Telemedicine Enhanced Asthma Management - Uniting Providers

NCT03545906 | Completed Results

• 1 other identifier: 72009
• Study Type: interventional
• Target: 326
• Locations: 1 country
• Sites: 1

Brief 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

Outcome Measures

Primary Outcomes (4)

• Mean Symptom-Free Days in Prior 14 Days

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

  3 months after baseline

• Mean Symptom-Free Days in Prior 14 Days

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

  5 months after baseline

• Mean Symptom-Free Days in Prior 14 Days

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

  7 months after baseline

• Mean Symptom-Free Days in Prior 14 Days

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

  12 months after baseline

Study Arms (2)

TEAM-UP Intervention Group

EXPERIMENTAL

Other: TEAM-UP Intervention Group

Enhanced Care Comparison Group

ACTIVE COMPARATOR

Other: Enhanced Care Comparison

Interventions

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.

TEAM-UP Intervention Group

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.

Enhanced Care Comparison Group

Eligibility Criteria

• Age: 4 Years - 12 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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).

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Rochester: lead
• University of Arkansas: collaborator
• University at Buffalo: collaborator

Study Sites (1)

University of Rochester

Rochester, New York, 14642, United States

Location

Related Publications (1)

• Halterman JS, Fagnano M, Tremblay PJ, Perry TT, Wang H, Mustafa SS, Ramsey A, Stern J. Effect of the Telemedicine Enhanced Asthma Management-Uniting Providers (TEAM-UP) Program on Asthma Outcomes: A Randomized Clinical Trial. J Pediatr. 2025 Oct 23;289:114872. doi: 10.1016/j.jpeds.2025.114872. Online ahead of print.

  PMID: 41139012 DERIVED

Results Point of Contact

• Title: Dr. Jill Halterman
• Organization: University of Rochester

jill_halterman@urmc.rochester.edu

5852755798

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: May 17, 2018
• First Posted: June 4, 2018
• Study Start: November 9, 2018
• Primary Completion: May 6, 2024
• Study Completion: June 28, 2025
• Last Updated: September 17, 2025
• Results First Posted: September 8, 2025

Record last verified: 2025-09

Locations

US (1)