NCT03545906

Telemedicine Enhanced Asthma Management - Uniting Providers

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 326 (actual)
• Sponsor: University of Rochester · Academic / Other
• Sex: All
• Age: 4 Years – 12 Years
• Healthy volunteers: Not accepted

Summary

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.

Conditions

• Asthma in Children

Interventions

Type	Name	Description
OTHER	TEAM-UP Intervention Group	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.
OTHER	Enhanced Care Comparison	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.

Timeline

• Start date: 2018-11-09
• Primary completion: 2024-05-06
• Completion: 2025-06-28
• First posted: 2018-06-04
• Last updated: 2025-09-17
• Results posted: 2025-09-08

Locations

1 site across 1 country: United States