NCT03377647

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.

Trial Health

55
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
300

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Aug 2017

Longer than P75 for not_applicable

Geographic Reach
1 country

2 active sites

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2017

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

November 1, 2017

Completed
2 months until next milestone

First Posted

Study publicly available on registry

December 19, 2017

Completed
6.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2024

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2025

Completed
Last Updated

February 24, 2025

Status Verified

February 1, 2025

Enrollment Period

6.9 years

First QC Date

November 1, 2017

Last Update Submit

February 20, 2025

Conditions

Outcome Measures

Primary Outcomes (6)

  • 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.

  • 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.

  • 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.

  • 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.

  • 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.

  • 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 Outcomes (5)

  • Community reports of asthma-related events Year 1

    In-person interviews will be conducted with families during year one of the project.

  • Community reports of asthma-related events Year 2

    In-person interviews will be conducted with families during year two of the project.

  • Community reports of asthma-related events Year 3

    In-person interviews will be conducted with families during year three of the project.

  • Community reports of asthma-related events Year 4

    In-person interviews will be conducted with families during year four of the project.

  • Community reports of asthma-related events Year 5

    In-person interviews will be conducted with families during year five of the project.

Study Arms (3)

Year two intervention

ACTIVE COMPARATOR

Both interventions will occur in the Tuba City Agency during year two.

Behavioral: Asthma Care Provider TrainingBehavioral: School Staff Asthma Education

Year three intervention

ACTIVE COMPARATOR

Both interventions will occur in the Chinle Agency during year three.

Behavioral: Asthma Care Provider TrainingBehavioral: School Staff Asthma Education

Year four intervention

ACTIVE COMPARATOR

Both interventions will occur in the Fort Defiance during year four.

Behavioral: Asthma Care Provider TrainingBehavioral: School Staff Asthma Education

Interventions

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.

Year four interventionYear three interventionYear two intervention

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.

Year four interventionYear three interventionYear two intervention

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • \- 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.

You may not qualify if:

  • \- This protocol pertains only to the three agencies listed above.
  • Community interviewees will be interested candidates who meet the following eligibility 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
  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

University of Arizona

Tucson, Arizona, 85721, United States

Location

National Jewish Health

Denver, Colorado, 80206, United States

Location

Related Publications (1)

  • Lowe AA, Ravi P, Hudson B, Begay E, Tso B, Liu AH, Bender BG, Gerald LB, King DK. Using document analysis methods and implementation science frameworks to conduct a process evaluation of the community asthma program on the Navajo Nation. Transl Behav Med. 2025 Jan 16;15(1):ibaf056. doi: 10.1093/tbm/ibaf056.

Study Officials

  • Bruce Bender, PhD

    National Jewish Health

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
SEQUENTIAL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 1, 2017

First Posted

December 19, 2017

Study Start

August 1, 2017

Primary Completion

June 30, 2024

Study Completion

June 30, 2025

Last Updated

February 24, 2025

Record last verified: 2025-02

Locations