Ignite Creation Date:
2024-05-06 @ 7:06 PM
Last Modification Date:
2024-10-26 @ 3:00 PM
Study NCT ID:
NCT05892302
Status:
RECRUITING
Last Update Posted:
2024-07-01
First Post:
2023-05-17
Brief Title:
A Culturally Tailored Scalable Asthma Intervention for Hispanic Children Asthma Guardian
Sponsor:
University of Texas at Austin
Organization:
University of Texas at Austin
Study Overview
Official Title:
A Culturally Tailored Scalable Asthma Intervention for Hispanic Children
Status:
RECRUITING
Status Verified Date:
2024-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 HispanicLatinx 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 AmericanHispanic 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 andor video calls The Investigators will examine Asthma Guardians effects on clinical outcomes as well as processfidelity 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 AmericanHispanic 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 11 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
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 11 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| R34HL159126 | NIH | None | httpsreporternihgovquickSearchR34HL159126 |