Asthma in ChildrenNCT05892302
A Culturally Tailored Scalable Asthma Intervention for Hispanic Children (Asthma Guardian)
A study testing Access to Asma Guardian website/app and Delayed Access to Asma Guardian website/app in people with Asthma in Children, run by University of Texas at Austin at 1 site in United States.
Trial summary
This is a two-arm, parallel design, randomized, controlled pilot trial comparing access to Asma Guardián, a culturally tailored multi-component app-based asthma intervention for Hispanic/Latinx school age children with asthma, to usual care. Read more about this study
- Who is it for?
- Ages 5 to 12 years
- Conditions the study is for
- Asthma in Children
- What is being tested?
- Access to Asma Guardian website/app and Delayed Access to Asma Guardian website/app
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 37 participants
- Where
- 1 siteUnited States
- Study dates
- 22 Mar 2024to 22 Dec 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 5 to 12 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Provision of signed and dated informed consent forms.
- Who has a child who is 5-12 years of age
- Whose child meets criteria for current persistent asthma defined as either:
- On a long-term controller medication for asthma, or
- Meet NAEPP guideline requirements for persistent disease:)(35)
- Asthma symptoms 3 or more days per week over the past 2 weeks OR
Show all 13Show fewer
- Nocturnal asthma symptoms at least 3 times in the past month
- Whose child has had an asthma exacerbation, defined as an oral steroid burst, in the previous 12 months
- Parent/Caregiver identifies as Mexican American or other Hispanic descent
- Whose child has clinician diagnosed asthma
- Access to necessary resources for participating in a technology-based intervention (i.e., computer, smart phone, internet access)
- Whose child is not currently participating in another asthma study.
- The parent/caregiver is the primary study participant, but the child will be asked to complete some surveys at baseline and six months, so an assent will be obtained from the child.
Who cannot join
- An individual who meets any of the following criteria will be excluded from participation in this study:
- Unwilling to provide consent for research activities
- Cognitive inability to provide consent
- Whose child has evidence of other chronic lung or significant cardiovascular disease
- Whose child has a history of intubation for asthma
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Culturally Tailored Scalable Asthma Intervention for Hispanic Children
This is a two-arm, parallel design, randomized, controlled pilot trial comparing access to Asma Guardián, a culturally tailored multi-component app-based asthma intervention for Hispanic/Latinx school age children with asthma, to usual care.
Read the detailed description
This is a pilot two-arm, parallel design, randomized, controlled clinical trial that will test a scalable, culturally-tailored, multilayered asthma intervention, Asthma Guardian, designed to reduce asthma morbidity among Mexican American/Hispanic children. This study will inform the planning of a statewide efficacy trial. Asthma Guardian will include three components: (1) support for accessing asthma specialist care, (2) asthma management education and support, and (3) home environment education, access to housing advocacy services, and access to environmental intervention supplies. These components will be accessed by families through a web-based platform, which will include educational materials, a portal for requesting environmental intervention supplies, and access to a virtual community health worker (vCHW), who will facilitate engagement with subspecialty care and housing advocacy services and support asthma self-management. A trained vCHW will communicate with families via telephone and/or video calls. The Investigators will examine Asthma Guardian's effects on clinical outcomes as well as process/fidelity outcomes, including uptake and implementation of the toolkits, education, vCHW support, and environmental intervention supplies. The Investigators propose achieving this goal by randomizing 50 Mexican American/Hispanic children with uncontrolled asthma to either immediate or delayed access (6 months after randomization for one month) to the Asthma Guardian platform. Participants randomized to receive immediate access will be enrolled for 6 months.
A randomization table will be generated by the study statistician and implemented through RedCAP. Using a computer-based algorithm accessed by web-enabled tablet, participants will be randomized 1:1 to the two conditions using a random block size (of 4 or 6) algorithm so that the order of randomization is not predictable by any study team member. The randomization scheme will only be accessible to the data manager. Participants will be given a unique ID number to logon to the website where they can access the vCHW and tool kits.
