Asthma in ChildrenNCT06513832
Asthma Navigator Intervention to Improve Health Equity in Children
A study testing The asthma navigator in people with Asthma in Children, run by Emory University at 1 site in United States.
Trial summary
The goal of this study is to improve health equity in children aged 5-16.9 years admitted to the PICU for asthma. The objectives are: To identify the factors related to differential experiences of asthma self-management To pilot the effectiveness of an individualized asthma navigator intervention at PICU discharge. Read more about this study
- Who is it for?
- Ages 5 to 17 years
- Conditions the study is for
- Asthma in Children
- What is being tested?
- The asthma navigator
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 75 participants
- Where
- 1 siteUnited States
- Study dates
- 17 Jan 2025to Aug 2026
- 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 5 to 17 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Admitted to the PICU for asthma
Who cannot join
- Cystic fibrosis
- Immune deficiency
- Prematurity <35 weeks
- Gestation and congenital airway deformities
- Non-English speaker
Trial locations and contacts
1 site in 1 country.
United States1 site
Children's Healthcare of Atlanta
Atlanta, Georgia, 30329
About this study
The goal of this study is to improve health equity in children aged 5-16.9 years admitted to the PICU for asthma. The objectives are:
- To identify the factors related to differential experiences of asthma self-management
- To pilot the effectiveness of an individualized asthma navigator intervention at PICU discharge.
Read the detailed description
Despite available asthma treatments, nearly 50% of children with asthma experience exacerbations annually, with disadvantaged children, particularly Black and Hispanic, being the most affected. These disparities are largely due to social determinants of health (SDOH), including socioeconomics and family hardship, which explain over 80% of the racial disparities in asthma outcomes. Children in lower opportunity neighborhoods face additional challenges like poor housing and limited green spaces, increasing exposure to pollutants and allergens.
At Children's Healthcare of Atlanta's Pediatric ICU (PICU), 85% of asthma admissions come from low-opportunity areas, with 36.7% having another exacerbation within a year. Significant barriers to better outcomes include limited provider understanding of SDOH and challenges in asthma self-management. Effective asthma self-management, supported by medical providers, is crucial for improving health outcomes in these disadvantaged children.
- Conditions
- Asthma in Children
- Being tested
- The asthma navigator
- Keywords
- Asthma self-management, Asthma in Children
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
The asthma navigatorBehavioural
The asthma navigator is a Registered Respiratory Therapist and Certified Asthma Educator who will review the care plan at discharge and provide asthma education; assist with follow-up clinic appointment scheduling, medication access, and transportation; and daily as-needed telephone support.
| Study group | Role | What they receive |
|---|---|---|
| The Asthma Navigator | Experimental | The Children's electronic medical record (EMR) of each child will be screened weekly for up to 52 weeks. When an asthma exacerbation prompting unscheduled healthcare utilization is noted (primary outcome), or at the end of 52 weeks, participant involvement in the study will end. Receives: Behavioral: The asthma navigator |
| Standard of Care | No intervention | This arm will not have access to the Asthma Navigator. The Children's EMR of each child will be screened weekly for up to 52 weeks. When an asthma exacerbation prompting unscheduled healthcare utilization is noted (primary outcome), or at the end of 52 weeks, participant involvement in the study will end. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Future unscheduled healthcare utilization for asthma exacerbation
The occurrence of unscheduled healthcare utilization and the date and time of occurrence will be assessed through weekly screenings of each child's EMR at Children's (Epic system).
Measured: Baseline, end of study (average of 52 weeks)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jul 2024
- Study start17 Jan 2025
- Primary completionAug 2026 (estimated)
- Study completionAug 2026 (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 Emory UniversityThe 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 75 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Emory University
- Sponsor type
- University, hospital or other
- Collaborators
- Georgia Clinical & Translational Science Alliance
- Responsible party
- Principal investigator, Anne M Fitzpatrick, Emory University
- Investigators
- Anne Fitzpatrick, PhD, APRN, Principal investigator, Emory University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06513832
- Sponsor's protocol ID
- STUDY00007482
- Status last verified
- May 2026
- First submitted
- 15 Jul 2024
- Last updated
- 22 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: All subject-level clinical data at enrollment will be preserved and shared during study completion on 7/31/26. Shared data will be deidentified and original data maintained at the Principal Investigator's institution. Recruitment progress and final study results will be documented at clinicaltrials.gov. Protocols, informed consent forms to participate in the trial and the data dictionary will be shared with the data. Data will be shared with qualified investigators with an appropriate research and approved data use agreement (DUA). Data will be accessed by restricted download once approved.
