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Asthma Ctrl SMART Trial
Asthma Ctrl SMART Trial

NCT07512622

Not Yet RecruitingNA

Sponsor: Children's Hospital Medical Center, Cincinnati

Conditions: Asthma in Children, Asthma Chronic

Interventions: Asthma Ctrl, Asthma Ctrl+, Control

Countries: United States

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 overview

Sex: ALL

Age: 12 Years to 18 Years

Healthy volunteers: No

Study type: INTERVENTIONAL

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
Locations (2)
  • Aurora, Colorado, United States
  • Cincinnati, Ohio, United States