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

Primary Purpose

Asthma

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
School-Based Medication Delivery
Sponsored by
University of Rochester
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Asthma focused on measuring Asthma

Eligibility Criteria

3 Years - 10 Years (Child)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Univeristy of Rochester

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

School-Based Medication Group

Usual Care Group

Arm 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.

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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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

Full Information

First Posted
April 16, 2010
Last Updated
December 31, 2013
Sponsor
University of Rochester
Collaborators
National Heart, Lung, and Blood Institute (NHLBI)
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1. Study Identification

Unique Protocol Identification Number
NCT01175434
Brief Title
School-Based Preventive Asthma Care Technology: A Trial Using a Novel Technology to Improve Adherence
Acronym
SB-PACT
Official Title
School-Based Preventive Asthma Care Technology: A Randomized Control Trial Using a Novel Technology to Improve Adherence
Study Type
Interventional

2. Study Status

Record Verification Date
December 2013
Overall Recruitment Status
Completed
Study Start Date
August 2010 (undefined)
Primary Completion Date
August 2011 (Actual)
Study Completion Date
August 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Rochester
Collaborators
National Heart, Lung, and Blood Institute (NHLBI)

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Asthma
Keywords
Asthma

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
99 (Actual)

8. Arms, Groups, and Interventions

Arm Title
School-Based Medication Group
Arm Type
Experimental
Arm 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.
Arm Title
Usual Care Group
Arm Type
No Intervention
Arm 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.
Intervention Type
Other
Intervention Name(s)
School-Based Medication Delivery
Intervention 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 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 Outcome Measure Information:
Title
Average Number of Symptom-free Days Over 14 Days; (Symptom-free Days Are Averaged Over 4 Bi-monthly Follow-ups)
Description
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.
Time Frame
Average number of days, over 2 weeks, throughout the school year
Secondary Outcome Measure Information:
Title
Cost Effectiveness
Description
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.
Time Frame
one year
Title
Feasibility and Acceptability
Description
We will conduct interviews with parents and school nurses to evaluate whether this new program is feasible and acceptable among this population.
Time Frame
one year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
3 Years
Maximum Age & Unit of Time
10 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jill S. Halterman, MD, MPH
Organizational Affiliation
University of Rochester
Official's Role
Principal Investigator
Facility Information:
Facility Name
Univeristy of Rochester
City
Rochester
State/Province
New York
ZIP/Postal Code
14642
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
22455402
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.
Results Reference
background
PubMed Identifier
22785264
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.
Results Reference
result

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

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