Asthma in ChildrenTEAM-UPNCT03545906
Telemedicine Enhanced Asthma Management - Uniting Providers
A study testing TEAM-UP Intervention Group and Enhanced Care Comparison in people with Asthma in Children, run by University of Rochester at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 4 to 12 years
- Conditions the study is for
- Asthma in Children
- What is being tested?
- TEAM-UP Intervention Group and Enhanced Care Comparison
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 326 participants
- Where
- 1 siteUnited States
- Study dates
- 9 Nov 2018to 28 Jun 2025
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 4 to 12 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Physician-diagnosed asthma (based on parent report with validation from the child's physician).
- Age >=4 and =<12 years.
- Residence in the City of Rochester and surrounding suburbs, with a. primary residence within the following zip codes: 14445, 14604, 14605, 14606, 14607, 14608, 14609, 14610, 14611, 14612, 14613, 14614, 14615, 14616, 14617, 14618, 14619, 14620, 14621, 14622, 14623, 14624, 14625, 14626.
- Moderate-severe persistent severity (requiring Step 3 or higher care) or difficult to control asthma despite therapy (based on age-specific NHLBI guidelines).
Who cannot join
- Inability to speak and understand English or Spanish. (*Parents unable to read will be eligible, and all instruments will be given verbally.)
- Current participation in an asthma study.
- Planning to leave the Rochester city school district area in fewer than 6 months.
- Having received asthma specialist care in the prior 3 months.
- Having other significant medical conditions, including congenital heart disease, cystic fibrosis, or other chronic lung disease, that could interfere with the assessment of asthma-related measures.
- In foster care or other situations in which consent cannot be obtained from a guardian.
Trial locations and contacts
1 site in 1 country.
About this study
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.
- Conditions
- Asthma in Children
- Being tested
- TEAM-UP Intervention Group, Enhanced Care Comparison
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TEAM-UP Intervention GroupOther
Children randomly assigned to TEAM-UP will have a telemedicine assisted specialist visit scheduled after 4 weeks of initiating DOT at school, as well as 2 subsequent follow-up visits. The visits will be performed by a specialist in pediatric asthma, to implement guideline-based care. Prescriptions for asthma medications will be prescribed to be delivered as directly observed therapy in school.
Enhanced Care ComparisonOther
Similar to the TEAM-UP group, children in the Enhanced Care group will receive a symptom assessment and asthma education materials at baseline, and we will contact the PCP by facsimile or email and will recommend DOT of preventive asthma medication through school as well as a referral to specialist. However specialist visits will not be facilitated via telemedicine.
| Study group | Role | What they receive |
|---|---|---|
| TEAM-UP Intervention Group | Experimental | Not described Receives: Other: TEAM-UP Intervention Group |
| Enhanced Care Comparison Group | Active comparator | Not described Receives: Other: Enhanced Care Comparison |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean Symptom-Free Days in Prior 14 Days
Mean number of symptom-free days in the prior 14 days (range 0-14)
Measured: 3 months after baseline
Mean Symptom-Free Days in Prior 14 Days
Mean number of symptom-free days in the prior 14 days (range 0-14)
Measured: 5 months after baseline
Mean Symptom-Free Days in Prior 14 Days
Mean number of symptom-free days in the prior 14 days (range 0-14)
Measured: 7 months after baseline
Mean Symptom-Free Days in Prior 14 Days
Mean number of symptom-free days in the prior 14 days (range 0-14)
Measured: 12 months after baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jun 2018
- Study start9 Nov 2018
- Primary completion6 May 2024
- Study completion28 Jun 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Asthma in ChildrenStudies of the same condition, open and under way.
- More trials run by University of RochesterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 326 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Rochester
- Sponsor type
- University, hospital or other
- Collaborators
- University of Arkansas, University at Buffalo
- Responsible party
- Principal investigator, Jill Halterman, University of Rochester
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03545906
- Sponsor's protocol ID
- 72009
- Acronym
- TEAM-UP
- Status last verified
- Sep 2025
- First submitted
- 17 May 2018
- Last updated
- 17 Sep 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Halterman JS, Fagnano M, Tremblay PJ, Perry TT, Wang H, Mustafa SS, Ramsey A, Stern J. Effect of the Telemedicine Enhanced Asthma Management-Uniting Providers (TEAM-UP) Program on Asthma Outcomes: A Randomized Clinical Trial. J Pediatr. 2026 Feb;289:114872. doi: 10.1016/j.jpeds.2025.114872. Epub 2025 Oct 23.
