Back to resultsAn Asthma Collaboration to Reduce Childhood Asthma Disparities on the Navajo Nation
Primary Purpose
Asthma in Children
Status
Enrolling by invitation
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Asthma Care Provider Training
School Staff Asthma Education
Sponsored by
About this trial
This is an interventional health services research trial for Asthma in Children
Eligibility 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:
- Able and willing to provide informed consent
- Greater than or equal to 18 years of age
- Guardianship of a child younger than 18 years of age who has been diagnosed with asthma
- Able to read and/or understand English or Navajo
Exclusion Criteria:
- Unable or unwilling to provide informed consent
- Younger than 18 years of age, without presence of guardian
- Unable to read and/or understand English or Navajo
Sites / Locations
- University of Arizona
- National Jewish Health
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Active Comparator
Active Comparator
Active Comparator
Arm Label
Year two intervention
Year three intervention
Year four intervention
Arm Description
Both interventions will occur in the Tuba City Agency during year two.
Both interventions will occur in the Chinle Agency during year three.
Both interventions will occur in the Fort Defiance during year four.
Outcomes
Primary Outcome Measures
Rate of pediatric asthma exacerbations in Year 1
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.
Rate of pediatric asthma exacerbations in Year 2
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.
Rate of pediatric asthma exacerbations in Year 3
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.
Rate of pediatric asthma exacerbation in Year 4
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.
Rate of pediatric asthma exacerbations in Year 5
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.
Rate of pediatric asthma exacerbations in Year 6
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
Community reports of asthma-related events Year 1
Families will be interviewed to assess child asthma symptom control and related care satisfaction.
Community reports of asthma-related events Year 2
Families will be interviewed to assess child asthma symptom control and related care satisfaction.
Community reports of asthma-related events Year 3
Families will be interviewed to assess child asthma symptom control and related care satisfaction.
Community reports of asthma-related events Year 4
Families will be interviewed to assess child asthma symptom control and related care satisfaction.
Community reports of asthma-related events Year 5
Families will be interviewed to assess child asthma symptom control and related care satisfaction.
Full Information
NCT ID
NCT03377647
First Posted
November 1, 2017
Last Updated
April 5, 2022
Sponsor
National Jewish Health
Collaborators
University of Arizona
1. Study Identification
Unique Protocol Identification Number
NCT03377647
Brief Title
An Asthma Collaboration to Reduce Childhood Asthma Disparities on the Navajo Nation
Official Title
An Asthma Collaboration to Reduce Childhood Asthma Disparities on the Navajo Nation
Study Type
Interventional
2. Study Status
Record Verification Date
April 2022
Overall Recruitment Status
Enrolling by invitation
Study Start Date
August 1, 2017 (Actual)
Primary Completion Date
June 30, 2023 (Anticipated)
Study Completion Date
June 30, 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
National Jewish Health
Collaborators
University of Arizona
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Asthma in Children
7. Study Design
Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Sequential Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
300 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Year two intervention
Arm Type
Active Comparator
Arm Description
Both interventions will occur in the Tuba City Agency during year two.
Arm Title
Year three intervention
Arm Type
Active Comparator
Arm Description
Both interventions will occur in the Chinle Agency during year three.
Arm Title
Year four intervention
Arm Type
Active Comparator
Arm Description
Both interventions will occur in the Fort Defiance during year four.
Intervention Type
Behavioral
Intervention Name(s)
Asthma Care Provider Training
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
School Staff Asthma Education
Intervention Description
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.
Primary Outcome Measure Information:
Title
Rate of pediatric asthma exacerbations in Year 1
Description
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.
Time Frame
Data will be collected once during Year 1 of the project.
Title
Rate of pediatric asthma exacerbations in Year 2
Description
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.
Time Frame
Data will be collected once during Year 2 of the project.
Title
Rate of pediatric asthma exacerbations in Year 3
Description
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.
Time Frame
Data will be collected once during Year 3 of the project.
Title
Rate of pediatric asthma exacerbation in Year 4
Description
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.
Time Frame
Data will be collected once during Year 4 of the project.
Title
Rate of pediatric asthma exacerbations in Year 5
Description
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.
Time Frame
Data will be collected once during Year 5 of the project.
Title
Rate of pediatric asthma exacerbations in Year 6
Description
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.
Time Frame
Data will be collected once during Year 6 of the project.
Secondary Outcome Measure Information:
Title
Community reports of asthma-related events Year 1
Description
Families will be interviewed to assess child asthma symptom control and related care satisfaction.
Time Frame
In-person interviews will be conducted with families during year one of the project.
Title
Community reports of asthma-related events Year 2
Description
Families will be interviewed to assess child asthma symptom control and related care satisfaction.
Time Frame
In-person interviews will be conducted with families during year two of the project.
Title
Community reports of asthma-related events Year 3
Description
Families will be interviewed to assess child asthma symptom control and related care satisfaction.
Time Frame
In-person interviews will be conducted with families during year three of the project.
Title
Community reports of asthma-related events Year 4
Description
Families will be interviewed to assess child asthma symptom control and related care satisfaction.
Time Frame
In-person interviews will be conducted with families during year four of the project.
Title
Community reports of asthma-related events Year 5
Description
Families will be interviewed to assess child asthma symptom control and related care satisfaction.
Time Frame
In-person interviews will be conducted with families during year five of the project.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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:
Able and willing to provide informed consent
Greater than or equal to 18 years of age
Guardianship of a child younger than 18 years of age who has been diagnosed with asthma
Able to read and/or understand English or Navajo
Exclusion Criteria:
Unable or unwilling to provide informed consent
Younger than 18 years of age, without presence of guardian
Unable to read and/or understand English or Navajo
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Bruce Bender, PhD
Organizational Affiliation
National Jewish Health
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Arizona
City
Tucson
State/Province
Arizona
ZIP/Postal Code
85721
Country
United States
Facility Name
National Jewish Health
City
Denver
State/Province
Colorado
ZIP/Postal Code
80206
Country
United States
12. IPD Sharing Statement
Learn more about this trial
An Asthma Collaboration to Reduce Childhood Asthma Disparities on the Navajo Nation
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