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.
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http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6541387 | PMC |
http://dx.doi.org/10.1016/j.cct.2019.02.006 | DOI Listing |
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