Asthma Action at Erie Trial
Phase: PHASE3
Conditions: Asthma, Children
Sponsor: University of Illinois at Chicago

 _____________________________________________________________________________________________  
Asthma Action at Erie Trial 
 Version 11 
Page 1 of 26 
  February 28, 2018 
 
 
 
Asthma Action at Erie Trial 
NCT02481986 
Principal Investigator: 
Molly Martin, MD 
 
Department of Pediatrics 
840 South Wood Street, M/C 856, Chicago, IL 60612 
Email: mollyma@uic.edu 
Landline: 312-996-2363 
 
Co-Investigators: 
Steven Rothschild, MD: Rush University Medical Center, 
steven_k_rothschild@rush.edu 
Giselle Mosnaim, MD: Northshore University Healthsystem, GMosnaim@northshore.org 
Sally Weinstein, PhD: UIC, sweinstein@psych.uic.edu 
Michael Berbaum, PhD: UIC, mberbaum@uic.edu 
Surrey Walton, PhD: UIC, walton@uic.edu 
Oksana Pugash, PhD: UIC, opugach@uic.edu 
 
Study Location(s):  
1. UIC: Department of Pediatrics 
2. UIC: Institute for Health Research and Policy 
3. Erie Family Health Centers (has multiple sites, intervention sites to be 
determined) 
Sponsor: National Institutes of Health  
National Heart, Lung, and Blood Institute (NHLBI) 
Version:   11 
Date:  February 28, 2018 

 _____________________________________________________________________________________________  
Asthma Action at Erie Trial 
 Version 11 
Page 2 of 26 
  February 28, 2018 
 
 
 
TABLE OF CONTENTS 
Page 
Table of Contents ............................................................................................................ 2 
List of Abbreviations ........................................................................................................ 3 
1.0 Project Summary/Abstract ................................................................................... 4 
2.0 Background/Scientific Rationale ......................................................................... 5 
3.0 Objectives/Aims .................................................................................................... 6 
4.0 Eligibility ................................................................................................................ 6 
4.1 Inclusion Criteria ............................................................................................. 6 
4.2 Exclusion Criteria ............................................................................................ 7 
4.3 Excluded or Vulnerable Populations ............................................................. 7 
5.0 Subject Enrollment................................................................................................ 7 
6.0 Study Design and Procedures ............................................................................. 8 
7.0 Expected Risks/Benefits ..................................................................................... 16 
8.0 Data Collection and Management Procedures ................................................. 16 
9.0 Data Analysis ....................................................................................................... 18 
10.0 Quality Control and Quality Assurance ............................................................. 20 
11.0 Data and Safety Monitoring ................................................................................ 20 
12.0 Statistical Considerations .................................................................................. 22 
13.0 Regulatory Requirements ................................................................................... 22 
13.1 
Informed Consent ..................................................................................... 23 
13.2 
Subject Confidentiality ............................................................................. 23 
14.0 References ........................................................................................................... 23 
 
 
 
 
 
 
 
 
 
 
 
 
 

 _____________________________________________________________________________________________  
Asthma Action at Erie Trial 
 Version 11 
Page 3 of 26 
  February 28, 2018 
 
 
 
LIST OF ABBREVIATIONS  
 
CAB  
 
Community Advisory Board 
CBPR  
 
Community Based Participatory Research 
CHW  
 
Community Health Worker 
DSMB  
 
Data and Safety Monitoring Board 
DSMP  
 
Data and Safety Monitoring Plan 
HIPAA 
 
Health Insurance Portability and Accountability Act 
IHRP  
 
Institute for Health Research and Policy 
IRB 
 
 
Institutional Review Board 
MRC  
 
Methodology Research Core 
OHRP  
 
Office of Human Research Protections 
OPRS  
 
Office for the Protection of Research Subjects 
PHI 
 
 
Protected Health Information 
PI 
 
 
Principal Investigator 
RS                           Research Specialist 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

 _____________________________________________________________________________________________  
Asthma Action at Erie Trial 
 Version 11 
Page 4 of 26 
  February 28, 2018 
 
 
1.0 
PROJECT SUMMARY/ABSTRACT 
Asthma prevalence and morbidity have been increasing among children over the last three 
decades despite significant advances in environmental control and asthma care. The annual 
costs for children with asthma range between $2.0 and $3.2 billion. Asthma morbidity and its 
associated costs are not borne equally; they are highest for urban, low income, African 
American and Puerto Rican children. Community health workers (CHWs) have been growing in 
popularity as a potential intervention to combat these asthma disparities. CHWs are frontline 
public health workers who serve as liaisons between health and social services and 
communities to facilitate access to services and improve the quality and cultural competence of 
service delivery. The evidence on CHW asthma intervention efficacy has been growing but 
several critical gaps still exist. The Asthma Action at Erie Trial will test the ability of a CHW 
intervention with three important modifications to achieve asthma control in high-risk children: 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.   
 
