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School-Based Telemedicine Enhanced Asthma Management (SB-TEAM)

Primary Purpose

Pediatric Asthma

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
School-Based Telemedicine Enhanced Asthma Management
Enhanced Usual Care
Sponsored by
University of Rochester
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Pediatric Asthma

Eligibility Criteria

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

Inclusion Criteria:

  1. Physician-diagnosed asthma (based on parent report)

  2. Persistent asthma or poor asthma control (based on NHLBI guidelines). Any 1 of the following:

    • In past month, >2 days per week with asthma symptoms
    • >2 days per week with rescue medication use
    • >2 days per month with nighttime symptoms
    • >=2 asthma episodes during the past year that required systemic corticosteroids.
  3. Age >=3 and =<10 years
  4. Attending school in Rochester City School District preschools or elementary schools

Exclusion Criteria:

  1. Inability to speak and understand English or Spanish
  2. No access to a phone for follow-up surveys
  3. Family planning to leave the 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

  • University of Rochester

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

School-based Telemedicine Enhanced Asthma Mangement Group

Enhanced Usual Care Group

Arm Description

We will use a web-based system to assess asthma severity or control and will send a symptom report to the child's primary care physician (PCP). Children randomized to the SB-TEAM group, will receive a telemedicine visit in the school health office at the start of the school year to provide an initial asthma assessment. The telemedicine provider will deliver brief asthma education and referrals to community resources, and will send a guideline-based preventive medication prescription electronically to a local pharmacy. The pharmacy will deliver the medications to home and school, and the school nurse will administer the medication as directly observed therapy throughout the school year. Follow-up telemedicine assessments will occur twice during the study period. These follow-up visits will focus on assessment of control, assessment of ongoing triggers or co-morbid conditions, and brief asthma education.

Children randomized to the enhanced usual care group will receive a symptom assessment using national care guidelines, a recommendation for appropriate preventive medications, and asthma education materials. We will use the web-based system to send a symptom report to the child's PCP with guideline-based recommendations for preventive care. We will provide systematic feedback to the family and providers at the same intervals as in the SB-TEAM group's telemedicine visits, by prompting providers to use care guidelines, and caregivers to schedule recommended follow-up visits with the PCP.

Outcomes

Primary Outcome Measures

Average Number of Days Without Asthma Symptoms (Symptom Free Days)
The primary outcome measure is asthma morbidity between groups. We will measure asthma morbidity by looking at the average number of days without asthma symptoms (symptom free days) over 2 weeks, during each follow-up assessment during the peak winter season (November-March). Symptom free days are defined as 24 hour periods of no asthma symptoms including, coughing, wheezing, tightness in the chest or shortness of breath. The number of symptom free days will be reported by the child's caregiver.

Secondary Outcome Measures

Full Information

First Posted
July 23, 2012
Last Updated
August 31, 2018
Sponsor
University of Rochester
Collaborators
National Heart, Lung, and Blood Institute (NHLBI)
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1. Study Identification

Unique Protocol Identification Number
NCT01650844
Brief Title
School-Based Telemedicine Enhanced Asthma Management
Acronym
SB-TEAM
Official Title
School-Based Telemedicine Enhanced Asthma Management: A Randomized Control Trial Using Novel Technology to Improve Preventive Asthma Care
Study Type
Interventional

2. Study Status

Record Verification Date
August 2018
Overall Recruitment Status
Completed
Study Start Date
August 2012 (undefined)
Primary Completion Date
July 2017 (Actual)
Study Completion Date
July 2018 (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
Yes

5. Study Description

Brief Summary
This project aims to improve guideline-based asthma care using enhanced communication and screening tools, telemedicine and directly observed therapy of preventive medications in city schools. Web-based screening will be used to identify children with persistent or poorly controlled asthma and to send reports to the child's primary care doctor. Children in the SB-TEAM group will receive a telemedicine asthma assessment in school and be prescribed a daily preventive asthma medication to be taken through school-based directly observed therapy. The overall aim of this study is to evaluate the use of the SB-TEAM intervention for improving guideline based care, enhancing adherence to effective preventive medications and at reducing morbidity among young urban children with asthma.

