Asthma Control Study

NCT ID: NCT03304067

Last Updated: 2018-07-17

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 262 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-10-03
• Study Completion Date: 2018-05-03

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.

Conditions

Childhood Asthma

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: HEALTH_SERVICES_RESEARCH
• Blinding Strategy: NONE

Study Groups

Intervention

Group Type: EXPERIMENTAL

Tueo Program

Intervention Type: 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.

Control

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

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.

Intervention Type: BEHAVIORAL

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Tueo Health

UNKNOWN

Sponsor Role: collaborator

Evidation Health

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Evidation Health

San Mateo, California, United States

Countries

United States

Other Identifiers

EH-005

Identifier Type: -

Identifier Source: org_study_id