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Not Yet Recruiting NCT07512622

Asthma Ctrl SMART Trial

Conditions: Asthma in Children, Asthma Chronic

Sex: All
Ages: 12 Years – 18 Years
Healthy volunteers: No
Phase: NA
Enrollment: 389
Sponsor: Children's Hospital Medical Center, Cincinnati

Location: University of Colorado AMC Aurora Colorado

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. 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

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

Interested in this study? View the official listing for contact and enrollment details.

View on ClinicalTrials.gov

Source: ClinicalTrials.gov (NCT07512622). StuddyBuddy aggregates publicly available trial information.