Community Health Equity Accelerator (CHEA) Pediatric Asthma Intervention

NCT06507943 | Active Not Recruiting

• 1 other identifier: 2000037314
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

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.

Conditions

Asthma in Children

Keywords

Medical Legal Partnership; Community Health Worker; Health Harming Legal Needs

Outcome Measures

Primary Outcomes (4)

• Percentage of Referrals Resulting in Home Visit, to Assess Feasibility of Promotora Visits

  Percent of referred participants (from all referrals placed) to the newly-established asthma home visiting Promotora Program that resulted in a home visit (in-person or virtual)

  One Year

• Percent of clinicians who use pathway, to assess feasibility of asthma pathway use

  Percent of clinicians at participating practices who have accessed the asthma intervention pathway (using data from pathway utilization metrics)

  One Year

• Percent of patients for whom the pathway is used, to assess feasibility of asthma pathway use

  Percent of patients for whom a clinician accessed the asthma pathway (using pathway utilization metrics) out of total potential children for whom it could be used (using deidentified electronic health (EHR) record data tool)

  One Year

• Count of use of individual asthma pathway component use

  Count of use of individual asthma pathway components (using pathway utilization metrics)

  One Year

Secondary Outcomes (6)

• Mean Asthma Control Test (ACT) for 4-11 years scores

  Baseline and 6-8 weeks later

• Mean Pediatric Quality of Life (Peds-QL) scores

  Baseline and 6-8 weeks later

• Mean number of hospital admissions for asthma

  Two years (year before and year after intervention)

• Mean number of emergency department (ED) visits for asthma

  Two years (year before and year after intervention)

• Mean number of urgent visits for asthma

  Two years (year before and year after intervention)

Study Arms (1)

Promotora

EXPERIMENTAL

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.

Behavioral: Promotora Home Visit

Interventions

Promotora Home Visit 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.

Promotora

Eligibility Criteria

• Age: 4 Years - 11 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• Living outside of New Haven Zip Code

Sponsors & Collaborators

• Yale University: lead
• Hispanic Federation, Inc.: collaborator

Study Sites (1)

Yale

New Haven, Connecticut, 06519, United States

Location

Study Officials

• Julia Rosenberg, MD MHS

  Yale University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 11, 2024
• First Posted: July 18, 2024
• Study Start: September 16, 2024
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2027
• Last Updated: January 13, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)