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

This study is currently recruiting participants.
Verified February 2013 by University of Rochester
Sponsor:
Collaborator:
National Heart, Lung, and Blood Institute (NHLBI)
Information provided by (Responsible Party):
Jill Halterman, University of Rochester
ClinicalTrials.gov Identifier:
NCT01650844
First received: July 23, 2012
Last updated: February 4, 2013
Last verified: February 2013
History of Changes
  Purpose

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 Intervention
Pediatric Asthma
 Other: School-Based Telemedicine Enhanced Asthma Management
Other: Enhanced Usual Care

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (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

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 without asthma symptoms (Symptom Free Days) [ Time Frame: Average number of days, over 2 weeks, during peak winter season (November-March) ] [ Designated as safety issue: No ]
    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.


Estimated Enrollment: 400
Study Start Date: August 2012
Estimated Study Completion Date: July 2017
Estimated Primary Completion Date: July 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   3 Years to 10 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01650844

Contacts
Contact: Jill S. Halterman, MD, MPH 5852757813 jill_halterman@urmc.rochester.edu
Contact: Maria Fagnano, MPH 5852758220 maria_fagnano@urmc.rochester.edu

Locations
United States, New York
University of Rochester Recruiting
Rochester, New York, United States, 14642
Contact: Jill S Halterman, MD, MPH     585-275-7813     jill_halterman@urmc.rochester.edu    
Principal Investigator: Jill S. Halterman, MD, MPH            
Sponsors and Collaborators
University of Rochester
National Heart, Lung, and Blood Institute (NHLBI)
  More Information

No publications provided

Responsible Party: Jill Halterman, Associate Professor of Pediatrics, University of Rochester
ClinicalTrials.gov Identifier: NCT01650844     History of Changes
Other Study ID Numbers: 42495
Study First Received: July 23, 2012
Last Updated: February 4, 2013
Health Authority: United States: Institutional Review Board
United States: Federal Government

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 19, 2013