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Behavioral Intervention
Digital Intervention for Childhood Asthma (TEACCCH Trial)
Chicago, IL
N/A
Recruiting
Research Sponsored by Ann & Robert H Lurie Children's Hospital of Chicago
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
The child is between the ages of 4-11 years old at the time of recruitment.
The child (patient) has a diagnosis of asthma associated with a clinic visit in the electronic health record.
Must not have
The patient is prescribed a controller (preventive) or rescue inhaler medication to which the Hailie electronic sensor cannot affix.
Parent/guardian does not pass the test of understanding at study enrollment.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline, 1, 3, 6, 9, and 12 months.
Awards & highlights
No Placebo-Only Group
Summary
This trial will test a mobile health app and digital sensors with additional support for children with asthma and their parents. Some families will receive remote patient monitoring from an asthma coordinator, while others will just use the
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Who is the study for?
This trial is for parent-child pairs where the child has persistent or uncontrolled asthma. It's important that they have not been part of similar studies before and are comfortable using a mobile health app and digital sensors.Check my eligibility
What is being tested?
The study tests a digital asthma care approach. Half the participants will use an mHealth app with remote monitoring by an asthma coordinator, while the other half will use the same technology without active support to track inhaler usage.See study design
What are the potential side effects?
Since this trial involves a non-medical intervention focusing on technology use, there aren't direct medical side effects. However, participants may experience issues related to tech usability or data privacy concerns.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My child is between 4 and 11 years old.
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My child has asthma diagnosed and recorded in their health record.
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My child uses a daily asthma inhaler with steroids or a steroid and long-acting beta agonist.
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Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
My inhaler can't attach to a Hailie sensor.
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My parent/guardian understands the study details.
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I am no longer working at LCH.
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Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ baseline, 1, 3, 6, 9, and 12 months.
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline, 1, 3, 6, 9, and 12 months.
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Study Feasibility
Secondary study objectives
Asthma Symptom Control
Inhaled Corticosteroid Adherence
Intervention Feasibility
Awards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: Digital Asthma InterventionExperimental Treatment1 Intervention
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.
Group II: ComparisonActive Control1 Intervention
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.
Find a Location
Closest Location:Ann & Robert H Lurie Children's Hospital of Chicago· Chicago, IL· 276 miles
Who is running the clinical trial?
National Heart, Lung, and Blood Institute (NHLBI)NIH
3,978 Previous Clinical Trials
47,866,124 Total Patients Enrolled
6 Trials studying Childhood Asthma
1,905 Patients Enrolled for Childhood Asthma
Ann & Robert H Lurie Children's Hospital of ChicagoLead Sponsor
274 Previous Clinical Trials
5,183,530 Total Patients Enrolled