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RECRUITING NA

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

NCT04089046 · View on ClinicalTrials.gov ↗

Study 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

Conditions Studied

Interventions

  • BEHAVIORAL TEAM-UP for Teens
  • BEHAVIORAL Enhanced Care (EC)

Study Locations (1)

New York

  • Department of Pediatrics, University of Rochester — Rochester

Trial Details

FieldValue
Enrollment Target 360 participants
Start Date 2021-02-18
Est. Completion 2027-06-30
Phase NA

Sponsor

University of Rochester

437 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT04089046

The ClinicalTrials.gov registry entry for NCT04089046 describes a study currently listed as recruiting. It is categorized as NA, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 360 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is University of Rochester, which has 437 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.

The record links to 1 condition, with Asthma in Children appearing as the primary indexed condition, and to 2 interventions — of which TEAM-UP for Teens is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.

Geographic footprint matters for practical reasons: NCT04089046 reports 1 study location spanning 1 distinct geographic area — top geographies include New York. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.

Frequently Asked Questions

What is clinical trial NCT04089046 about?

NCT04089046 is a clinical study titled "Telemedicine Enhanced Asthma Management - Uniting Providers for Teens (TEAM-UP for Teens)". 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 stu...

What is the current status of trial NCT04089046?

This trial is currently recruiting. It is a NA study. The enrollment target is 360 participants. The study started on 2021-02-18. Estimated completion is 2027-06-30.

What conditions does trial NCT04089046 study?

This clinical trial studies the following conditions: Asthma in Children. These conditions were identified from the trial registry and reflect the primary focus areas of the research.

What interventions are being tested in trial NCT04089046?

The interventions under investigation include: TEAM-UP for Teens (BEHAVIORAL), Enhanced Care (EC) (BEHAVIORAL). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT04089046?

This trial is sponsored by University of Rochester, which has 437 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.

Where is trial NCT04089046 being conducted?

This trial has 1 study location across New York. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

Related

Data sourced from official U.S. government datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial