The Puerto Rico Asthma Integrated Response Program ("PR-AIR")
- Conditions
- Pediatric Asthma
- Interventions
- Behavioral: CASE and HARP in person (High Intensity package)Behavioral: CASE in person version (High Intensity Package)Behavioral: CASE-V remote version (Low Intensity Package)Behavioral: CASE-V and HARP-V remote version (Low Intensity package)
- Registration Number
- NCT05999032
- Lead Sponsor
- Rhode Island Hospital
- 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.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 480
- Children between the ages of 2 and 12 years old
- Children must reside in one of the identified catchment areas
- Children must meet the screening criteria as having not well controlled or poorly controlled asthma
- Children with complex medical conditions
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description High Intensity (in-Person) Intervention Implementation CASE and HARP in person (High Intensity package) During high intensity implementation, all interventions are administered in person. Specifically, families of children with poorly controlled asthma will receive in-person versions of HARP and CASE. Children with not well controlled asthma will receive an in-person version of CASE only. Low-Intensity (Virtual) Intervention Implementation CASE-V remote version (Low Intensity Package) During low intensity implementation, families of children with poorly controlled asthma will be referred to the remote version of HARP (HARP-V) and will receive CASE remotely (CASE-V). Children with not well controlled asthma will receive only CASE-V remotely. High Intensity (in-Person) Intervention Implementation CASE-V and HARP-V remote version (Low Intensity package) During high intensity implementation, all interventions are administered in person. Specifically, families of children with poorly controlled asthma will receive in-person versions of HARP and CASE. Children with not well controlled asthma will receive an in-person version of CASE only. Low-Intensity (Virtual) Intervention Implementation CASE in person version (High Intensity Package) During low intensity implementation, families of children with poorly controlled asthma will be referred to the remote version of HARP (HARP-V) and will receive CASE remotely (CASE-V). Children with not well controlled asthma will receive only CASE-V remotely.
- Primary Outcome Measures
Name Time Method Change in Child Asthma Control (Individual Level, ages 2-4 years) 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. Effectiveness of the intervention on child-level asthma control is measured using the Test for Respiratory and Asthma Control in Kids (TRACK). The TRACK is a 5-item measure assessing asthma symptoms and control in young children by caregiver report. Items assessing frequency of various asthma-related events (e.g., breathing problems, quick-relief medication use, etc.) are rated on a Likert-type scale from Not at all (scored 20) to Extremely (scored 0). Scores \< 80 suggest child's asthma is not well controlled.
Change in Child Asthma Control (Individual Level; ages 12 and up) 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. Effectiveness of the intervention on child-level asthma control is measured using the Asthma Control Test. Youth ages 12 and up complete 5-items related to their asthma on Likert-type scales ranging from 1-5, with lower scores indicating more severe symptoms. A cutoff score \<19 indicates suboptimal asthma control; scores \<=15 suggest poorly controlled asthma.
Health Care Utilization-ED visits (Community Level) 12 months pre- and post-intervention year Health care utilization will be assessed by community-level rates of Emergency Department visits of children within the targeted geographic area. Obtaining utilization rates in this way will help the researchers to assess effectiveness of the intervention on the community level.
Health Care Utilization-Urgent Care Visits (Community Level) 12 months pre- and post-intervention year Effectiveness of the intervention on the community level. Health care utilization will be assessed by community-level rates of urgent care visits in children within the targeted geographic area.
Change in Child Asthma Control (Individual Level, ages 5-11 years) 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. Effectiveness of the intervention on child-level asthma control is measured using the Childhood Asthma Control Test (cACT). Children answer 4 questions on a 0-3 scale, and caregivers answer 3 questions on a 0-5 scale related to the frequency child's asthma symptoms in the previous 4 weeks. Lower scores indicate worse symptoms. Scores of 19 or less suggest asthma is not well controlled.
Health Care Utilization-Hospitalizations (Community Level) 12 months pre- and post-intervention year Effectiveness of the intervention on the community level. Health care utilization will be assessed by community-level rates of hospitalizations in children within the targeted geographic area.
- Secondary Outcome Measures
Name Time Method School Absences (Community Level) 12 months pre- and post-intervention year Community-level school absences will be assessed by attendance data (i.e., number of school absences) from the schools in the targeted area that correspond to each "step" in the wedge of the study design.
Asthma-related Quality of Life (QoL) (Individual Level) 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. Effectiveness on child-level quality of life (QOL) will be measured by the Pediatric Asthma Quality of Life Questionnaire (PAQLQ). The instrument consists of 23 items related to limitation across three domains (activity limitation, symptoms and emotional function). Each item is rated 1-7 on a Likert scale, with lower numerical responses indicating greater impairment.
Trial Locations
- Locations (2)
Rhode Island Hospital
🇺🇸Providence, Rhode Island, United States
Medial Sciences Campus, University of Puerto Rico
🇵🇷San Juan, Puerto Rico