An Asthma Collaboration to Reduce Childhood Asthma Disparities on the Navajo Nation

February 20, 2025 updated by: National Jewish Health
National Jewish Health and The University of Arizona worked with Navajo Nation organizations to develop this program to improve the health of children with asthma. The Navajo Community Asthma Program will have two main parts. One will train doctors and health care professionals to improve the diagnosis and treatment of asthma. The second part will work with area schools to provide education to school nurses, teachers, and children to help them better understand asthma. The project also works with families to help them know how to best take care of their child's asthma. A major project aim is to make sure that doctors, teachers, and families work together to manage asthma.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

300

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Arizona
      • Tucson, Arizona, United States, 85721
        • University of Arizona
    • Colorado
      • Denver, Colorado, United States, 80206
        • National Jewish Health

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

The project will involve three Navajo Nation Agencies: Tuba City, Chinle, and Fort Defiance. Project interventions will run for one year in each Agency. Interventions are population-level interventions. No intervention will be administered at the individual level.

Inclusion Criteria:

- The study will be conducted within three agencies on the Navajo Nation, each of which has its own IHS service unit. The three agencies are Chinle, Tuba City, and Fort Defiance.

Exclusion Criteria:

- This protocol pertains only to the three agencies listed above.

Community interviewees will be interested candidates who meet the following eligibility criteria:

Inclusion Criteria:

  1. Able and willing to provide informed consent
  2. Greater than or equal to 18 years of age
  3. Guardianship of a child younger than 18 years of age who has been diagnosed with asthma
  4. Able to read and/or understand English or Navajo

Exclusion Criteria:

  1. Unable or unwilling to provide informed consent
  2. Younger than 18 years of age, without presence of guardian
  3. Unable to read and/or understand English or Navajo

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Health Services Research
  • Allocation: Non-Randomized
  • Interventional Model: Sequential Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Year two intervention
Both interventions will occur in the Tuba City Agency during year two.
Behavioral: Asthma Care Provider Training
In this intervention, asthma care providers will be trained in current, evidence-based guidelines for care of children with asthma, and will be provided with tools that their practice may use to facilitate care improvements.
Behavioral: School Staff Asthma Education
In this intervention, teachers and other school staff will be provided current, evidence-based training in understanding asthma and will be provided tools to help schools address the special needs of children with asthma.
Active Comparator: Year three intervention
Both interventions will occur in the Chinle Agency during year three.
Behavioral: Asthma Care Provider Training
In this intervention, asthma care providers will be trained in current, evidence-based guidelines for care of children with asthma, and will be provided with tools that their practice may use to facilitate care improvements.
Behavioral: School Staff Asthma Education
In this intervention, teachers and other school staff will be provided current, evidence-based training in understanding asthma and will be provided tools to help schools address the special needs of children with asthma.
Active Comparator: Year four intervention
Both interventions will occur in the Fort Defiance during year four.
Behavioral: Asthma Care Provider Training
In this intervention, asthma care providers will be trained in current, evidence-based guidelines for care of children with asthma, and will be provided with tools that their practice may use to facilitate care improvements.
Behavioral: School Staff Asthma Education
In this intervention, teachers and other school staff will be provided current, evidence-based training in understanding asthma and will be provided tools to help schools address the special needs of children with asthma.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Rate of pediatric asthma exacerbations in Year 1
Time Frame: Data will be collected once during Year 1 of the project.
The rate of asthma exacerbations among children living on the Navajo Nation during Year 1 of the project as measured by hospitalizations and urgent care visits. This rate will be assessed by review of Indian Health Service (IHS) data.
Data will be collected once during Year 1 of the project.
Rate of pediatric asthma exacerbations in Year 2
Time Frame: Data will be collected once during Year 2 of the project.
The rate of asthma exacerbations among children living on the Navajo Nation during Year 2 of the project as measured by hospitalizations and urgent care visits. This rate will be assessed by review of Indian Health Service (IHS) data.
Data will be collected once during Year 2 of the project.
Rate of pediatric asthma exacerbations in Year 3
Time Frame: Data will be collected once during Year 3 of the project.
The rate of asthma exacerbations among children living on the Navajo Nation during Year 3 of the project as measured by hospitalizations and urgent care visits. This rate will be assessed by review of Indian Health Service (IHS) data.
Data will be collected once during Year 3 of the project.
Rate of pediatric asthma exacerbation in Year 4
Time Frame: Data will be collected once during Year 4 of the project.
The rate of asthma exacerbations among children living on the Navajo Nation during Year 4 of the project as measured by hospitalizations and urgent care visits. This rate will be assessed by review of Indian Health Service (IHS) data.
Data will be collected once during Year 4 of the project.
Rate of pediatric asthma exacerbations in Year 5
Time Frame: Data will be collected once during Year 5 of the project.
The rate of asthma exacerbations among children living on the Navajo Nation during Year 5 of the project as measured by hospitalizations and urgent care visits. This rate will be assessed by review of Indian Health Service (IHS) data.
Data will be collected once during Year 5 of the project.
Rate of pediatric asthma exacerbations in Year 6
Time Frame: Data will be collected once during Year 6 of the project.
The rate of asthma exacerbations among children living on the Navajo Nation during Year 6 of the project as measured by hospitalizations and urgent care visits. This rate will be assessed by review of Indian Health Service (IHS) data.
Data will be collected once during Year 6 of the project.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Community reports of asthma-related events Year 1
Time Frame: In-person interviews will be conducted with families during year one of the project.
Families will be interviewed to assess child asthma symptom control and related care satisfaction.
In-person interviews will be conducted with families during year one of the project.
Community reports of asthma-related events Year 2
Time Frame: In-person interviews will be conducted with families during year two of the project.
Families will be interviewed to assess child asthma symptom control and related care satisfaction.
In-person interviews will be conducted with families during year two of the project.
Community reports of asthma-related events Year 3
Time Frame: In-person interviews will be conducted with families during year three of the project.
Families will be interviewed to assess child asthma symptom control and related care satisfaction.
In-person interviews will be conducted with families during year three of the project.
Community reports of asthma-related events Year 4
Time Frame: In-person interviews will be conducted with families during year four of the project.
Families will be interviewed to assess child asthma symptom control and related care satisfaction.
In-person interviews will be conducted with families during year four of the project.
Community reports of asthma-related events Year 5
Time Frame: In-person interviews will be conducted with families during year five of the project.
Families will be interviewed to assess child asthma symptom control and related care satisfaction.
In-person interviews will be conducted with families during year five of the project.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

National Jewish Health

Collaborators

University of Arizona

Investigators

  • Principal Investigator: Bruce Bender, PhD, National Jewish Health

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 1, 2017

Primary Completion (Actual)

June 30, 2024

Study Completion (Estimated)

June 30, 2025

Study Registration Dates

First Submitted

November 1, 2017

First Submitted That Met QC Criteria

December 15, 2017

First Posted (Actual)

December 19, 2017

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

February 20, 2025

Last Verified

February 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HS2970

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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