Telemedicine Enhanced Asthma Management - Uniting Providers

Asthma in Children Clinical Trial

— TEAM-UP  

Official title:

Telemedicine Enhanced Asthma Management - Uniting Providers

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03545906
• Other study ID #: 72009
• Status: Recruiting
• Phase: N/A
• Start date: November 9, 2018
• Est. completion date: July 2025

Study information

• Verified date: April 2024
• Source: University of Rochester
• Contact: Maria Fagnano, MPH
• Phone: 585-275-8220
• Email: maria_fagnano[@]urmc.rochester.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 360
• Est. completion date: July 2025
• Est. primary completion date: December 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 4 Years to 12 Years

Eligibility

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.

Related Conditions & MeSH terms

• Asthma
• Asthma in Children

Intervention

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.
• 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.

Locations

Country	Name	City	State
United States	University of Rochester	Rochester	New York

Sponsors (3)

Lead Sponsor	Collaborator
University of Rochester	University at Buffalo, University of Arkansas

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	Mean Symptom-Free Days in prior 14 days	Mean number of symptom-free days in the prior 14 days (range 0-14)	6 months after baseline
Primary	Mean Symptom-Free Days in prior 14 days	Mean number of symptom-free days in the prior 14 days (range 0-14)	9 months after baseline
Primary	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