Design and baseline characteristics of a low-income urban cohort of children with asthma: The Asthma Action at Erie Trial.

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.