The Puerto Rico Asthma Integrated Response Program ("PR-AIR")
NCT05999032 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 480
Last updated 2025-08-20
Summary
The purpose of this study is to adapt and deliver an evidence-based multi-level intervention to reduce asthma disparities, and that promote and improve population health in the high-burden communities of San Juan, Puerto Rico.
The Puerto Rico-Asthma Integrated Response Program (PR-AIR) will be implemented and evaluated to address pediatric asthma disparities in San Juan, PR, an area of high asthma burden. This study unfolds in two phases: In Phase 1, the researchers will collaborate with community stakeholders to identify needs, barriers and facilitators of PR-AIR implementation. Phase 2 consists of an evaluation of low-intensity (virtual) and high-intensity (in-person) methods of PR-AIR implementation outcomes using the RE-AIM (Reach, Effectiveness, Adoption, Implementation, and Maintenance) framework and a mixed methods approach.
Conditions
- Pediatric Asthma
Interventions
- BEHAVIORAL
-
CASE in person version (High Intensity Package)
Controlling Asthma in Schools Effectively (CASE) is a multi-level school-based asthma management program delivered by a Community Health Worker (CHW) that includes 1) staff training involving education on asthma management in school, 2) child-based asthma management education with an emphasis on control of symptoms in the school setting provided in a group setting during the school day, 3) caregiver education after school involving supporting children's asthma control in the school setting, 4), and provision of an Asthma Action Plan (AAP) to the school for child enrollees.
- BEHAVIORAL
-
CASE-V remote version (Low Intensity Package)
CASE-V, the low intensity version of CASE, includes similar child and caregiver-based asthma management education that is provided in a remote format with adaptation to integrate technological feature of Zoom. All CASE-V components (for staff, children, and parents) have been adapted to promote engagement (e.g., use of chat and polling function).
- BEHAVIORAL
-
CASE and HARP in person (High Intensity package)
Children with "poorly controlled" asthma will receive both the CASE and HARP programs. HARP is a home-visiting program that includes individualized asthma management education and strategies and supplies for environmental remediation. All 3 visits can be conducted by a CHW. The first includes a "walk-through" to identify triggers. Asthma education and self-management strategies are provided using a structured protocol and low-literacy flip-book (English or Spanish). Referrals and advocacy are offered to address asthma management barriers (e.g., communication with landlord/housing re: code violation). The 2nd and 3rd visits include delivery of supplies (e.g., HEPA vacuum, pest gels, mattress covers), instruction for use, review of AAP, and follow-up on environmental control recommendations provided during the 1st visit.
- BEHAVIORAL
-
CASE-V and HARP-V remote version (Low Intensity package)
HARP-V replicates the content delivered in HARP in a remote format. The first session includes a virtual "walk-through" in which the educator uses a structured script and checklist to guide the caregiver through the home and show specific components of the environment (e.g., carpeting, area under the kitchen sink, exhaust fan in bathroom) to identify asthma triggers. Asthma education and self-management strategies are provided using a structured protocol and slide overview based on the HARP flip-book. Supplies for environmental remediation are delivered prior to the 2nd visit. The 2nd and 3rd visit include instruction for use of supplies, review of AAP, and follow-up on recommendations and referrals.
Sponsors & Collaborators
-
University of Puerto Rico
collaborator OTHER -
Rhode Island Hospital
lead OTHER
Principal Investigators
-
Daphne Koinis Mitchell, PhD · Rhode Island Hospital
-
Elizabeth L McQuaid, PhD, ABPP · Rhode Island Hospital
-
Ligia Chavez, PhD · University of Puerto Rico
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- PARALLEL
Eligibility
- Min Age
- 2 Years
- Max Age
- 12 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2024-12-16
- Primary Completion
- 2026-11-30
- Completion
- 2027-07-31
Countries
- United States
- Puerto Rico
Study Locations
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