A participant is considered to have completed the study if he or she has completed the baseline assessment, receive access to intervention application (either at baseline or 6 month mark), and the 6-month follow-up assessments.
- Conditions
- Asthma in Children
- Being tested
- Access to Asma Guardian website/app, Delayed Access to Asma Guardian website/app
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Access to Asma Guardian website/appBehavioural
The Asma Guardian intervention application is a culturally-tailored web-platform that includes 3 tool kits. The contents of the tool kits include Asthma Specialty Care, Family Asthma Management, and Home Environmental Intervention.
Delayed Access to Asma Guardian website/appBehavioural
Delayed access to the website/app. The Asma Guardian intervention application is a culturally-tailored web-platform that includes 3 tool kits. The contents of the tool kits include Asthma Specialty Care, Family Asthma Management, and Home Environmental Intervention.
| Study group | Role | What they receive |
|---|---|---|
| Access to Asma Guardian website/app | Active comparator | Participants who are randomized to the Asma Guardian website at their baseline visit will have access to the website for 6 months starting at baseline. Access will be turned off at 6 months. Receives: Behavioral: Access to Asma Guardian website/app |
| No Access to Asma Guardian website/app for 6 months | Other | Note: Participants who are randomized to no access will not receive access during the 6 months of the study; however they will receive 1 month of access after their 6 month study visit but any information gained during this time will not be part of analysis. Receives: Behavioral: Delayed Access to Asma Guardian website/app |
What is being measured
The primary outcome is the main question the study is designed to answer.
Participant engagement with the Asthma Guardian website/app
Engagement is a composite outcome which is defined as engagement with at least 2 of the 3 toolkits. It will be expressed as the percentage of participants with engagement. Engagement with each of the toolkits is defined as follows:
(i) Asthma Specialist: at least one documented appointment with an asthma specialist; (ii) Asthma Management: Controller medication prescription fills covering at least 3 months of dosing; (iii) Home environment Toolkit: New deployment of at least some of the available environmental intervention materials, such as air purifiers.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jun 2023
- Study start22 Mar 2024
- Primary completion22 Dec 2025
- Study completion22 Dec 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Asthma in ChildrenStudies of the same condition, open and under way.
- More trials run by University of Texas at AustinThe sponsor's other registered studies.
- 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 37 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Texas at Austin
- Sponsor type
- University, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI)
- Responsible party
- Principal investigator, Elizabeth Matsui, University of Texas at Austin
- Investigators
- Elizabeth Matsui, MD, Principal investigator, University of Texas at Austin
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05892302
- Sponsor's protocol ID
- STUDY00004576
- Other IDs
- R34HL159126
- Status last verified
- Apr 2026
- First submitted
- 17 May 2023
- Last updated
- 30 Apr 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Culturally Tailored Scalable Asthma Intervention for Hispanic Children
- ClinicalTrials.gov ID
- NCT05892302
- Acronym / sponsor ID
- STUDY00004576
- Conditions
- Asthma in Children
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 37 participants (actual)
- Lead sponsor
- University of Texas at AustinUniversity, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI)
- Study start
- 22 Mar 2024 (actual)
- Primary completion
- 22 Dec 2025 (actual)
- Study completion
- 22 Dec 2025 (actual)
- First posted
- 7 Jun 2023 (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.
This is a two-arm, parallel design, randomized, controlled pilot trial comparing access to Asma Guardián, a culturally tailored multi-component app-based asthma intervention for Hispanic/Latinx school age children with asthma, to usual care.
