Clinical trial NCT05999032: The Puerto Rico Asthma Integrated Response Program ("PR-AIR")
Official title: The Puerto Rico Asthma Integrated Response Program ("PR-AIR")
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Pediatric Asthma
Keywords: Pediatric asthma
Community intervention program
Hybrid Type III
Effectiveness and implementation
Home-based intervention
School-based intervention
Lead sponsor: Rhode Island Hospital
Sponsor class: OTHER
Collaborators: name: University of Puerto Rico
First posted: 2023-08-21
Enrollment: 480
Sex: ALL
Minimum age (years): 2
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

Detailed description: During the formative evaluation (Phase 1), the researchers will engage community stakeholders (primary caregivers of children with asthma, school personnel, asthma healthcare providers) to help identify, adapt and finalize strategies for PR-AIR implementation. The Consolidated Framework for Implementation Research (CFIR) will be used to identify barriers and facilitators of low-intensity and high-intensity implementation approaches, the Adaptome to guide intervention adaptation to the context of PR, and the CFIR-ERIC matching tool to identify strategies to support but low- and high-intensity implementation packages. Fifteen stakeholders will complete in-depth interviews early in Phase 1, and 16 will participate in two focus groups at the end of Phase 1 prior to the transition to Phase 2, in preparation for trial implementation. A collaborative of community stakeholders will be convened (the PR-AIR CC) to provide input throughout both phases of the trial.

In Phase 2 (Years 2-4) 480 urban children will be enrolled, ages 2-12 (expected retention for full protocol, n = 400) with asthma across 12 areas in San Juan with high asthma burden. Randomization is at the level of targeted geographic area, and data will be collected from groups in each of these areas over time. Individual-level (asthma control, QOL) and community-specific (ED use/hospitalizations, school absence) effectiveness outcomes will be evaluated. All families will participate in both a control (in our case, baseline period for the community indicators) and intervention (active trial). Each target area will begin with a low-intensity (virtual) implementation phase, and transition to a high-intensity implementation phase mid-year. Families enrolled in the first 5 months of the school year will receive the low-intensity intervention package, and those enrolled in the last 5 months of the school year will receive the high-intensity intervention package. Input will be collected throughout each year from community stakeholders about the trial, through in-depth interviews and surveys. Reach, Adoption, Implementation, and Maintenance will be measured using a mixed-methods approach at the end of each trial year (years 2 - 4). Repeated assessments will measure individual-level effectiveness outcomes (asthma control, QOL) at time points linked to the start of intervention participation; at enrollment, end of treatment (EOT; 1 - 2 months after baseline, depending on intervention assignment), and every 3 months for 1 year.

Eligibility criteria: Inclusion Criteria:

1. Children between the ages of 2 and 12 years old
2. Children must reside in one of the identified catchment areas
3. Children must meet the screening criteria as having not well controlled or poorly controlled asthma

Exclusion Criteria:

1. Children with complex medical conditions

Primary outcomes:
measure: Change in Child Asthma Control (Individual Level, ages 2-4 years)
timeFrame: Asthma Control will be measured at baseline, End of Treatment (EOT; 1 - 2 months after baseline, depending on intervention assignment), and every 3 months for 1 year.
measure: Change in Child Asthma Control (Individual Level, ages 5-11 years)
timeFrame: Asthma Control will be measured at baseline, End of Treatment (EOT; 1 - 2 months after baseline, depending on intervention assignment), and every 3 months for 1 year.
measure: Change in Child Asthma Control (Individual Level; ages 12 and up)
timeFrame: Asthma Control will be measured at baseline, End of Treatment (EOT; 1 - 2 months after baseline, depending on intervention assignment), and every 3 months for 1 year.
measure: Health Care Utilization-ED visits (Community Level)
timeFrame: 12 months pre- and post-intervention year
measure: Health Care Utilization-Hospitalizations (Community Level)
timeFrame: 12 months pre- and post-intervention year
measure: Health Care Utilization-Urgent Care Visits (Community Level)
timeFrame: 12 months pre- and post-intervention year
Secondary outcomes:
measure: Asthma-related Quality of Life (QoL) (Individual Level)
timeFrame: Asthma-related QOL will be measured at baseline, End of Treatment (EOT; 1 - 2 months after baseline, depending on intervention assignment), and every three months for 1 year.
measure: School Absences (Community Level)
timeFrame: 12 months pre- and post-intervention year
Other outcomes:
Locations:
city: Providence
country: United States
facility: Rhode Island Hospital
state: Rhode Island
city: San Juan
country: Puerto Rico
facility: Medial Sciences Campus, University of Puerto Rico
Study officials:
affiliation: Rhode Island Hospital
name: Daphne Koinis Mitchell, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Rhode Island Hospital
name: Elizabeth L McQuaid, PhD, ABPP
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Puerto Rico
name: Ligia Chavez, PhD
role: PRINCIPAL_INVESTIGATOR
References:
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