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

NCT07301060 | Recruiting

• 2 other identifiers: STUDY00150433R34HL167214
• Study Type: interventional
• Target: 160
• Locations: 1 country
• Sites: 2

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)

Keywords

Asthma; Adolescent; Digital Health; mHealth

Outcome Measures

Primary Outcomes (7)

• Feasibility of Recruitment

  We will compute frequency statistics to ensure we met our recruitment goal of 50% of the sample self-identifying as a racial/ethnic minority.

  6 months

• Retention

  Retention will be calculated for study arms and compared to the hypothesized rate in one-sample tests. Retention rates for sex subgroups within each arm will also be examined descriptively. Consistent with evidence-based medicine recommendations for evaluating clinical trials, our criterion for success is no more than 20% attrition.

  6 months

• Engagement

  Engagement will be considered a success if the intervention and control groups complete an average of 4/7 (57%) symptom monitoring messages each week.

  6 months

• Acceptability

  The ReAct Satisfaction Questionnaire is an 8-item modification of the Client Satisfaction Questionnaire that assesses overall participant satisfaction with the ReACT intervention. Participants respond on a 4-point scale.

  6 months

• Usability

  System Usability Scale

  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

  We will use the Perceived Ease of Use subscale of the ITUES to measure burden. The subscale consists of 5 items.

  6 months

• Qualitative Acceptability

  We will conduct qualitative interviews with 20% of participants who complete ReACT we will administer a semi-structured interview with questions about features, usability, general impressions, and solicit unstructured feedback.

  6 months

Secondary Outcomes (2)

• Asthma Control Test

  Baseline, 3 months, 6 months

• Pediatric Asthma Quality of Life Questionnaire

  Baseline, 3 months, 6 months

Other Outcomes (1)

• Adolescent Self-Regulatory Inventory

  Baseline, 3-months, 6-months

Study Arms (2)

ReACT Intervention Arm

EXPERIMENTAL

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.

Behavioral: Sensor-Enabled mHealth Intervention for Adolescents with Suboptimal Asthma Control

mHealth standard of care control

ACTIVE COMPARATOR

In this condition participants will use a sensor to passively monitor adherence, receive general asthma education, and report on their asthma symptoms.

Behavioral: mHealth standard of care control condition

Interventions

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.

mHealth standard of care control

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.

ReACT Intervention Arm

Eligibility Criteria

• Age: 13 Years - 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

Sponsors & Collaborators

• University of Kansas: lead
• National Heart, Lung, and Blood Institute (NHLBI): collaborator

Study Sites (2)

Nemours Children's Health

Jacksonville, Florida, 32207, United States

RECRUITING

University of Kanas

Lawrence, Kansas, 66045, United States

RECRUITING

MeSH Terms

Conditions

Asthma; Disease

Condition Hierarchy (Ancestors)

Bronchial Diseases; Respiratory Tract Diseases; Lung Diseases, Obstructive; Lung Diseases; Respiratory Hypersensitivity; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Christopher C. Cushing, Ph.D.

CONTACT

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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 18, 2025
• First Posted: December 24, 2025
• Study Start: December 22, 2025
• Primary Completion (Estimated): December 31, 2027
• Study Completion (Estimated): January 15, 2028
• Last Updated: December 24, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)