Status:

RECRUITING

SMART Implementation-Effectiveness Trial 2

Lead Sponsor:

Children's Hospital of Philadelphia

Collaborating Sponsors:

National Heart, Lung, and Blood Institute (NHLBI)

Conditions:

Asthma in Children

Eligibility:

All Genders

5-18 years

Phase:

NA

Brief Summary

While single maintenance and reliever therapy (SMART) has been the preferred management strategy for Step 3 and 4 (moderate/severe) asthma management since the 2020 NIH asthma guideline updates, adopt...

Detailed Description

Asthma is a leading cause of childhood morbidity nationwide. Limited provider adoption of and patient adherence to the prevailing evidence-based recommendations for chronic management represent tracta...

Eligibility Criteria

Inclusion

  • Clinic
  • The clinic is a pediatric primary care clinic that is part of the Children's Hospital of Philadelphia (CHOP) Pediatric Research Consortium (PeRC).
  • The clinic agrees to participate in SMART \& SIMPLE study.
  • Clinic

Exclusion

  • \- The clinic is not willing to participate in SMART \& SIMPLE study interventions.
  • Patient Inclusion Criteria:
  • Ages 5-18 years;
  • Has clinic visit at participating practice during study interval (sick, well, or follow-up)
  • Prescribed at least one prescription for an inhaled corticosteroid (ICS) or ICS-long-acting beta agonist (ICS-LABA) for maintenance asthma therapy in the past year;
  • Evidence of uncontrolled asthma as determined by: (1) uncontrolled Asthma Control Tool score in the past 6 months OR (2) two or more systemic corticosteroids prescribed for an asthma exacerbation in the past 12 months (one occurring in the past 6 months)
  • Patient

Key Trial Info

Start Date :

September 3 2025

Trial Type :

INTERVENTIONAL

Allocation :

ESTIMATED

End Date :

February 29 2028

Estimated Enrollment :

18 Patients enrolled

Trial Details

Trial ID

NCT07138027

Start Date

September 3 2025

End Date

February 29 2028

Last Update

September 17 2025

Active Locations (1)

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1

Children's Hospital of Philadelphia

Philadelphia, Pennsylvania, United States, 19104