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NCT Number: NCT07512622

Asthma Ctrl SMART Trial

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.

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Key information

Conditions

Asthma in Children Asthma Asthma Chronic Bronchial Diseases Hypersensitivity Hypersensitivity, Immediate Immune System Diseases Lung Diseases Lung Diseases, Obstructive Respiratory Hypersensitivity Respiratory Tract Diseases

Age range

12 year–18 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Colorado AMC, Aurora, Colorado, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • 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

Treatment and study plan

Asthma Ctrl

Behavioral

Individualized adherence feedback via text messaging intervention based on real-time adherence monitoring

Asthma Ctrl+

Behavioral

Interventions described in Asthma Ctrl with problem-solving skills training via four telehealth sessions to occur every other week.

Control

Behavioral

Asthma management application providing education and automated reminders

Primary outcomes

  1. 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%.

Secondary outcomes

  1. Composite Asthma Severity Index (CASI)

    Time frame: Baseline assessment and then once a month for 12 months

    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.

  2. Asthma Control: Asthma Control Test (ACT)

    Time frame: Baseline assessment and then once a month for 12 months

    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

  3. Lung Function

    Time frame: Baseline and then once a month for 12 months

    Mobile spirometry to capture Forced Vital Capacity (FVC)

  4. Lung Function

    Time frame: Baseline and then once a month for 12 months.

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

  5. Lung Function

    Time frame: Baseline and then once a month for 12 months

    Mobile spirometry to capture Ration of Forced Expiratory Volume to Forced Vital Capacity (FEV1/FVC)

  6. Lung Function

    Time frame: Baseline and then once a month for 12 months

    Mobile Spirometry to capture Forced Expiratory Flow (FEF)

  7. Healthcare Utilization

    Time frame: Baseline assessment and then once a month for 12 months.

    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.

  8. Asthma Exacerbations

    Time frame: Baseline assessment and then once a month for 12 months.

    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.

Other outcomes

  1. Demographic Questionnaire

    Time frame: Baseline

    Adolescents and caregivers will complete a questionnaire to collect information about demographics.

  2. Hardship questionnaire

    Time frame: Baseline assessment and then at 6 months and 12 months

    Adolescents and caregivers will complete a 19-item validated questionnaire designed to capture current hardships.

  3. Asthma Knowledge

    Time frame: Baseline assessment and then at 6 months and 12 months

    Adolescents will complete a 13-item a questionnaire assessing the extent to which they agree with facts or information about asthma to provide a measure of health beliefs.

  4. Adolescent Medication Barriers Scale (AMBS)

    Time frame: Baseline assessment and then at 6 months and 12 months.

    16 (adolescent) item report assessing perceived barriers to treatment adherence using a 5-point Likert scale from 1 ("strongly disagree") to 5 ("strongly agree"). Higher scores on the AMBS are linked to poorer adherence and increased medical complications.

Study contacts

Contact information is provided by the study sponsor or research team.

Rachelle R Ramsey

CONTACT

[email protected]

513-803-8348

Sponsors and collaborators

Lead sponsor

Children's Hospital Medical Center, Cincinnati

Other

Collaborators

  • National Heart, Lung, and Blood Institute (NHLBI)

Registry information

Official study title

Improving Medication Adherence Using an Adaptive mHealth Intervention in Adolescents With Asthma.

Important dates

Study start
2026
Primary completion
2030
Study completion
2030
First posted
Apr 6, 2026
Registry last updated
May 11, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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