School-Based Preventive Asthma Care Technology: A Trial Using a Novel Technology to Improve Adherence (SB-PACT)

University of Rochester

Status: Completed

Conditions: Asthma

Treatments: Other: School-Based Medication Delivery

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT01175434

32479

1RC1HL099432-01 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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.

Enrollment: 99 patients

Sex: All

Ages: 3 to 10 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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99 participants in 2 patient groups

School-Based Medication Group

Experimental group

Description:

For children assigned to the School-Based Medication group, an asthma coordinator will send the child's primary care physician a report indicating the child's asthma symptoms, and will recommend that the child receive a preventive asthma medication at school. If the child's doctor agrees, the preventive asthma medication will be delivered to the child's school and to his/her home by a local pharmacy. The child's school nurse will begin directly observed therapy of the preventive asthma medication at school, and will routinely assess the child's asthma symptoms throughout the school year.

Treatment:

Other: School-Based Medication Delivery

Usual Care Group

No Intervention group

Description:

Children in the Usual Care group will not receive preventive medications delivered at school. These children will continue to receive all of their asthma care from their parents and primary care physicians.