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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01650844
Recruitment Status : Completed
First Posted : July 26, 2012
Results First Posted : April 17, 2018
Last Update Posted : September 28, 2018
National Heart, Lung, and Blood Institute (NHLBI)
Information provided by (Responsible Party):
Jill Halterman, University of Rochester

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.

Condition or disease Intervention/treatment Phase
Pediatric Asthma Other: School-Based Telemedicine Enhanced Asthma Management Other: Enhanced Usual Care Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 400 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Health Services Research
Official Title: School-Based Telemedicine Enhanced Asthma Management: A Randomized Control Trial Using Novel Technology to Improve Preventive Asthma Care
Study Start Date : August 2012
Actual Primary Completion Date : July 2017
Actual Study Completion Date : July 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Asthma

Arm Intervention/treatment
Experimental: School-based Telemedicine Enhanced Asthma Mangement Group
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.
Other: School-Based Telemedicine Enhanced Asthma Management
Active Comparator: Enhanced Usual Care Group
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.
Other: Enhanced Usual Care

Primary Outcome Measures :
  1. Average Number of Days Without Asthma Symptoms (Symptom Free Days) [ Time Frame: Average number of days, over 2 weeks, during peak winter season (November-March), assessed over 4 years. ]
    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.

Information from the National Library of Medicine

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Ages Eligible for Study:   3 Years to 10 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01650844

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United States, New York
University of Rochester
Rochester, New York, United States, 14642
Sponsors and Collaborators
University of Rochester
National Heart, Lung, and Blood Institute (NHLBI)
  Study Documents (Full-Text)

Documents provided by Jill Halterman, University of Rochester:
Publications of Results:
Other Publications:
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Responsible Party: Jill Halterman, Associate Professor of Pediatrics, University of Rochester Identifier: NCT01650844    
Other Study ID Numbers: 42495
First Posted: July 26, 2012    Key Record Dates
Results First Posted: April 17, 2018
Last Update Posted: September 28, 2018
Last Verified: August 2018
Additional relevant MeSH terms:
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Bronchial Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive
Lung Diseases
Respiratory Hypersensitivity
Hypersensitivity, Immediate
Immune System Diseases