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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03377647
Recruitment Status : Enrolling by invitation
First Posted : December 19, 2017
Last Update Posted : April 7, 2022
Sponsor:
Collaborator:
University of Arizona
Information provided by (Responsible Party):
National Jewish Health

Study Description
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Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Asthma in Children Behavioral: Asthma Care Provider Training Behavioral: School Staff Asthma Education Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 300 participants
Allocation: Non-Randomized
Intervention Model: Sequential Assignment
Masking: None (Open Label)
Primary Purpose: Health Services Research
Official Title: An Asthma Collaboration to Reduce Childhood Asthma Disparities on the Navajo Nation
Actual Study Start Date : August 1, 2017
Estimated Primary Completion Date : June 30, 2023
Estimated Study Completion Date : June 30, 2024

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Asthma

Arms and Interventions
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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.


Outcome Measures
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Primary Outcome Measures :
  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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.

  6. 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.


Secondary Outcome Measures :
  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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.


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03377647


Locations
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United States, Arizona
University of Arizona
Tucson, Arizona, United States, 85721
United States, Colorado
National Jewish Health
Denver, Colorado, United States, 80206
Sponsors and Collaborators
National Jewish Health
University of Arizona
Investigators
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Principal Investigator: Bruce Bender, PhD National Jewish Health
More Information
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Responsible Party: National Jewish Health
ClinicalTrials.gov Identifier: NCT03377647    
Other Study ID Numbers: HS2970
First Posted: December 19, 2017    Key Record Dates
Last Update Posted: April 7, 2022
Last Verified: April 2022

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Asthma
Bronchial Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive
Lung Diseases
 Respiratory Hypersensitivity
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases