Telemedicine Enhanced Asthma Management - Uniting Providers (TEAM-UP)

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.

Study Overview

• Status: Recruiting
• Conditions: Asthma in Children
• Intervention / Treatment: Other: TEAM-UP Intervention Group; Other: Enhanced Care Comparison

• Study Type: Interventional
• Enrollment (Estimated): 360
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Maria Fagnano, MPH; Phone Number: 585-275-8220; Email: maria_fagnano@urmc.rochester.edu
• Study Contact Backup: Name: Reynaldo Tajon; Phone Number: 585-276-5141; Email: reynaldo_tajon@urmc.rochester.edu

Study Locations

• United States
  • New York
    • Rochester, New York, United States, 14642
      • Recruiting
      • University of Rochester
      • Contact: Jill S Halterman, MD, MPH; Phone Number: 585-275-5798; Email: jill_halterman@urmc.rochester.edu
      • Principal Investigator: Jill S. Halterman, MD, MPH

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 4 years to 12 years (Child)
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: TEAM-UP Intervention Group	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.
Active Comparator: Enhanced Care Comparison Group	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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)	6 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)	9 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

Collaborators and Investigators

• Sponsor: University of Rochester
• Collaborators: University at Buffalo; University of Arkansas

Study record dates

Study Major Dates

• Study Start (Actual): November 9, 2018
• Primary Completion (Estimated): December 1, 2024
• Study Completion (Estimated): July 1, 2025

Study Registration Dates

• First Submitted: May 17, 2018
• First Submitted That Met QC Criteria: May 22, 2018
• First Posted (Actual): June 4, 2018

Study Record Updates

• Last Update Posted (Actual): April 5, 2024
• Last Update Submitted That Met QC Criteria: April 4, 2024
• Last Verified: April 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Immune System Diseases; Lung Diseases; Hypersensitivity, Immediate; Bronchial Diseases; Lung Diseases, Obstructive; Respiratory Hypersensitivity; Hypersensitivity; Asthma
• Other Study ID Numbers: 72009

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No