Asthma Control Study

Childhood Asthma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03304067
• Other study ID #: EH-005
• Status: Completed
• Phase: N/A
• Start date: October 3, 2017
• Est. completion date: May 3, 2018

Study information

• Verified date: July 2018
• Source: Evidation Health
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 262
• Est. completion date: May 3, 2018
• Est. primary completion date: May 3, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Asthma
• Childhood Asthma

Intervention

Behavioral:
• Tueo Program
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.

Locations

Country	Name	City	State
United States	Evidation Health	San Mateo	California

Sponsors (2)

Lead Sponsor	Collaborator
Evidation Health	Tueo Health

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in ACT/C-ACT scores	Change in ACT/C-ACT scores from baseline to study end	Baseline and Week 16