Asthma Ctrl SMART Trial

NCT07512622 | Not Yet Recruiting DMC

• 2 other identifiers: 2024-04341R01HL172827-01A1
• Study Type: interventional
• Target: 389
• Locations: 1 country
• Sites: 2

Brief 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

Keywords

sequential, multiple assignment, randomized trial (SMART); adherence; asthma; adolescents

Outcome Measures

Primary Outcomes (1)

• Electronically Monitored Controller Medication Adherence

  Monthly adherence rates will be calculated by dividing the number of doses recorded by the electronic monitor by the total number of prescribed doses; the rate is then multiplied by 100 to determine the percentage. For patients prescribed Single Maintenance and Reliever Therapy, per the new asthma guidelines, the study investigators will assume that initial doses taken are for prevention and adherence will be capped at 100%.

  12 months

Secondary Outcomes (8)

• Composite Asthma Severity Index (CASI)

  Baseline assessment and then once a month for 12 months

• Asthma Control: Asthma Control Test (ACT)

  Baseline assessment and then once a month for 12 months

• Lung Function

  Baseline and then once a month for 12 months

• Lung Function

  Baseline and then once a month for 12 months.

• Lung Function

  Baseline and then once a month for 12 months

Other Outcomes (4)

• Demographic Questionnaire

  Baseline

• Hardship questionnaire

  Baseline assessment and then at 6 months and 12 months

• Asthma Knowledge

  Baseline assessment and then at 6 months and 12 months

Study Arms (3)

Control

ACTIVE COMPARATOR

Participants will receive access to an asthma management application providing education and automated reminders

Behavioral: Control

Asthma Ctrl

EXPERIMENTAL

Participants will receive the Asthma Ctrl intervention

Behavioral: Asthma Ctrl

Asthma Ctrl+

EXPERIMENTAL

Participants will receive the Asthma Ctrl+ intervention

Behavioral: Asthma Ctrl+

Interventions

Asthma Ctrl+ BEHAVIORAL

Interventions described in Asthma Ctrl with problem-solving skills training via four telehealth sessions to occur every other week.

Asthma Ctrl+

Control BEHAVIORAL

Asthma management application providing education and automated reminders

Control

Eligibility Criteria

• Age: 12 Years - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Children's Hospital Medical Center, Cincinnati: lead
• National Heart, Lung, and Blood Institute (NHLBI): collaborator

Study Sites (2)

University of Colorado AMC

Aurora, Colorado, 80262, United States

Location

Cincinnati Children's Hospital Medical Center

Cincinnati, Ohio, 45229, United States

Location

MeSH Terms

Conditions

Asthma

Condition Hierarchy (Ancestors)

Bronchial Diseases; Respiratory Tract Diseases; Lung Diseases, Obstructive; Lung Diseases; Respiratory Hypersensitivity; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Study Officials

• Rachelle R Ramsey

  Children's Hospital Medical Center, Cincinnati

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Rachelle R Ramsey

CONTACT

513-803-8348; rachelle.ramsey@cchmc.org

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Sequential, multiple assignment, randomized trial

Study Record Dates

• First Submitted: March 26, 2026
• First Posted: April 6, 2026
• Study Start: May 30, 2026
• Primary Completion (Estimated): January 1, 2030
• Study Completion (Estimated): June 1, 2030
• Last Updated: May 11, 2026

Record last verified: 2026-05

Locations

US (2)