NCT03545906Completed

Telemedicine Enhanced Asthma Management - Uniting Providers

Source: ClinicalTrials.gov · Last updated 17 Sept 2025

Brief summary (registry, in English)

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.

Status (registry): Completed
Study type: Interventional
Enrollment: 326 (actual)
First submitted: 17 May 2018
Start date: 9 Nov 2018
Primary completion date: 6 May 2024
Lead sponsor: University of Rochester
Diseases: Asthma
NCT number: NCT03545906

What you commit to

Study type: Interventional
Participants enrolled: 326
From 9 Nov 2018 to the primary completion date, 6 May 2024
1 site in 1 country
Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

Having received asthma specialist care in the prior 3 months.

Other illness

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.

Other

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.
In foster care or other situations in which consent cannot be obtained from a guardian.

Who the study is looking for

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).

Age in the registry: 4 years to 12 years · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (1)

Sites in registry order. Pick your city on the disease page to sort them by distance.

Site	City	Country	Site status
University of Rochester Coordinator of this site? Confirm its status	Rochester	United States	Unknown status

This page is information, not medical advice. Discuss any trial with your doctor.