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.

Abstract

Objective: To describe the methodology of a randomized controlled trial comparing the efficacy of integrated asthma community health workers (CHW) and a certified asthma educator (AE-C) to improve asthma outcomes in low-income minority children in Chicago.

Methods: Child/caregiver dyads were randomized to CHW home visits or education in the clinic from an AE-C. Intervention was delivered in the first year after enrollment. Data collection occured at baseline, 6-, 12-, 18, and 24-months. The co-primary outcomes included asthma control using the Asthma Control Test/childhood Asthma Control Test (ACT/cACT) and activity limitation over the past 14 days.

Results: A total of 223 participants ages 5-16 years were randomized. The majority of children were in the 5-11 year old range (78.9%). Most caregivers (96.9%) and 44% of children were female. Approximately 85% of caregivers and children reported Hispanic ethnicity and 62.3% reported a household income of ≤ $59,000. Over half (55.7%) had uncontrolled asthma as measured by ACT/cACT; 13.9% had a normal ACT/cACT score but were uncontrolled using the Asthma Control Questionnaire and 20.2% were controlled on both measures but had received oral steroids in the past year for asthma.

Conclusion: The Asthma Action at Erie Trial successfully recruited a largely Hispanic cohort of children with uncontrolled or high-risk asthma to study the differential effects of clinic-based AE-C and home-based CHW interventions. Strengths of the trial include its comparative effectivness design that integrates interventionists and intervention delivery into a clinical setting. Categorizing asthma control in community settings for research purposes presents unique challenges.

Clinical trial registration: University of Illinois at Chicago Protocol Record R01HL123797, Asthma Action at Erie TrialClinicalTrials.gov Identifier: NCT02481986 "ClinicalTrials.gov Registration" register@clinicaltrials.gov.

Keywords: Adherence; Asthma; Community health workers; Disparities; Health outcomes; Pediatrics.

Publication types

  • Clinical Trial Protocol
  • Research Support, N.I.H., Extramural

MeSH terms

  • Adolescent
  • Anti-Asthmatic Agents / therapeutic use
  • Asthma* / drug therapy
  • Asthma* / ethnology
  • Asthma* / physiopathology
  • Caregivers / education
  • Chicago
  • Child
  • Child, Preschool
  • Community Health Workers* / organization & administration
  • Female
  • Hispanic or Latino* / education
  • House Calls
  • Humans
  • Male
  • Patient Education as Topic* / organization & administration
  • Poverty*
  • Randomized Controlled Trials as Topic
  • Research Design
  • Severity of Illness Index
  • Socioeconomic Factors
  • Urban Population

Substances

  • Anti-Asthmatic Agents

Associated data

  • ClinicalTrials.gov/NCT02481986