A two-arm behavioral randomized controlled trial (N=223) 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.  We hypothesize that the CHW arm will have at 
least 30% less days with activity limitation than the AE-C arm at 12-months. 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. This trial compares the current best practice in asthma self-management education 
(AE-C services) to an integrated 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.   
 
 
 
 
 
 

 _____________________________________________________________________________________________  
Asthma Action at Erie Trial 
 Version 11 
Page 5 of 26 
  February 28, 2018 
 
 
2.0 
BACKGROUND/SCIENTIFIC RATIONALE  
Asthma morbidity and its associated costs are not borne equally.  African American and 
Puerto Rican children suffer disproportionately higher asthma prevalence and morbidity.1 
Asthma disparities measured over ten years ago1 still persist2 due to an interaction of individual, 
environmental, health system, and provider factors.3-4 These disparities are clearly seen in 
Chicago, which has some of the highest asthma prevalence rates ever reported. A survey of 
randomly selected Chicago households in 2002, which measured both diagnosed asthma and 
children with probable asthma, reported potential total asthma rates of 14% in Mexican children, 
20% in White children, 25% in Black children, and 34% in Puerto Rican children.5 Effective 
interventions to control asthma are needed, especially within minority urban populations where 
the highest asthma burden exists. Interest is growing around the potential role of community 
health workers (CHWs) to control pediatric asthma in these high risk populations.  However, 
major gaps remain regarding specific CHW dose and protocols, associated efficacy on clinical 
outcomes, and integration into the healthcare system before the intervention can be effectively 
disseminated.6-9 Using a rigorous design, we will assess the efficacy of a well-developed CHW 
home asthma intervention that is fully integrated into a clinical setting. At the completion of the 
study, we will be able to describe the expected clinical outcomes associated with a CHW 
intervention integrated into clinical care, as well as the anticipated costs relative to the benefits. 
The results of this study will clarify the necessary resources and realistic expectations of the 
intervention for clinicians, administrators, and insurers.  As healthcare reform progresses, this 
study will provide essential information about the optimal role of CHWs in routine clinical care 
for pediatric asthma. 
The Community United to Challenge Asthma - Project CURA (Clinical Trials ID 
NCT01065883 and NCT01061424) was a behavioral randomized controlled trial to test the 
efficacy of a CHW intervention to improve medication adherence and reduce home triggers 
among Puerto Rican children and adolescents.10-12 Fifty-one children in elementary school and 
50 children in high school were recruited and randomized to receive either CHW home visits or 
mailed information. Both interventions lasted four months and covered a standard asthma core 
curriculum emphasizing physiology, triggers, medications, and physician communication. The 
interventions also included information on self-management skills. Data were collected at the 
end of the intervention period and one-year from the start date to assess maintenance. The 
sample was intentionally poorly controlled at baseline; all met criteria for either uncontrolled 
and/or persistent asthma over the past year. Only 45% of the Elementary School Cohort and 
12% of the High School Cohort had an inhaled corticosteroid at baseline.  For those with an 
inhaled corticosteroid, the combined median adherence was 1.0 doses/day (range 0-3.3), 
meaning about 25% adherent to standard metered dose inhaler regimens.  Homes had an 
average of six asthma triggers.  Prevalence of depression was very high: 59% of caregivers and 
68% of teens reported signs of depression.  In the Elementary School Cohort (n=51), no 
differences were seen in outcomes between arms at any time point with one exception: the 
CHW arm had lower odds of having an ICS (OR=0.2; p=0.02) at 12-months. Every point 
increase in baseline caregiver depressive symptoms was associated with a lower odds of 
controlled asthma (OR 0.9; 95% CI = 0.8, 1.0; p=0.02). The only significant treatment arm 
difference in the High School Cohort (n=50) was in inhaler technique. At 5-months, the CHW 
arm performed 18.0% (95% CI = 8.0, 28.1; p <0.01) more steps correct than the Mailings arm. 
At 12-months, the CHW arm performed 14.2% (95% CI = 4.4, 24.1; p <0.01) more steps correct 
than the Mailings arm.   
The Community United to Raise Awareness: Asthma and Active Living: CURA 2 
(1P50HL105189-01) was a follow-up to Project CURA where the number of CHW visits was 

