Asthma (Diagnosis)NCT07301060
Optimizing a Sensor-Enabled mHealth Intervention for Adolescents With Suboptimal Asthma Control
A study of Asthma (Diagnosis), run by University of Kansas at 2 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 13 to 17 years
- Conditions the study is for
- Asthma (Diagnosis)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 160 participants
- Where
- 2 sitesUnited States
- Study dates
- 22 Dec 2025to 15 Jan 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 13 to 17 years
- All sexes
- No healthy volunteers
- Child
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.
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
United States2 sites, 2 recruiting
- Recruiting
Nemours Children's Health
Jacksonville, Florida, 32207
David A. Fedele, Ph.D., ABPP, 904-697-2610, david.fedele@nemours.org
- Recruiting
University of Kanas
Lawrence, Kansas, 66045
Christopher C Cushing, Ph.D., 785-864-0713, christopher.cushing@ku.edu
Christopher C Cushing, Ph.D.
About this study
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.
Read more
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)
- Being tested
- Sensor-Enabled mHealth Intervention for Adolescents with Suboptimal Asthma Control, mHealth standard of care control condition
- Keywords
- Asthma, Adolescent, Digital Health, mHealth
- Medical subject headings
- Asthma, Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sensor-Enabled mHealth Intervention for Adolescents with Suboptimal Asthma ControlBehavioural
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 conditionBehavioural
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 group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Behavioral: mHealth standard of care control condition |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 6 months
Usability
System Usability Scale
Measured: 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.
Measured: 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.
Measured: 6 months
Secondary outcomes (2)
Asthma Control Test
The Asthma Control Test (ACT) is a brief, standardized patient-reported outcome measure used to assess current asthma control from the patient's perspective. It is widely used in clinical practice and research to monitor symptom control and guide treatment decisions.
The ACT contains 5 items assessing:
Frequency of shortness of breath Nighttime awakenings due to asthma Interference with daily activities Use of rescue medication Overall self-rating of asthma control Response format and scoring Each item is rated on a 5-point Likert scale Total score ranges from 5 to 25 25 = completely controlled 20-24 = well controlled <20 = not well controlled (often used as a clinical cutoff) Higher scores indicate better asthma control
Measured: Baseline, 3 months, 6 months
Pediatric Asthma Quality of Life Questionnaire
The Pediatric Asthma Quality of Life Questionnaire (PAQLQ) is a disease-specific, patient-reported outcome measure designed to assess how asthma affects the daily functioning and well-being of children.
The standard PAQLQ contains 23 items across three domains:
Symptoms (10 items) Assesses the frequency and severity of asthma symptoms such as wheezing, shortness of breath, chest tightness, coughing, and nocturnal symptoms.
Activity Limitation (5 items) Measures limitations in physical, social, and daily activities due to asthma. Three activities are individualized: each child identifies activities most affected by their asthma.
Two items assess general activity limitations. Emotional Function (8 items) Captures emotional responses to asthma, including frustration, fear, concern, anger, or feeling different from peers.
Measured: Baseline, 3 months, 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Dec 2025
- Study start22 Dec 2025 (estimated)
- Primary completion31 Dec 2027 (estimated)
- Study completion15 Jan 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Asthma (Diagnosis)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 160 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Kansas
- Sponsor type
- University, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07301060
- Sponsor's protocol ID
- STUDY00150433
- Other IDs
- R34HL167214
- Status last verified
- Dec 2025
- First submitted
- 18 Dec 2025
- Last updated
- 24 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Optimizing a Sensor-Enabled mHealth Intervention for Adolescents With Suboptimal Asthma Control
- ClinicalTrials.gov ID
- NCT07301060
- Acronym / sponsor ID
- STUDY00150433
- Conditions
- Asthma (Diagnosis)
- Keywords
- Asthma, Adolescent, Digital Health, mHealth
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 160 participants (estimated)
- Lead sponsor
- University of KansasUniversity, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI)
- Study start
- 22 Dec 2025 (estimated)
- Primary completion
- 31 Dec 2027 (estimated)
- Study completion
- 15 Jan 2028 (estimated)
- First posted
- 24 Dec 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| ReACT Intervention Arm | Experimental | Behavioral: Sensor-Enabled mHealth Intervention for Adolescents with Suboptimal Asthma ControlIn 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. |
| mHealth standard of care control | Active comparator | Behavioral: mHealth standard of care control conditionIn this condition participants will use a sensor to passively monitor adherence, receive general asthma education, and report on their asthma symptoms. |
Who may qualify
- Ages
- 13 to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Sensor-Enabled mHealth Intervention for Adolescents with Suboptimal Asthma ControlParticipants 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. | Behavioural | ReACT Intervention Arm |
| mHealth standard of care control conditionParticipants 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. | Behavioural | mHealth standard of care control |
Primary outcome
Feasibility of Recruitment
Time frame: 6 months
We will compute frequency statistics to ensure we met our recruitment goal of 50% of the sample self-identifying as a racial/ethnic minority.
Retention
Time frame: 6 months
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.
Engagement
Time frame: 6 months
Engagement will be considered a success if the intervention and control groups complete an average of 4/7 (57%) symptom monitoring messages each week.
Acceptability
Time frame: 6 months
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.
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.
System Usability Scale
Burden
Time frame: 6 months
We will use the Perceived Ease of Use subscale of the ITUES to measure burden. The subscale consists of 5 items.
Qualitative Acceptability
Time frame: 6 months
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.
2 secondary outcomes
Asthma Control Test
Time frame: Baseline, 3 months, 6 months
Pediatric Asthma Quality of Life Questionnaire
Time frame: Baseline, 3 months, 6 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Dec 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study of Asthma (Diagnosis), run by University of Kansas at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 24 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Christopher C. Cushing, Ph.D. (785-864-0713, christopher.cushing@ku.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Feasibility of Recruitment (time frame: 6 months). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Dec 2025.