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| Name | Class |
|---|---|
| University of Arkansas | OTHER |
| University at Buffalo | OTHER |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| TEAM-UP Intervention Group | Experimental |
| |
| Enhanced Care Comparison Group | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| TEAM-UP Intervention Group | Other | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Mean Symptom-Free Days in Prior 14 Days | Mean number of symptom-free days in the prior 14 days (range 0-14) | 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) | 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) | 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) | 12 months after baseline |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Rochester | Rochester | New York | 14642 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 41139012 | Derived | 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. |
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| ID | Title | Description |
|---|---|---|
| FG000 | TEAM-UP Intervention Group | TEAM-UP Intervention Group: Children randomly assigned to TEAM-UP will have a telemedicine assisted specialist visit scheduled after approximately 4 weeks of initiating DOT at school, as well as up to 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. |
| FG001 | Enhanced Care Comparison Group | Enhanced Care Comparison: 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
There was one participant randomized to the TEAM-UP intervention. Shortly after the baseline assessment, it was discovered that the participant did not meet enrollment criteria and was withdrawn from the study. This participant's data is not included in the outcomes.
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| ID | Title | Description |
|---|---|---|
| BG000 | TEAM-UP Intervention Group | TEAM-UP Intervention Group: Children randomly assigned to TEAM-UP will have a telemedicine assisted specialist visit scheduled after approximately 4 weeks of initiating DOT at school, as well as up to 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Mean Symptom-Free Days in Prior 14 Days | Mean number of symptom-free days in the prior 14 days (range 0-14) | Posted | Mean | Standard Deviation | days | 3 months after baseline |
|
1 year
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | TEAM-UP Intervention Group | TEAM-UP Intervention Group: Children randomly assigned to TEAM-UP will have a telemedicine assisted specialist visit scheduled after approximately 4 weeks of initiating DOT at school, as well as up to 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. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Hospitalizations due to asthma | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Jill Halterman | University of Rochester | 5852755798 | jill_halterman@urmc.rochester.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Nov 7, 2022 | Jul 23, 2025 | Prot_SAP_000.pdf |
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|
| Enhanced Care Comparison | Other | 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. |
|
| BG001 | Enhanced Care Comparison Group | Enhanced Care Comparison: 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. |
| BG002 | Total | Total of all reporting groups |
| years |
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| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| Public Insurance | Count of Participants | Participants |
|
| Symptom-free days over 2 weeks | Mean | Standard Deviation | days |
|
Enhanced Care Comparison: 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.
|
|
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| Primary | Mean Symptom-Free Days in Prior 14 Days | Mean number of symptom-free days in the prior 14 days (range 0-14) | Posted | Mean | Standard Deviation | days | 5 months after baseline |
|
|
|
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| Primary | Mean Symptom-Free Days in Prior 14 Days | Mean number of symptom-free days in the prior 14 days (range 0-14) | Posted | Mean | Standard Deviation | days | 7 months after baseline |
|
|
|
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| Primary | Mean Symptom-Free Days in Prior 14 Days | Mean number of symptom-free days in the prior 14 days (range 0-14) | Posted | Mean | Standard Deviation | days | 12 months after baseline |
|
|
|
|
| 0 |
| 163 |
| 12 |
| 163 |
| 0 |
| 163 |
| EG001 | Enhanced Care Comparison Group | Enhanced Care Comparison: 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. | 0 | 163 | 10 | 163 | 0 | 163 |
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