Clinical trial NCT02481986: Asthma Action at Erie Trial
Official title: Asthma Action at Erie Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Asthma
Children
Lead sponsor: University of Illinois at Chicago
Sponsor class: OTHER
Collaborators: name: Erie Family Health Center
name: Rush University Medical Center
name: National Heart, Lung, and Blood Institute (NHLBI)
First posted: 2015-06-25
Enrollment: 223
Sex: ALL
Minimum age (years): 5
Maximum age (years): 16
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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: 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Asthma Control Test/Childhood Asthma Control Test at 12-months
timeFrame: assessed 12-months from baseline, assessed over past 4 weeks
measure: Activity Limitation at 12-months
timeFrame: assessed 12-months after baseline, assessed over past 14 days
Secondary outcomes:
measure: Asthma Control Questionnaire at 12-months
timeFrame: assessed 12-months after baseline, prior week assessed
measure: Health Care Utilization at 12-months
timeFrame: assessed 12-months after baseline, assessed from baseline to 12-months
measure: Costs of Intervention Delivery
timeFrame: assessed 12-months from baseline, assessed from baseline to 12-months
Other outcomes:
Locations:
city: Chicago
country: United States
facility: Erie Family Health Center
state: Illinois
Study officials:
References:
citation: 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.
citation: 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.
citation: 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.