Nav-Team Program for Childhood Asthma

(Nav-TEAM Trial)

Overseen By Rose Prieto

Age: Any Age

Sex: Any

Trial Phase: Academic

Sponsor: University of Colorado, Denver

Must be taking: Controller medications

Disqualifiers: Age, Language, Respiratory support, others

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

Compensation: Varies

Number of Visits: 6

Duration: 9 months

570 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores how a program called Nav-Team can assist children with asthma and their caregivers by offering additional support and education. The study partners with community organizations to customize the program and examines data to assess its effectiveness, particularly in reducing emergency room visits. The trial is suitable for children aged 4-12 with persistent asthma who are on controller medication, and whose caregivers do not primarily speak English. Participants will either receive Nav-Team assistance or complete surveys without extra help. As an unphased trial, this study provides a unique opportunity for participants to contribute to innovative asthma care solutions.

Do I need to stop my current medications to join the trial?

The trial does not specify if you need to stop taking your current medications. However, since it involves children with persistent asthma who are already on controller medication, it seems likely that continuing current asthma medications is expected.

What prior data suggests that the Nav-Team program is safe for children with asthma?

Research shows that the Nav-Team program for children with asthma emphasizes education and support, rather than new drugs or medical treatments. This program helps children and their caregivers manage asthma more effectively through guidance and learning.

As it is not a medication or medical procedure, there are no typical safety concerns like side effects. Instead, the program aims to enhance asthma management skills and provide helpful resources. This approach is generally safe because it involves educational support rather than medical intervention.

Similar programs, such as the School-Based Telemedicine Enhanced Asthma Management (SB-TEAM), have shown positive results with no reported safety issues. These programs have helped children manage asthma better without causing harm.

Overall, the Nav-Team offers assistance and guidance, making it a safe choice for families seeking to improve their asthma management skills. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the Nav-Team program for childhood asthma because it offers a unique approach by providing additional personalized assistance and support, which is not typically part of standard asthma treatments like inhaled corticosteroids or bronchodilators. Unlike these medications, the Nav-Team program focuses on helping children and their families manage asthma more effectively through regular encounters over nine months, potentially leading to better adherence to treatments and fewer asthma attacks. This personalized support could fill in crucial gaps in care, offering a complementary strategy to existing therapies.

What evidence suggests that the Nav-Team program is effective for improving the lives of children with asthma?

Research has shown that programs like the Nav-Team, which participants in this trial may receive, can greatly help children manage their asthma. In a similar program, emergency room visits dropped by 55%, and hospital stays decreased by 70% for high-risk children. This indicates that specific support and education can reduce asthma attacks and improve health. Another study found that these programs were more effective when led by individuals with similar experiences, enhancing asthma control and quality of life. Overall, this evidence suggests that the Nav-Team program could effectively support children with asthma and their families. ^{6 7 8 9 10}

Are You a Good Fit for This Trial?

This trial is for children with asthma and their caregivers, particularly those who communicate in a language other than English. It aims to help immigrant families by providing tailored support through an asthma navigator/coordinator program.

Inclusion Criteria

I am a parent or guardian over 18.

My child is on medication for ongoing asthma.

My child is between 4 and 12 years old.

Exclusion Criteria

I am a parent/guardian and I prefer to speak in English.

Child requires additional continuous respiratory support (e.g., tracheostomy with home ventilation, continuous daytime oxygen)

Child is enrolled in another study health system associated asthma navigation program (e.g. school or home-visiting programs)

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive the Nav-TEAM intervention, including asthma education and care coordination, tailored for families communicating in languages other than English

9 months

≈6 encounters (telehealth)

Follow-up

Participants are monitored for asthma-related outcomes, including emergency department utilization and quality of life, through surveys and questionnaires

12 months

What Are the Treatments Tested in This Trial?

Interventions

• Nav-Team

Trial Overview The Nav-Team study is testing the effectiveness of an asthma management program designed for children and their caregivers. The study evaluates emergency department use, community engagement, cost-effectiveness, adherence to goals, and educational support provided.

How Is the Trial Designed?

Group I: Nav-Team Experimental Treatment 1 Intervention

Participants in this arm will receive additional assistance related to asthma, and will participate in encounters over the subsequent 9 months

Group II: Non-Nav-Team Active Control 1 Intervention

Participants in this arm will participate in surveys but will receive no navigation assistance.

Who Is Running the Clinical Trial?

University of Colorado, Denver

Lead Sponsor

Trials

1,842

Recruited

3,028,000+

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT06239844

Navigating Together for Equitable Asthma Management ... The Nav-Team study reviews how well the asthma navigators/coordinator program can improve the lives of asthmatic children, and their caregivers.

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11325631/

Reducing asthma attacks in disadvantaged school children ... Students with asthma and their families will be assessed for the Reach and Effectiveness outcomes. Elementary schools and their staff will be assessed for the ...

3. implementationscience.biomedcentral.com implementationscience.biomedcentral.com/articles/10.1186/s13012-024-01387-3

Reducing asthma attacks in disadvantaged school children ... Our school-based asthma intervention has reduced asthma exacerbations for children experiencing health disparities in the Denver Metropolitan Area.

4. childrenshospitals.org childrenshospitals.org/news/childrens-hospitals-today/2021/09/improving-asthma-management-in-highrisk-pediatric-patients

Improving Asthma Management in High-risk Pediatric ... Successful asthma patient outcomes · 55% reduction in emergency department visits · 70% reduction in hospitalizations and observations · 39% reduction in urgent ...

5. jamanetwork.com jamanetwork.com/journals/jamanetworkopen/fullarticle/2786918

Long-term Effectiveness of a Peer-Led Asthma Self ... The peer-led program was significantly more effective than a program led by adult educators in improving asthma control, quality of life, and self-efficacy ...

6. trial.medpath.com trial.medpath.com/clinical-trial/cb0960f7ab08fb21/nct06239844-navigating-together-equitable-asthma

Navigating Together for Equitable Asthma Management for ... The overall scientific goals of this community-engaged study are to: evaluate the effectiveness of Nav-TEAM on pediatric asthma outcomes for 320 children whose ...

7. withpower.com withpower.com/trial/nav-team-program-for-childhood-asthma-e1a72

Nav-Team Program for Childhood Asthma The Nav-Team study reviews how well the asthma navigators/coordinator program can improve the lives of asthmatic children, and their caregivers, ...

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

Effect of the School-Based Telemedicine Enhanced ... We found that the SB-TEAM intervention yielded statistically significant improvements in outcomes among urban children with persistent asthma.

9. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC7275896/

Asthma Across Childhood: Improving Adherence to ... In this paper, we will analyze challenges and methods to control asthma in three age groups—early childhood, school-aged years, and adolescence ...

10. cdc.gov cdc.gov/mmwr/volumes/65/su/su6501a4.htm

Community Asthma Initiative to Improve Health Outcomes ... A randomized clinical trial to reduce asthma morbidity among inner-city children: results of the National Cooperative Inner-City Asthma Study.