N/A
N=99
School-Based Preventive Asthma Care Technology: A Trial Using a Novel Technology to Improve Adherence
Asthma
Bottom Line
View on ClinicalTrials.gov: NCT01175434 ↗Enrolled (actual)
99
Serious AEs
0.0%
Results posted
Feb 2014
Primary outcome: Primary: Average Number of Symptom-free Days Over 14 Days; (Symptom-free Days Are Averaged Over 4 Bi-monthly Follow-ups) — 11.33; 10.40 Days
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- School-Based Medication Delivery (Other)
- Age
- Pediatric · 3+ yrs
- Sex
- All
- Sponsor
- University of Rochester
- Primary completion
- Aug 2011
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Average Number of Symptom-free Days Over 14 Days; (Symptom-free Days Are Averaged Over 4 Bi-monthly Follow-ups) |
11.33; 10.40 | — |
| SECONDARY Cost Effectiveness |
— | — |
| SECONDARY Feasibility and Acceptability |
— | — |
Summary
The goal of this new translational project is to test the feasibility and effectiveness of implementing school-based directly observed therapy of preventive asthma medications in a real-world setting, using state-of-the-art web-based technology for systematic screening, electronic report generation, and communication between nurses, caregivers, and primary care providers. With the use of a novel method to improve adherence and subsequently reduce morbidity, the investigators hypothesize that this novel adaptation of school-based asthma care will; 1) be feasible and acceptable among this population and among school and community stakeholders, and 2) yield reduced asthma morbidity (symptom-free days, absenteeism, and emergency room / urgent care use for asthma care). The investigators anticipate that enhancing preventive healthcare for young urban children with asthma through partnerships with the schools using a novel technology will yield improved health, prevention of suffering, decreased absenteeism from school, and reduced healthcare costs.
Eligibility Criteria
Inclusion Criteria (all 4 criteria must be met):
- Physician-diagnosed asthma (based on parent report).
- Persistent asthma (criteria based on NHLBI guidelines). Any 1 of the following:
- An average of >2 days per week with asthma symptoms
- >2 days per week with rescue medication use
- >2 days per month with nighttime symptoms
- ≥2 episodes of asthma during the past year that have required systemic corticosteroids
- Age ≥3 and ≤10 years.
- Attending school in participating Rochester City School District preschools or elementary schools.
Exclusion Criteria
- Inability to speak and understand English. (*Parents unable to read will be eligible, and all instruments will be given verbally.)
- No access to a working phone for follow-up surveys (either at the subject's home or an easily accessible alternate phone number).
- Family planning to leave the school district within fewer than 6 months.
- The child having other significant medical conditions, including congenital heart disease, cystic fibrosis, or other chronic lung disease, that could interfere with the assessment of asthma-related measures.
- Children in foster care or other situations in which consent cannot be obtained from a guardian.
Data sourced from ClinicalTrials.gov (NCT01175434). 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.