 _____________________________________________________________________________________________  
Asthma Action at Erie Trial 
 Version 11 
Page 6 of 26 
  February 28, 2018 
 
 
expanded, the inclusion criteria expanded to all race/ethnicities, and content on pediatric obesity 
added. Similar to the original study, no environmental remediation equipment was provided and 
there was no clinical partner. Participants were children ages 5-12 with asthma who were 
overweight or obese. They were offered 12 CHW home visits over one year. Of the 46 
participating families, the median number of home visits received was 10; 3 families refused all 
and 3 families were lost at one-year. Scores of uncontrolled asthma (<20) on the Childhood 
Asthma Control Test improved significantly pre/post (38% to 14%, p<0.01). Improvements were 
seen in nighttime symptoms (49% to 26%, p<0.05), activity limitation (33% to 7%, p<0.01), and 
inhaler technique (steps correct: 60% to 90%, p<0.01). Medication adherence and home 
triggers did not change. Obesity changes did not mediate asthma outcomes. 
There is an urgent need for evidence from practical clinical trials where the CHW asthma 
intervention is integrated into a clinical real-world setting. We need to know: 1) How to formally 
connect CHWs and medical providers in a way that allows CHWs to keep their community focus 
but maintains a reimbursable and replicable clinical structure. 2) How to achieve environmental 
remediation for trigger reduction within the current medical system. 3) How to integrate CHWs 
with existing resources for the management of psychosocial problems.  4) Cost data on the 
intervention delivery and outcomes.  The proposed study will answer these questions. 
 
3.0 
Objectives/Aims 
 
Primary Aim 1:  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.  We hypothesize that the CHW arm will have significantly greater asthma control 
than the AE-C arm at 12-months as measured by days with activity limitation over the 
previous 14 days and the Asthma Control Test/childhood Asthma Control Test. 
Specific Aim 2:  To assess maintenance of intervention efficacy, as demonstrated by asthma 
control at 18 and 24 months after randomization.  We hypothesize that changes in 
efficacy outcomes will be maintained after cessation of the intervention.  
Specific Aim 3: 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: 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 post-traumatic stress disorder (PTSD).  
We hypothesize that among those living with depression, stress, and/or PTSD, the CHW 
intervention will be significantly more effective in achieving and maintaining asthma 
control than the AE-C education intervention. 
 
4.0 
Eligibility 
The procedures for determining eligibility are described in Section 5.0. 
 
4.1 
 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 

 _____________________________________________________________________________________________  
Asthma Action at Erie Trial 
 Version 11 
Page 7 of 26 
  February 28, 2018 
 
 
- Child has uncontrolled asthma.13  This is defined as a score of 1.25 or greater on the 
Asthma Control Questionnaire,14-17 a score of less than 20 on the Asthma Control 
Test/childhood Asthma Control Test,20-24 or report of oral corticosteroid use at least 
once in the past year.13  
- Family has a working telephone 
 
4.2       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. 
 
4.3       Excluded or Vulnerable Populations 
This study targets vulnerable populations because they suffer disproportionately worse 
outcomes from asthma. They are also the target population of Erie Family Health 
Center. Almost all participants will be low income and either African American or 
Hispanic ethnicity. Many will have Spanish as their primary language.  
The study also includes children, by enrolling child/caregiver dyads. Children under the 
age of 5 are excluded because the diagnosis of chronic asthma in this population is 
challenging.13 Children over 16 years of age are excluded because the management of 
their asthma usually changes from a caregiver/child partnership to mainly child-driven 
and the role of environmental trigger reduction changes as well since the children spend 
less time in their parent’s home. 
 
5.0 
Subject Enrollment 
1. There are multiple pathways for enrollment. 
Erie will query the electronic medical record for all patients with a diagnosis of asthma, 
eliminating those who fall outside of the age range.  Potentially eligible families will be 
sent a letter stating they should call if they do not wish to be considered for this study. A 
bilingual brochure will also be included with the letter. If families do not respond to the 
letter within one week, they will be called on the telephone by designated, trained study 
staff to assess interest in the study. Study staff may be Erie or UIC employees. Families 
without addresses or whose letters are returned undelivered will be called on the 
telephone by Erie staff to assess interest in the study. Families who do not answer their 
telephone will be sent a second letter and their chart flagged for Erie staff to address the 
study when the family returns to clinic. Potential participants that express interest in the 
study will be formally screened by UIC research specialists. 
2. Erie providers and staff will be instructed to refer potential participants to call the study 
enrollment number, email the study enrollment team, talk to one of the study staff in 
clinic, or allow study staff to call them. During high volume times (school physical 
season, flu vaccine season), charts will also be flagged for Erie providers and staff to 
address the study directly with families at the time of their visit. Study staff in clinic or on 
the phone/email will give descriptions of the study and if a potential participant is 
interested, a formal screen will be initiated by a UIC research specialist. 
3. Flyers and signs advertising the study will be created and distributed/posted.  
 
