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New treatment option for Asthma in Children
Official title Technology-Enhanced Asthma Care in Children at Clinic and Home Study
ClinicalTrials.gov ID: NCT06820593
What this study is testing
- What it's testing
- 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).
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 4 and older. Healthy volunteers may be eligible.
You may be able to join if
- 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...
- 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...
- 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.
You likely can't join if
- 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. a. With this trial, the intent is to first establish feasibility and broaden to different...
- The child has clinically significant, comorbid diagnoses, such as cystic fibrosis, cyanotic heart disease, or bronchopulmonary dysplasia, that could...
- 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.
See the full eligibility criteria
- 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 1. Caregivers must be at least 18 years...
- 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...
- 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...
- \>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
- 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. a. 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) 1\. Participant departs LCH and is no longer an active employee at the time of assessment
The study team makes the final eligibility decision.
Where it's taking place
- Chicago, Illinois, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 4 years and older. Healthy volunteers may be eligible. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Chicago, Illinois, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.