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

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
National Heart, Lung, and Blood Institute (NHLBI)
Information provided by:
University of Rochester
ClinicalTrials.gov Identifier:
NCT01175434
First received: April 16, 2010
Last updated: August 12, 2011
Last verified: August 2011
History of Changes
  Purpose

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.


Condition Intervention
Asthma
 Other: School-Based Medication Delivery

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: School-Based Preventive Asthma Care Technology: A Randomized Control Trial Using a Novel Technology to Improve Adherence

Resource links provided by NLM:

MedlinePlus related topics: Asthma
U.S. FDA Resources

Further study details as provided by University of Rochester:

Primary Outcome Measures:
  • Average number of days with asthma symptoms [ Time Frame: Average number of days, over 2 weeks, throughout the school year ] [ Designated as safety issue: No ]
    The primary outcome is asthma morbidity between groups. We will measure asthma morbidity by looking at the average number of days, over 2 weeks, with asthma symptoms at each follow-up time point over the school year. Number of days with asthma symptoms will be reported by the child's caregiver.


Secondary Outcome Measures:
  • Cost Effectiveness [ Time Frame: one year ] [ Designated as safety issue: No ]
    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.

  • Feasibility and Acceptability [ Time Frame: one year ] [ Designated as safety issue: No ]
    We will conduct interviews with parents and school nurses to evaluate whether this new program is feasible and acceptable among this population.


Estimated Enrollment: 100
Study Start Date: August 2010
Estimated Study Completion Date: August 2012
Estimated Primary Completion Date: August 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: School-Based Medication Group
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
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.
No Intervention: Usual Care Group
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.

  Eligibility

Ages Eligible for Study:   3 Years to 10 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01175434

Locations
United States, New York
Univeristy of Rochester
Rochester, New York, United States, 14642
Sponsors and Collaborators
University of Rochester
National Heart, Lung, and Blood Institute (NHLBI)
Investigators
Principal Investigator: Jill S. Halterman, MD, MPH University of Rochester
  More Information

No publications provided

Responsible Party: Jill Halterman, MD, MPH, University of Rochester
ClinicalTrials.gov Identifier: NCT01175434     History of Changes
Other Study ID Numbers: 32479, 1RC1HL099432-01
Study First Received: April 16, 2010
Last Updated: August 12, 2011
Health Authority: United States: Institutional Review Board

Keywords provided by University of Rochester:
Asthma

Additional relevant MeSH terms:
Asthma
Bronchial Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive
Lung Diseases
 Respiratory Hypersensitivity
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases

ClinicalTrials.gov processed this record on May 16, 2013