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Completed

NCT Number: NCT03545906

Telemedicine Enhanced Asthma Management - Uniting Providers

This research study is an innovative school-based program for urban children with moderate to severe persistent or difficult-to-control asthma. The Telemedicine Enhanced Asthma Management-Uniting Providers (TEAM-UP) program enhances a school-based, primary care directed asthma program with specialist-supported care to ensure optimal guideline based treatment. This study is a full-scale randomized trial of TEAM-UP versus an enhanced care comparison group. Primary care physicians (PCP) of all enrolled children (n=360, 4-12 yrs.) will be prompted to initiate directly observed therapy (DOT) of preventive asthma medication through school and to make a specialist referral. For children in the TEAM-UP group, the specialist visits will be facilitated via telemedicine at school. The telemedicine specialist visit will be scheduled after approximately 4 weeks of initiating DOT, in order to allow for accurate guideline-based assessments of medication and care needs once adherence with a daily controller medication is established. There will also be up to 2 telemedicine follow-up specialist visits to assess the child's response to treatment and make needed adjustments. The study will use the existing community infrastructure by implementing both telemedicine and DOT in school, and maintaining collaboration with PCPs. Blinded follow-ups will occur at 3-, 5-, 7- and 12-months after baseline, and the primary outcome is the comparison of symptom-free days (SFD) at each follow-up time point.

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Key information

Conditions

Asthma in Children

Age range

4 year–12 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 with validation from the child's physician).
  • Age >=4 and =<12 years.
  • Residence in the City of Rochester and surrounding suburbs, with a. primary residence within the following zip codes: 14445, 14604, 14605, 14606, 14607, 14608, 14609, 14610, 14611, 14612, 14613, 14614, 14615, 14616, 14617, 14618, 14619, 14620, 14621, 14622, 14623, 14624, 14625, 14626.
  • Moderate-severe persistent severity (requiring Step 3 or higher care) or difficult to control asthma despite therapy (based on age-specific NHLBI guidelines).

Exclusion criteria

  • Inability to speak and understand English or Spanish. (*Parents unable to read will be eligible, and all instruments will be given verbally.)
  • Current participation in an asthma study.
  • Planning to leave the Rochester city school district area in fewer than 6 months.
  • Having received asthma specialist care in the prior 3 months.
  • 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.
  • In foster care or other situations in which consent cannot be obtained from a guardian.

Treatment and study plan

TEAM-UP Intervention Group

Other

Children randomly assigned to TEAM-UP will have a telemedicine assisted specialist visit scheduled after 4 weeks of initiating DOT at school, as well as 2 subsequent follow-up visits. The visits will be performed by a specialist in pediatric asthma, to implement guideline-based care. Prescriptions for asthma medications will be prescribed to be delivered as directly observed therapy in school.

Enhanced Care Comparison

Other

Similar to the TEAM-UP group, children in the Enhanced Care group will receive a symptom assessment and asthma education materials at baseline, and we will contact the PCP by facsimile or email and will recommend DOT of preventive asthma medication through school as well as a referral to specialist. However specialist visits will not be facilitated via telemedicine.

Primary outcomes

  1. Mean Symptom-Free Days in Prior 14 Days

    Time frame: 3 months after baseline

    Mean number of symptom-free days in the prior 14 days (range 0-14)

  2. Mean Symptom-Free Days in Prior 14 Days

    Time frame: 5 months after baseline

    Mean number of symptom-free days in the prior 14 days (range 0-14)

  3. Mean Symptom-Free Days in Prior 14 Days

    Time frame: 7 months after baseline

    Mean number of symptom-free days in the prior 14 days (range 0-14)

  4. Mean Symptom-Free Days in Prior 14 Days

    Time frame: 12 months after baseline

    Mean number of symptom-free days in the prior 14 days (range 0-14)

Sponsors and collaborators

Lead sponsor

University of Rochester

Other

Collaborators

  • University at Buffalo
  • University of Arkansas

Registry information

Acronym: TEAM-UP

Important dates

Study start
2018
Primary completion
2024
Study completion
2025
First posted
Jun 4, 2018
Registry last updated
Sep 17, 2025

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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