Asthma Control Study

Not Applicable

Completed

• Conditions: Childhood Asthma
• Interventions: Behavioral: Tueo Program

• Registration Number: NCT03304067
• Lead Sponsor: Evidation Health

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2017-10-02
• Study First Submitted QC: 2017-10-02
• Study Start: 2017-10-03
• Study First Posted: 2017-10-06
• Primary Completion: 2018-05-03
• Study Completion: 2018-05-03
• Status Verified: 2018-07
• Last Update Submitted: 2018-07-13
• Last Update Posted: 2018-07-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 262

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Intervention	Tueo Program	-

Primary Outcome Measures

Name	Time	Method
Change in ACT/C-ACT scores	Baseline and Week 16	Change in ACT/C-ACT scores from baseline to study end

Trial Locations

Locations (1)

Evidation Health; 🇺🇸 San Mateo, California, United States