Asthma in ChildrenNCT04089046
Telemedicine Enhanced Asthma Management - Uniting Providers for Teens (TEAM-UP for Teens)
A study testing TEAM-UP for Teens and Enhanced Care (EC) in people with Asthma in Children, run by University of Rochester at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 12 to 17 years
- Conditions the study is for
- Asthma in Children
- What is being tested?
- TEAM-UP for Teens and Enhanced Care (EC)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 333 participants
- Where
- 1 siteUnited States
- Study dates
- 18 Feb 2021to 30 Jun 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 12 to 17 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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.
Who cannot join
- 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
- Planning to move outside of Rochester in less than 6 months
- If they have received asthma specialist care in the prior 3 months, they will be asked if they would be comfortable seeing an additional asthma specialist for our study if their current specialist is unable to participate in the study. If the family is not comfortable with seeing an additional asthma specialist for the study, they will be excluded.
- Having other significant medical conditions (congenital heart disease, cystic fibrosis, 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.
United States1 site
Department of Pediatrics, University of Rochester
Rochester, New York, 14642
About this study
Official title: Telemedicine Enhanced Asthma Management - Uniting Providers 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 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.
- Conditions
- Asthma in Children
- Being tested
- TEAM-UP for Teens, Enhanced Care (EC)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TEAM-UP for TeensBehavioural
TEAM-UP for Teens pairs school-based directly observed therapy (DOT) of daily preventive asthma medications with specialist care and ongoing self-management support using live, real-time telemedicine through school.
Enhanced Care (EC)Behavioural
Teens in the EC group will receive a symptom assessment and asthma education materials at baseline, and their PCPs will be contacted by facsimile or email to recommend DOT of preventive asthma medication through school as well as referral to an asthma specialist. Systematic reminders will be sent to the family and PCPs to schedule recommended healthcare visits and consider specialist referral at the same intervals as the TEAM-UP group's virtual visits.
| Study group | Role | What they receive |
|---|---|---|
| TEAM-UP for Teens Intervention | Experimental | TEAM-UP for Teens pairs school-based and video-supported directly observed therapy (DOT) of daily preventive asthma medications with specialist care and ongoing self-management support using live, real-time telemedicine through school. Receives: Behavioral: TEAM-UP for Teens |
| Enhanced Care Comparison | Active comparator | Teens in the EC group will receive a symptom assessment and asthma education materials at baseline, and their PCPs will be contacted by facsimile or email to recommend DOT of preventive asthma medication through school as well as referral to an asthma specialist. Systematic reminders will be sent to the family and PCPs to schedule recommended healthcare visits and consider specialist referral at the same intervals as the TEAM-UP group's virtual visits. Receives: Behavioral: Enhanced Care (EC) |
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 Symptom Free Days will be calculated as a mean using data collected at 3-, 5-, 7- and 12-months post baseline. Caregivers and teens will report the number of days the teen experienced no symptoms of asthma (defined as 24 hrs with no coughing, wheezing, shortness of breath, and no need for rescue medicine) in the past 2 weeks (range 0-14).
Measured: 12-month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Sep 2019
- Study start18 Feb 2021
- Primary completion31 Jan 2027 (estimated)
- Study completion30 Jun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- 333 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Rochester
- Sponsor type
- University, hospital or other
- Collaborators
- Johns Hopkins University, University of Arkansas
- Responsible party
- Principal investigator, Jill Halterman, University of Rochester
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04089046
- Sponsor's protocol ID
- 00004160
- Status last verified
- May 2026
- First submitted
- 10 Sep 2019
- Last updated
- 13 May 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Data sets to be submitted to the NHLBI Data Repository will include baseline, follow up visit, procedural based data, and outcome data. Prior to providing data, patient identifiers will be deleted, original identification numbers will be replaced with new, randomized identification numbers, dates will be coded relative to date of enrollment, and identifiers will be removed. Variables such as socioeconomic and demographic data, household and family composition, anthropometric measures, prior medical conditions, and parent and teen medical history will be grouped or recoded.
Study at a glance
From the registry record, last updated by the sponsor on 13 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Telemedicine Enhanced Asthma Management - Uniting Providers for Teens
- ClinicalTrials.gov ID
- NCT04089046
- Acronym / sponsor ID
- 00004160
- Conditions
- Asthma in Children
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 333 participants (actual)
- Lead sponsor
- University of RochesterUniversity, hospital or other
- Collaborators
- Johns Hopkins University, University of Arkansas
- Study start
- 18 Feb 2021 (actual)
- Primary completion
- 31 Jan 2027 (estimated)
- Study completion
- 30 Jun 2027 (estimated)
- First posted
- 13 Sep 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 for Teens Intervention | Experimental | Behavioral: TEAM-UP for TeensTEAM-UP for Teens pairs school-based and video-supported directly observed therapy (DOT) of daily preventive asthma medications with specialist care and ongoing self-management support using live, real-time telemedicine through school. |
| Enhanced Care Comparison | Active comparator | Behavioral: Enhanced Care (EC)Teens in the EC group will receive a symptom assessment and asthma education materials at baseline, and their PCPs will be contacted by facsimile or email to recommend DOT of preventive asthma medication through school as well as referral to an asthma specialist. Systematic reminders will be sent to the family and PCPs to schedule recommended healthcare visits and consider specialist referral at the same intervals as the TEAM-UP group's virtual visits. |
Who may qualify
- Ages
- 12 to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (6 listed)
- 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
- Planning to move outside of Rochester in less than 6 months
- If they have received asthma specialist care in the prior 3 months, they will be asked if they would be comfortable seeing an additional asthma specialist for our study if their current specialist is unable to participate in the study. If the family is not comfortable with seeing an additional asthma specialist for the study, they will be excluded.
- Having other significant medical conditions (congenital heart disease, cystic fibrosis, 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 for TeensTEAM-UP for Teens pairs school-based directly observed therapy (DOT) of daily preventive asthma medications with specialist care and ongoing self-management support using live, real-time telemedicine through school. | Behavioural | TEAM-UP for Teens Intervention |
| Enhanced Care (EC)Teens in the EC group will receive a symptom assessment and asthma education materials at baseline, and their PCPs will be contacted by facsimile or email to recommend DOT of preventive asthma medication through school as well as referral to an asthma specialist. Systematic reminders will be sent to the family and PCPs to schedule recommended healthcare visits and consider specialist referral at the same intervals as the TEAM-UP group's virtual visits. | Behavioural | Enhanced Care Comparison |
Primary outcome
Mean Symptom Free Days in prior 14 days
Time frame: 12-month
Mean Symptom Free Days will be calculated as a mean using data collected at 3-, 5-, 7- and 12-months post baseline. Caregivers and teens will report the number of days the teen experienced no symptoms of asthma (defined as 24 hrs with no coughing, wheezing, shortness of breath, and no need for rescue medicine) in the past 2 weeks (range 0-14).
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 May 2026.
- Individual participant dataSharing planned: Yes. Data sets to be submitted to the NHLBI Data Repository will include baseline, follow up visit, procedural based data, and outcome data. Prior to providing data, patient identifiers will be deleted, original identification numbers will be replaced with new, randomized identification numbers, dates will be coded relative to date of enrollment, and identifiers will be removed. Variables such as socioeconomic and demographic data, household and family composition, anthropometric measures, prior medical conditions, and parent and teen medical history will be grouped or recoded.
Related trials for Asthma in Children
Not yet recruiting
Asthma Ctrl SMART Trial
Asthma in Children, Asthma Chronic
Not yet recruiting
Artificially Intelligent Robot Control
Asthma in Children, Artificial Intelligence
Enrolling by invitationObservational study
Allergy, Asthma, and Atopic Eczema in Finland
Asthma, Asthma in Children
Active, not recruiting
Community Health Equity Accelerator (CHEA) Pediatric Asthma Intervention
Asthma in Children
Not yet recruitingObservational study
Prevelance of Bronchial Asthma and Allergic Rhinitis Among Children With Nephrotic Syndrom at Sohag University Hospital
Allergic Diseases in Nephrotic Children, Nephrotic Syndrom
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 for Teens and Enhanced Care (EC) 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: under way, not looking for participants, as of the sponsor's last update on 13 May 2026. 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?
This study is still under way. Results are not available in the source record yet.
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: 12-month). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 13 May 2026; AzTrials last refreshed its copy on 7 Nov 2026.