Community Health Equity Accelerator (CHEA) Pediatric Asthma Intervention

NCT ID: NCT06507943

Last Updated: 2026-01-13

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 50 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-09-16
• Study Completion Date: 2027-12-31

Brief Summary

The purpose of this pilot is to initiate an academic-community partnership and launch a multi-level intervention that includes an asthma exposure pathway (an online decision support and resource) and a health Promotora program that will provide culturally responsive asthma support alongside legal and medical services to improve access to asthma care and ultimately improve asthma-related outcomes in the New Haven region.

Detailed Description

In this will be a prospective, non-randomized, observational, multi-level pilot intervention, general pediatricians and specialists in New Haven, Connecticut will utilize a newly developed clinical pathway that will be publicly available at the Yale Pediatrics Clinical Pathways website and accessible within the electronic health record (EHR) via integrated software to submit referrals for participants in a Promotora (Community Health Worker) asthma home-visiting intervention.

The Hispanic Federation Promotoras, who are partners in this study who have received Human Subjects research training, will enroll participants in the study. For each participating family, Promotora home visits will be scheduled 6-8 weeks apart, with in-person or virtual visits conducted per the family's preference. The Promotoras, who have received specialized asthma training, will address concerns raised by families, using the clinical pathway as a resource (the pathway will have resources for asthma-related concerns that are raised). A clinician from the study team will be on call at all times for the Promotoras in case urgent questions arise, and weekly case-conferences will be arranged to discuss any additional needs for support.

In this study, the primary outcomes will include measures of feasibility of both Promotora home visits and pathway utilization. The investigators will evaluate secondary outcomes using an interrupted time series analysis to evaluate asthma-related outcomes. In addition to survey data, asthma exacerbation metrics will be collected from the electronic health record.

Conditions

Asthma in Children

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: HEALTH_SERVICES_RESEARCH
• Blinding Strategy: NONE

Study Groups

Promotora

Two Hispanic Federation Promotoras (community health workers) will provide culturally competent, bilingual home visits for asthma-related education and evaluation and support for health-harming legal needs (e.g., mold, rodents), including an initial visit and a follow-up visit 6-8 weeks later.

Group Type: EXPERIMENTAL

Promotora Home Visit

Intervention Type: BEHAVIORAL

For each participating family, Promotora home visits will be scheduled 6-8 weeks apart, with in-person or virtual visits conducted per the family's preference. The visits will begin with a survey which will evaluate concerns related to asthma for the child and the family, including their asthma control (via the ACT), their home environment (via screening for environmental exposures), and quality of life for the child. These surveys will be available in both online or physical forms for potential connectivity concerns, and Promotoras will have IPads for the online forms. The Promotoras, who have received specialized asthma training, will then address concerns raised by families, using the Clinical Pathway which will have resources for asthma-related concerns that are raised.

Interventions

Promotora Home Visit

For each participating family, Promotora home visits will be scheduled 6-8 weeks apart, with in-person or virtual visits conducted per the family's preference. The visits will begin with a survey which will evaluate concerns related to asthma for the child and the family, including their asthma control (via the ACT), their home environment (via screening for environmental exposures), and quality of life for the child. These surveys will be available in both online or physical forms for potential connectivity concerns, and Promotoras will have IPads for the online forms. The Promotoras, who have received specialized asthma training, will then address concerns raised by families, using the Clinical Pathway which will have resources for asthma-related concerns that are raised.

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

Children with a diagnosis of asthma with at least one of the following:

• Oral steroid prescription in past 12m
• ED visit for asthma in past 12m
• Hospital admission for asthma in past 12m
• Asthma control test (ACT) score at visit ≤19
• Concern for asthmogenic exposure in the home (such as mold, pests, smoking, or pollution)
• At least one missed follow-up appointment for asthma
• At least one asthma exacerbation in the prior year
• Interested in asthma education (such as education in how to prevent asthma or how to administer medications)
• Concern for medication non-adherence

Exclusion Criteria

• Living outside of New Haven Zip Code

• Minimum Eligible Age: 4 Years
• Maximum Eligible Age: 11 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Hispanic Federation, Inc.

UNKNOWN

Sponsor Role: collaborator

Yale University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Julia Rosenberg, MD MHS

Role: PRINCIPAL_INVESTIGATOR

Yale University

Locations

Yale

New Haven, Connecticut, United States

Countries

United States

Other Identifiers

2000037314

Identifier Type: -

Identifier Source: org_study_id