Asthma Ctrl SMART Trial

Part of paid clinical trials in Aurora, Colorado.

Sponsor
Children's Hospital Medical Center, Cincinnati
Study ID
NCT07512622
Status
Not Yet Recruiting

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Conditions

  • Asthma Chronic
  • Asthma in Children

Eligibility Criteria

Sex
ALL
Age
12 Years - 18 Years
Healthy Volunteers
Not accepted

Interventions

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

Study Details

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.

Key Dates

Start date
May 30, 2026
Status verified
May 2026
Primary completion
Jan 1, 2030
Completion
Jun 1, 2030

Study Design

Enrollment
389 participants (estimated)
Allocation
RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT

Arms

  • Active Comparator: Control
    Participants will receive access to an asthma management application providing education and automated reminders
  • Experimental: Asthma Ctrl
    Participants will receive the Asthma Ctrl intervention
  • Experimental: Asthma Ctrl+
    Participants will receive the Asthma Ctrl+ intervention

Primary Outcome Measure

Electronically Monitored Controller Medication Adherence [ Time Frame: 12 months ]

Central Contacts

Locations (2)

FacilityCityStateZIPSite coordinators
University of Colorado AMCAuroraColorado80262
Heather DeKeyser
Heather De Keyser (PRINCIPAL_INVESTIGATOR)
Cincinnati Children's Hospital Medical CenterCincinnatiOhio45229
Rachelle R Ramsey
[email protected]
513-803-8348
Rachelle R Ramsey (PRINCIPAL_INVESTIGATOR)

Find similar trials in Aurora, CO

By research site
University of Colorado AMC· Aurora, COCincinnati Children's Hospital Medical Center· Cincinnati, OH

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