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

Asthma in Children Clinical Trial

Official title:

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

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT03377647
• Other study ID #: HS2970
• Status: Enrolling by invitation
• Phase: N/A
• Start date: August 1, 2017
• Est. completion date: June 30, 2024

Study information

• Verified date: November 2023
• Source: National Jewish Health
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 300
• Est. completion date: June 30, 2024
• Est. primary completion date: June 30, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Asthma
• Asthma in Children

Intervention

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.
• 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.

Locations

Country	Name	City	State
United States	National Jewish Health	Denver	Colorado
United States	University of Arizona	Tucson	Arizona

Sponsors (2)

Lead Sponsor	Collaborator
National Jewish Health	University of Arizona

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Data will be collected once during Year 1 of the project.
Primary	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.	Data will be collected once during Year 2 of the project.
Primary	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.	Data will be collected once during Year 3 of the project.
Primary	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.	Data will be collected once during Year 4 of the project.
Primary	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.	Data will be collected once during Year 5 of the project.
Primary	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.	Data will be collected once during Year 6 of the project.
Secondary	Community reports of asthma-related events Year 1	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.
Secondary	Community reports of asthma-related events Year 2	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.
Secondary	Community reports of asthma-related events Year 3	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.
Secondary	Community reports of asthma-related events Year 4	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.
Secondary	Community reports of asthma-related events Year 5	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.