6. Conditions and Keywords

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

7. Study Design

Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
400 (Actual)

8. Arms, Groups, and Interventions

Arm Title
School-based Telemedicine Enhanced Asthma Mangement Group
Arm Type
Experimental
Arm Description
We will use a web-based system to assess asthma severity or control and will send a symptom report to the child's primary care physician (PCP). Children randomized to the SB-TEAM group, will receive a telemedicine visit in the school health office at the start of the school year to provide an initial asthma assessment. The telemedicine provider will deliver brief asthma education and referrals to community resources, and will send a guideline-based preventive medication prescription electronically to a local pharmacy. The pharmacy will deliver the medications to home and school, and the school nurse will administer the medication as directly observed therapy throughout the school year. Follow-up telemedicine assessments will occur twice during the study period. These follow-up visits will focus on assessment of control, assessment of ongoing triggers or co-morbid conditions, and brief asthma education.
Arm Title
Enhanced Usual Care Group
Arm Type
Active Comparator
Arm Description
Children randomized to the enhanced usual care group will receive a symptom assessment using national care guidelines, a recommendation for appropriate preventive medications, and asthma education materials. We will use the web-based system to send a symptom report to the child's PCP with guideline-based recommendations for preventive care. We will provide systematic feedback to the family and providers at the same intervals as in the SB-TEAM group's telemedicine visits, by prompting providers to use care guidelines, and caregivers to schedule recommended follow-up visits with the PCP.
Intervention Type
Other
Intervention Name(s)
School-Based Telemedicine Enhanced Asthma Management
Intervention Type
Other
Intervention Name(s)
Enhanced Usual Care
Primary Outcome Measure Information:
Title
Average Number of Days Without Asthma Symptoms (Symptom Free Days)
Description
The primary outcome measure is asthma morbidity between groups. We will measure asthma morbidity by looking at the average number of days without asthma symptoms (symptom free days) over 2 weeks, during each follow-up assessment during the peak winter season (November-March). Symptom free days are defined as 24 hour periods of no asthma symptoms including, coughing, wheezing, tightness in the chest or shortness of breath. The number of symptom free days will be reported by the child's caregiver.
Time Frame
Average number of days, over 2 weeks, during peak winter season (November-March), assessed over 4 years.

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: Physician-diagnosed asthma (based on parent report) Persistent asthma or poor asthma control (based on NHLBI guidelines). Any 1 of the following: In past month, >2 days per week with asthma symptoms >2 days per week with rescue medication use >2 days per month with nighttime symptoms >=2 asthma episodes during the past year that required systemic corticosteroids. Age >=3 and =<10 years Attending school in Rochester City School District preschools or elementary schools Exclusion Criteria: Inability to speak and understand English or Spanish No access to a phone for follow-up surveys Family planning to leave the 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.
Facility Information:
Facility Name
University of Rochester
City
Rochester
State/Province
New York
ZIP/Postal Code
14642
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
28434913
Citation
Halterman JS, Tajon R, Tremblay P, Fagnano M, Butz A, Perry TT, McConnochie KM. Development of School-Based Asthma Management Programs in Rochester, New York: Presented in Honor of Dr Robert Haggerty. Acad Pediatr. 2017 Aug;17(6):595-599. doi: 10.1016/j.acap.2017.04.008. Epub 2017 Apr 18.
Results Reference
background
PubMed Identifier
28268134
Citation
Holderness H, Chin N, Ossip DJ, Fagnano M, Reznik M, Halterman JS. Physical activity, restrictions in activity, and body mass index among urban children with persistent asthma. Ann Allergy Asthma Immunol. 2017 Apr;118(4):433-438. doi: 10.1016/j.anai.2017.01.014. Epub 2017 Mar 6.
Results Reference
background
PubMed Identifier
29309483
Citation
Halterman JS, Fagnano M, Tajon RS, Tremblay P, Wang H, Butz A, Perry TT, McConnochie KM. Effect of the School-Based Telemedicine Enhanced Asthma Management (SB-TEAM) Program on Asthma Morbidity: A Randomized Clinical Trial. JAMA Pediatr. 2018 Mar 5;172(3):e174938. doi: 10.1001/jamapediatrics.2017.4938. Epub 2018 Mar 5.
Results Reference
result

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School-Based Telemedicine Enhanced Asthma Management

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