Asthma in ChildrenNCT07512622
Asthma Ctrl SMART Trial
A study testing Asthma Ctrl and Asthma Ctrl+ in people with Asthma in Children and Asthma Chronic, run by Children's Hospital Medical Center, Cincinnati at 2 sites in United States.
Trial summary
The primary objective is to examine the efficacy of an mHealth adherence intervention (Asthma Ctrl) on adherence to daily inhaled corticosteroids as measured by electronically monitored adherence in adolescents with asthma. The secondary objective is to compare the effectiveness of three intervention strategies: 1. Read more about this study
- Who is it for?
- Ages 12 to 18 years
- Conditions the study is for
- Asthma in Children, Asthma Chronic
- What is being tested?
- Asthma Ctrl and Asthma Ctrl+
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 389 participants
- Where
- 2 sitesUnited States
- Study dates
- 15 Oct 2026to 1 Jun 2030
- 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 12 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Patient age between 12-18 years
- Patient is diagnosed with severe-persistent or moderate-persistent asthma per NAEPP asthma guidelines
- Patient is prescribed at least one daily inhaled controller medication or a daily combination inhaled corticosteroid and long-acting beta-agonist and a beta-agonist bronchodilator
- English fluency for patient, caregiver, and clinician
Who cannot join
- Significant cognitive deficits that may interfere with comprehension per medical team or chart review
- Diagnosis of serious mental illness (e.g., schizophrenia)
- Diagnosis of pervasive developmental disorder
- Active chronic disease apart from asthma or allergic disease (e.g. Bronchiectasis, pulmonary hypertension, and moderate or severe tracheomalacia)
- Patient receives school administered daily controller medication at the time of the enrollment visit
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
University of Colorado AMC
Aurora, Colorado, 80262
Heather DeKeyser
Heather De Keyser
Cincinnati Children's Hospital Medical Center
Cincinnati, Ohio, 45229
Rachelle R Ramsey, 513-803-8348, rachelle.ramsey@cchmc.org
Rachelle R Ramsey
About this study
Official title: Improving Medication Adherence Using an Adaptive mHealth Intervention in Adolescents With Asthma.
The primary objective is to examine the efficacy of an mHealth adherence intervention (Asthma Ctrl) on adherence to daily inhaled corticosteroids as measured by electronically monitored adherence in adolescents with asthma. The secondary objective is to compare the effectiveness of three intervention strategies: 1. asthma management app (control); 2. Asthma Ctrl; 3. Asthma Ctrl+ on adherence, lung function, and health care utilization at post-intervention and 1- and 6-month follow-up. The third objective is to explore and contrast different challenges and combinations of challenges to identify which are most impactful in determining response to the three intervention strategies.
Read the detailed description
Our goal is to evaluate our promising mHealth intervention (Asthma Ctrl) that is easily accessible and tailored based on adherence barriers and to examine predictors of treatment response. In this multi-site R01 with Children's Hospital Colorado, the study investigators will conduct a 2-stage sequential, multiple assignment, randomized trial (SMART) to evaluate the effectiveness of our mHealth intervention strategies for improving adherence to daily inhaled corticosteroids in adolescents with asthma. Following a baseline period, adolescents will be randomized to a mHealth asthma management app (control group) or Asthma Ctrl, a text-messaging intervention providing adherence feedback based on adherence monitoring (treatment) for SMART Stage 1. Participants will be excluded from the study if they have an adherence that is >68%. For SMART Stage 2, adolescents randomized to the treatment group who demonstrate non-adherence (≤68% adherence; non-response) will undergo a second randomization to receive either 1) continued Asthma Ctrl (text messaging) or 2) Asthma Ctrl+ (Asthma Ctrl augmented with a problem-solving intervention delivered via telehealth). Thus, there are three intervention strategies that will be tested in this SMART: #1 control condition, #2 treatment, and #3 adapted treatment after Stage 2 and at follow-up (1 and 6 months). This innovative SMART design will address objectives described in the brief summary.
- Conditions
- Asthma in Children, Asthma Chronic
- Being tested
- Asthma Ctrl, Asthma Ctrl+, Control
- Keywords
- sequential, multiple assignment, randomized trial (SMART), adherence, asthma, adolescents
- Medical subject headings
- Asthma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Asthma CtrlBehavioural
Individualized adherence feedback via text messaging intervention based on real-time adherence monitoring
Asthma Ctrl+Behavioural
Interventions described in Asthma Ctrl with problem-solving skills training via four telehealth sessions to occur every other week.
ControlBehavioural
Asthma management application providing education and automated reminders
| Study group | Role | What they receive |
|---|---|---|
| Control | Active comparator | Participants will receive access to an asthma management application providing education and automated reminders Receives: Behavioral: Control |
| Asthma Ctrl | Experimental | Participants will receive the Asthma Ctrl intervention Receives: Behavioral: Asthma Ctrl |
| Asthma Ctrl+ | Experimental | Participants will receive the Asthma Ctrl+ intervention Receives: Behavioral: Asthma Ctrl+ |
What is being measured
The primary outcome is the main question the study is designed to answer.
Electronically Monitored Controller Medication Adherence
Monthly adherence rates will be calculated by dividing the number of doses recorded by the electronic monitor by the total number of prescribed doses; the rate is then multiplied by 100 to determine the percentage. For patients prescribed Single Maintenance and Reliever Therapy, per the new asthma guidelines, the study investigators will assume that initial doses taken are for prevention and adherence will be capped at 100%.
Measured: 12 months
Secondary outcomes (8)
Composite Asthma Severity Index (CASI)
A weighted score comprised of:
- number of days with symptoms and albuterol use in past 2 weeks
- number of nights with symptoms and albuterol use in past 2 weeks
- Type/dose of controller medication
- Exacerbations (i.e., prednisone burst, hospitalizations) in last 2 months
The CASI score, ranging from 0 to 20 points, includes 5 domains: day symptoms and albuterol use, night symptoms and albuterol use, controller treatment, lung function measures, and exacerbations. The CASI is designed for children and adults ages 6 and older. A CASI score in the range of 0 to 3 indicates low severity. A CASI score greater than 3 may indicate medium to high asthma severity.
Measured: Baseline assessment and then once a month for 12 months
Asthma Control: Asthma Control Test (ACT)
Five-item adolescent self-report, 4-week recall of frequency of asthma symptoms, use of rescue medications, effect of asthma on daily functioning, perception of asthma control. Items are rated using a 5-point scale. The total score ranges from 5 to 25. A score of 19 or less indicates that asthma may not be well controlled, signaling the need for a review with a healthcare provide
Measured: Baseline assessment and then once a month for 12 months
Lung Function
Mobile spirometry to capture Forced Vital Capacity (FVC)
Measured: Baseline and then once a month for 12 months
Lung Function
Mobile Spirometry to capture Forced Expiratory Volume in 1 second (FEV1)
Measured: Baseline and then once a month for 12 months.
Lung Function
Mobile spirometry to capture Ration of Forced Expiratory Volume to Forced Vital Capacity (FEV1/FVC)
Measured: Baseline and then once a month for 12 months
Lung Function
Mobile Spirometry to capture Forced Expiratory Flow (FEF)
Measured: Baseline and then once a month for 12 months
Healthcare Utilization
Patients and caregivers will self-report the occurrence of asthma-related emergency department and urgent care visits, hospital admissions, and ICU admissions in the past month. Study staff will also review the patient's medical chart for the above information as well as asthma-intubation.
Measured: Baseline assessment and then once a month for 12 months.
Asthma Exacerbations
Adolescents will provide a two-week recall of their use of oral steroids to treat an exacerbation. Study staff will also review the medical chart for this information.
Measured: Baseline assessment and then once a month for 12 months.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Apr 2026
- Study start15 Oct 2026 (estimated)
- Primary completion1 Jan 2030 (estimated)
- Study completion1 Jun 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Asthma in ChildrenStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Model description
- Sequential, multiple assignment, randomized trial
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 389 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Children's Hospital Medical Center, Cincinnati
- Sponsor type
- University, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI)
- Responsible party
- Sponsor
- Investigators
- Rachelle R Ramsey, Principal investigator, Children's Hospital Medical Center, Cincinnati
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07512622
- Sponsor's protocol ID
- 2024-0434
- Other IDs
- 1R01HL172827-01A1
- Status last verified
- Oct 2026
- First submitted
- 26 Mar 2026
- Last updated
- 2 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: Sufficient data from this project will be preserved to enable sharing via BioLINCC. The study investigators will share summary data (a less detailed data table) with data that is of sufficient quality to validate and replicate research findings described in the Aims.
Study at a glance
From the registry record, last updated by the sponsor on 2 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Improving Medication Adherence Using an Adaptive mHealth Intervention in Adolescents With Asthma.
- ClinicalTrials.gov ID
- NCT07512622
- Acronym / sponsor ID
- 2024-0434
- Conditions
- Asthma in Children, Asthma Chronic
- Keywords
- sequential, multiple assignment, randomized trial (SMART), adherence, asthma, adolescents
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 389 participants (estimated)
- Lead sponsor
- Children's Hospital Medical Center, CincinnatiUniversity, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI)
- Study start
- 15 Oct 2026 (estimated)
- Primary completion
- 1 Jan 2030 (estimated)
- Study completion
- 1 Jun 2030 (estimated)
- First posted
- 6 Apr 2026 (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.
The primary objective is to examine the efficacy of an mHealth adherence intervention (Asthma Ctrl) on adherence to daily inhaled corticosteroids as measured by electronically monitored adherence in adolescents with asthma. The secondary objective is to compare the effectiveness of three intervention strategies: 1. asthma management app (control); 2. Asthma Ctrl; 3. Asthma Ctrl+ on adherence, lung function, and health care utilization at post-intervention and 1- and 6-month follow-up. The third objective is to explore and contrast different challenges and combinations of challenges to identify which are most impactful in determining response to the three intervention strategies.
Detailed description
Our goal is to evaluate our promising mHealth intervention (Asthma Ctrl) that is easily accessible and tailored based on adherence barriers and to examine predictors of treatment response. In this multi-site R01 with Children's Hospital Colorado, the study investigators will conduct a 2-stage sequential, multiple assignment, randomized trial (SMART) to evaluate the effectiveness of our mHealth intervention strategies for improving adherence to daily inhaled corticosteroids in adolescents with asthma. Following a baseline period, adolescents will be randomized to a mHealth asthma management app (control group) or Asthma Ctrl, a text-messaging intervention providing adherence feedback based on adherence monitoring (treatment) for SMART Stage 1. Participants will be excluded from the study if they have an adherence that is >68%. For SMART Stage 2, adolescents randomized to the treatment group who demonstrate non-adherence (≤68% adherence; non-response) will undergo a second randomization to receive either 1) continued Asthma Ctrl (text messaging) or 2) Asthma Ctrl+ (Asthma Ctrl augmented with a problem-solving intervention delivered via telehealth). Thus, there are three intervention strategies that will be tested in this SMART: #1 control condition, #2 treatment, and #3 adapted treatment after Stage 2 and at follow-up (1 and 6 months). This innovative SMART design will address objectives described in the brief summary.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Single blind (investigator)
- Number of arms
- 3
- Model description
- Sequential, multiple assignment, randomized trial
| Arm | Type | Receives |
|---|---|---|
| Control | Active comparator | Behavioral: ControlParticipants will receive access to an asthma management application providing education and automated reminders |
| Asthma Ctrl | Experimental | Behavioral: Asthma CtrlParticipants will receive the Asthma Ctrl intervention |
| Asthma Ctrl+ | Experimental | Behavioral: Asthma Ctrl+Participants will receive the Asthma Ctrl+ intervention |
Who may qualify
- Ages
- 12 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (4 listed)
- Patient age between 12-18 years
- Patient is diagnosed with severe-persistent or moderate-persistent asthma per NAEPP asthma guidelines
- Patient is prescribed at least one daily inhaled controller medication or a daily combination inhaled corticosteroid and long-acting beta-agonist and a beta-agonist bronchodilator
- English fluency for patient, caregiver, and clinician
Key exclusion criteria (5 listed)
- Significant cognitive deficits that may interfere with comprehension per medical team or chart review
- Diagnosis of serious mental illness (e.g., schizophrenia)
- Diagnosis of pervasive developmental disorder
- Active chronic disease apart from asthma or allergic disease (e.g. Bronchiectasis, pulmonary hypertension, and moderate or severe tracheomalacia)
- Patient receives school administered daily controller medication at the time of the enrollment visit
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 |
|---|---|---|
| Asthma CtrlIndividualized adherence feedback via text messaging intervention based on real-time adherence monitoring | Behavioural | Asthma Ctrl |
| Asthma Ctrl+Interventions described in Asthma Ctrl with problem-solving skills training via four telehealth sessions to occur every other week. | Behavioural | Asthma Ctrl+ |
| ControlAsthma management application providing education and automated reminders | Behavioural | Control |
Primary outcome
Electronically Monitored Controller Medication Adherence
Time frame: 12 months
Monthly adherence rates will be calculated by dividing the number of doses recorded by the electronic monitor by the total number of prescribed doses; the rate is then multiplied by 100 to determine the percentage. For patients prescribed Single Maintenance and Reliever Therapy, per the new asthma guidelines, the study investigators will assume that initial doses taken are for prevention and adherence will be capped at 100%.
8 secondary outcomes
Composite Asthma Severity Index (CASI)
Time frame: Baseline assessment and then once a month for 12 months
Asthma Control: Asthma Control Test (ACT)
Time frame: Baseline assessment and then once a month for 12 months
Lung Function
Time frame: Baseline and then once a month for 12 months
Lung Function
Time frame: Baseline and then once a month for 12 months.
Lung Function
Time frame: Baseline and then once a month for 12 months
Lung Function
Time frame: Baseline and then once a month for 12 months
Healthcare Utilization
Time frame: Baseline assessment and then once a month for 12 months.
Asthma Exacerbations
Time frame: Baseline assessment and then once a month for 12 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 2 Oct 2026.
- Individual participant dataSharing planned: Undecided. Sufficient data from this project will be preserved to enable sharing via BioLINCC. The study investigators will share summary data (a less detailed data table) with data that is of sufficient quality to validate and replicate research findings described in the Aims.
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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.
Rachelle R Ramsey principal investigator
Children's Hospital Medical Center, Cincinnati
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Asthma Ctrl and Asthma Ctrl+ in people with Asthma in Children and Asthma Chronic, run by Children's Hospital Medical Center, Cincinnati 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?
The sponsor lists 4 inclusion and 5 exclusion criteria. 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: opening soon, as of the sponsor's last update on 2 Oct 2026. 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 Rachelle R Ramsey (513-803-8348, rachelle.ramsey@cchmc.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Electronically Monitored Controller Medication Adherence (time frame: 12 months). 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 2 Oct 2026.