Telemedicine Enhanced Asthma Management - Uniting Providers

Not Applicable

Active, not recruiting

• Conditions: Asthma in Children
• Interventions: Other: Enhanced Care Comparison; Other: TEAM-UP Intervention Group

• Registration Number: NCT03545906
• Lead Sponsor: University of Rochester

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 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 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-, 6-, 9- and 12-months after baseline, and the primary outcome is the comparison of symptom-free days (SFD) at each follow-up time point.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2018-05-17
• Study First Submitted QC: 2018-05-22
• Study First Posted: 2018-06-04
• Study Start: 2018-11-09
• Primary Completion: 2024-05-06
• Status Verified: 2025-05
• Last Update Submitted: 2025-05-02
• Last Update Posted: 2025-05-06
• Study Completion: 2025-07

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 326

Inclusion Criteria

1. Physician-diagnosed asthma (based on parent report with validation from the child's physician).
2. Age >=4 and =<12 years.
3. 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.
4. 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

1. Inability to speak and understand English or Spanish. (*Parents unable to read will be eligible, and all instruments will be given verbally.)
2. Current participation in an asthma study.
3. Planning to leave the Rochester city school district area in fewer than 6 months.
4. Having received asthma specialist care in the prior 3 months.
5. 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.
6. In foster care or other situations in which consent cannot be obtained from a guardian.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Enhanced Care Comparison Group	Enhanced Care Comparison	-
TEAM-UP Intervention Group	TEAM-UP Intervention Group	-

Primary Outcome Measures

Name	Time	Method
Mean Symptom-Free Days in prior 14 days	12 months after baseline	Mean number of symptom-free days in the prior 14 days (range 0-14)

Trial Locations

Locations (1)

University of Rochester; 🇺🇸 Rochester, New York, United States