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

August 31, 2018 updated by: Jill Halterman, University of Rochester

School-Based Telemedicine Enhanced Asthma Management: A Randomized Control Trial Using Novel Technology to Improve Preventive Asthma Care

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

400

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • New York
      • Rochester, New York, United States, 14642
        • University of Rochester

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

3 years to 10 years (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Health Services Research
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Average number of days, over 2 weeks, during peak winter season (November-March), assessed over 4 years.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Rochester

Collaborators

National Heart, Lung, and Blood Institute (NHLBI)

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2012

Primary Completion (Actual)

July 1, 2017

Study Completion (Actual)

July 1, 2018

Study Registration Dates

First Submitted

July 23, 2012

First Submitted That Met QC Criteria

July 25, 2012

First Posted (Estimate)

July 26, 2012

Study Record Updates

Last Update Posted (Actual)

September 28, 2018

Last Update Submitted That Met QC Criteria

August 31, 2018

Last Verified

August 1, 2018

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 42495

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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