If a family is interested and passes the screener, they will then be scheduled for a home 
visit. A University of Illinois at Chicago (UIC) research specialist (RS) will go to the home to 
perform informed consent/assent and to collect the baseline data. At that point, the family is 
ready for randomization. If recruitment at the Erie primary care centers does not yield 

 _____________________________________________________________________________________________  
Asthma Action at Erie Trial 
 Version 11 
Page 8 of 26 
  February 28, 2018 
 
 
sufficient participants, other sites (school-based centers) will be opened. We will recruit 223 
participants (caregiver/child dyads), 111-112 per study arm. 
 
Participants that fail the screener or who chose to not provide informed consent will be 
thanked for their time. Participants that fail the screener but are interested in the study will be 
offered the option of being put on a re-contact list. If they agree to be put on this list, their 
contact information will be saved and research staff can call them again in several months to 
rescreen them. Personal identifying data from the screening (initial and re-contact lists) will be 
kept in a secure location until recruitment is ended, at which point it will be destroyed. (We will 
keep their name during the recruitment period only to prevent contacting people who have 
screened out.)  All staff involved in recruitment will receive careful training about the study and 
the clinic services to ensure that everyone approached understands that participation is 
voluntary and services at Erie will continue regardless of study participation, and so that Erie 
staff understands their primary role is patient care. Recruitment will not impinge on clinical 
responsibilities or clinic operations. Staff involved in recruitment have their time covered by the 
study. Providers who refer the study to patients do so when they have time and feel comfortable 
only. 
Randomization will be conducted in a 1:1 ratio using randomly mixed permuted blocks of 
size 4 and 6 to ensure reasonably equal allocation while reducing predictability of the 
assignment sequence. Upon completion of the randomization assignment, the data 
management team will generate a letter to the participant informing him/her of their study status 
and also notify the Erie Intervention Coordinator who will assign the patient to a CHW if 
randomized to that arm. Although double blinding in a behavioral randomized clinical trial is 
impossible, blinding will be maximized by: 1) incomplete disclosure of study goals for 
participants during consent (see Human Subjects for details), 2) blinding outcomes assessors; 
3) incomplete disclosure of research hypotheses for non-investigators staff; and 4) training co-
investigators and staff in the concept of equipoise. Intervention investigators and staff will be 
unblinded to treatment arm because they will need to work with the CHWs and monitor 
intervention fidelity and data accuracy. Study staff and investigators (with the exception of the 
Safety Officer) will not have access to interim outcomes data. 
 
6.0 
Study Design and Procedures 
6.1  
Study Locations 
Research will be performed at Erie Family Health Center, in homes, and at UIC. Erie is 
the recruitment site. Erie is also the site where the AE-C intervention will occur. CHWs will be 
employed by Erie and will work out of Erie, but they will provide home visits as well. For more 
than fifty-five years, Erie has provided high quality, culturally sensitive, and compassionate 
health care services to medically underserved populations on Chicago’s north and west sides. 
Today, Erie serves nearly 40,000 patients annually at thirteen sites.  Seventy-nine percent of 
Erie’s patients are Hispanic, 54% are best served in Spanish, 68% are female, 49% are under 
the age of 19, 28% are school-aged children, 31% are uninsured, and 83% come from 
households with incomes that fall below the federal poverty line. Erie offers a wide range of 
behavioral health services in addition to medical and dental services. Individual therapy, group 
therapy, women’s support groups, and substance abuse referrals are provided in the languages 
and settings preferred by patients. As an early adopter of innovative practices, Erie is well 
positioned to embrace the challenges presented by a changing health care environment.  
Systems like Erie’s Electronic Health Record system, Practice Management System, and 
advanced open access scheduling contribute to the delivery of coordinated care that is high 

 _____________________________________________________________________________________________  
Asthma Action at Erie Trial 
 Version 11 
Page 9 of 26 
  February 28, 2018 
 
 
quality, efficient, and affordable.  In addition Erie has robust systems, policies and procedures 
for managing grants and assuring that they meet stated goals and objectives. Erie successfully 
manages over $11 million in government and private grants by ensuring direct lines of 
communication between its Board of Directors, President and CEO, program and cost center 
directors, development, and finance staff. 
UIC is the site for data management and analysis. No UIC patients will be involved in the 
research. Intervention will not occur at UIC. 
 
