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

Not Applicable

Recruiting

• Conditions: Asthma in Children
• Interventions: Behavioral: Delayed Access to Asma Guardian website/app; Behavioral: Access to Asma Guardian website/app

• Registration Number: NCT05892302
• Lead Sponsor: University of Texas at Austin

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.

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 Timeline

• Study First Submitted: 2023-05-17
• Study First Submitted QC: 2023-05-26
• Study First Posted: 2023-06-07
• Study Start: 2024-03-22
• Status Verified: 2024-06
• Last Update Submitted: 2024-06-28
• Last Update Posted: 2024-07-01
• Primary Completion: 2025-04-01
• Study Completion: 2025-05-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 50

Inclusion Criteria

1. Provision of signed and dated informed consent forms.

2. Who has a child who is 5-12 years of age

3. Whose child meets criteria for current persistent asthma defined as either:

   1. On a long-term controller medication for asthma, or

   2. 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

4. Whose child has had an asthma exacerbation, defined as an oral steroid burst, in the previous 12 months

5. Parent/Caregiver identifies as Mexican American or other Hispanic descent

6. Whose child has clinician diagnosed asthma

7. Access to necessary resources for participating in a technology-based intervention (i.e., computer, smart phone, internet access)

8. 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.

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Exclusion Criteria

• An individual who meets any of the following criteria will be excluded from participation in this study:

  1. Unwilling to provide consent for research activities
  2. Cognitive inability to provide consent
  3. Whose child has evidence of other chronic lung or significant cardiovascular disease
  4. Whose child has a history of intubation for asthma

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
No Access to Asma Guardian website/app for 6 months	Delayed Access to Asma Guardian website/app	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.
Access to Asma Guardian website/app	Access to Asma Guardian website/app	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.

Primary Outcome Measures

Name	Time	Method
Participant engagement with the Asthma Guardian website/app	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.

Trial Locations

Locations (1)

University of Texas at Austin; 🇺🇸 Austin, Texas, United States