Active — Not RecruitingNot Applicable

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

United States333 participantsStarted 2021-02-18

Plain-language 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.

Who can participate

Age range

12 Years – 17 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

. 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.

Exclusion criteria

. 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

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1This trial is specifically for teenagers with asthma and uses telemedicine to coordinate care — would my teen's current asthma severity and situation make them a reasonable candidate to discuss with the research team, or would a more standard in-person specialist referral be a better first step?
2The trial is measuring 'symptom-free days' over a 14-day period as its main outcome — how does my teen's current number of symptom-free days compare to what this kind of study would be trying to improve, and does that help us understand what they might realistically gain?
3Since the trial is listed as 'active but no longer recruiting,' is there any chance there are still open slots worth asking about, or should we focus on finding similar telemedicine-based asthma programs that are currently enrolling?
4The study seems to involve multiple providers working together through telemedicine — how would that kind of team-based remote care fit into my teen's existing asthma treatment plan, and could it create any confusion about who is managing their day-to-day care?
5Since this trial doesn't have a traditional phase number, which usually means it's more focused on care delivery than testing a new drug, what does that mean for what's already known about the safety and effectiveness of this telemedicine approach compared to standard asthma management?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Mean Symptom Free Days in prior 14 days

Timeframe: 12-month

Trial details

NCT IDNCT04089046

SponsorUniversity of Rochester

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2027-01-31

View on ClinicalTrials.gov More Asthma in Children trials