Asthma in ChildrenNav-TEAMNCT06239844
Navigating Together for Equitable Asthma Management for Children in Families Who Communicate in Language Other Than English
A study testing Experimental: Nav-Team in people with Asthma in Children, run by University of Colorado, Denver at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 4 to 89 years
- Conditions the study is for
- Asthma in Children
- What is being tested?
- Experimental: Nav-Team
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 570 participants
- Where
- 1 siteUnited States
- Study dates
- 21 Mar 2025to Oct 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 4 to 89 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
None listed.
Who cannot join
- 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).
Show all 10Show fewer
- 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).
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Children's Hospital Colorado
Aurora, Colorado, 80045
Lisa DeCamp, MD, 303-724-6499, lisa.decamp@cuanchutz.edu
About this study
Official title: Navigating Together for Equitable Asthma Management for Children in Families Who Communicate in Languages Other Than English (Nav-TEAM)
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.
Read the detailed description
Children in families with healthcare communication in a language other than English are at increased risk of poor asthma care and worse asthma outcomes compared to those without a language barrier. As the most common chronic childhood disease, asthma causes substantial family- and patient-level burden as well as economic impact. Caregivers of children with asthma whose healthcare communication is in languages other than English (LOE) are more likely to report poor asthma care experiences, less use of recommended asthma management practices, and higher hospitalization rates compared to children with caregivers with English healthcare communication. A focus on improving asthma care specifically for families who communicate in LOE is needed to address such disparities.
Asthma navigators play a key role in asthma education and care coordination, resulting in improved asthma outcomes, particularly for low-income and racial/ethnic minority children but studies have not focused on children in LOE families. 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. However, school feasibility concerns and limited opportunities for cultural and language tailoring prevent focusing on this priority. Addressing these barriers, the Navigating Toward Equitable Asthma Management Program (Nav-TEAM) is an adaptation of evidence-based asthma navigation specifically for children in families who communicate in LOE.
Nav-TEAM will include core components of evidence-based asthma navigation/care coordination through a different implementation approach and via specific tailoring for LOE families. Children with asthma and their families will be connected to Nav-TEAM via their healthcare provider rather than the school. Nav-TEAM encounters will take place via telehealth because frequent asthma care in clinic can be difficult for families, and home visits present coordination challenges and increased costs. While emerging research points to inequitable reach of telehealth for LOE patients/families, the telehealth program at the proposed study health system, is committed to equity via integrated interpretation and continuous improvement to increase use with LOE families informed by research partnerships to assess telehealth equity.
Use of lay health workers to provide asthma education and care coordination is a well-established effective intervention. Nav-TEAM will build on the successes of school and home-visiting programs affiliated with the study health system, Children's Hospital Colorado (CHCO) with a novel focus on reaching LOE families. As with existing CHCO asthma navigation programs, Nav-TEAM will align with EXHALE, the Centers for Disease Control and Prevention National Asthma Control Program compilation of asthma management strategies that have been proven to reduce asthma-related ED visits, hospitalization, and healthcare costs. EXHALE strategies include EDUCATION on asthma -self-management, X-TINGUISHING smoking and exposure to secondhand smoke, Home Visits, ACHIEVEMENT of guidelines-based medical management, LINKAGES and coordination of care across settings, ENVIRONMENTAL policies \& best practices to reduce asthma triggers.
When will Nav-TEAM Encounters occur and what will take place during encounters? Families will participate in the Nav-TEAM intervention for 9 months which is similar to the length of school- and home-based programs. There will be scheduled Nav-TEAM encounters with additional encounters to follow-up any asthma-related clinic, ED or hospital visits. We expect most patients will complete ≈6 encounters based on current utilization patterns. Encounters will follow an intervention guide used in existing programs with some adapted elements based on Aim 1 feedback and tailoring. There will be the availability to schedule Nav-TEAM encounters during evening hours and to accommodate families' work schedules.
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 families communicate in LOE, evaluate implementation outcomes, and assess cost and contextual factors to support sustained implementation, scale up and scale out. The study will be implemented in a large primary care clinic serving primarily Medicaid-insured children and in subspecialty pediatric pulmonary clinics using the Practical Robust Implementation and Sustainability Model (PRISM) - inclusive of RE-AIM (Reach, Effectiveness, Adoption, Implementation Maintenance outcomes with an equity lens- as the guiding Dissemination \& Implementation Science framework.
- Conditions
- Asthma in Children
- Being tested
- Experimental: Nav-Team
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Experimental: Nav-TeamOther
Participants in this arm will receive additional assistance related to asthma, log encounters, complete surveys.
| Study group | Role | What they receive |
|---|---|---|
| Nav-Team | Experimental | Participants in this arm will receive additional assistance related to asthma, and will participate in encounters over the subsequent 9 months Receives: Other: Experimental: Nav-Team |
| Non-Nav-Team | No intervention | Participants in this arm will participate in surveys but will receive no navigation assistance. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 12 months
Secondary outcomes (11)
Parent-reported asthma-related ED utilization
Sum of counts of asthma-related ED use based on parent-report. Asthma-related ED use in the past 3 months will be assessed via parent survey. At 3, 6,9, and 12 months this will be determined via a question on the Asthma Care Questionnaire (ACQ. The ACQ will be delivered via text-link for most participants. At 15 months parents will report asthma-related ED use in the past 3 months on the follow-up survey.
