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

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

Trial Summary

What is the purpose of this trial?

The Nav-Team study reviews how well the asthma navigators/coordinator program can improve the lives of asthmatic children, and their caregivers, by providing additional assistance and education. Aim 1 of the study will partner with immigrant serving community organizations to hold meetings that will help tailor the programs. Aim 2 of the study looks at data to help see if the program is working to help children and their caregivers. Aim 2a looks at difference in emergency department use between families that did not use the Nav-Team program and those that did. Aim 2b reviews how well the Nav-Team program did with reaching and connecting with the asthma child and caregiver community. Aim 2b, also reviews the costs of the program, how well the program did will sticking to the program goals, and how well the staff was able to keep up with providing education and help.

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+