A Phase 3 interventional study of Community Health Worker and Certified asthma educator in Asthma and Children, sponsored by University of Illinois at Chicago. Completed at 1 site in United States. Open to participants aged 5 Years to 16 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2021-12-09.
Sponsored by University of Illinois at Chicago · Phase 3, Interventional, and Treatment
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.
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.
3,921 studies on the registry are indexed under Asthma; 507 are open to participants now.
This study's enrollment of 223 is above the median of 83 across 2,752 interventional studies indexed under Asthma.
Browse Asthma studies →University of Illinois at Chicago is the lead sponsor of 515 studies on the registry; 133 are open to participants now.
Of its 31 completed or terminated interventional studies of FDA-regulated products, 18 (58%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
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.
Behavioral: Community Health Worker
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.
Behavioral: Certified asthma educator
A community health worker is para-professional who performs education, case management, and social support.
A certified asthma educator has is certified and performs asthma education.
Asthma Control Test/Childhood Asthma Control Test at 12-months
Asthma Control Test (12 years or older) or Childhood Asthma Control Test (under 12 years old) minimum 5, maximum 27, higher score means better asthma control
Time frame: assessed 12-months from baseline, assessed over past 4 weeks
Activity Limitation at 12-months
Days of activity limitation over past 14 days minimum 0, maximum 14, higher means worse asthma control
Time frame: assessed 12-months after baseline, assessed over past 14 days
Asthma Control Questionnaire at 12-months
Asthma Control Questionnaire minimum 0, maximum 6, higher score means worse asthma control
Time frame: assessed 12-months after baseline, prior week assessed
Health Care Utilization at 12-months
Any ED visits or hospitalizations for asthma (each ED visit or hospitalization is a single event, ED visits that transition into hospitalizations are coded as one event)
Time frame: assessed 12-months after baseline, assessed from baseline to 12-months
Costs of Intervention Delivery
This measure is the total dollars spent to deliver the intervention by arm. Costs include CHW and AE-C salaries, supervision, training costs, and intervention materials that resulted in 84 AE-visits and 722 CHW visits.
Time frame: assessed 12-months from baseline, assessed from baseline to 12-months
| Milestone | Community Health Worker | Certified Asthma Educator |
|---|---|---|
| Started | 108 | 115 |
| Completed | 103 | 106 |
| Not completed | 5 | 9 |
Asthma Control Test (12 years or older) or Childhood Asthma Control Test (under 12 years old) minimum 5, maximum 27, higher score means better asthma control
| score on a scale | Community Health Worker | Certified Asthma Educator |
|---|---|---|
| Asthma Control Test/Childhood Asthma Control Test at 12-months | 21.23 (19.82 to 22.63) | 20.58 (19.31 to 21.85) |
Days of activity limitation over past 14 days minimum 0, maximum 14, higher means worse asthma control
| ratio of days | Community Health Worker | Certified Asthma Educator |
|---|---|---|
| Activity Limitation at 12-months | 0.42 (0.04 to 0.80) | 0.88 (0.52 to 1.23) |
Asthma Control Questionnaire minimum 0, maximum 6, higher score means worse asthma control
| score on a scale | Community Health Worker | Certified Asthma Educator |
|---|---|---|
| Asthma Control Questionnaire at 12-months | 0.80 (0.57 to 1.04) | 0.88 (0.66 to 1.09) |
Any ED visits or hospitalizations for asthma (each ED visit or hospitalization is a single event, ED visits that transition into hospitalizations are coded as one event)
| events | Community Health Worker | Certified Asthma Educator |
|---|---|---|
| Health Care Utilization at 12-months | 0.11 (0.07 to 0.18) | 0.20 (0.13 to 0.28) |
This measure is the total dollars spent to deliver the intervention by arm. Costs include CHW and AE-C salaries, supervision, training costs, and intervention materials that resulted in 84 AE-visits and 722 CHW visits.
| dollars spent per arm on intervention | Community Health Worker | Certified Asthma Educator |
|---|---|---|
| Costs of Intervention Delivery | 53390 | 11373 |
Collected over 24 months per participant. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Community Health Worker | 0/108 (0%) | 0/108 (0%) | 0/108 (0%) |
| Certified Asthma Educator | 0/115 (0%) | 0/115 (0%) | 0/115 (0%) |
| Age, Categorical(Participants) | Community Health Worker | Certified Asthma Educator | Total |
|---|---|---|---|
| <=18 years | 108 | 115 | 223 |
| Between 18 and 65 years | 0 | 0 | 0 |
| >=65 years | 0 | 0 | 0 |
| Age, Continuous(years) | Community Health Worker | Certified Asthma Educator | Total |
|---|---|---|---|
| Mean | 9.3 ± 2.9 | 9.5 ± 3.2 | 9.4 ± 3.0 |
| Sex: Female, Male(Participants) | Community Health Worker | Certified Asthma Educator | Total |
|---|---|---|---|
| Female | 46 | 52 | 98 |
| Male | 62 | 63 | 125 |
| Race/Ethnicity, Customized(Participants) | Community Health Worker | Certified Asthma Educator | Total |
|---|---|---|---|
| Hispanic ethnicity child | 92 | 98 | 190 |
| Not Hispanic ethnicity child | 16 | 17 | 33 |
| Black race child | 18 | 21 | 39 |
| Not Black race child | 90 | 93 | 183 |
| Region of Enrollment(participants) | Community Health Worker | Certified Asthma Educator | Total |
|---|---|---|---|
| United States | 108 | 115 | 223 |
Documents are hosted by the registry — open the source record to download them.
This study is completed, as verified in Nov 2021. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
University of Illinois at Chicago