Telemedicine Enhanced Asthma Management - Uniting Providers for Teens

Status: Recruiting
Location: See location...
Intervention Type: Behavioral
Study Type: Interventional
Study Phase: Not Applicable
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 12
Maximum Age: 17
Healthy Volunteers: f
View:

• 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.

Locations
United States
New York
Department of Pediatrics, University of Rochester
RECRUITING
Rochester
Contact Information
Primary
Maria Fagnano, MPH
maria_fagnano@urmc.rochester.edu
585-275-8220
Time Frame
Start Date: 2021-02-18
Estimated Completion Date: 2027-06-30
Participants
Target number of participants: 360
Treatments
Experimental: TEAM-UP for Teens Intervention
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.
Active_comparator: Enhanced Care Comparison
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.
Related Therapeutic Areas
Sponsors
Collaborators: University of Arkansas, Johns Hopkins University
Leads: University of Rochester

This content was sourced from clinicaltrials.gov

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