A Culturally Tailored Scalable Asthma Intervention for Hispanic Children (Asthma Guardian)

NCT05892302 | Completed DMC

• 2 other identifiers: STUDY00004576R34HL159126
• Study Type: interventional
• Target: 37
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Asthma in Children

Outcome Measures

Primary Outcomes (1)

• 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.

  6 months

Other Outcomes (18)

• Asthma Control Test (ACT)

  6 months follow-up visit

• Asthma Exacerbation

  6 months

• Asthma related acute care use

  6 months

Study Arms (2)

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.

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.

Behavioral: Delayed Access to Asma Guardian website/app

Interventions

Access to Asma Guardian website/app BEHAVIORAL

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.

Access to Asma Guardian website/app

Delayed Access to Asma Guardian website/app BEHAVIORAL

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.

No Access to Asma Guardian website/app for 6 months

Eligibility Criteria

• Age: 5 Years - 12 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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
• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Texas at Austin: lead
• National Heart, Lung, and Blood Institute (NHLBI): collaborator

Study Sites (1)

University of Texas at Austin

Austin, Texas, 78712, United States

Location

Study Officials

• Elizabeth Matsui, MD

  University of Texas at Austin

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: Only the statistician will be blinded to study group.
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor, Departments of Population Health and Pediatrics

Study Record Dates

• First Submitted: May 17, 2023
• First Posted: June 7, 2023
• Study Start: March 22, 2024
• Primary Completion: December 22, 2025
• Study Completion: December 22, 2025
• Last Updated: April 30, 2026

Record last verified: 2026-04

Locations

US (1)