Asthma Control Study

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

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.

Study Overview

• Status: Completed
• Conditions: Childhood Asthma
• Intervention / Treatment: Behavioral: Tueo Program

• Study Type: Interventional
• Enrollment (Actual): 262
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • California
    • San Mateo, California, United States, 94401
      • Evidation Health

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.
No Intervention: Control

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Evidation Health
• Collaborators: Tueo Health

Study record dates

Study Major Dates

• Study Start (Actual): October 3, 2017
• Primary Completion (Actual): May 3, 2018
• Study Completion (Actual): May 3, 2018

Study Registration Dates

• First Submitted: October 2, 2017
• First Submitted That Met QC Criteria: October 2, 2017
• First Posted (Actual): October 6, 2017

Study Record Updates

• Last Update Posted (Actual): July 17, 2018
• Last Update Submitted That Met QC Criteria: July 13, 2018
• Last Verified: July 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Immune System Diseases; Lung Diseases; Hypersensitivity, Immediate; Bronchial Diseases; Lung Diseases, Obstructive; Respiratory Hypersensitivity; Hypersensitivity; Asthma
• Other Study ID Numbers: EH-005

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No