Clinical trial NCT01175434: School-Based Preventive Asthma Care Technology: A Trial Using a Novel Technology to Improve Adherence
Official title: School-Based Preventive Asthma Care Technology: A Randomized Control Trial Using a Novel Technology to Improve Adherence
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Asthma
Keywords: Asthma
Lead sponsor: University of Rochester
Sponsor class: OTHER
Collaborators: name: National Heart, Lung, and Blood Institute (NHLBI)
First posted: 2010-08-04
Enrollment: 99
Sex: ALL
Minimum age (years): 3
Maximum age (years): 10
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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):

1. Physician-diagnosed asthma (based on parent report).
2. Persistent asthma (criteria based on NHLBI guidelines). Any 1 of the following:

   1. An average of \>2 days per week with asthma symptoms
   2. \>2 days per week with rescue medication use
   3. \>2 days per month with nighttime symptoms
   4. ≥2 episodes of asthma during the past year that have required systemic corticosteroids
3. Age ≥3 and ≤10 years.
4. Attending school in participating Rochester City School District preschools or elementary schools.

Exclusion Criteria:

1. Inability to speak and understand English. (\*Parents unable to read will be eligible, and all instruments will be given verbally.)
2. No access to a working phone for follow-up surveys (either at the subject's home or an easily accessible alternate phone number).
3. Family planning to leave the school district within fewer than 6 months.
4. 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.
5. Children in foster care or other situations in which consent cannot be obtained from a guardian.

Primary outcomes:
measure: Average Number of Symptom-free Days Over 14 Days; (Symptom-free Days Are Averaged Over 4 Bi-monthly Follow-ups)
timeFrame: Average number of days, over 2 weeks, throughout the school year
Secondary outcomes:
measure: Cost Effectiveness
timeFrame: one year
measure: Feasibility and Acceptability
timeFrame: one year
Other outcomes:
Locations:
city: Rochester
country: United States
facility: Univeristy of Rochester
state: New York
Study officials:
affiliation: University of Rochester
name: Jill S. Halterman, MD, MPH
role: PRINCIPAL_INVESTIGATOR
References:
citation: Halterman JS, Sauer J, Fagnano M, Montes G, Fisher S, Tremblay P, Tajon R, Butz A. Working toward a sustainable system of asthma care: development of the School-Based Preventive Asthma Care Technology (SB-PACT) trial. J Asthma. 2012 May;49(4):395-400. doi: 10.3109/02770903.2012.669441. Epub 2012 Mar 28.
citation: Halterman JS, Fagnano M, Montes G, Fisher S, Tremblay P, Tajon R, Sauer J, Butz A. The school-based preventive asthma care trial: results of a pilot study. J Pediatr. 2012 Dec;161(6):1109-15. doi: 10.1016/j.jpeds.2012.05.059. Epub 2012 Jul 10.