Optimizing a Sensor-Enabled mHealth Intervention for Adolescents With Suboptimal Asthma Control
NCT ID: NCT07301060
Last Updated: 2025-12-24
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
160 participants
INTERVENTIONAL
2025-12-22
2028-01-15
Brief Summary
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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.
Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
SUPPORTIVE_CARE
SINGLE
Study Groups
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ReACT Intervention Arm
In this condition, participants will receive the full ReACT behavior change intervention. They will use a sensor to passively monitor adherence, receive general asthma education, and report on their asthma symptoms. Participants will receive training in techniques of problem-solving. In addition, they will receive ongoing text messages with adherence feedback and encouragement tailored to their pattern of adherence and symptoms.
Sensor-Enabled mHealth Intervention for Adolescents with Suboptimal Asthma Control
Participants assigned to ReACT will contribute passively monitored sensor data to track their adherence to their asthma regimen. They will also report on their symptoms. These data will be used to provide tailored feedback and support delivered via text message. These messages will encourage adolescents to adhere to their asthma regimen and address barriers using problem-solving skills taught to them at baseline.
mHealth standard of care control
In this condition participants will use a sensor to passively monitor adherence, receive general asthma education, and report on their asthma symptoms.
mHealth standard of care control condition
Participants assigned to ReACT will contribute passively monitored sensor data to track their adherence to their asthma regimen. They will also report on their symptoms. Participants will be provided with general asthma education at baseline.
Interventions
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Sensor-Enabled mHealth Intervention for Adolescents with Suboptimal Asthma Control
Participants assigned to ReACT will contribute passively monitored sensor data to track their adherence to their asthma regimen. They will also report on their symptoms. These data will be used to provide tailored feedback and support delivered via text message. These messages will encourage adolescents to adhere to their asthma regimen and address barriers using problem-solving skills taught to them at baseline.
mHealth standard of care control condition
Participants assigned to ReACT will contribute passively monitored sensor data to track their adherence to their asthma regimen. They will also report on their symptoms. Participants will be provided with general asthma education at baseline.
Eligibility Criteria
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Inclusion Criteria
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.
13 Years
17 Years
ALL
No
Sponsors
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National Heart, Lung, and Blood Institute (NHLBI)
NIH
University of Kansas
OTHER
Responsible Party
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Locations
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Nemours Children's Health
Jacksonville, Florida, United States
University of Kanas
Lawrence, Kansas, United States
Countries
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Central Contacts
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Facility Contacts
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David A. Fedele, Ph.D., ABPP
Role: primary
Christopher C Cushing, Ph.D.
Role: primary
Other Identifiers
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STUDY00150433
Identifier Type: -
Identifier Source: org_study_id