Clinical trial NCT05892302: A Culturally Tailored Scalable Asthma Intervention for Hispanic Children (Asthma Guardian)
Official title: A Culturally Tailored Scalable Asthma Intervention for Hispanic Children
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Asthma in Children
Lead sponsor: University of Texas at Austin
Sponsor class: OTHER
Collaborators: name: National Heart, Lung, and Blood Institute (NHLBI)
First posted: 2023-06-07
Enrollment: 50
Sex: ALL
Minimum age (years): 5
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

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.

Eligibility criteria: 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.

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

Primary outcomes:
measure: Participant engagement with the Asthma Guardian website/app
timeFrame: 6 months
Secondary outcomes:
Other outcomes:
measure: Asthma Control Test (ACT)
timeFrame: 6 months follow-up visit
measure: Asthma Exacerbation
timeFrame: 6 months
measure: Asthma related acute care use
timeFrame: 6 months
measure: Asthma controller medication
timeFrame: 6 month follow-up visit
measure: Asthma controller medication treatment step
timeFrame: 6 month follow-up visit
measure: Asthma symptoms
timeFrame: 6 month follow-up visit
measure: Asthma Specialty Visit
timeFrame: 6 months
measure: Short adapted Questionnaire to Measure Asthma Knowledge of Parents.
timeFrame: 6 months
measure: Pharmacy prescription data
timeFrame: 6 months
measure: Use of the asthma control test
timeFrame: 6 months
measure: Request for home environmental supplies
timeFrame: 6 months
measure: Deployment of home environmental supplies
timeFrame: 6 months
measure: Settled Dust allergen concentrations
timeFrame: 6 month follow-up visit
measure: Fine particulate matter (PM)
timeFrame: 6 months
measure: Use of educational material
timeFrame: 6 months
measure: Use of the App
timeFrame: 6 months
measure: Acceptability of Intervention Measure (AIM), Intervention Appropriateness Measure (IAM), and Feasibility of Intervention Measure (FIM)
timeFrame: 6 month follow-up visit
measure: Number of interactions with the virtual Community Health Worker (CHW)
timeFrame: 6 months
Locations:
city: Austin
country: United States
facility: University of Texas at Austin
state: Texas
Study officials:
affiliation: University of Texas at Austin
name: Elizabeth Matsui, MD
role: PRINCIPAL_INVESTIGATOR
References: