Telemedicine for Childhood Asthma

(TEAM-UP Trial)

Overseen By Reynaldo Tajon

Age: < 18

Sex: Any

Trial Phase: Academic

Sponsor: University of Rochester

Must be taking: Preventive asthma medication

Disqualifiers: Non-English/Spanish, Other studies, Moving, Others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 3

Duration: 4 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new school-based program designed to help children with moderate to severe asthma manage their condition more effectively. It compares a telemedicine-supported approach, where children receive specialist care remotely, to standard enhanced care. The goal is to determine if this new approach increases the number of symptom-free days for children. Children aged 4 to 12 living in specific areas around Rochester, who continue to struggle with asthma despite treatment, may be suitable candidates for this trial. As an unphased trial, this study provides a unique opportunity to contribute to innovative asthma care solutions for children.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop your current medications. It focuses on enhancing asthma care through telemedicine and directly observed therapy at school.

What prior data suggests that this telemedicine program is safe for children with asthma?

Research shows that the Telemedicine Enhanced Asthma Management-Uniting Providers (TEAM-UP) program is safe and improves asthma management. Studies have found that telemedicine for asthma care helps people adhere to treatment plans and enhances their overall quality of life. It also reduces unexpected doctor visits. Reports from earlier trials indicate that children in the TEAM-UP program experienced more symptom-free days and missed less school.

The studies mention no specific safety concerns. The program connects children with asthma specialists via telemedicine, facilitating quick management and treatment adjustments. This method appears well-received, with no major negative effects reported in the trials. Overall, the TEAM-UP program seems to be a safe way to manage asthma in children. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the Telemedicine Enhanced Asthma Management-Uniting Providers (TEAM-UP) program because it offers a novel way to manage childhood asthma using telemedicine. Unlike traditional face-to-face visits, this approach leverages digital technology to connect patients with healthcare providers from home, which can make asthma care more accessible and convenient. The TEAM-UP program aims to enhance ongoing care by providing a more continuous and personalized management plan, potentially leading to better asthma control and fewer hospital visits. This method could be a game-changer for families who struggle with frequent in-person appointments and want to manage asthma more effectively from their own living rooms.

What evidence suggests that this trial's treatments could be effective for childhood asthma?

The current trial will compare the TEAM-UP program with an Enhanced Care Comparison group. Studies have shown that the TEAM-UP program can help manage asthma in children. Specifically, research indicates that children using the TEAM-UP program experienced more symptom-free days than those receiving enhanced usual care, with an average difference of 1.32 days. These children also missed school less often due to asthma issues. Another study found that telemedicine, similar to that used in TEAM-UP, effectively improved asthma control, offering a strong alternative to in-person visits. This suggests that TEAM-UP might better manage asthma symptoms and keep children in school. ^{1 2 6 7 8}

Are You a Good Fit for This Trial?

This trial is for urban children aged 4-12 with moderate to severe asthma or difficult-to-control asthma, living in specific areas of Rochester. They must not be currently in another asthma study, planning to move soon, have seen an asthma specialist recently, be in foster care without guardian consent, or have other major health issues like heart disease.

Inclusion Criteria

My asthma is severe and hard to control despite treatment.

My child's doctor has diagnosed them with asthma.

I am between 4 and 12 years old.

Exclusion Criteria

I do not have major health issues like heart or severe lung diseases that could affect asthma evaluation.

I have seen an asthma specialist in the last 3 months.

Inability to speak and understand English or Spanish (*Parents unable to read will be eligible, and all instruments will be given verbally)

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Initiation of directly observed therapy (DOT) of preventive asthma medication through school and telemedicine specialist visits

4 weeks

1 telemedicine visit (in-school)

Follow-up

Telemedicine follow-up specialist visits to assess the child's response to treatment and make needed adjustments

8 weeks

2 telemedicine visits (in-school)

Blinded Follow-up

Blinded follow-ups to compare symptom-free days at 3-, 6-, 9-, and 12-months after baseline

12 months

What Are the Treatments Tested in This Trial?

Interventions

• Enhanced Care Comparison
• Telemedicine Enhanced Asthma Management-Uniting Providers (TEAM-UP) program

Trial Overview The TEAM-UP program is being tested against enhanced care. It includes a school-based system where primary care doctors start treatment and refer kids to specialists who then use telemedicine for check-ups. The goal is to see if this improves the number of symptom-free days over a year.

How Is the Trial Designed?

Group I: TEAM-UP Intervention Group Experimental Treatment 1 Intervention

Group II: Enhanced Care Comparison Group Active Control 1 Intervention

Who Is Running the Clinical Trial?

