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Asthma in ChildrenTEACCCHNCT06820593

Technology-Enhanced Asthma Care in Children at Clinic and Home Study

A study testing Digital Asthma Intervention and Comparison Group in people with Asthma in Children and Chronic Diseases in Children, run by Ann & Robert H Lurie Children's Hospital of Chicago at 1 site in United States.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial summary

A randomized controlled trial with parent-child pairs of children with persistent or uncontrolled asthma. An intervention group (n=40 parent-child pairs) will receive the mobile health (mHealth) app and digital sensors with enhanced support from a population health manager role, hereinafter referred to as an asthma… Read more about this study

Who is it for?
Ages 4 years and olderHealthy volunteers can take part
What is being tested?
Digital Asthma Intervention and Comparison Group
Could I receive a placebo?
No, everyone receives an active treatment
How many people
80 participants
Where
1 siteUnited States
Study dates
14 Mar 2025to Apr 2027
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 4 years and older
  • All sexes
  • Healthy volunteers accepted
  • Child, Adult, Older adult

Inclusion into the study will not depend on sex, ethnicity, or race. We will monitor enrollment to ensure a diversity of sex and race/ethnicity are represented.

PARENT-CHILD PAIR INCLUSION CRITERIA

  1. Caregivers must be at least 18 years old (defined as parent or legal guardian)
  2. The child (patient) has a diagnosis of asthma associated with a clinic visit in the electronic health record
  3. The child is between the ages of 4-17 years old at the time of recruitment
  4. The study is interested in the self-management of asthma by caregivers, whom are still primarily responsible for their child's chronic disease management.
  5. Children younger than 4 years old will not be included in this study as the diagnosis of asthma is typically difficult to confirm in younger ages.
  6. The child is prescribed inhaled corticosteroid or corticosteroid/long-acting beta agonist combination for daily use. The patient can have an inhaled corticosteroid/long-acting beta agonist for both daily preventive and rescue use, as in Single Maintenance and Reliever Therapy (SMART).
  7. Persistent or un controlled asthma based on NHLBI guidelines40; Any 1 of the following:
  8. In past month, >2 days per week with asthma symptoms
  9. >2 days per week with rescue medication use
  10. >2 days per month with nighttime awakenings (for children who are not taking a controller asthma medication) OR >2 days per month with nighttime awakenings (for children who are currently taking a controller asthma medication)
  11. >2 asthma episodes during the past year that required systemic corticosteroids
  12. The child is a patient in Primary Care Uptown, Primary Care Deming, Allergy, or Pulmonary Clinics at LCH

PARENT-CHILD PAIR EXCLUSION CRITERIA

  1. The caregiver has a smartphone that is not compatible with the Hailie® app.
  2. The patient is prescribed a controller (preventive) or rescue inhaler medication to which the Hailie electronic sensor cannot affix.
  3. The caregiver is unable to speak and understand English.
  4. With this trial, the intent is to first establish feasibility and broaden to different languages in future.
  5. The child has clinically significant, comorbid diagnoses, such as cystic fibrosis, cyanotic heart disease, or bronchopulmonary dysplasia, that could interact with their assessment of asthma-related measures.
  6. The family has active Department of Child and Family Services (DCFS) involvement
  7. The participant is enrolled in another asthma intervention study at the time of enrollment to this study.
  8. Child or sibling living in the same home was previously enrolled in this study.
  9. Consent is not obtained from the parent/guardian.
  10. Parent/guardian does not pass the test of understanding at study enrollment.

HEALTH CARE PROVIDER INCLUSION CRITERIA (IMPLEMENTATION OUTCOMES)

  1. Participant is an employee of LCH system
  2. Works at or supports the operations of Primary Care Uptown, Primary Care Deming, Allergy, or Pulmonary Clinics at LCH
  3. Able to provide informed consent

HEALTH CARE PROVIDER EXCLUSION CRITERIA (IMPLEMENTATION OUTCOMES)

  1. Participant departs LCH and is no longer an active employee at the time of assessment

Trial locations and contacts

1 site in 1 country.

