NCT05892302

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

A Culturally Tailored Scalable Asthma Intervention for Hispanic Children

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 50 (estimated)
• Sponsor: University of Texas at Austin · Academic / Other
• Sex: All
• Age: 5 Years – 12 Years
• Healthy volunteers: Not accepted

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.

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

Interventions

Type	Name	Description
BEHAVIORAL	Access to Asma Guardian 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.
BEHAVIORAL	Delayed Access to Asma Guardian website/app	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.

Timeline

• Start date: 2024-03-22
• Primary completion: 2025-04-01
• Completion: 2025-05-01
• First posted: 2023-06-07
• Last updated: 2024-07-01

Locations

1 site across 1 country: United States