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Asthma Ctrl SMART Trial

NCT07512622 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 389

Last updated 2026-05-11

No results posted yet for this study

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.

Conditions

  • Asthma in Children
  • Asthma Chronic

Interventions

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

Sponsors & Collaborators

  • National Heart, Lung, and Blood Institute (NHLBI)

    collaborator NIH

  • Children's Hospital Medical Center, Cincinnati

    lead OTHER

Principal Investigators

  • Rachelle R Ramsey · Children's Hospital Medical Center, Cincinnati

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
SEQUENTIAL

Eligibility

Min Age
12 Years
Max Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-05-30
Primary Completion
2030-01-01
Completion
2030-06-01

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07512622 on ClinicalTrials.gov