Study at a glance
From the registry record, last updated by the sponsor on 22 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Asthma Navigator Intervention to Improve Health Equity in Children
- ClinicalTrials.gov ID
- NCT06513832
- Acronym / sponsor ID
- STUDY00007482
- Conditions
- Asthma in Children
- Keywords
- Asthma self-management, Asthma in Children
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 75 participants (estimated)
- Lead sponsor
- Emory UniversityUniversity, hospital or other
- Collaborators
- Georgia Clinical & Translational Science Alliance
- Study start
- 17 Jan 2025 (actual)
- Primary completion
- Aug 2026 (estimated)
- Study completion
- Aug 2026 (estimated)
- First posted
- 22 Jul 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 goal of this study is to improve health equity in children aged 5-16.9 years admitted to the PICU for asthma. The objectives are:
- To identify the factors related to differential experiences of asthma self-management
- To pilot the effectiveness of an individualized asthma navigator intervention at PICU discharge.
Detailed description
Despite available asthma treatments, nearly 50% of children with asthma experience exacerbations annually, with disadvantaged children, particularly Black and Hispanic, being the most affected. These disparities are largely due to social determinants of health (SDOH), including socioeconomics and family hardship, which explain over 80% of the racial disparities in asthma outcomes. Children in lower opportunity neighborhoods face additional challenges like poor housing and limited green spaces, increasing exposure to pollutants and allergens.
At Children's Healthcare of Atlanta's Pediatric ICU (PICU), 85% of asthma admissions come from low-opportunity areas, with 36.7% having another exacerbation within a year. Significant barriers to better outcomes include limited provider understanding of SDOH and challenges in asthma self-management. Effective asthma self-management, supported by medical providers, is crucial for improving health outcomes in these disadvantaged children.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| The Asthma Navigator | Experimental | Behavioral: The asthma navigatorThe Children's electronic medical record (EMR) of each child will be screened weekly for up to 52 weeks. When an asthma exacerbation prompting unscheduled healthcare utilization is noted (primary outcome), or at the end of 52 weeks, participant involvement in the study will end. |
| Standard of Care | No intervention | –This arm will not have access to the Asthma Navigator. The Children's EMR of each child will be screened weekly for up to 52 weeks. When an asthma exacerbation prompting unscheduled healthcare utilization is noted (primary outcome), or at the end of 52 weeks, participant involvement in the study will end. |
Who may qualify
- Ages
- 5 to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- Admitted to the PICU for asthma
Key exclusion criteria (5 listed)
- Cystic fibrosis
- Immune deficiency
- Prematurity <35 weeks
- Gestation and congenital airway deformities
- Non-English speaker
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 |
|---|---|---|
| The asthma navigatorThe asthma navigator is a Registered Respiratory Therapist and Certified Asthma Educator who will review the care plan at discharge and provide asthma education; assist with follow-up clinic appointment scheduling, medication access, and transportation; and daily as-needed telephone support. | Behavioural | The Asthma Navigator |
Primary outcome
Future unscheduled healthcare utilization for asthma exacerbation
Time frame: Baseline, end of study (average of 52 weeks)
The occurrence of unscheduled healthcare utilization and the date and time of occurrence will be assessed through weekly screenings of each child's EMR at Children's (Epic system).
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 22 May 2026.
- Individual participant dataSharing planned: Yes. All subject-level clinical data at enrollment will be preserved and shared during study completion on 7/31/26. Shared data will be deidentified and original data maintained at the Principal Investigator's institution. Recruitment progress and final study results will be documented at clinicaltrials.gov. Protocols, informed consent forms to participate in the trial and the data dictionary will be shared with the data. Data will be shared with qualified investigators with an appropriate research and approved data use agreement (DUA). Data will be accessed by restricted download once approved.
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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. This study is not recruiting at the moment.
Anne Fitzpatrick, PhD, APRN principal investigator
Emory University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing The asthma navigator in people with Asthma in Children, run by Emory University 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 1 inclusion and 5 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: under way, not looking for participants, as of the sponsor's last update on 22 May 2026. 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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Future unscheduled healthcare utilization for asthma exacerbation (time frame: Baseline, end of study (average of 52 weeks)). 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 22 May 2026.