NCT07138027Recruiting
SMART Implementation-Effectiveness Trial 2
Single Maintenance And Reliever Therapy Strategies for IMPLementation and Effectiveness (SMART & SIMPLE) Trial
Source: ClinicalTrials.gov · Last updated 18 Sept 2026
Brief summary (registry, in English)
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, adoption of SMART has not been rigorously assessed. This study will test population health management (PHM; asthma community health worker, asthma nurse care manager) implementation strategies building on electronic medical record clinical decision support and education implementation strategies (CDS+), to increase adoption of SMART. This is the second of two related records.
- Status (registry)
- Recruiting
- Study type
- Interventional
- Enrollment
- 18 (estimated)
- First submitted
- 15 Aug 2025
- Start date
- 3 Sept 2025
- Primary completion date
- 31 Aug 2027
- Lead sponsor
- Children's Hospital of Philadelphia
- Diseases
- Asthma
- NCT number
- NCT07138027
What you commit to
- Study type: Interventional
- Planned participants: 18
- From 3 Sept 2025 to the primary completion date, 31 Aug 2027
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Criteria the registry did not label
- Clinic Inclusion Criteria:
- 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.
- 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)
- Clinic Exclusion Criteria:
- \- The clinic is not willing to participate in SMART \& SIMPLE study interventions.
- Patient Exclusion Criteria:
- \- Transferred clinics or left the CHOP Pediatric Care Network.
Age in the registry: 5 years to 18 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Children's Hospital of Philadelphia Coordinator of this site? Confirm its status | Philadelphia | United States | Recruiting |
Related publications
This page is information, not medical advice. Discuss any trial with your doctor.