480 Participants Needed

Asthma Intervention Programs for Asthma

(PR-AIR Trial)

Recruiting at 1 trial location
DK
EM
Overseen ByElizabeth McQuaid, PhD, ABPP
Age: < 18
Sex: Any
Trial Phase: Academic
Sponsor: Rhode Island Hospital
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to improve asthma care for children in San Juan, Puerto Rico, where the condition is particularly common. Researchers seek to determine whether in-person or online asthma management education is more effective. Families with children who have poorly controlled asthma will receive hands-on assistance through programs like CASE and HARP (High Intensity package). In contrast, those with less severe cases will receive remote support through programs like CASE-V and HARP-V (Low Intensity package). The trial seeks children aged 2 to 12 living in specific areas of San Juan who struggle with managing their asthma. As an unphased trial, it offers families the opportunity to contribute directly to enhancing asthma care strategies for children in their community.

Will I have to stop taking my current medications?

The trial information does not specify whether participants need to stop taking their current medications.

What prior data suggests that this intervention program is safe for children with asthma?

Research shows that both the in-person and remote versions of the CASE and HARP programs are safe. The Home Asthma Response Program (HARP) led to a 75% reduction in asthma-related hospital and emergency room costs after one year, indicating fewer severe asthma attacks and suggesting the programs are well-tolerated.

While the remote versions (CASE-V and HARP-V) are newer, studies indicate that remote asthma check-ups can be as effective and safe as in-person visits. This suggests that participants should also tolerate the remote versions well.

Overall, evidence from similar programs like RI-AIR suggests that both in-person and remote interventions are safe for participants.12345

Why are researchers excited about this trial?

Researchers are excited about these asthma intervention programs because they offer flexible delivery methods tailored to meet different needs. Unlike traditional asthma treatments that often rely on medication, these programs focus on personalized education and support, which can be delivered either in-person or remotely. The High Intensity package, which includes in-person versions of CASE and HARP, provides a comprehensive approach for families needing hands-on support. Meanwhile, the Low Intensity package, delivered virtually, offers more accessibility for families who prefer remote engagement. This flexibility and personalized approach aim to improve asthma control by addressing specific family dynamics and preferences, potentially leading to better outcomes for children with poorly controlled asthma.

What evidence suggests that this trial's interventions could be effective for asthma?

Research has shown that the Home Asthma Response Program (HARP) helps people manage asthma more effectively. This is evident from an increase in the correct use of asthma medications, rising from 32% to 46%. Simply put, more individuals are taking their medications properly, aiding in the control of asthma symptoms. The CASE program has also succeeded in teaching both children and their caregivers how to manage asthma, leading to better understanding and control of the condition.

In this trial, participants will join different intervention arms. The High Intensity (in-Person) Intervention Implementation arm offers in-person versions of HARP and CASE for families of children with poorly controlled asthma, and an in-person version of CASE for children with not well-controlled asthma. Meanwhile, the Low-Intensity (Virtual) Intervention Implementation arm provides remote versions, CASE-V and HARP-V, aiming to achieve similar success by delivering the same education and support online. This approach reaches more people, especially in communities with high asthma rates, ensuring they receive the support needed to manage asthma effectively.13456

Who Is on the Research Team?

DK

Daphne Koinis Mitchell, PhD

Principal Investigator

Rhode Island Hospital

EL

Elizabeth L McQuaid, PhD, ABPP

Principal Investigator

Rhode Island Hospital

LC

Ligia Chavez, PhD

Principal Investigator

University of Puerto Rico

Are You a Good Fit for This Trial?

This trial is for children aged 2-12 with not well controlled or poorly controlled asthma, living in specific areas of San Juan, Puerto Rico. It's not suitable for kids with complex medical conditions.

Inclusion Criteria

My child is between 2 and 12 years old.
My child's asthma is not well controlled.
Children must reside in one of the identified catchment areas

Exclusion Criteria

My child has multiple health issues.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Phase 1: Formative Evaluation

Researchers collaborate with community stakeholders to identify needs, barriers, and facilitators for PR-AIR implementation.