Detailed description
This is a pilot two-arm, parallel design, randomized, controlled clinical trial that will test a scalable, culturally-tailored, multilayered asthma intervention, Asthma Guardian, designed to reduce asthma morbidity among Mexican American/Hispanic children. This study will inform the planning of a statewide efficacy trial. Asthma Guardian will include three components: (1) support for accessing asthma specialist care, (2) asthma management education and support, and (3) home environment education, access to housing advocacy services, and access to environmental intervention supplies. These components will be accessed by families through a web-based platform, which will include educational materials, a portal for requesting environmental intervention supplies, and access to a virtual community health worker (vCHW), who will facilitate engagement with subspecialty care and housing advocacy services and support asthma self-management. A trained vCHW will communicate with families via telephone and/or video calls. The Investigators will examine Asthma Guardian's effects on clinical outcomes as well as process/fidelity outcomes, including uptake and implementation of the toolkits, education, vCHW support, and environmental intervention supplies. The Investigators propose achieving this goal by randomizing 50 Mexican American/Hispanic children with uncontrolled asthma to either immediate or delayed access (6 months after randomization for one month) to the Asthma Guardian platform. Participants randomized to receive immediate access will be enrolled for 6 months.
A randomization table will be generated by the study statistician and implemented through RedCAP. Using a computer-based algorithm accessed by web-enabled tablet, participants will be randomized 1:1 to the two conditions using a random block size (of 4 or 6) algorithm so that the order of randomization is not predictable by any study team member. The randomization scheme will only be accessible to the data manager. Participants will be given a unique ID number to logon to the website where they can access the vCHW and tool kits.
A participant is considered to have completed the study if he or she has completed the baseline assessment, receive access to intervention application (either at baseline or 6 month mark), and the 6-month follow-up assessments.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Access to Asma Guardian website/app | Active comparator | Behavioral: Access to Asma Guardian website/appParticipants who are randomized to the Asma Guardian website at their baseline visit will have access to the website for 6 months starting at baseline. Access will be turned off at 6 months. |
| No Access to Asma Guardian website/app for 6 months | Other | Behavioral: Delayed Access to Asma Guardian website/appNote: Participants who are randomized to no access will not receive access during the 6 months of the study; however they will receive 1 month of access after their 6 month study visit but any information gained during this time will not be part of analysis. |
Who may qualify
- Ages
- 5 to 12 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (13 listed)
- Provision of signed and dated informed consent forms.
- Who has a child who is 5-12 years of age
- Whose child meets criteria for current persistent asthma defined as either:
- Whose child has had an asthma exacerbation, defined as an oral steroid burst, in the previous 12 months
- Parent/Caregiver identifies as Mexican American or other Hispanic descent
Key exclusion criteria (5 listed)
- An individual who meets any of the following criteria will be excluded from participation in this study:
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 |
|---|---|---|
| Access to Asma Guardian website/appThe Asma Guardian intervention application is a culturally-tailored web-platform that includes 3 tool kits. The contents of the tool kits include Asthma Specialty Care, Family Asthma Management, and Home Environmental Intervention. | Behavioural | Access to Asma Guardian website/app |
| Delayed Access to Asma Guardian website/appDelayed access to the website/app. The Asma Guardian intervention application is a culturally-tailored web-platform that includes 3 tool kits. The contents of the tool kits include Asthma Specialty Care, Family Asthma Management, and Home Environmental Intervention. | Behavioural | No Access to Asma Guardian website/app for 6 months |
Primary outcome
Participant engagement with the Asthma Guardian website/app
Time frame: 6 months
Engagement is a composite outcome which is defined as engagement with at least 2 of the 3 toolkits. It will be expressed as the percentage of participants with engagement. Engagement with each of the toolkits is defined as follows: (i) Asthma Specialist: at least one documented appointment with an asthma specialist; (ii) Asthma Management: Controller medication prescription fills covering at least 3 months of dosing; (iii) Home environment Toolkit: New deployment of at least some of the available environmental intervention materials, such as air purifiers.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Apr 2026.
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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.
Elizabeth Matsui, MD principal investigator
University of Texas at Austin
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Access to Asma Guardian website/app and Delayed Access to Asma Guardian website/app in people with Asthma in Children, run by University of Texas at Austin at 1 site 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 13 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: finished, as of the sponsor's last update on 30 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Participant engagement with the Asthma Guardian website/app (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 30 Apr 2026.