United States1 site
  • Ann & Robert H Lurie Children's Hospital of Chicago

    Chicago, Illinois, 60611

Other trials in United States

About this study

Official title: Technology-Enhanced Asthma Care in Children at Clinic and Home (TEACCCH) Study (Aim 2): A Feasibility Randomized Controlled Trial

A randomized controlled trial with parent-child pairs of children with persistent or uncontrolled asthma. An intervention group (n=40 parent-child pairs) will receive the mobile health (mHealth) app and digital sensors with enhanced support from a population health manager role, hereinafter referred to as an asthma coordinator, to provide remote patient monitoring (RPM). A comparison group (n=40 parent-child pairs) will receive the mHealth app and sensors without RPM support to silently collect inhaler use information without mHealth app features. The focus of this project is to evaluate the feasibility and acceptability of delivering a digital intervention for pediatric asthma with RPM in the outpatient setting.

Being tested
Digital Asthma Intervention, Comparison Group
Keywords
Digital Health

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Digital Asthma InterventionBehavioural

    The intervention consists of two main components-the mHealth app and sensors that is part of the Adherium's Hailie® Solution-and the remote patient monitoring (RPM), conducted in this intervention by an asthma coordinator.

  • Comparison GroupBehavioural

    Participants in the comparison group will receive the sensors for their ICS inhalers and a limited version of the app that only collects the sensor information by Bluetooth, without app features, and sends the information to the Hailie web portal. This passive adherence data collection will allow for comparison of the two groups' adherence rates without the mHealth app self-management support or RPM.

Study groups in NCT06820593
Study groupRoleWhat they receive
Digital Asthma InterventionExperimentalThe intervention group will receive digital tools (mHealth app and sensors) and remote patient monitoring (RPM) assisted by an asthma coordinator, that supports an enhanced standard of care for their child's asthma. The mHealth intervention includes inhaler sensors on their rescue (SABA) and ICS inhaler and a mHealth app on the parent's smartphone. The asthma coordinator, as part of the implementation plan, will respond to information from the mHealth app and contact the participants about their adherence and asthma symptom control, following an algorithm aligned with NAEPP guidelines.
Receives: Behavioral: Digital Asthma Intervention
ComparisonActive comparatorThe comparison group will also receive enhanced standard of asthma care. A research "control" version of the mHealth app will be downloaded to smartphones to allow for data collection from inhaler sensors, but the mHealth app will only silently transmit data to the web portal and not provide any app interaction or feedback to participants.
Receives: Behavioral: Comparison Group

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Study Feasibility

    Measured as the number and percentage of participants who complete the 12-month visit, between intervention and comparison group.

    Measured: Baseline, 12 months

Secondary outcomes (3)
  1. Intervention Feasibility

    Measured as the number and percentage of participants who synced their ICS sensor >80% of enrolled days in the trial, comparing intervention and comparison groups.

    Measured: 12 months

  2. Asthma Symptom Control

    Investigators will use the validated childhood Asthma Control Test (c-ACT) for assessing asthma symptom control, or Asthma Control Test (ACT) if the child becomes 12 years old during the study.

    Measured: Baseline, 1, 3, 6, 9, and 12 months.

  3. Inhaled Corticosteroid Adherence

    Investigators will compare overall raw ICS adherence rates between intervention and comparison groups using two-sample tests for proportions of mean daily proportion of taken doses over prescribed doses of ICS by study month, measured by digital sensors on the ICS. Participants' data will be included if they had at least 1 ICS inhaler actuation during the trial.

    Measured: Continuously through the 12 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted11 Feb 2025
  2. Study start14 Mar 2025
  3. Primary completionApr 2027 (estimated)
  4. Study completionApr 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Supportive care
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
80 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06820593
Sponsor's protocol ID
2023-6333
Other IDs
K23HL157615
Acronym
TEACCCH
Status last verified
Sep 2026
First submitted
24 Jan 2025
Last updated
26 Oct 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A study testing Digital Asthma Intervention and Comparison Group in people with Asthma in Children and Chronic Diseases in Children, run by Ann & Robert H Lurie Children's Hospital of Chicago at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 26 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Study Feasibility (time frame: Baseline, 12 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Oct 2026.

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