160 Participants Needed

Sensor-Enabled mHealth for Asthma

Recruiting at 1 trial location
CC
Overseen ByChristopher C. Cushing, Ph.D.
Age: < 18
Sex: Any
Trial Phase: Academic
Sponsor: University of Kansas
Must be taking: Inhaled corticosteroids
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

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.

Are You a Good Fit for This Trial?

This trial is for teens aged 13-17 with a doctor-confirmed diagnosis of persistent asthma that isn't well-controlled, despite having a prescription for daily inhaled corticosteroids. Participants must be able to speak and read English along with their caregivers.

Inclusion Criteria

I have been diagnosed with asthma for at least 6 months.
I am between 13 and 17 years old.
Adolescent-caregiver dyad speak and read English
See 2 more

Exclusion Criteria

Does not have their own smart phone
Currently involved in an asthma management intervention beyond usual care
I have a chronic health condition like cystic fibrosis that affects my lungs.
See 1 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants are randomly assigned to use ReACT or a comparison intervention for six months. The ReACT system includes a sensor to monitor adherence, general asthma education, and feedback through text messages.

6 months
Assessments at baseline, 3 months, and 6 months

Follow-up

Participants are monitored for safety and effectiveness after treatment, with assessments of asthma control and quality of life.

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

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

Trial Overview

The study tests the ReACT system, an mHealth intervention using smartphones to help teens manage asthma by tracking medication use and symptoms. It's compared against standard care which includes basic education and symptom logging.

How Is the Trial Designed?

2

Treatment groups

Experimental Treatment

Active Control

Group I: ReACT Intervention ArmExperimental Treatment1 Intervention
Group II: mHealth standard of care controlActive Control1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

University of Kansas

Lead Sponsor

Trials
157
Recruited
332,000+

National Heart, Lung, and Blood Institute (NHLBI)

Collaborator

Trials
3,987
Recruited
47,860,000+