The Puerto Rico Asthma Integrated Response Program ("PR-AIR")

NCT05999032 | Recruiting DMC

• 1 other identifier: R01HL159701
• Study Type: interventional
• Target: 480
• Locations: 2 countries
• Sites: 2

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.

Conditions

Pediatric Asthma

Keywords

Pediatric asthma; Community intervention program; Hybrid Type III; Effectiveness and implementation; Home-based intervention; School-based intervention

Outcome Measures

Primary Outcomes (6)

• Change in Child Asthma Control (Individual Level, ages 2-4 years)

  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.

  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.

• Change in Child Asthma Control (Individual Level, ages 5-11 years)

  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.

  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.

• Change in Child Asthma Control (Individual Level; ages 12 and up)

  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.

  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.

• Health Care Utilization-ED visits (Community Level)

  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.

  12 months pre- and post-intervention year

• Health Care Utilization-Hospitalizations (Community Level)

  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.

  12 months pre- and post-intervention year

• Health Care Utilization-Urgent Care Visits (Community Level)

  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.

  12 months pre- and post-intervention year

Secondary Outcomes (2)

• 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.

• School Absences (Community Level)

  12 months pre- and post-intervention year

Study Arms (2)

Low-Intensity (Virtual) Intervention Implementation

ACTIVE COMPARATOR

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.

Behavioral: CASE in person version (High Intensity Package); Behavioral: CASE-V remote version (Low Intensity Package)

High Intensity (in-Person) Intervention Implementation

ACTIVE COMPARATOR

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.

Behavioral: CASE and HARP in person (High Intensity package); Behavioral: CASE-V and HARP-V remote version (Low Intensity package)

Interventions

CASE in person version (High Intensity Package) BEHAVIORAL

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.

Low-Intensity (Virtual) Intervention Implementation

CASE-V remote version (Low Intensity Package) BEHAVIORAL

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).

Low-Intensity (Virtual) Intervention Implementation

CASE and HARP in person (High Intensity package) BEHAVIORAL

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.

High Intensity (in-Person) Intervention Implementation

CASE-V and HARP-V remote version (Low Intensity package) BEHAVIORAL

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.

High Intensity (in-Person) Intervention Implementation

Eligibility Criteria

• Age: 2 Years - 12 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• \. Children with complex medical conditions

Sponsors & Collaborators

• Rhode Island Hospital: lead
• University of Puerto Rico: collaborator

Study Sites (2)

Rhode Island Hospital

Providence, Rhode Island, 02903, United States

ACTIVE NOT RECRUITING

Medial Sciences Campus, University of Puerto Rico

San Juan, Puerto Rico, 00937, Puerto Rico

RECRUITING

Related Publications (8)

• Glasgow RE, Harden SM, Gaglio B, Rabin B, Smith ML, Porter GC, Ory MG, Estabrooks PA. RE-AIM Planning and Evaluation Framework: Adapting to New Science and Practice With a 20-Year Review. Front Public Health. 2019 Mar 29;7:64. doi: 10.3389/fpubh.2019.00064. eCollection 2019.

  PMID: 30984733 BACKGROUND

• CFIR Research Team. Strategy Design [Web]. Consolidated Framework for Implementation Research; 2019 [Available from: https://cfirguide.org/choosing-strategies/ accessed 22 November 2019.

  BACKGROUND

• Chambers DA, Norton WE. The Adaptome: Advancing the Science of Intervention Adaptation. Am J Prev Med. 2016 Oct;51(4 Suppl 2):S124-31. doi: 10.1016/j.amepre.2016.05.011. Epub 2016 Jun 28.

  PMID: 27371105 BACKGROUND

• Waltz TJ, Powell BJ, Fernandez ME, Abadie B, Damschroder LJ. Choosing implementation strategies to address contextual barriers: diversity in recommendations and future directions. Implement Sci. 2019 Apr 29;14(1):42. doi: 10.1186/s13012-019-0892-4.

  PMID: 31036028 BACKGROUND

• Murphy KR, Zeiger RS, Kosinski M, Chipps B, Mellon M, Schatz M, Lampl K, Hanlon JT, Ramachandran S. Test for respiratory and asthma control in kids (TRACK): a caregiver-completed questionnaire for preschool-aged children. J Allergy Clin Immunol. 2009 Apr;123(4):833-9.e9. doi: 10.1016/j.jaci.2009.01.058.

  PMID: 19348922 BACKGROUND

• Liu AH, Zeiger R, Sorkness C, Mahr T, Ostrom N, Burgess S, Rosenzweig JC, Manjunath R. Development and cross-sectional validation of the Childhood Asthma Control Test. J Allergy Clin Immunol. 2007 Apr;119(4):817-25. doi: 10.1016/j.jaci.2006.12.662. Epub 2007 Mar 13.

  PMID: 17353040 BACKGROUND

• Nathan RA, Sorkness CA, Kosinski M, Schatz M, Li JT, Marcus P, Murray JJ, Pendergraft TB. Development of the asthma control test: a survey for assessing asthma control. J Allergy Clin Immunol. 2004 Jan;113(1):59-65. doi: 10.1016/j.jaci.2003.09.008.

  PMID: 14713908 BACKGROUND

• Juniper EF, Guyatt GH, Feeny DH, Ferrie PJ, Griffith LE, Townsend M. Measuring quality of life in the parents of children with asthma. Qual Life Res. 1996 Feb;5(1):27-34. doi: 10.1007/BF00435966.

  PMID: 8901364 BACKGROUND

MeSH Terms

Interventions

pleiotrophin

Study Officials

• Daphne Koinis Mitchell, PhD

  Rhode Island Hospital

  PRINCIPAL INVESTIGATOR

• Elizabeth L McQuaid, PhD, ABPP

  Rhode Island Hospital

  PRINCIPAL INVESTIGATOR

• Ligia Chavez, PhD

  University of Puerto Rico

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Daphne Koinis Mitchell, PhD

CONTACT

401-793-8632; dkoinismitchell@lifespan.org

Elizabeth McQuaid, PhD, ABPP

CONTACT

401-444-7573; elizabeth_mcquaid@brown.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: There is no masking in this trial.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 22, 2023
• First Posted: August 21, 2023
• Study Start: December 16, 2024
• Primary Completion (Estimated): November 30, 2026
• Study Completion (Estimated): July 31, 2027
• Last Updated: August 20, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
• Time Frame: Data will become available within roughly one year of completion of the studies and dissemination of primary study results and will be available for 10 years following the completion of the study.
• Access Criteria: Once they become available, researchers requesting the data would follow the PR-AIR data request procedures. We will make the data available to potential users only under a NIH-approved data-sharing agreement that provides for: (1) a commitment to using the data only for research purposes and not to identify any individual participant in any way; (2) a commitment to securing the data using appropriate information security that is compliant with the most recent federal guidelines that are outlined by our information security protocol; and (3)a commitment to destroying or returning the data after analyses are completed.

Locations

US (1); PR (1)