NCT07301060 · University of Kansas
Optimizing a Sensor-Enabled mHealth Intervention for Adolescents With Suboptimal Asthma Control
What this study is about
Asthma affects nearly 1 in 10 teenagers in the United States and can seriously impact their health and daily life. Teens are expected to manage their asthma by taking medications correctly and paying attention to symptoms, but this can be hard.
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Asthma affects nearly 1 in 10 teenagers in the United States and can seriously impact their health and daily life. Teens are expected to manage their asthma by taking medications correctly and paying attention to symptoms, but this can be hard. Adolescents are still developing the skills needed to manage their thoughts, feelings, and behaviors, and they often receive less help from parents during this time. Because each teen struggles in different ways and at different times, they need support that is personalized and responds to what is happening in the moment. Smartphones offer a promising way to help teens manage asthma well. However, most existing asthma apps do not use the full range of proven behavior-change strategies or adapt to what the teen is actually doing day to day. To address this gap, our team created Responsive Asthma Care for Teens (ReACT)-a system that collects data about each time an adolescent takes or misses a dose of medication and monitors symptoms. ReACT helps teens set goals, get feedback, notice barriers, and practice problem-solving skills. Early testing showed that teens liked ReACT and that it improved the skills needed for better asthma management. In this study, the investigators will pilot test ReACT in a study with 160 teens ages 13-17 who have poorly controlled asthma. Teens will be randomly assigned to use ReACT or a comparison intervention for six months. The comparison intervention provides basic asthma education and a place to log symptoms and medication use-similar to what they might normally receive in standard care. Investigators will look at how well the study procedures work across multiple sites and whether ReACT improves the skills that help teens manage their asthma. The investigators will also explore whether ReACT leads to better asthma control and quality of life. Teens will complete assessments at the start of the study, at three months, and at six months. The investigators will gather information through surveys and objective data such as medication use. By the end of this project, the investigators will know whether the ReACT system and study protocol are feasible and ready for a larger clinical trial, and will have early estimates of how much ReACT may improve asthma outcomes for teens.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
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
- Jacksonville, Florida
- Lawrence, Kansas
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Dec 24, 2025 · Source of record for eligibility and locations