Measured: 12 months
Asthma hospitalization
Count of asthma-related hospitalizations based on EHR ED encounters and corresponding encounter diagnosis codes
Measured: 12 months
Parent-reported asthma-related hospitalization
Sum of counts of asthma-related hospitalization based on parent-report. Asthma-related hospitalization in the past 3 months will be assessed via parent survey. This will be determined at 3, 6, 9, and 12 months via an ACQ question. The ACQ will be delivered via text-link for most participants. At 15 months parents will report asthma-related hospitalization the past 3 months on the follow-up survey.
Measured: 12 months
Asthma Exacerbations
% of patients with an oral steroid burst during the trial period. We define the need for oral steroids as an asthma exacerbation. Steroid bursts in the past 3 months will be assessed via parent survey. This will be determined at 3, 6, 9, and 12 months via an ACQ question. The ACQ will be delivered via text-link for most participants. At 15 months parents will report steroids bursts in the past 3 months on the follow-up survey.
Measured: 12 months
Asthma Control
% of Asthma Control Test scores in the complete/well-controlled range (Score >19) Sum of counts of child missed school days based on parent-report. The Asthma Control Test will be administered at 3, 6, 9, and 12 months as part of the ACQ. The ACQ will be delivered via text-link for most participants. At 15 months parents will complete an additional Asthma Control Test on the follow-up survey.
Measured: 12 months
Missed School Days
Sum of counts of child missed school days based on parent-report. Missed school days in the past 3 months will be assessed via parent survey. This will be determined at 3, 6, 9, and 12 months via an ACQ question. The ACQ will be delivered via text-link for most participants. At 15 months parents will report missed school days the past 3 months on the follow-up survey.
Measured: 12 months
Missed Work Days
Sum of counts of parent missed work days based on parent-report. Missed work days in the past 3 months will be assessed via parent survey. This will be determined at 3, 6, 9, and 12 months via an ACQ question. The ACQ will be delivered via text-link for most participants. At 15 months parents will report missed work days the past 3 months on the follow-up survey.
Measured: 12 months
General child health
Assessed via the PROMIS® Pediatric Global Health questionnaire which will be included in the follow-up survey
Measured: 12 months
Child asthma-related quality of life
Assessed via the the PROMIS® Asthma Impact Scale which will be included in the follow-up survey.
Measured: 12 months
Parent asthma-related quality of life
Assessed via the Pediatric Asthma Caregiver's Quality of Life Questionnaire which will be included in the follow-up survey.
Measured: 12 months
Parent asthma self-efficacy
Assessed via the Parental Asthma Management Self-Efficacy Scale which will be included in the follow-up survey
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Feb 2024
- Study start21 Mar 2025
- Primary completionOct 2027 (estimated)
- Study completionOct 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Asthma in ChildrenStudies of the same condition, open and under way.
- More trials run by University of Colorado, DenverThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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.
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 570 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Colorado, Denver
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06239844
- Sponsor's protocol ID
- 23-1544
- Acronym
- Nav-TEAM
- Status last verified
- Apr 2025
- First submitted
- 6 Nov 2023
- Last updated
- 3 Apr 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Navigating Together for Equitable Asthma Management for Children in Families Who Communicate in Languages Other Than English (Nav-TEAM)
- ClinicalTrials.gov ID
- NCT06239844
- Acronym / sponsor ID
- Nav-TEAM / 23-1544
- Conditions
- Asthma in Children
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 570 participants (estimated)
- Lead sponsor
- University of Colorado, DenverUniversity, hospital or other
- Study start
- 21 Mar 2025 (actual)
- Primary completion
- Oct 2027 (estimated)
- Study completion
- Oct 2028 (estimated)
- First posted
- 2 Feb 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Children in families with healthcare communication in a language other than English are at increased risk of poor asthma care and worse asthma outcomes compared to those without a language barrier. As the most common chronic childhood disease, asthma causes substantial family- and patient-level burden as well as economic impact. Caregivers of children with asthma whose healthcare communication is in languages other than English (LOE) are more likely to report poor asthma care experiences, less use of recommended asthma management practices, and higher hospitalization rates compared to children with caregivers with English healthcare communication. A focus on improving asthma care specifically for families who communicate in LOE is needed to address such disparities.
Asthma navigators play a key role in asthma education and care coordination, resulting in improved asthma outcomes, particularly for low-income and racial/ethnic minority children but studies have not focused on children in LOE families. 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. However, school feasibility concerns and limited opportunities for cultural and language tailoring prevent focusing on this priority. Addressing these barriers, the Navigating Toward Equitable Asthma Management Program (Nav-TEAM) is an adaptation of evidence-based asthma navigation specifically for children in families who communicate in LOE.