6.2  
Design 
This study employs a modified community-based participatory research (CBPR) 
approach.  CBPR involves co-learning about issues of concern, reciprocal transfer of expertise, 
shared decision-making power, and mutual ownership of research products and processes.18 
The proposed study leverages the resources and interests of each partner. Partners share 
control of study design, procedures, and outcomes. Erie will convene a Community Advisory 
Board (CAB), an internal group made up of patients and staff, on an as-needed basis, to advise 
the project team. In addition, the Chicago Asthma Consortium will function as our external 
advisory group.  The Chicago Asthma Consortium Advisory Board will meet twice yearly. Major 
decisions on design, implementation, and dissemination will require approval of the CAB. 
This study is designed as a behavioral randomized controlled trial.  Child/caregiver 
dyads will be recruited and then randomized to one of two arms: CHW home visits, or education 
in the clinic from a certified asthma educator (AE-C).  Intervention will be delivered in the first 
year of the study only.  Data will be collected at baseline, 6, 12-months (post intervention), 18-
months, and 24-months. 
   
 
              
 
 
 
 
6.3. Treatment Arm:  Pediatric Asthma CHW Home Intervention 
The pediatric asthma CHW home intervention is modeled after that of Krieger et.al.19 and 
refined from Project CURA. 
6.3.1 Asthma Home Visit Protocol and Topics: Families will be offered 10 home visits over 12 
months. At the CHW home visits, CHWs will spend 1-2 hours with the family. CHWs will 
educate them on the “core curriculum.” The topics in the core curriculum are standard topics for 
asthma educators and are intended to reduce impairment (prevent chronic symptoms, 
infrequent use of quick relief medications, maintain normal activity levels) and reduce risk 
(prevent exacerbations, minimize emergency care, prevent reduced lung growth, and minimize 
adverse therapy effects).13 The CHWs will approach each visit with the intention to teach one or 
two of the core curriculum topics. Each visit will begin with several minutes of social discussion 
for the purpose of relationship building. Behavior change plans from the previous visit will be 
reviewed and discussed. Behavior change plans are small goals for a specific change over a 
several-week period. Examples include: “getting a prescription from my doctor” or “writing down 
 
    CHW home 
visits 
X 
X 
X 
X 
X 
X 
X 
X 
X 
 
X 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
AE-C clinic 
sessions  
X 
 
 
 
 
X 
 
 
 
  
 
  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Data Collection 
 
 
Data Collection 
 
 
Data Collection 
Month 
1 
2 
3 
4 
5 
6 
7 
8 
9 
10 
11 
12 
13 
14 
15 
16 
17 
18 
19 
20 
21 
22 
23 
24 
 
 
Recruitment and 
baseline data 
collection 
Randomization 

 _____________________________________________________________________________________________  
Asthma Action at Erie Trial 
 Version 11 
Page 10 of 26 
  February 28, 2018 
 
