Asthma Control Study

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.

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Key information

Conditions

Childhood Asthma

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Evidation Health

San Mateo, California, 94401, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Tueo Program

Behavioral

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.

Primary outcomes

Change in ACT/C-ACT scores

Time frame: Baseline and Week 16

Change in ACT/C-ACT scores from baseline to study end

Sponsors and collaborators

Lead sponsor

Evidation Health

Industry

Collaborators

Tueo Health

Registry information

Official study title

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

Important dates

Study start: 2017
Primary completion: 2018
Study completion: 2018
First posted: Oct 6, 2017
Registry last updated: Jul 17, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed