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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.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record
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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+
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.

Rachelle R Ramsey contact

513-803-8348

rachelle.ramsey@cchmc.org

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

Other trials in United States

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.

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 groups in NCT07512622
Study groupRoleWhat they receive
ControlActive comparatorParticipants will receive access to an asthma management application providing education and automated reminders
Receives: Behavioral: Control
Asthma CtrlExperimentalParticipants will receive the Asthma Ctrl intervention
Receives: Behavioral: Asthma Ctrl
Asthma Ctrl+ExperimentalParticipants 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.

  1. 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)

  1. Composite Asthma Severity Index (CASI)

    A weighted score comprised of:

    1. number of days with symptoms and albuterol use in past 2 weeks
    2. number of nights with symptoms and albuterol use in past 2 weeks
    3. Type/dose of controller medication
    4. 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

  2. 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

  3. Lung Function

    Mobile spirometry to capture Forced Vital Capacity (FVC)

    Measured: Baseline and then once a month for 12 months

  4. Lung Function

    Mobile Spirometry to capture Forced Expiratory Volume in 1 second (FEV1)

    Measured: Baseline and then once a month for 12 months.

  5. 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

  6. Lung Function

    Mobile Spirometry to capture Forced Expiratory Flow (FEF)

    Measured: Baseline and then once a month for 12 months

  7. 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.

  8. 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.

  1. First posted6 Apr 2026
  2. Study start15 Oct 2026 (estimated)
  3. Primary completion1 Jan 2030 (estimated)
  4. Study completion1 Jun 2030 (estimated)

Resources

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)
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.

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?

On the ClinicalTrials.gov record for NCT07512622.

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.

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