NCT07512622

Asthma Ctrl SMART Trial

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

• Status: Not Yet Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 389 (estimated)
• Sponsor: Children's Hospital Medical Center, Cincinnati · Academic / Other
• Sex: All
• Age: 12 Years – 18 Years
• Healthy volunteers: Not accepted

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.

Detailed description

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.

Conditions

• Asthma in Children
• Asthma Chronic

Interventions

Type	Name	Description
BEHAVIORAL	Asthma Ctrl	Individualized adherence feedback via text messaging intervention based on real-time adherence monitoring
BEHAVIORAL	Asthma Ctrl+	Interventions described in Asthma Ctrl with problem-solving skills training via four telehealth sessions to occur every other week.
BEHAVIORAL	Control	Asthma management application providing education and automated reminders

Timeline

• Start date: 2026-04-01
• Primary completion: 2030-01-01
• Completion: 2030-06-01
• First posted: 2026-04-06
• Last updated: 2026-04-06

Locations

2 sites across 1 country: United States