University of Rochester

Lead Sponsor

Trials

883

Recruited

555,000+

University of Arkansas

Collaborator

Trials

500

Recruited

153,000+

University at Buffalo

Collaborator

Trials

139

Recruited

105,000+

Published Research Related to This Trial

The telemedicine-based program (TEAM-ED) significantly improved follow-up visits and preventive care actions for children with asthma after an emergency department visit, with 91% of participants attending at least one telemedicine visit.

While TEAM-ED showed better follow-up and preventive medication use, it did not lead to overall improvements in asthma morbidity or medication adherence, highlighting the need for ongoing management support.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effect of the Telemedicine Enhanced Asthma Management through the Emergency Department (TEAM-ED) Program on Asthma Morbidity: A Randomized Controlled Trial. Halterman, JS., Fagnano, M., Tremblay, P., et al.[2023]

The SB-TEAM program, which includes supervised asthma medication administration and telemedicine visits, significantly increased the number of symptom-free days for children with persistent asthma, showing an improvement from 10.97 to 11.6 days per two weeks compared to usual care.

Children in the SB-TEAM group had a lower rate of emergency department visits and hospitalizations for asthma (7% vs 15%), indicating that this program not only improved symptoms but also reduced the need for urgent medical care.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effect of the School-Based Telemedicine Enhanced Asthma Management (SB-TEAM) Program on Asthma Morbidity: A Randomized Clinical Trial. Halterman, JS., Fagnano, M., Tajon, RS., et al.[2022]

A telemedicine program connecting asthma specialists with school-based asthma programs was found to be feasible and well-accepted, with 94% of participants rating it as good or excellent.

The study, involving 83 subjects over 32 weeks, showed significant improvements in family social activities and a reduction in asthma attacks, highlighting the potential benefits of expert asthma care access through telemedicine.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The use of telemedicine access to schools to facilitate expert assessment of children with asthma. Bergman, DA., Sharek, PJ., Ekegren, K., et al.[2021]

The New Mexico Pictorial Asthma Action Plan (NM PicAAP) was developed and validated to improve asthma management in children, particularly for those with low literacy, through telehealth services.

In a small study with seven youth, the implementation of NM PicAAP via telehealth resulted in increased asthma control scores over one month, suggesting it may be an effective tool for enhancing asthma care in children.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Formative Evaluation for Implementation of a Low Literacy Pictorial Asthma Action Plan Delivered via Telehealth Improves Asthma Control. Vallabhan, MK., Jimenez, EY., McCauley, GL., et al.[2021]

Citations

1. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/38065280/

Effect of the Telemedicine Enhanced Asthma Management ... TEAM-ED significantly improved follow-up and preventive care after an ED visit for asthma. We also saw improved SFDs with prepandemic data.

2. jpeds.com jpeds.com/article/S0022-3476(25)00413-5/abstract

Effect of the Telemedicine Enhanced Asthma Management ... We found that children in TEAM-UP vs eUC had more SFDs (mean difference: 1.32; 95% CI 0.58–2.05) and were less likely to miss school (OR: 0.70; ...

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10922928/

Effect of the Telemedicine Enhanced Asthma Management ... TEAM-ED significantly improved follow-up and preventive care after an ED visit for asthma. We also saw improved SFDs with pre-pandemic data.

4. sciencedirect.com sciencedirect.com/science/article/abs/pii/S002234762300731X

Effect of the Telemedicine Enhanced Asthma Management ... At 3 months, caregivers of children in TEAM-ED reported more follow-up visits (66% vs 48%; aOR, 2.07; 95% CI, 1.28-3.33), preventive asthma medication actions ( ...

5. journals.lww.com journals.lww.com/prcm/fulltext/2024/08020/the_effectiveness_of_telemedicine_consultation_in.3.aspx

The Effectiveness of Telemedicine Consultation in ... The present findings suggest that telemedicine may be an effective alternative to in-person visits for improving asthma control.

6. clinicaltrials.gov clinicaltrials.gov/ct2/show/NCT03648203?term=teams%26draw=2%26rank=1

Technology Enabled Asthma Management System ... The overarching goal of TEAMS is to improve asthma outcomes by leveraging capabilities of existing technology (smartphone, telemedicine, electronic medical ...

7. explorationpub.com explorationpub.com/Journals/eaa/Article/100981

A telemedicine care protocol for pediatric and adolescent ... Telemedicine significantly enhances asthma management, improving treatment adherence, quality of life, and patient education while reducing unplanned visits.

8. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC5885835/

Effect of the School-Based Telemedicine Enhanced ... This randomized clinical trial evaluates the effect of the School-Based Telemedicine Enhanced Asthma Management program on asthma morbidity ...