Clinical trial NCT03377647: 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
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Asthma in Children
Lead sponsor: National Jewish Health
Sponsor class: OTHER
Collaborators: name: University of Arizona
First posted: 2017-12-19
Enrollment: 300
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SEQUENTIAL
Primary purpose: HEALTH_SERVICES_RESEARCH

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.


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:

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

Primary outcomes:
measure: Rate of pediatric asthma exacerbations in Year 1
timeFrame: Data will be collected once during Year 1 of the project.
measure: Rate of pediatric asthma exacerbations in Year 2
timeFrame: Data will be collected once during Year 2 of the project.
measure: Rate of pediatric asthma exacerbations in Year 3
timeFrame: Data will be collected once during Year 3 of the project.
measure: Rate of pediatric asthma exacerbation in Year 4
timeFrame: Data will be collected once during Year 4 of the project.
measure: Rate of pediatric asthma exacerbations in Year 5
timeFrame: Data will be collected once during Year 5 of the project.
measure: Rate of pediatric asthma exacerbations in Year 6
timeFrame: Data will be collected once during Year 6 of the project.
Secondary outcomes:
measure: Community reports of asthma-related events Year 1
timeFrame: In-person interviews will be conducted with families during year one of the project.
measure: Community reports of asthma-related events Year 2
timeFrame: In-person interviews will be conducted with families during year two of the project.
measure: Community reports of asthma-related events Year 3
timeFrame: In-person interviews will be conducted with families during year three of the project.
measure: Community reports of asthma-related events Year 4
timeFrame: In-person interviews will be conducted with families during year four of the project.
measure: Community reports of asthma-related events Year 5
timeFrame: In-person interviews will be conducted with families during year five of the project.
Other outcomes:
Locations:
city: Tucson
country: United States
facility: University of Arizona
state: Arizona
city: Denver
country: United States
facility: National Jewish Health
state: Colorado
Study officials:
affiliation: National Jewish Health
name: Bruce Bender, PhD
role: PRINCIPAL_INVESTIGATOR
References: