Sensor-enabled smartphone support to help teens with poorly controlled asthma
Optimizing a Sensor-Enabled mHealth Intervention for Adolescents With Suboptimal Asthma Control
NA · University of Kansas · NCT07301060
This project will test whether a sensor-linked app (ReACT) can help 13–17-year-olds with suboptimal asthma control take their inhaled medicines and manage symptoms better.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 160 (estimated) |
| Ages | 13 Years to 17 Years |
| Sex | All |
| Sponsor | University of Kansas (other) |
| Locations | 2 sites (Jacksonville, Florida and 1 other locations) |
| Trial ID | NCT07301060 on ClinicalTrials.gov |
What this trial studies
Adolescents with persistent asthma and suboptimal control are enrolled and receive a sensor that attaches to their daily inhaled corticosteroid plus a smartphone app that monitors inhaler use and symptoms. The sensor-enabled intervention delivers tailored, in-the-moment prompts and problem-solving support, while a comparison group receives a standard mHealth control condition. The team tracks inhaler adherence, symptom reports, and asthma control over the study period to see if the adaptive, personalized approach improves outcomes. Participants must speak English, have their own smartphone, and meet age and medication compatibility criteria.
Who should consider this trial
Good fit: Ideal candidates are 13–17-year-olds with physician-verified persistent asthma, suboptimal control (ACT ≤19 or guideline-defined symptoms), a daily inhaled corticosteroid compatible with the sensor, who speak English and have their own smartphone.
Not a fit: Teens without a personal smartphone, with other lung diseases that affect breathing, currently enrolled in another asthma program, or with significant cognitive impairment are unlikely to benefit from this intervention.
Why it matters
Potential benefit: If successful, this approach could improve daily medication use and reduce asthma symptoms and flare-ups for participating teens.
How similar studies have performed: Prior sensor- and app-based asthma programs have generally improved inhaler adherence in adolescents and adults, though impacts on clinical outcomes have been mixed, so the approach is promising but not yet definitively proven.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion criteria for adolescents are: 1) they are between 13-17 years-old; 2) they have a physician-verified diagnosis of persistent asthma for at least 6 months; 3) they have suboptimal asthma control as defined by national asthma guidelines;5 4) they have a daily inhaled corticosteroid prescription that is compatible with the ReACT sensor; and 5) the adolescent-caregiver dyad speak and read English. Exclusion criteria are: 1) the adolescent is currently involved in an asthma management intervention beyond usual care; 2) the adolescent has a comorbid chronic health condition that may impact lung function (e.g., cystic fibrosis); 3) the adolescent has significant cognitive impairment or developmental delay that interferes with study completion, and 4) the adolescent does not have their own smart phone. Consistent with national asthma guidelines, we define suboptimal as control as a score of ≤19 on the Asthma Control Test (ACT) or by endorsing one or more of the following symptoms of on \>4 days in the past 2 weeks: (a) use of any short-acting beta-agonist medication, (b) experiencing asthma symptoms (i.e., wheezing, tightness of chest, coughing) during the day or night, (c) nighttime awakening due to asthma, or (d) activity limitation or school absence due to asthma.
Where this trial is running
Jacksonville, Florida and 1 other locations
- Nemours Children's Health — Jacksonville, Florida, United States (RECRUITING)
- University of Kanas — Lawrence, Kansas, United States (RECRUITING)
Study contacts
- Study coordinator: Christopher C. Cushing, Ph.D.
- Email: christopher.cushing@ku.edu
- Phone: 785-864-0713
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Asthma, Adolescent, Digital Health, mHealth