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Completed

NCT Number: NCT01650844

School-Based Telemedicine Enhanced Asthma Management

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.

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Key information

Conditions

Pediatric Asthma

Age range

3 year–10 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Rochester

Rochester, New York, 14642, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

School-Based Telemedicine Enhanced Asthma Management

Other

Enhanced usual care

Other

Primary outcomes

  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.

Sponsors and collaborators

Lead sponsor

University of Rochester

Other

Collaborators

  • National Heart, Lung, and Blood Institute (NHLBI)

Registry information

Official study title

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

Acronym: SB-TEAM

Important dates

Study start
2012
Primary completion
2017
Study completion
2018
First posted
Jul 26, 2012
Registry last updated
Sep 28, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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