Asthma in ChildrenNCT03377647
An Asthma Collaboration to Reduce Childhood Asthma Disparities on the Navajo Nation
A study testing Asthma Care Provider Training and School Staff Asthma Education in people with Asthma in Children, run by National Jewish Health at 2 sites in United States.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Asthma in Children
- What is being tested?
- Asthma Care Provider Training and School Staff Asthma Education
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 300 participants
- Where
- 2 sitesUnited States
- Study dates
- 1 Aug 2017to 30 Jun 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
- 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
Who cannot join
- This protocol pertains only to the three agencies listed above.
- Community interviewees will be interested candidates who meet the following eligibility 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
Trial locations and contacts
2 sites in 1 country.
United States2 sites
National Jewish Health
Denver, Colorado, 80206
University of Arizona
Tucson, Arizona, 85721
About this study
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.
- Conditions
- Asthma in Children
- Being tested
- Asthma Care Provider Training, School Staff Asthma Education
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Asthma Care Provider TrainingBehavioural
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 EducationBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Year two intervention | Active comparator | Both interventions will occur in the Tuba City Agency during year two. Receives: Behavioral: Asthma Care Provider Training; Behavioral: School Staff Asthma Education |
| Year three intervention | Active comparator | Both interventions will occur in the Chinle Agency during year three. Receives: Behavioral: Asthma Care Provider Training; Behavioral: School Staff Asthma Education |
| Year four intervention | Active comparator | Both interventions will occur in the Fort Defiance during year four. Receives: Behavioral: Asthma Care Provider Training; Behavioral: School Staff Asthma Education |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Data will be collected once during Year 6 of the project.
Secondary outcomes (5)
Community reports of asthma-related events Year 1
Families will be interviewed to assess child asthma symptom control and related care satisfaction.
Measured: In-person interviews will be conducted with families during year one of the project.
Community reports of asthma-related events Year 2
Families will be interviewed to assess child asthma symptom control and related care satisfaction.
Measured: In-person interviews will be conducted with families during year two of the project.
Community reports of asthma-related events Year 3
Families will be interviewed to assess child asthma symptom control and related care satisfaction.
Measured: In-person interviews will be conducted with families during year three of the project.
Community reports of asthma-related events Year 4
Families will be interviewed to assess child asthma symptom control and related care satisfaction.
Measured: In-person interviews will be conducted with families during year four of the project.
Community reports of asthma-related events Year 5
Families will be interviewed to assess child asthma symptom control and related care satisfaction.
Measured: In-person interviews will be conducted with families during year five of the project.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Dec 2017
- Study start1 Aug 2017
- Primary completion30 Jun 2024
- Study completion30 Jun 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Asthma in ChildrenStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National Jewish Health
- Sponsor type
- University, hospital or other
- Collaborators
- University of Arizona
- Responsible party
- Sponsor
- Investigators
- Bruce Bender, PhD, Principal investigator, National Jewish Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03377647
- Sponsor's protocol ID
- HS2970
- Status last verified
- Feb 2025
- First submitted
- 1 Nov 2017
- Last updated
- 24 Feb 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 41027683
Study at a glance
From the registry record, last updated by the sponsor on 24 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Asthma Collaboration to Reduce Childhood Asthma Disparities on the Navajo Nation
- ClinicalTrials.gov ID
- NCT03377647
- Acronym / sponsor ID
- HS2970
- Conditions
- Asthma in Children
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- National Jewish HealthUniversity, hospital or other
- Collaborators
- University of Arizona
- Study start
- 1 Aug 2017 (actual)
- Primary completion
- 30 Jun 2024 (actual)
- Study completion
- 30 Jun 2025 (estimated)
- First posted
- 19 Dec 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Health services research
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Year two intervention | Active comparator | Behavioral: Asthma Care Provider Training, Behavioral: School Staff Asthma EducationBoth interventions will occur in the Tuba City Agency during year two. |
| Year three intervention | Active comparator | Behavioral: Asthma Care Provider Training, Behavioral: School Staff Asthma EducationBoth interventions will occur in the Chinle Agency during year three. |
| Year four intervention | Active comparator | Behavioral: Asthma Care Provider Training, Behavioral: School Staff Asthma EducationBoth interventions will occur in the Fort Defiance during year four. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
- 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
Key exclusion criteria (5 listed)
- This protocol pertains only to the three agencies listed above.
- Community interviewees will be interested candidates who meet the following eligibility 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Asthma Care Provider TrainingIn 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. | Behavioural | Year four intervention, Year three intervention, Year two intervention |
| School Staff Asthma EducationIn 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. | Behavioural | Year four intervention, Year three intervention, Year two intervention |
Primary outcome
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.
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.
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.
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.
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.
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.
5 secondary outcomes
Community reports of asthma-related events Year 1
Time frame: In-person interviews will be conducted with families during year one of the project.
Community reports of asthma-related events Year 2
Time frame: In-person interviews will be conducted with families during year two of the project.
Community reports of asthma-related events Year 3
Time frame: In-person interviews will be conducted with families during year three of the project.
Community reports of asthma-related events Year 4
Time frame: In-person interviews will be conducted with families during year four of the project.
Community reports of asthma-related events Year 5
Time frame: In-person interviews will be conducted with families during year five of the project.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Feb 2025.
- Derived from this study: PubMed 41027683Lowe 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Bruce Bender, PhD principal investigator
National Jewish Health
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Asthma Care Provider Training and School Staff Asthma Education in people with Asthma in Children, run by National Jewish Health at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 24 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Rate of pediatric asthma exacerbations in Year 1 (time frame: Data will be collected once during Year 1 of the project.). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03377647, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Feb 2025.