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Asthma Action at Erie Trial

NCT ID: NCT02481986

Last Updated: 2021-12-09

Study Results

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

223 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-04-01

Study Completion Date

2021-03-31

Brief Summary

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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

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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

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Asthma Children

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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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.

Group Type EXPERIMENTAL

Community Health Worker

Intervention Type BEHAVIORAL

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

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.

Group Type ACTIVE_COMPARATOR

Certified asthma educator

Intervention Type BEHAVIORAL

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

Interventions

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Community Health Worker

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

Intervention Type BEHAVIORAL

Certified asthma educator

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

Intervention Type BEHAVIORAL

Eligibility Criteria

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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
Minimum Eligible Age

5 Years

Maximum Eligible Age

16 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Erie Family Health Center

OTHER_GOV

Sponsor Role collaborator

Rush University Medical Center

OTHER

Sponsor Role collaborator

National Heart, Lung, and Blood Institute (NHLBI)

NIH

Sponsor Role collaborator

University of Illinois at Chicago

OTHER

Sponsor Role lead

Responsible Party

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Molly A. Martin

Associate Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Erie Family Health Center

Chicago, Illinois, United States

Site Status

Countries

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United States

References

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Lalji R, Koh L, Francis A, Khalid R, Guha C, Johnson DW, Wong G. Patient navigator programmes for children and adolescents with chronic diseases. Cochrane Database Syst Rev. 2024 Oct 9;10(10):CD014688. doi: 10.1002/14651858.CD014688.pub2.

Reference Type DERIVED
PMID: 39382077 (View on PubMed)

Weinstein SM, Pugach O, Rosales G, Mosnaim GS, Orozco K, Pappalardo AA, Martin MA. Psychosocial Moderators and Outcomes of a Randomized Effectiveness Trial for Child Asthma. J Pediatr Psychol. 2021 Jul 20;46(6):673-687. doi: 10.1093/jpepsy/jsab011.

Reference Type DERIVED
PMID: 33616185 (View on PubMed)

Weinstein SM, Pugach O, Rosales G, Mosnaim GS, Walton SM, Martin MA. Family Chaos and Asthma Control. Pediatrics. 2019 Aug;144(2):e20182758. doi: 10.1542/peds.2018-2758. Epub 2019 Jul 9.

Reference Type DERIVED
PMID: 31289192 (View on PubMed)

Mosnaim GS, Weinstein SM, Pugach O, Rosales G, Roy A, Walton S, Martin MA. Design and baseline characteristics of a low-income urban cohort of children with asthma: The Asthma Action at Erie Trial. Contemp Clin Trials. 2019 Apr;79:55-65. doi: 10.1016/j.cct.2019.02.006. Epub 2019 Feb 14.

Reference Type DERIVED
PMID: 30772471 (View on PubMed)

Provided Documents

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Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

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R01HL123797

Identifier Type: NIH

Identifier Source: secondary_id

View Link

2015-0026

Identifier Type: -

Identifier Source: org_study_id