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

Status: Recruiting
Location: See location...
Intervention Type: Behavioral
Study Type: Interventional
Study Phase: Not Applicable
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 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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 4
Healthy Volunteers: t
View:

∙ 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

Locations
United States
Illinois
Ann & Robert H Lurie Children's Hospital of Chicago
RECRUITING
Chicago
Contact Information
Primary
Kristin Kan, MD
kkan@luriechildrens.org
3122276110
Backup
Olivia Orr
oorr@luriechildrens.org
Time Frame
Start Date: 2025-03-14
Estimated Completion Date: 2027-01
Participants
Target number of participants: 80
Treatments
Experimental: Digital Asthma 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.
Active_comparator: Comparison
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.
Related Therapeutic Areas
Sponsors
Leads: Ann & Robert H Lurie Children's Hospital of Chicago
Collaborators: National Heart, Lung, and Blood Institute (NHLBI)

This content was sourced from clinicaltrials.gov

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