Recruiting

Observational Study

Sponsor:

University of Colorado, Denver

Code:

NCT06239844

Conditions

Asthma in Children

Eligibility Criteria

Sex: All

Age: 4 - 70+

Healthy Volunteers: Not accepted

Interventions

Experimental: Nav-Team

Study Details

Brief summary:

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.

Conditions

Asthma in Children

Study ID

NCT06239844

Start date

Mar 21, 2025

Status verified date

Apr, 2025

Completion date

Oct, 2028

Anticipated

Primary completion date

Oct, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 4 - 70+

Healthy Volunteers: Not accepted

eria for Nav-TEAM Intervention Dyads include:

  • Child aged 4-12 years.
  • Child with persistent asthma (defined by currently prescribed controller medication).
  • Parent/legal guardian who is at least 18 years old.

Exclusion criteria for Nav-TEAM Intervention Dyads include:

  • Child aged under 4 and over 12 years of age.
  • Child with no persistent asthma (defined by currently prescribed controller medication).
  • Parent/legal guardian who is under 18 years old.
  • Any parent/legal guardian whose preferred spoken language is 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).
  • Spoken non-English preferred healthcare language of parent/legal guardian.
  • Child does NOT require additional continuous respiratory support (e.g., nighttime use of Continuous positive airway pressure machine for obstructive sleep apnea would be eligible).
  • Child does NOT have a complex medical/genetic condition that affects swallowing or lung function (e.g. g-tube with aspiration, cystic fibrosis)
  • Child is NOT enrolled in another study health system associated asthma navigation program (e.g. school or home-visiting programs).

Study Design

Enrollment

570 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Health Services Research

Interventions and Outcome Measures

Arms

experimental: Nav-Team

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

no intervention: Non-Nav-Team

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

Interventions

Experimental: Nav-Team

Participants in this arm will receive additional assistance related to asthma, log encounters, complete surveys.

Primary outcome measure

  • Asthma-related emergency department (ED) utlization [ Time Frame: 12 months ]

Central Contacts and Locations

Central contacts

Lisa Ross DeCamp, MD, MPH

3037246499lisa.decamp@cuanschutz.edu

Rose Prieto

303.724.9785rosa.prieto@cuanschutz.edu

Locations

Children's Hospital Colorado

Recruiting

Aurora, Colorado, United States, 80045

Contacts

Lisa DeCamp, MD

303-724-6499lisa.decamp@cuanchutz.edu

More Information

Sponsor

University of Colorado, Denver

Last update posted

Apr 3, 2025

Last verified

Apr, 2025

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of Colorado, Denver on 2025-04-03.