Asthma Action at Erie Trial

Asthma Clinical Trial

Official title:

Asthma Action at Erie Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02481986
• Other study ID #: 2015-0026
• Secondary ID: R01HL123797
• Status: Completed
• Phase: Phase 3
• Start date: April 1, 2015
• Est. completion date: March 31, 2021

Study information

• Verified date: November 2021
• Source: University of Illinois at Chicago
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 223
• Est. completion date: March 31, 2021
• Est. primary completion date: March 31, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 5 Years to 16 Years

Eligibility

Inclusion Criteria:

• Child is a patient at Erie Family Health Center

• Child is age 5-16 at the start of the study

• Child lives with the index caregiver at least 5 days out of the week

• Child has uncontrolled asthma. This is defined as a score of 1.25 or greater on the Asthma Control Questionnaire, or report of oral corticosteroid use in the past year

• Family has a working telephone

Exclusion Criteria:

• Exclusion criteria include family not fluent in English or Spanish, family lives in temporary housing such as a shelter, caregiver does not have permanent custody of child, or child has significant developmental delays or co-morbidities that would limit their ability to participate in the program.

Related Conditions & MeSH terms

• Asthma
• Children

Intervention

Behavioral:
• Community Health Worker
A community health worker is para-professional who performs education, case management, and social support.
• Certified asthma educator
A certified asthma educator has is certified and performs asthma education.

Locations

Country	Name	City	State
United States	Erie Family Health Center	Chicago	Illinois

Sponsors (4)

Lead Sponsor	Collaborator
University of Illinois at Chicago	Erie Family Health Center, National Heart, Lung, and Blood Institute (NHLBI), Rush University Medical Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Asthma Control Test/Childhood Asthma Control Test at 12-months	Asthma Control Test (12 years or older) or Childhood Asthma Control Test (under 12 years old) minimum 5, maximum 27, higher score means better asthma control	assessed 12-months from baseline, assessed over past 4 weeks
Primary	Activity Limitation at 12-months	Days of activity limitation over past 14 days minimum 0, maximum 14, higher means worse asthma control	assessed 12-months after baseline, assessed over past 14 days
Secondary	Asthma Control Questionnaire at 12-months	Asthma Control Questionnaire minimum 0, maximum 6, higher score means worse asthma control	assessed 12-months after baseline, prior week assessed
Secondary	Health Care Utilization at 12-months	Any ED visits or hospitalizations for asthma (each ED visit or hospitalization is a single event, ED visits that transition into hospitalizations are coded as one event)	assessed 12-months after baseline, assessed from baseline to 12-months
Secondary	Costs of Intervention Delivery	This measure is the total dollars spent to deliver the intervention by arm. Costs include CHW and AE-C salaries, supervision, training costs, and intervention materials that resulted in 84 AE-visits and 722 CHW visits.	assessed 12-months from baseline, assessed from baseline to 12-months