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

326 Participants Needed

Trial Summary

What is the purpose of this trial?

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 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 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-, 6-, 9- and 12-months after baseline, and the primary outcome is the comparison of symptom-free days (SFD) at each follow-up time point.

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 data supports the effectiveness of the treatment Telemedicine Enhanced Asthma Management-Uniting Providers (TEAM-UP) program for childhood asthma?

Research shows that telemedicine can improve asthma control and quality of life in children by providing access to specialist care and consistent follow-up. Studies have demonstrated that telemedicine programs, like the TEAM-ED program, can reduce asthma-related issues by promoting guideline-based care and facilitating primary care follow-up. ^{1 2 3 4 5}

Is telemedicine for childhood asthma safe?

The studies on telemedicine for childhood asthma, including programs like TEAM-ED and SB-TEAM, do not report any safety concerns, suggesting it is generally safe for use in children. ^{1 2 4 6 7}

How does the TEAM-UP program treatment for childhood asthma differ from other treatments?

The TEAM-UP program is unique because it uses telemedicine to enhance asthma management by connecting children with asthma specialists remotely, improving access to expert care and facilitating follow-up with primary care providers, which can lead to better asthma control compared to traditional in-person visits. ^{1 2 4 5 8}

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

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 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]

References

1. Netherlands pubmed.ncbi.nlm.nih.gov

Formative Evaluation for Implementation of a Low Literacy Pictorial Asthma Action Plan Delivered via Telehealth Improves Asthma Control. [2021]

2. United States pubmed.ncbi.nlm.nih.gov

Improvement in asthma symptoms and quality of life in pediatric patients through specialty care delivered via telemedicine. [2021]

3. England pubmed.ncbi.nlm.nih.gov

Improving care for children in a multi-agency alliance. [2004]

4. United States 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. [2023]

5. Egypt pubmed.ncbi.nlm.nih.gov

The use of telemedicine access to schools to facilitate expert assessment of children with asthma. [2021]

6. United States pubmed.ncbi.nlm.nih.gov

Effect of the School-Based Telemedicine Enhanced Asthma Management (SB-TEAM) Program on Asthma Morbidity: A Randomized Clinical Trial. [2022]

7. United States pubmed.ncbi.nlm.nih.gov

Telemedicine and adherence monitoring in children with asthma. [2023]

8. United States pubmed.ncbi.nlm.nih.gov

The Breathmobile Program: structure, implementation, and evolution of a large-scale, urban, pediatric asthma disease management program. [2019]