Nav-TEAM will include core components of evidence-based asthma navigation/care coordination through a different implementation approach and via specific tailoring for LOE families. Children with asthma and their families will be connected to Nav-TEAM via their healthcare provider rather than the school. Nav-TEAM encounters will take place via telehealth because frequent asthma care in clinic can be difficult for families, and home visits present coordination challenges and increased costs. While emerging research points to inequitable reach of telehealth for LOE patients/families, the telehealth program at the proposed study health system, is committed to equity via integrated interpretation and continuous improvement to increase use with LOE families informed by research partnerships to assess telehealth equity.
Use of lay health workers to provide asthma education and care coordination is a well-established effective intervention. Nav-TEAM will build on the successes of school and home-visiting programs affiliated with the study health system, Children's Hospital Colorado (CHCO) with a novel focus on reaching LOE families. As with existing CHCO asthma navigation programs, Nav-TEAM will align with EXHALE, the Centers for Disease Control and Prevention National Asthma Control Program compilation of asthma management strategies that have been proven to reduce asthma-related ED visits, hospitalization, and healthcare costs. EXHALE strategies include EDUCATION on asthma -self-management, X-TINGUISHING smoking and exposure to secondhand smoke, Home Visits, ACHIEVEMENT of guidelines-based medical management, LINKAGES and coordination of care across settings, ENVIRONMENTAL policies \& best practices to reduce asthma triggers.
When will Nav-TEAM Encounters occur and what will take place during encounters? Families will participate in the Nav-TEAM intervention for 9 months which is similar to the length of school- and home-based programs. There will be scheduled Nav-TEAM encounters with additional encounters to follow-up any asthma-related clinic, ED or hospital visits. We expect most patients will complete ≈6 encounters based on current utilization patterns. Encounters will follow an intervention guide used in existing programs with some adapted elements based on Aim 1 feedback and tailoring. There will be the availability to schedule Nav-TEAM encounters during evening hours and to accommodate families' work schedules.
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 families communicate in LOE, evaluate implementation outcomes, and assess cost and contextual factors to support sustained implementation, scale up and scale out. The study will be implemented in a large primary care clinic serving primarily Medicaid-insured children and in subspecialty pediatric pulmonary clinics using the Practical Robust Implementation and Sustainability Model (PRISM) - inclusive of RE-AIM (Reach, Effectiveness, Adoption, Implementation Maintenance outcomes with an equity lens- as the guiding Dissemination \& Implementation Science framework.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| Nav-Team | Experimental | Other: Experimental: Nav-TeamParticipants in this arm will receive additional assistance related to asthma, and will participate in encounters over the subsequent 9 months |
| Non-Nav-Team | No intervention | –Participants in this arm will participate in surveys but will receive no navigation assistance. |
Who may qualify
- Ages
- 4 to 89 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (0 listed)
Key exclusion criteria (10 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Experimental: Nav-TeamParticipants in this arm will receive additional assistance related to asthma, log encounters, complete surveys. | Other | Nav-Team |
Primary outcome
Asthma-related emergency department (ED) utlization
Time frame: 12 months
Count of asthma-related ED visits based on EHR ED encounters and corresponding encounter diagnosis codes during the trial period
11 secondary outcomes
Parent-reported asthma-related ED utilization
Time frame: 12 months
Asthma hospitalization
Time frame: 12 months
Parent-reported asthma-related hospitalization
Time frame: 12 months
Asthma Exacerbations
Time frame: 12 months
Asthma Control
Time frame: 12 months
Missed School Days
Time frame: 12 months
Missed Work Days
Time frame: 12 months
General child health
Time frame: 12 months
Child asthma-related quality of life
Time frame: 12 months
Parent asthma-related quality of life
Time frame: 12 months
Parent asthma self-efficacy
Time frame: 12 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Apr 2025.
Related trials for Asthma in Children
Not yet recruiting
Asthma Ctrl SMART Trial
Asthma in Children, Asthma Chronic
Not yet recruiting
Artificially Intelligent Robot Control
Asthma in Children, Artificial Intelligence
Not yet recruiting
Bilevel Positive Airway Pressure (BPAP) for Severe Asthma
Pediatric Asthma, Acute Asthma
Recruiting
Effects of Tele-rehabilitation-Guided Qigong on Children and Adolescents With Asthma
Asthma Childhood
Enrolling by invitationObservational study
Investigating Novel Strategies in Pediatric Immune Responses and Microbiome Environment: Comprehensive Lung Disease Investigation in Children.
Lung Diseases
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Experimental: Nav-Team in people with Asthma in Children, run by University of Colorado, Denver at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 0 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 3 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Lisa Ross DeCamp, MD, MPH (3037246499, lisa.decamp@cuanschutz.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Asthma-related emergency department (ED) utlization (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Apr 2025.