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Asthma Control Study

Primary Purpose

Childhood Asthma

Status

Completed

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

Tueo Program

About this trial

This is an interventional health services research trial for Childhood Asthma

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Evidation Health

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Intervention

Control

Arm Description

Outcomes

Primary Outcome Measures

Change in ACT/C-ACT scores

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

Secondary Outcome Measures

Full Information

NCT ID

NCT03304067

First Posted

October 2, 2017

Last Updated

July 13, 2018

Sponsor

Evidation Health

Collaborators

Tueo Health

1. Study Identification

Unique Protocol Identification Number

NCT03304067

Brief Title

Asthma Control Study

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

July 2018

Overall Recruitment Status

Completed

Study Start Date

October 3, 2017 (Actual)

Primary Completion Date

May 3, 2018 (Actual)

Study Completion Date

May 3, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Evidation Health

Collaborators

Tueo Health

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Childhood Asthma

7. Study Design

Primary Purpose

Health Services Research

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

262 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Intervention

Arm Type

Experimental

Arm Title

Control

Arm Type

No Intervention

Intervention Type

Behavioral

Intervention Name(s)

Tueo Program

Intervention Description

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 Outcome Measure Information:

Title

Change in ACT/C-ACT scores

Description

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

Time Frame

Baseline and Week 16

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

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

Facility Information:

Facility Name

Evidation Health

City

San Mateo

State/Province

California

ZIP/Postal Code

94401

Country

United States

12. IPD Sharing Statement

Plan to Share IPD

Learn more about this trial

Asthma Control Study

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