N/A
N=626
West Philadelphia Controls Asthma
Childhood Asthma · Community Health Workers
Bottom Line
View on ClinicalTrials.gov: NCT03514485 ↗Enrolled (actual)
626
Serious AEs
0.0%
Results posted
Oct 2024
Primary outcome: Primary: Change in Asthma Control — 1.35; 1.42; 1.38; 1.37 units on a scale
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Yes We Can Children's Asthma Program (Behavioral); School-Based Asthma Therapy (Behavioral); Open Airways for School Plus (Behavioral)
- Age
- Pediatric · 5+ yrs
- Sex
- All
- Sponsor
- Children's Hospital of Philadelphia
- Primary completion
- Jun 2022
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change in Asthma Control |
1.35; 1.42; 1.38; 1.37; 0.74; 0.85 | — |
| SECONDARY Change in Daytime Asthma Symptoms |
1; 1.5; 1; 1; 0; 1 | — |
| SECONDARY Change in Nighttime Symptoms |
0; 0; 0; 0; 0; 0 | — |
| SECONDARY Change in School Absences |
11; 10; 17; 13; 12; 13 | — |
| SECONDARY Change in Emergency Department (ED) Visits |
1; 1; 1; 1; 0; 0 | — |
| SECONDARY Change in Hospitalizations |
0; 0; 0; 0; 0; 0 | — |
| SECONDARY Change in Asthma Emotional Functioning Domain |
5.72; 5.79; 5.55; 5.63; 6.47; 6.21 | — |
| SECONDARY Change in Activity Limitations Domain |
5.13; 5.18; 5.00; 5.09; 6.09; 5.89 | — |
| SECONDARY Baseline School Organizational Climate Index |
538.83; 528.8; 471.46; 441.59 | — |
| SECONDARY Baseline School Leadership |
1.76; 1.82; 1.57; 1.7; 2.03 | — |
| SECONDARY Baseline School Staff Attitudes |
2.53; 2.31; 2.42; 2.56; 1.01 | — |
Summary
This project uses community health workers (CHW) or lay health educators to implement asthma interventions that have been proven to work in the primary care setting and in schools. The objective is to integrate the home, school, healthcare system, and community for 600 school-aged asthmatic children in West Philadelphia through use of CHWs.
The children enrolled in the study will be randomized to one of four groups including: primary care CHW, school CHW, primary care and school CHW or the control group (no CHW).
Eligibility Criteria
Inclusion Criteria
- Children 5-13 years of age and their parents/guardians
- Children with a diagnosis of asthma
- Children with uncontrolled asthma (as evidenced within the previous 12 months by an asthma exacerbation requiring oral steroids -OR- an Emergency Department (ED) visit for asthma -OR- an inpatient admission for asthma)
- West Philadelphia residence in zip code 19104, 19131, 19139, 19142, 19143, 19151 or 19153
- Children in grades K-8
- Pediatric primary care received at Children's Hospital of Philadelphia Care Network (CN) Karabots, Cobbs Creek, or South Philadelphia locations or pediatric care received at the Pediatric and Adolescent Medicine Centers of Philadelphia (PAMCOP) serving West Philadelphia residents
- Parental/guardian permission (informed consent) and, if appropriate, child assent
- English Language Speaking
Exclusion Criteria
- Subjects with other chronic respiratory illnesses such as cystic fibrosis
- Cyanotic congenital heart disease
- Mental retardation and/or cerebral palsy (MRCP)
- Severe Neurological Disorder
- Cyanotic congenital heart disease
- Parents/guardians or subjects who, in the opinion of the Investigator, may be non-compliant with study schedules or procedures
Data sourced from ClinicalTrials.gov (NCT03514485). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.