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Completed

NCT Number: NCT02481986

Asthma Action at Erie Trial

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.

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Key information

Age range

5 year–16 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Erie Family Health Center

Chicago, Illinois, 60622, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Community health worker

Behavioral

A community health worker is para-professional who performs education, case management, and social support.

Certified asthma educator

Behavioral

A certified asthma educator has is certified and performs asthma education.

Primary outcomes

  1. 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

  2. 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

Secondary outcomes

  1. 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

  2. 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)

  3. 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.

Sponsors and collaborators

Lead sponsor

University of Illinois at Chicago

Other

Collaborators

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

Registry information

Important dates

Study start
2015
Primary completion
2020
Study completion
2021
First posted
Jun 25, 2015
Registry last updated
Dec 9, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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