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.
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
- Conditions the study is for
- Asthma in Children, Chronic Diseases in Children
- What is being tested?
- Digital Asthma Intervention and Comparison Group
- Type of treatment
- Lifestyle or therapy programme
- 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
- Caregivers must be at least 18 years old (defined as parent or legal guardian)
- The child (patient) has a diagnosis of asthma associated with a clinic visit in the electronic health record
- The child is between the ages of 4-17 years old at the time of recruitment
- The study is interested in the self-management of asthma by caregivers, whom are still primarily responsible for their child's chronic disease management.
- 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.
- 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).
- Persistent or un controlled asthma based on NHLBI guidelines40; Any 1 of the following:
- In past month, >2 days per week with asthma symptoms
- >2 days per week with rescue medication use
- >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)
- >2 asthma episodes during the past year that required systemic corticosteroids
- The child is a patient in Primary Care Uptown, Primary Care Deming, Allergy, or Pulmonary Clinics at LCH
PARENT-CHILD PAIR EXCLUSION CRITERIA
- The caregiver has a smartphone that is not compatible with the Hailie® app.
- The patient is prescribed a controller (preventive) or rescue inhaler medication to which the Hailie electronic sensor cannot affix.
- The caregiver is unable to speak and understand English.
- With this trial, the intent is to first establish feasibility and broaden to different languages in future.
- 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.
- The family has active Department of Child and Family Services (DCFS) involvement
- The participant is enrolled in another asthma intervention study at the time of enrollment to this study.
- Child or sibling living in the same home was previously enrolled in this study.
- Consent is not obtained from the parent/guardian.
- Parent/guardian does not pass the test of understanding at study enrollment.
HEALTH CARE PROVIDER INCLUSION CRITERIA (IMPLEMENTATION OUTCOMES)
- Participant is an employee of LCH system
- Works at or supports the operations of Primary Care Uptown, Primary Care Deming, Allergy, or Pulmonary Clinics at LCH
- Able to provide informed consent
HEALTH CARE PROVIDER EXCLUSION CRITERIA (IMPLEMENTATION OUTCOMES)
- 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
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.
- Conditions
- Asthma in Children, Chronic Diseases in Children
- 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 group | Role | What they receive |
|---|---|---|
| Digital Asthma Intervention | Experimental | The 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 |
| Comparison | Active comparator | The 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.
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)
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
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.
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.
- First posted11 Feb 2025
- Study start14 Mar 2025
- Primary completionApr 2027 (estimated)
- Study completionApr 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Asthma in ChildrenStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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)
Sponsor and investigators
- Lead sponsor
- Ann & Robert H Lurie Children's Hospital of Chicago
- Sponsor type
- University, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI)
- Responsible party
- Principal investigator, Kristin Kan, Ann & Robert H Lurie Children's Hospital of Chicago
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
Study at a glance
From the registry record, last updated by the sponsor on 26 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Technology-Enhanced Asthma Care in Children at Clinic and Home (TEACCCH) Study (Aim 2): A Feasibility Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT06820593
- Acronym / sponsor ID
- TEACCCH / 2023-6333
- Conditions
- Asthma in Children, Chronic Diseases in Children
- Keywords
- Digital Health
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Ann & Robert H Lurie Children's Hospital of ChicagoUniversity, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI)
- Study start
- 14 Mar 2025 (actual)
- Primary completion
- Apr 2027 (estimated)
- Study completion
- Apr 2027 (estimated)
- First posted
- 11 Feb 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Digital Asthma Intervention | Experimental | Behavioral: Digital Asthma InterventionThe 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. |
| Comparison | Active comparator | Behavioral: Comparison GroupThe 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. |
Who may qualify
- Ages
- 4 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Digital Asthma InterventionThe 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. | Behavioural | Digital Asthma Intervention |
| Comparison GroupParticipants 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. | Behavioural | Comparison |
Primary outcome
Study Feasibility
Time frame: Baseline, 12 months
Measured as the number and percentage of participants who complete the 12-month visit, between intervention and comparison group.
3 secondary outcomes
Intervention Feasibility
Time frame: 12 months
Asthma Symptom Control
Time frame: Baseline, 1, 3, 6, 9, and 12 months.
Inhaled Corticosteroid Adherence
Time frame: Continuously through the 12 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Oct 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
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.