RecruitingNot ApplicableNCT04089046

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

Telemedicine Enhanced Asthma Management - Uniting Providers for Teens


Sponsor

University of Rochester

Enrollment

360 participants

Start Date

Feb 18, 2021

Study Type

INTERVENTIONAL

Conditions

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

Min Age: 12 YearsMax Age: 17 Years

Plain Language Summary

Simplified for easier understanding

This study (TEAM-UP for Teens) tests whether a telemedicine-based program connecting teenagers with asthma specialists can improve asthma control better than standard care. Teens would receive remote consultations with asthma experts through video or phone visits. **You may be eligible if...** - You are between 12 and 17 years old - A doctor has diagnosed you with asthma - Your asthma is moderate-to-severe and not well controlled even with current treatment - You live in the Rochester, NY metro area - You can speak and understand English or Spanish **You may NOT be eligible if...** - You are currently in another asthma research study - You are planning to move outside of Rochester within 6 months - You have another major illness like cystic fibrosis or congenital heart disease - You are in foster care or another situation where a guardian cannot provide consent Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

BEHAVIORALTEAM-UP for Teens

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.

BEHAVIORALEnhanced Care (EC)

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.


Locations(1)

Department of Pediatrics, University of Rochester

Rochester, New York, United States

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NCT04089046


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