Asthma Intervention Programs for Asthma

(PR-AIR Trial)

Recruiting at 1 trial location

Overseen By Elizabeth McQuaid, PhD, ABPP

Age: < 18

Sex: Any

Trial Phase: Academic

Sponsor: Rhode Island Hospital

Disqualifiers: Complex medical conditions

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 3

480 Participants Needed

Trial Summary

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 data supports the effectiveness of the treatment CASE and HARP for asthma?

Research on remote patient monitoring (RPM) for chronic conditions like heart failure and chronic obstructive pulmonary disease (COPD) shows that RPM can help reduce hospital visits and improve self-care. This suggests that similar remote monitoring approaches, like CASE-V and HARP-V, might also be beneficial for managing asthma. ^{1 2 3 4 5}

How is the Asthma Intervention Programs treatment different from other asthma treatments?

The Asthma Intervention Programs treatment is unique because it offers both high and low intensity packages, with options for in-person and remote delivery, focusing on comprehensive patient education and support through a systems approach. This includes early diagnosis, use of oral steroids, and a nurse case manager to oversee patient care, which is not typically emphasized in standard asthma treatments. ^{6 7 8 9 10}

What is the purpose of this trial?

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.

Research Team

Daphne Koinis Mitchell, PhD

Principal Investigator

Rhode Island Hospital

Elizabeth L McQuaid, PhD, ABPP

Principal Investigator

Rhode Island Hospital

Ligia Chavez, PhD

Principal Investigator

University of Puerto Rico

Eligibility Criteria

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

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

Treatment Details

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).

Participant Groups

Group I: High Intensity (in-Person) Intervention Implementation Active Control 2 Interventions

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.

Group II: Low-Intensity (Virtual) Intervention Implementation Active Control 2 Interventions

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.

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+

Findings from Research

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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]

Remote patient management (RPM) significantly improved heart failure-specific self-care behaviors in patients, with an increase in self-care scores from 78.7 to 84.5 in the RPM group compared to a smaller increase in the usual care group, indicating better adherence to heart failure regimens.

The most notable improvements in self-care were observed in patients living alone and those with initially low self-care scores, suggesting that RPM can be particularly beneficial for vulnerable populations.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effects of remote patient management on self-care behaviour in heart failure patients: results from the randomized TIM-HF2 trial. Deckwart, O., Koehler, K., Lezius, S., et al.[2023]

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Pediatric asthma self-management: current concepts. Robinson, LD.[2018]

The adapted asthma management program in a smaller clinic successfully reduced emergency department visits by 69% and hospitalizations by 92% over one year, demonstrating significant improvements in asthma control.

By utilizing existing resources and staff, the program achieved comparable outcomes to larger systems, with up to 70% of patients reaching asthma control by their third visit, indicating that effective asthma management can be implemented in smaller health systems.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Adaptation of an asthma management program to a small clinic. Kwong, KY., Redjal, N., Scott, L., et al.[2022]

References

1. England pubmed.ncbi.nlm.nih.gov

Development and implementation of a remote patient monitoring program for heart failure: a single-centre experience. [2021]

2. Canada pubmed.ncbi.nlm.nih.gov

A Remote Patient Monitoring Intervention for Patients With Chronic Obstructive Pulmonary Disease and Chronic Heart Failure: Pre-Post Economic Analysis of the Smart Program. [2020]

3. England pubmed.ncbi.nlm.nih.gov

A flexible protocol for a systematic review of remote patient monitoring. [2021]

4. England pubmed.ncbi.nlm.nih.gov

Economic impact of remote patient monitoring: an integrated economic model derived from a meta-analysis of randomized controlled trials in heart failure. [2022]

5. England pubmed.ncbi.nlm.nih.gov

Effects of remote patient management on self-care behaviour in heart failure patients: results from the randomized TIM-HF2 trial. [2023]

6. United States pubmed.ncbi.nlm.nih.gov

A systems approach to asthma care. [2019]

7. England pubmed.ncbi.nlm.nih.gov

Evaluation of a breathing retraining intervention to improve quality of life in asthma: quantitative process analysis of the BREATHE randomized controlled trial. [2022]

8. England pubmed.ncbi.nlm.nih.gov

Effectiveness of a modified open airways curriculum. [2015]

9. United States pubmed.ncbi.nlm.nih.gov

Pediatric asthma self-management: current concepts. [2018]

10. United States pubmed.ncbi.nlm.nih.gov

Adaptation of an asthma management program to a small clinic. [2022]