Asthma Ctrl SMART Trial
Improving Medication Adherence Using an Adaptive mHealth Intervention in Adolescents With Asthma.
Who can join
As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.
- Age
- 12 Years to 18 Years
- Sex
- All sexes
- Healthy volunteers
- Not accepted
- Compensation
- Not stated
Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.
What to expect
No one can promise a trial will help you personally — that is what the research is trying to find out.
What participation involves
Not stated in the study description — ask the study team about visits and procedures.
- Compensation
- Not stated
- Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
- Participants are monitored closely by the research team throughout the study.
- Some participants may receive access to an investigational treatment, which is still being studied.
- Your participation helps researchers learn whether this approach could help future patients.
About this study
In plain language
This study tests whether Asthma Ctrl, a mobile health program, helps teens with asthma take their daily inhaled steroid medicine. It compares an asthma management app, Asthma Ctrl, and Asthma Ctrl+ to see how they affect medicine use, lung function, and health care use. It is for teens ages 12–18 with ongoing moderate or severe 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.
Compensation is read from the study's own description and may be missing — always confirm with the study team.
Eligibility
Who can join
- You are 12–18 years old.
- You have ongoing moderate or severe asthma, based on national asthma guidelines.
- You are prescribed at least one daily inhaled asthma control medicine, or a daily inhaler combining a steroid and a long-acting airway-opening medicine plus a beta-agonist medicine to open your airways.
- You, your caregiver, and your clinician speak English fluently.
Who can't join
- You have major thinking or learning problems that may make it hard to understand the study, based on your medical team's review.
- You have a serious mental illness, such as schizophrenia.
- You have a pervasive developmental disorder, a condition that affects development and social skills.
- You have an active long-term illness other than asthma or an allergic condition.
- You receive your daily asthma control medicine at school when you enroll.
Simplified for readability. The official criteria below are what the study team uses.
Official eligibility criteria
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
Study sites (2)
CO
- University of Colorado AMC · Aurora, CO 80262Heather DeKeyser · Study contactHeather De Keyser · Principal investigatorMore trials in Aurora
OH
- Cincinnati Children's Hospital Medical Center · Cincinnati, OH 45229Rachelle R Ramsey · Study contact · 513-803-8348 · rachelle.ramsey@cchmc.orgRachelle R Ramsey · Principal investigatorMore trials in Cincinnati