PubMed 41139012
Study at a glance
From the registry record, last updated by the sponsor on 17 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Telemedicine Enhanced Asthma Management - Uniting Providers
- ClinicalTrials.gov ID
- NCT03545906
- Acronym / sponsor ID
- TEAM-UP / 72009
- Conditions
- Asthma in Children
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 326 participants (actual)
- Lead sponsor
- University of RochesterUniversity, hospital or other
- Collaborators
- University of Arkansas, University at Buffalo
- Study start
- 9 Nov 2018 (actual)
- Primary completion
- 6 May 2024 (actual)
- Study completion
- 28 Jun 2025 (actual)
- First posted
- 4 Jun 2018 (actual)
- Results
- Posted 8 Sep 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| TEAM-UP Intervention Group | Experimental | Other: TEAM-UP Intervention Group |
| Enhanced Care Comparison Group | Active comparator | Other: Enhanced Care Comparison |
Who may qualify
- Ages
- 4 to 12 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- Physician-diagnosed asthma (based on parent report with validation from the child's physician).
- Age >=4 and =<12 years.
- Residence in the City of Rochester and surrounding suburbs, with a. primary residence within the following zip codes: 14445, 14604, 14605, 14606, 14607, 14608, 14609, 14610, 14611, 14612, 14613, 14614, 14615, 14616, 14617, 14618, 14619, 14620, 14621, 14622, 14623, 14624, 14625, 14626.
- Moderate-severe persistent severity (requiring Step 3 or higher care) or difficult to control asthma despite therapy (based on age-specific NHLBI guidelines).
Key exclusion criteria (6 listed)
- Inability to speak and understand English or Spanish. (*Parents unable to read will be eligible, and all instruments will be given verbally.)
- Current participation in an asthma study.
- Planning to leave the Rochester city school district area in fewer than 6 months.
- Having received asthma specialist care in the prior 3 months.
- Having other significant medical conditions, including congenital heart disease, cystic fibrosis, or other chronic lung disease, that could interfere with the assessment of asthma-related measures.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| TEAM-UP Intervention GroupChildren randomly assigned to TEAM-UP will have a telemedicine assisted specialist visit scheduled after 4 weeks of initiating DOT at school, as well as 2 subsequent follow-up visits. The visits will be performed by a specialist in pediatric asthma, to implement guideline-based care. Prescriptions for asthma medications will be prescribed to be delivered as directly observed therapy in school. | Other | TEAM-UP Intervention Group |
| Enhanced Care ComparisonSimilar to the TEAM-UP group, children in the Enhanced Care group will receive a symptom assessment and asthma education materials at baseline, and we will contact the PCP by facsimile or email and will recommend DOT of preventive asthma medication through school as well as a referral to specialist. However specialist visits will not be facilitated via telemedicine. | Other | Enhanced Care Comparison Group |
Primary outcome
Mean Symptom-Free Days in Prior 14 Days
Time frame: 3 months after baseline
Mean number of symptom-free days in the prior 14 days (range 0-14)
Mean Symptom-Free Days in Prior 14 Days
Time frame: 5 months after baseline
Mean number of symptom-free days in the prior 14 days (range 0-14)
Mean Symptom-Free Days in Prior 14 Days
Time frame: 7 months after baseline
Mean number of symptom-free days in the prior 14 days (range 0-14)
Mean Symptom-Free Days in Prior 14 Days
Time frame: 12 months after baseline
Mean number of symptom-free days in the prior 14 days (range 0-14)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Sep 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 41139012Halterman JS, Fagnano M, Tremblay PJ, Perry TT, Wang H, Mustafa SS, Ramsey A, Stern J. Effect of the Telemedicine Enhanced Asthma Management-Uniting Providers (TEAM-UP) Program on Asthma Outcomes: A Randomized Clinical Trial. J Pediatr. 2026 Feb;289:114872. doi: 10.1016/j.jpeds.2025.114872. Epub 2025 Oct 23.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing TEAM-UP Intervention Group and Enhanced Care Comparison in people with Asthma in Children, run by University of Rochester at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 8 Sep 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mean Symptom-Free Days in Prior 14 Days (time frame: 3 months after baseline). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03545906, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Sep 2025.