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

NCT01175434 | Completed Results

• 2 other identifiers: 324791RC1HL099432-01
• Study Type: interventional
• Target: 99
• Locations: 1 country
• Sites: 1

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.

Conditions

Asthma

Keywords

Asthma

Outcome Measures

Primary Outcomes (1)

• Average Number of Symptom-free Days Over 14 Days; (Symptom-free Days Are Averaged Over 4 Bi-monthly Follow-ups)

  The primary outcome is asthma morbidity between groups. We will measure asthma morbidity by looking at the average number of symptom-free days, over 2 weeks, at each bi-monthly follow-up time point over the school year. Number of days without asthma symptoms will be reported by the child's caregiver.

  Average number of days, over 2 weeks, throughout the school year

Secondary Outcomes (2)

• Cost Effectiveness

  one year

• Feasibility and Acceptability

  one year

Study Arms (2)

School-Based Medication Group

EXPERIMENTAL

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.

Other: School-Based Medication Delivery

Usual Care Group

NO INTERVENTION

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.

Interventions

School-Based Medication Delivery OTHER

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 begin directly observed therapy of the preventive asthma medication at school, and will routinely assess the child's asthma symptoms throughout the school year.

School-Based Medication Group

Eligibility Criteria

• Age: 3 Years - 10 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Rochester: lead
• National Heart, Lung, and Blood Institute (NHLBI): collaborator

Study Sites (1)

Univeristy of Rochester

Rochester, New York, 14642, United States

Location

Related Publications (2)

• 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.

  PMID: 22455402 BACKGROUND

• 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.

  PMID: 22785264 RESULT

MeSH Terms

Conditions

Asthma

Condition Hierarchy (Ancestors)

Bronchial Diseases; Respiratory Tract Diseases; Lung Diseases, Obstructive; Lung Diseases; Respiratory Hypersensitivity; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Results Point of Contact

• Title: Dr. Jill Halterman
• Organization: University of Rochester

jill_halterman@urmc.rochester.edu

5852755798

Study Officials

• Jill S. Halterman, MD, MPH

  University of Rochester

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor of Pediatrics

Study Record Dates

• First Submitted: April 16, 2010
• First Posted: August 4, 2010
• Study Start: August 1, 2010
• Primary Completion: August 1, 2011
• Study Completion: August 1, 2012
• Last Updated: February 17, 2014
• Results First Posted: February 17, 2014

Record last verified: 2013-12

Locations

US (1)