 18 years old Exclusion Criteria: Child's asthma has been controlled over the past 4 weeks Child has any of the following conditions: sleep apnea, congenital heart disease, cardiac arrhythmias, or any other heart abnormalities, neurologic conditions including seizures, cerebral palsy, muscular dystrophy, genetic conditions or developmental disorders, autism, other major medical condition Child is currently pregnant Child was born premature (earlier than 36 weeks) Parent is not fluent in English No in-home WiFi Parent does not use an Android phone as their primary phone In a household with an existing enrolled participant in the study, even for a different child (e.g. only one child in a household may have questions reported back to the researchers by their parent) Lives in Hawaii or Alaska

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Health Services Research
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intervention<br> | Behavioral: Tueo Program<br>* The asthma management solution utilizes devices (2 to attach on the child's bed and 1 for data transmission), which collect various metrics for a tailored smartphone application experience. The smartphone application provides access to view metrics from the devices, educational and clinical context content, and an asthma coach.<br>|
| No Intervention: Control<br> | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in ACT/C-ACT scores | Change in ACT/C-ACT scores from baseline to study end | Baseline and Week 16 |