Optimizing a Sensor-Enabled mHealth Intervention for Adolescents With Suboptimal Asthma Control

Part of paid clinical trials in Jacksonville, Florida.

Sponsor
University of Kansas
Study ID
NCT07301060
Status
Recruiting
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Conditions

  • Asthma (Diagnosis)

Eligibility Criteria

Sex
ALL
Age
13 Years - 17 Years
Healthy Volunteers
Not accepted

Interventions

  • Sensor-Enabled mHealth Intervention for Adolescents with Suboptimal Asthma Control — BEHAVIORAL
    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 — BEHAVIORAL
    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.

Study Details

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.

Key Dates

Start date
Dec 22, 2025
Status verified
Dec 2025
Primary completion
Dec 31, 2027
Completion
Jan 15, 2028

Study Design

Enrollment
160 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE

Arms

  • Experimental: 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.
  • Active Comparator: 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.

Primary Outcome Measure

Feasibility of Recruitment [ Time Frame: 6 months ]

Central Contacts

Locations (2)

FacilityCityStateZIPSite coordinators
Nemours Children's HealthJacksonvilleFlorida32207
David A. Fedele, Ph.D., ABPP
[email protected]
904-697-2610
University of KanasLawrenceKansas66045
Christopher C Cushing, Ph.D.
[email protected]
785-864-0713
Christopher C Cushing, Ph.D. (PRINCIPAL_INVESTIGATOR)

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By research site
Nemours Children's Health· Jacksonville, FLUniversity of Kanas· Lawrence, KS

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