Asthma Navigator for Childhood Asthma

Overseen By Anne Fitzpatrick, PhD, APRN

Age: < 18

Sex: Any

Trial Phase: Academic

Sponsor: Emory University

Disqualifiers: Cystic fibrosis, Immune deficiency, Prematurity, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

Duration: 52 weeks

75 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new approach called the Asthma Navigator, designed to assist children admitted to the PICU for asthma. The goal is to understand why some children manage their asthma better than others and to determine if this tool can help after discharge. Children who often require unscheduled medical visits for asthma might be suitable candidates. The trial compares children using the Asthma Navigator with those receiving standard care to assess the tool's effectiveness. As an unphased trial, it offers participants a unique opportunity to contribute to innovative asthma care solutions.

Do I need to stop my current medications for the trial?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What prior data suggests that the Asthma Navigator is safe for children?

Research has shown that patient navigators can help manage childhood asthma more effectively. These navigators offer personalized support and create treatment plans for children. One study found that when caregivers received help from patient navigators, children's asthma care improved. This suggests that this approach is well-received and helpful for managing asthma symptoms.

Another study demonstrated that electronic health records can track asthma risk in children. This method doesn't involve direct treatment but aids in better managing the condition. While these findings don't directly address safety in the usual sense, they indicate that using navigators to manage asthma is practical and yields positive results.

Overall, using an asthma navigator appears to be a safe and supportive way to help children manage their asthma better. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the Asthma Navigator because it offers a tech-driven approach to managing childhood asthma. Unlike traditional treatments that primarily focus on medication to control symptoms, the Asthma Navigator uses electronic medical records to proactively monitor each child's condition. This method aims for early detection of asthma exacerbations, potentially reducing unscheduled healthcare visits. By integrating technology into asthma care, this approach hopes to enhance the timeliness and efficiency of interventions, offering a promising new angle in asthma management.

What evidence suggests that the Asthma Navigator is effective for childhood asthma?

Research has shown that asthma management programs can greatly improve children's health. For instance, a program in Denver schools reduced asthma attacks in children from low-income families. Another program at a camp taught minority teenagers better asthma management, leading to improved health. Coordinated care in resource-limited urban areas also had positive effects on asthma. In this trial, participants in one arm will receive personalized support through the Asthma Navigator, which may help children, especially those in disadvantaged situations, manage their asthma more effectively. ^{1 6 7 8 9}

Who Is on the Research Team?

Anne Fitzpatrick, PhD, APRN

Principal Investigator

Emory University

Are You a Good Fit for This Trial?

This trial is for children aged 5 to nearly 17 who have been admitted to the Pediatric Intensive Care Unit (PICU) due to asthma. It's designed to help improve how they manage their asthma after leaving the PICU.

Inclusion Criteria

I am admitted to the Pediatric Intensive Care Unit for asthma.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive the Asthma Navigator intervention, with weekly EMR screenings for asthma exacerbations

52 weeks

Weekly EMR screenings

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Asthma Navigator

Trial Overview The study tests an 'asthma navigator'—a personalized guide or support system—to see if it can help these kids better handle their asthma once they're discharged from the PICU.

How Is the Trial Designed?

Group I: The Asthma Navigator Experimental Treatment 1 Intervention

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.

Group II: Standard of Care Active Control 1 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 Is Running the Clinical Trial?

Emory University

Lead Sponsor

Trials

1,735

Recruited

2,605,000+

Georgia Clinical & Translational Science Alliance (CTSA)

Collaborator

Trials

2

Recruited

150+

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC4861671/

Practice variation in management of childhood asthma is ... In this study, variation in preventive care at the practice-level was associated with significant differences in asthma outcomes for individual patients.

2. implementationscience.biomedcentral.com implementationscience.biomedcentral.com/articles/10.1186/s13012-024-01387-3

Reducing asthma attacks in disadvantaged school children ... Our school-based asthma intervention has reduced asthma exacerbations for children experiencing health disparities in the Denver Metropolitan Area.

3. jamanetwork.com jamanetwork.com/journals/jamanetworkopen/fullarticle/2786918

Long-term Effectiveness of a Peer-Led Asthma Self ... Asthma education offered at a day-camp setting was effective in improving asthma outcomes and self-management in primarily minority adolescents ...

4. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC5055769/

Pediatric Asthma Care Coordination in Underserved ... Objectives. To assess the effect of care coordination on asthma outcomes among children in underserved urban communities. Methods.

5. cdc.gov cdc.gov/mmwr/volumes/65/su/su6501a4.htm

Community Asthma Initiative to Improve Health Outcomes ... CAI was developed to decrease asthma morbidity for children aged 2–18 years with poorly controlled asthma. Before the initiation of the CAI ...

6. sciencedirect.com sciencedirect.com/science/article/pii/S2589537025001865

External validation and update of the pediatric asthma risk ... This study demonstrates that it is feasible to use electronic health records (EHR) data to develop a passive digital marker (PDM) for childhood asthma risk ...

7. jamanetwork.com jamanetwork.com/journals/jamanetworkopen/fullarticle/2797046

Development of a Screening Tool for Children at High Risk ... Of 301 children (13.8%) diagnosed with asthma at 5 years of age, 145 (48.2%) were identified as being at high risk by CHART at 3 years. Wheeze ...

8. cdc.gov cdc.gov/asthma/most_recent_national_asthma_data.htm

Most Recent National Asthma Data These tables feature the latest national and state statistics on the burden of asthma among children and adults.

9. ncbi.nlm.nih.gov ncbi.nlm.nih.gov/books/NBK476530/

The Role of Patient Navigators in Improving Caregiver ... - NCBI Findings suggest that patient navigators may support children's asthma management by providing individualized treatment plans and hands-on practice, improving ...