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

NCT04089046 | Recruiting DMC

• 1 other identifier: 00004160
• Study Type: interventional
• Target: 360
• Locations: 1 country
• Sites: 1

Brief Summary

Low-income, minority teenagers have disproportionately high rates of asthma morbidity, including excess risk of emergency department visits, hospitalizations, and death from asthma. Despite well established guidelines, under-treatment for asthma is common, particularly for poor urban teens. This study aims to test a novel, developmentally appropriate and scalable model of care to ensure optimal guideline-based treatment for urban teens with difficult to control asthma. The Telemedicine Enhanced Asthma Management-Uniting Providers for Teens (TEAM-UP for Teens) program includes 3 core components: 1- An individualized asthma management plan developed at the start of the school year via a real-time, synchronous school-based telemedicine visit that directly connects the teen to an asthma specialist, 2- School-based or video supported directly observed therapy (DOT) to implement the medication plan and allow for teens to experience the benefits of consistent therapy, 3- Follow-up telehealth visits with a nurse asthma educator to facilitate ongoing care and provide developmentally appropriate self-management support. This study is a randomized trial of TEAM-UP for Teens vs an enhanced care (EC) control group (n=360, 12-16 years). We will assess the effectiveness of the program in reducing morbidity and improving guideline-based asthma care. Our main hypothesis is that Teens receiving the TEAM-UP for Teens intervention will have more symptom-free days at 3, 5, 7, and 12-months compared to EC. We will assess a number of secondary outcomes, including additional clinical outcomes, functional outcomes, airway inflammation, and receipt of specific care measures including medication adjustments and treatment of and other comorbidities. We will also identify potential mediators and moderators of the intervention effect, and will evaluate the process of intervention implementation. At the completion of the study, the program will be better defined as a sustainable means to improve care and reduce morbidity for high risk teens with difficult to control asthma.

Conditions

Asthma in Children

Outcome Measures

Primary Outcomes (1)

• Mean Symptom Free Days in prior 14 days

  Mean Symptom Free Days will be calculated as a mean using data collected at 3-, 5-, 7- and 12-months post baseline. Caregivers and teens will report the number of days the teen experienced no symptoms of asthma (defined as 24 hrs with no coughing, wheezing, shortness of breath, and no need for rescue medicine) in the past 2 weeks (range 0-14).

  12-month

Study Arms (2)

TEAM-UP for Teens Intervention

EXPERIMENTAL

TEAM-UP for Teens pairs school-based and video-supported directly observed therapy (DOT) of daily preventive asthma medications with specialist care and ongoing self-management support using live, real-time telemedicine through school.

Behavioral: TEAM-UP for Teens

Enhanced Care Comparison

ACTIVE COMPARATOR

Teens in the EC group will receive a symptom assessment and asthma education materials at baseline, and their PCPs will be contacted by facsimile or email to recommend DOT of preventive asthma medication through school as well as referral to an asthma specialist. Systematic reminders will be sent to the family and PCPs to schedule recommended healthcare visits and consider specialist referral at the same intervals as the TEAM-UP group's virtual visits.

Behavioral: Enhanced Care (EC)

Interventions

TEAM-UP for Teens BEHAVIORAL

TEAM-UP for Teens pairs school-based directly observed therapy (DOT) of daily preventive asthma medications with specialist care and ongoing self-management support using live, real-time telemedicine through school.

TEAM-UP for Teens Intervention

Enhanced Care (EC) BEHAVIORAL

Teens in the EC group will receive a symptom assessment and asthma education materials at baseline, and their PCPs will be contacted by facsimile or email to recommend DOT of preventive asthma medication through school as well as referral to an asthma specialist. Systematic reminders will be sent to the family and PCPs to schedule recommended healthcare visits and consider specialist referral at the same intervals as the TEAM-UP group's virtual visits.

Enhanced Care Comparison

Eligibility Criteria

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

You may qualify if:

• Physician-diagnosed asthma (based on caregiver report with validation from teen's physician).
• Moderate-severe persistent severity (requiring Step 3 or higher care) or asthma that is uncontrolled despite therapy
• Age \>=12 and =\<17 years
• Residence in the City of Rochester and surrounding metro area.

You may not qualify if:

• Inability to speak and understand either English or Spanish. (\*Participants unable to read will be eligible, and all instruments will be given verbally.)
• Current participation in an asthma study
• Planning to move outside of Rochester in less than 6 months
• If they have received asthma specialist care in the prior 3 months, they will be asked if they would be comfortable seeing an additional asthma specialist for our study if their current specialist is unable to participate in the study. If the family is not comfortable with seeing an additional asthma specialist for the study, they will be excluded.
• Having other significant medical conditions (congenital heart disease, cystic fibrosis, 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
• Johns Hopkins University: collaborator
• University of Arkansas: collaborator

Study Sites (1)

Department of Pediatrics, University of Rochester

Rochester, New York, 14642, United States

RECRUITING

Central Study Contacts

Maria Fagnano, MPH

CONTACT

585-275-8220; maria_fagnano@urmc.rochester.edu

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: September 10, 2019
• First Posted: September 13, 2019
• Study Start: February 18, 2021
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): June 30, 2027
• Last Updated: May 6, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will share

Locations

US (1)