Recruiting

ReACT

Sponsor:

University of Kansas

Code:

NCT07301060

Conditions

Asthma (Diagnosis)

Eligibility Criteria

Sex: All

Age: 13 - 17

Healthy Volunteers: Not accepted

Interventions

Sensor-Enabled mHealth Intervention for Adolescents with Suboptimal Asthma Control

mHealth standard of care control condition

Study Details

Brief summary:

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.

Conditions

Asthma (Diagnosis)

Study ID

NCT07301060

Start date

Dec 22, 2025

Status verified date

Dec, 2025

Completion date

Jan 15, 2028

Anticipated

Primary completion date

Dec 31, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 13 - 17

Healthy Volunteers: Not accepted

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.

Study Design

Enrollment

160 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Supportive Care

Interventions and Outcome Measures

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.

Interventions

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.

Primary outcome measure

  • Feasibility of Recruitment [ Time Frame: 6 months ]
  • Retention [ Time Frame: 6 months ]
  • Engagement [ Time Frame: 6 months ]
  • Acceptability [ Time Frame: 6 months ]
  • Usability [ Time Frame: The System Usabiltity Scale is a 10-item measure scored on a 5-point Likert scale. It assesses ease of use, learnability, user conficence, system complexity, and need for technical support. ]
  • Burden [ Time Frame: 6 months ]
  • Qualitative Acceptability [ Time Frame: 6 months ]

Central Contacts and Locations

Central contacts

Christopher C. Cushing, Ph.D.

785-864-0713christopher.cushing@ku.edu

Locations

Nemours Children's Health

Recruiting

Jacksonville, Florida, United States, 32207

Contacts

David A. Fedele, Ph.D., ABPP

904-697-2610david.fedele@nemours.org

University of Kanas

Recruiting

Lawrence, Kansas, United States, 66045

Contacts

Christopher C Cushing, Ph.D.

785-864-0713christopher.cushing@ku.edu

Principal Investigator:

Christopher C Cushing, Ph.D.

More Information

Sponsor

University of Kansas

Last update posted

Dec 24, 2025

Last verified

Dec, 2025

Keywords

  • Asthma
  • Adolescent
  • Digital Health
  • mHealth

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of Kansas on 2025-12-24.