Asthma Action at Erie Trial

November 11, 2021 updated by: Molly A. Martin, University of Illinois at Chicago
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

223

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Illinois
      • Chicago, Illinois, United States, 60622
        • Erie Family Health Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

5 years to 16 years (Child)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Community health worker
Participants in this arm will be offered 10 home visits in a 12-month period from community health workers (CHWs). Visits will cover a core asthma curriculum and provide social support.
Behavioral: Community Health Worker
A community health worker is para-professional who performs education, case management, and social support.
Active Comparator: Certified asthma educator
Participants in this arm will be offered 2 education sessions with a certified asthma educator in the clinic at start of the study and again at 6-months. These sessions will be followed by a telephone call from the certified asthma educator several weeks after the sessions.
Behavioral: Certified asthma educator
A certified asthma educator has is certified and performs asthma education.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Asthma Control Test/Childhood Asthma Control Test at 12-months
Time Frame: assessed 12-months from baseline, assessed over past 4 weeks
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
Activity Limitation at 12-months
Time Frame: assessed 12-months after baseline, assessed over past 14 days
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Asthma Control Questionnaire at 12-months
Time Frame: assessed 12-months after baseline, prior week assessed
Asthma Control Questionnaire minimum 0, maximum 6, higher score means worse asthma control
assessed 12-months after baseline, prior week assessed
Health Care Utilization at 12-months
Time Frame: assessed 12-months after baseline, assessed from baseline to 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
Costs of Intervention Delivery
Time Frame: assessed 12-months from baseline, assessed from baseline to 12-months
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Illinois at Chicago

Collaborators

National Heart, Lung, and Blood Institute (NHLBI)
Rush University Medical Center
Erie Family Health Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 1, 2015

Primary Completion (Actual)

March 31, 2020

Study Completion (Actual)

March 31, 2021

Study Registration Dates

First Submitted

June 5, 2015

First Submitted That Met QC Criteria

June 24, 2015

First Posted (Estimate)

June 25, 2015

Study Record Updates

Last Update Posted (Actual)

December 9, 2021

Last Update Submitted That Met QC Criteria

November 11, 2021

Last Verified

November 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2015-0026
  • R01HL123797 (U.S. NIH Grant/Contract)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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