NCT06239844

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
570

participants targeted

Target at P75+ for not_applicable

Timeline
29mo left

Started Mar 2025

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress33%
Mar 2025Oct 2028

First Submitted

Initial submission to the registry

November 6, 2023

Completed
3 months until next milestone

First Posted

Study publicly available on registry

February 2, 2024

Completed
1.1 years until next milestone

Study Start

First participant enrolled

March 21, 2025

Completed
2.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2027

Expected
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2028

Last Updated

April 3, 2025

Status Verified

April 1, 2025

Enrollment Period

2.5 years

First QC Date

November 6, 2023

Last Update Submit

April 2, 2025

Conditions

Asthma in Children

Outcome Measures

Primary Outcomes (1)

  • Asthma-related emergency department (ED) utlization

    Count of asthma-related ED visits based on EHR ED encounters and corresponding encounter diagnosis codes during the trial period

    12 months

Secondary Outcomes (11)

  • Parent-reported asthma-related ED utilization

    12 months

  • Asthma hospitalization

    12 months

  • Parent-reported asthma-related hospitalization

    12 months

  • Asthma Exacerbations

    12 months

  • Asthma Control

    12 months

  • +6 more secondary outcomes

Study Arms (2)

Nav-Team

EXPERIMENTAL

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

Other: Experimental: Nav-Team

Non-Nav-Team

NO INTERVENTION

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

Interventions

Experimental: Nav-TeamOTHER

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

Nav-Team

Eligibility Criteria

Age4 Years - 89 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may not qualify if:

  • 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).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Children's Hospital Colorado

Aurora, Colorado, 80045, United States

RECRUITING

Central Study Contacts

Lisa Ross DeCamp, MD, MPH

CONTACT

3037246499lisa.decamp@cuanschutz.edu

Rose Prieto

CONTACT

303.724.9785rosa.prieto@cuanschutz.edu

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Model Details: The proposed study builds on a successful local model of asthma navigation and care coordination to support meeting social determinants of health (SDOH) needs using a lay health worker model that has improved asthma outcomes among urban racial/ethnic minority school children. This model is currently being disseminated via community-engaged processes to select school districts across Colorado. Community advisory board members from that initiative identified increasing language inclusivity as a priority in program dissemination.
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 6, 2023

First Posted

February 2, 2024

Study Start

March 21, 2025

Primary Completion (Estimated)

October 1, 2027

Study Completion (Estimated)

October 1, 2028

Last Updated

April 3, 2025

Record last verified: 2025-04

Locations

US(1)