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

Official title

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

Overview

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.

Interventions

• Behavioral Digital Asthma Intervention
  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.
• Behavioral Comparison Group
  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.

Primary outcome measures

• Study Feasibility [Time frame: Baseline, 12 months]

Secondary outcome measures (3)

• 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]

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 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.

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Open label

Primary purpose

Supportive care

Study locations

United States · 1 center

• Ann & Robert H Lurie Children's Hospital of Chicago — Chicago

Identifiers

NCT: NCT06820593 · 2023-6333 · K23HL157615

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