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

Overview

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.

Interventions

• Behavioral 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.
• Behavioral 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 measures

• 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]

Secondary outcome measures (2)

• Asthma Control Test [Time frame: Baseline, 3 months, 6 months]
• Pediatric Asthma Quality of Life Questionnaire [Time frame: Baseline, 3 months, 6 months]

Eligibility criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Single blind

Primary purpose

Supportive care

Study locations

United States · 2 centers

• Nemours Children's Health — Jacksonville
• University of Kanas — Lawrence

Identifiers

NCT: NCT07301060 · STUDY00150433 · R34HL167214

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