Asthma Ctrl SMART Trial
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age12-18
SponsorChildren's Hospital Medical Center, Cincinnati
About this 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.
Eligibility criteria
Qualifiers
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
Disqualifiers
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)
Trial design
Treatments tested in this trial
- Asthma Ctrl
- Asthma Ctrl+
- Control
Treatment groups
389 Participants
are divided into 3 treatment groupsSponsors and collaborators
Children's Hospital Medical Center, Cincinnati
Lead sponsor
National Heart, Lung, and Blood Institute (NHLBI)
Collaborator
Source ClinicalTrials.gov