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Completed

NCT Number: NCT01175434

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

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.

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Key information

Conditions

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

Age range

3 year–10 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Univeristy of Rochester

Rochester, New York, 14642, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

Primary outcomes

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

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

    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.

Secondary outcomes

  1. Cost Effectiveness

    Time frame: one year

    We will evaluate the cost effectiveness to implement and sustain the web-based system in schools. We will review the cost of the intervention using three main categories of costs; programmatic costs (costs of initiating and running the program), productivity costs, and medical costs estimated at the individual child level.

  2. Feasibility and Acceptability

    Time frame: one year

    We will conduct interviews with parents and school nurses to evaluate whether this new program is feasible and acceptable among this population.

Sponsors and collaborators

Lead sponsor

University of Rochester

Other

Collaborators

  • National Heart, Lung, and Blood Institute (NHLBI)

Registry information

Official study title

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

Acronym: SB-PACT

Important dates

Study start
2010
Primary completion
2011
Study completion
2012
First posted
Aug 4, 2010
Registry last updated
Feb 17, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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