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NCT03545906 · ClinicalTrials.gov registry record · NA
Telemedicine Enhanced Asthma Management - Uniting Providers
A NA study, sponsored by University of Rochester.
- Completed
- Registry status
- NA
- Development phase
- 326
- Enrollment target
NCT03545906 is a NA study that has completed, run by University of Rochester. The registered enrollment target is 326 participants.
The verdict
NCT03545906, a NA study, has completed, sponsored by University of Rochester.
- COMPLETED
- Registry status
- NA
- Development phase
- 326 participants
- Enrollment target
Study Summary
This research study is an innovative school-based program for urban children with moderate to severe persistent or difficult-to-control asthma. The Telemedicine Enhanced Asthma Management-Uniting Providers (TEAM-UP) program enhances a school-based, primary care directed asthma program with specialist-supported care to ensure optimal guideline based treatment. This study is a full-scale randomized trial of TEAM-UP versus an enhanced care comparison group. Primary care physicians (PCP) of all enrolled children (n=360, 4-12 yrs.) will be prompted to initiate directly observed therapy (DOT) of preventive asthma medication through school and to make a specialist referral. For children in the TEAM-UP group, the specialist visits will be facilitated via telemedicine at school. The telemedicine specialist visit will be scheduled after approximately 4 weeks of initiating DOT, in order to allow for accurate guideline-based assessments of medication and care needs once adherence with a daily controller medication is established. There will also be up to 2 telemedicine follow-up specialist visits to assess the child's response to treatment and make needed adjustments. The study will use the existing community infrastructure by implementing both telemedicine and DOT in school, and maintaining collaboration with PCPs. Blinded follow-ups will occur at 3-, 5-, 7- and 12-months after baseline, and the primary outcome is the comparison of symptom-free days (SFD) at each follow-up time point.
Interventions
- OTHER TEAM-UP Intervention Group
- OTHER Enhanced Care Comparison
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 326 participants |
| Start Date | 2018-11-09 |
| Est. Completion | 2025-06-28 |
| Phase | NA |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03545906
The ClinicalTrials.gov registry entry for NCT03545906 describes a study currently listed as completed, categorized as NA. The registered enrollment target is 326 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is University of Rochester, which has 636 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which TEAM-UP Intervention Group is the first listed.
NCT03545906 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT03545906 about?
NCT03545906 is a clinical study titled "Telemedicine Enhanced Asthma Management - Uniting Providers". This research study is an innovative school-based program for urban children with moderate to severe persistent or difficult-to-control asthma. The Telemedicine Enhanced Asthma Management-Uniting Providers (TEAM-UP) program enhances a school-based, primary care directed asthma program with specialis...
What is the current status of trial NCT03545906?
This trial is currently completed. It is a NA study. The enrollment target is 326 participants. The study started on 2018-11-09. Estimated completion is 2025-06-28.
What interventions are being tested in trial NCT03545906?
The interventions under investigation include: TEAM-UP Intervention Group (OTHER), Enhanced Care Comparison (OTHER).
Who is sponsoring clinical trial NCT03545906?
This trial is sponsored by University of Rochester, which has 636 total clinical trials registered on ClinicalTrials.gov.
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