1 year
Multiple visits for interviews and focus groups

Phase 2: Low-Intensity Implementation

Families receive virtual interventions for asthma management.

5 months
Virtual visits

Phase 2: High-Intensity Implementation

Families receive in-person interventions for asthma management.

5 months
In-person visits

Follow-up

Participants are monitored for safety and effectiveness after treatment

12 months
Assessments every 3 months

What Are the Treatments Tested in This Trial?

Interventions

  • CASE and HARP in person (High Intensity package)
  • CASE in person version (High Intensity Package)
  • CASE-V and HARP-V remote version (Low Intensity package)
  • CASE-V remote version (Low Intensity Package)
Trial Overview The PR-AIR program aims to reduce asthma disparities in high-burden communities through two approaches: a low-intensity virtual package (CASE-V and HARP-V) and a high-intensity in-person package (CASE and HARP).
How Is the Trial Designed?
2Treatment groups
Active Control
Group I: High Intensity (in-Person) Intervention ImplementationActive Control2 Interventions
Group II: Low-Intensity (Virtual) Intervention ImplementationActive Control2 Interventions

Find a Clinic Near You

Who Is Running the Clinical Trial?

Rhode Island Hospital

Lead Sponsor

Trials
275
Recruited
71,400+

University of Puerto Rico

Collaborator

Trials
69
Recruited
22,300+

Published Research Related to This Trial

Remote patient monitoring (RPM) significantly reduces hospitalizations for heart failure by 23% and for any cause by 13%, based on a meta-analysis of 21 randomized clinical trials involving 5715 patients.
RPM is cost-effective, saving between €300 to €1000 per patient compared to usual care, while also providing a slight increase in quality-adjusted life years (QALYs), making it a favorable option for heart failure management.
Economic impact of remote patient monitoring: an integrated economic model derived from a meta-analysis of randomized controlled trials in heart failure.Klersy, C., De Silvestri, A., Gabutti, G., et al.[2022]
The modified asthma education program, taught in ten 20-minute sessions, effectively increased children's knowledge about managing asthma triggers and symptoms, similar to the original program taught in six 40-minute sessions.
With 45 students participating in the modified program compared to 20 in the original, this approach offers a more flexible option for schools, potentially allowing more children to benefit from asthma education despite scheduling challenges.
Effectiveness of a modified open airways curriculum.Crane, LM., O'Neal, KS., Honey, BL., et al.[2015]
Asthma self-management programs, particularly those like Open Airways, are crucial for minority children and have shown to be effective in reducing asthma recidivism when they include interactive and culturally relevant education.
Programs that also focus on improving literacy skills in asthmatic children can lead to significant health benefits, including a 47% decrease in asthma recidivism and very few hospitalizations over 18 months.
Pediatric asthma self-management: current concepts.Robinson, LD.[2018]

Citations

Rhode Island Asthma Integrated Response Program (RI-AIR)Outcomes for participants assigned to this arm (CASE and HARP) will be compared in a pre-post within subject comparison. Regardless of intervention arm ...
The Home Asthma Response Program (HARP)Demonstrated Outcomes: Quality Improvement: The asthma medication ratio HEDIS score for participants increased from 32% to 46%. Improved Asthma Control ...
The Rhode Island Asthma Integrated Response (RI-AIR ...HARP and CASE interventions ended February 2022. A total of 433 children were enrolled (13% Black/African American, 19% White, 9% More than one race, 31 ...
Asthma Intervention Programs for Asthma (PR-AIR Trial)What data supports the effectiveness of the treatment CASE and HARP for asthma? ... CASE and HARP in person (High Intensity package); CASE in person version ...
Exhale A Technical Package to Control AsthmaEvidence included in this technical package had to show a beneficial impact on asthma control.
Rhode Island Asthma Integrated Response Program (RI-AIR)We plan to demonstrate that RI-AIR ACIP is a replicable, evidence-based and cost-saving model that improves asthma outcomes for children at most risk, and can ...
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