NCT02481986

Asthma Action at Erie Trial

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 223 (actual)
• Sponsor: University of Illinois at Chicago · Academic / Other
• Sex: All
• Age: 5 Years – 16 Years
• Healthy volunteers: Accepted

Summary

The Asthma Action at Erie Trial compares the current best practice in asthma self-management education (certified asthma educator services) to an integrated community health worker (CHW) home intervention in which the real-life challenges of patients and the health care system are taken fully into account. This trial will provide clarity as to the expected effect size, cost savings, and resources needed to integrate asthma CHWs into clinical practice.

Detailed description

The Asthma Action at Erie Trial will test the ability of a community health worker (CHW) intervention with three important modifications to achieve asthma control in high-risk children. These modifications are: 1) CHWs will be integrated into both the clinical and the home setting, 2) A system for directly addressing mental health and psychosocial barriers will be provided, and 3) Participants will be provided only materials and equipment for trigger remediation that are supported by the current medical reimbursement system. To test this intervention, a two-arm behavioral randomized controlled trial (N=220) will be conducted in partnership with a federally-qualified health center (FQHC) serving a low income, minority population that is at high-risk for significant asthma morbidity. The intervention arm will receive an integrated CHW home intervention for pediatric asthma education. The comparison arm will received clinic-based certified asthma educator (AE-C) services. Primary Aim 1 is to assess the efficacy of the integrated CHW home asthma intervention, relative to clinic-based AE-C education over 12-months, as demonstrated by asthma control. Specific Aim 2 is to assess maintenance of intervention efficacy, as demonstrated by asthma control at 18 and 24 months after randomization. Specific Aim 3 is to determine the cost-effectiveness at 12-months of CHW and AE-C intervention delivery, and additional costs or savings related to asthma exacerbations at 12- and 24-months. Specific Aim 4 is to assess the efficacy of the integrated CHW home asthma intervention relative to clinic-based AE-C education, as demonstrated by asthma control, among those experiencing depression, stress, and/or a post-traumatic stress disorder.

Conditions

• Asthma
• Children

Interventions

Type	Name	Description
BEHAVIORAL	Community Health Worker	A community health worker is para-professional who performs education, case management, and social support.
BEHAVIORAL	Certified asthma educator	A certified asthma educator has is certified and performs asthma education.

Timeline

• Start date: 2015-04-01
• Primary completion: 2020-03-31
• Completion: 2021-03-31
• First posted: 2015-06-25
• Last updated: 2021-12-09
• Results posted: 2021-12-09

Locations

1 site across 1 country: United States