 
when my child coughs”. The main portion of the visit will involve the education session around a 
core curriculum topic. When a CHW notes a barrier in the delivery of the education, he or she 
will then incorporate a relevant self-management skill. For example, the CHW may know that 
the family is not giving a medication as often as prescribed but instead of just saying that, the 
CHW will have the family track how often the child is receiving their medication (self-monitoring).  
The family will “self-discover” they do not give the medicine as often as recommended.  Then 
the CHW will have the family problem solve as to why that might be (storage location, parent 
work schedules, medication fear, etc.). Once they have a list of the problems, the family will 
create a behavior change plan for one problem they want to solve.   
6.3.2 Integrating CHWs in the Clinic: Several of the Erie clinics are quite near each other in the 
Humboldt Park neighborhood. CHWs will be based out of one of these centrally located clinics 
but they will have access to all Erie clinics, computers, and staff. Once a participant is assigned 
to a CHW, the CHW will review the child’s health record. The goal will be to review the child’s 
health with the child’s clinician. Erie clinicians manage pediatric asthma using a detailed asthma 
smart form in the electronic medical record (EMR). They have access to spirometry and other 
support tools through the American Lung Association Enhancing Care for Children with Asthma 
Program. Whenever possible, the clinician will outline his or her concerns and recommendations 
for the patient. If the provider is not available to meet with the CHW, the CHW will proceed with 
the standard home protocol. Then the CHW will meet with the family and determine their 
concerns and expectations. The CHW will fill out a report of the topics covered, behavior 
change plans, and potentially relevant issues after each visit. Summaries of these reports, and 
communications with providers, will be uploaded into the EMR. The clinician and CHW will aim 
to discuss the participant at least two other times during the year and possibly more, depending 
on the needs of the family. CHWs will communicate directly with the behavioral health staff and 
case managers at Erie on an as-needed basis for participants.  
6.3.3 CHW Training for Asthma 
Potential candidates for the CHW positions will be recruited through Erie, community list-serves, 
and word of mouth. Preference will be given to candidates who have been patients at Erie, are 
bilingual in English and Spanish, and have personal experience in their families with asthma. A 
cohort of 12-15 candidates will complete an initial training (Phase 1, see next paragraph) which 
serves several purposes: 1) The training builds community capacity and skills around asthma, 
2) It allows investigators to determine the best candidates for the position, 3) It provides a pool 
of back-up candidates for the future. Dr. Martin has developed a comprehensive asthma CHW 
training curriculum 
(http://cuhe.rush.edu/Cura%202/Pages/CommunityHealthWorkerTraining.aspx) which 
she will conduct in three phases. Phase 1 provides 30 hours of training on asthma basics and 
self-management.  First, the self-management concepts will be taught using popular education 
methods. Asthma concepts are subsequently taught in a similar fashion and then linked with the 
self-management concepts. At the end of training, trainees individually conduct a standardized 
role play and must demonstrate their skills with the asthma medication devices in order to 
determine competency for future intervention delivery. Phase 2 will provide follow-up training for 
the three CHWs chosen for the study. This phase will familiarize the CHWs with the study 
protocol, Erie policies, home visitation strategies, and documentation. Medications and trigger 
remediation will be reinforced through role plays and practical exercises. CHWs will complete 
the 12-hour Mental Health First Aid course (http://www.c4chicago.org/MHFA). Dr. Weinstein 
will then provide a follow-up session to discuss anticipated mental health challenges and how to 
obtain services for their participants. She will also train them in motivational interviewing. They 
will receive training on the Erie electronic medical record (EMR) system.  CHWs will shadow 

 _____________________________________________________________________________________________  
Asthma Action at Erie Trial 
 Version 11 
Page 11 of 26 
  February 28, 2018 
 
 
experienced CHWs on other projects for a minimum of 3 visits and they will shadow Erie 
clinicians for a minimum of 20 hours. Phase 3 is ongoing continual education. CHWs will attend 
local educational seminars (www.chicagoasthma.org) twice a year.  
6.3.4 CHW Supervision 
CHWs are not clinicians and they often struggle with many of the same issues as their clients in 
terms of health problems, children, housing, and poverty. This allows them to intimately 
understand the challenges their clients face and usually translates into strong bonds between 
CHWs and clients, but it sometimes transforms into a tremendous burden when clients struggle 
with serious issues. The CHWs also must deal with the stresses of home visitation (safety, 
cleanliness, hectic households, and poverty). In order for CHWs to successfully perform their 
job, they require adequate supervision and support. Supervision is best conducted using a team 
approach with a group of CHWs in order to facilitate self-discovery and group learning. In this 
trial, CHWs will report directly to the Erie AE-C for day-to-day supervision and support as 
needed. Every two weeks, CHWs and the Erie AE-C will also meet with Dr. Martin and/or Dr. 
Roy for discussion of clinical issues, self-management skills support, and for continuing 
education. Dr. Weinstein or an Erie mental health provider will meet with CHWs once a month to 
discuss mental health issues related to participants or the CHW job and to generate strategies 
for resolution.   
6.4 Comparison Arm:  Clinic-based AE-C Education 
6.4.1 AE-C Training: Most candidates for the AE-C certification have prior experience as an 
asthma educator and therefore require only a preparatory course to pass the certification exam.  
Erie leadership will identify the appropriate candidate for this position. This person will then 
complete a 2-day comprehensive workshop offered in Chicago by the Respiratory Health 
Association (www.lungchicago.org/certified-asthma-educator-training/).  If further training is 
required, an additional online course if available through the American Association of 
Respiratory Care (www.aarc.org/education/asthma_ course). Once this person has passed 
the AE-C certification exam, he/she will complete a subsequent 2-day training with the research 
investigators to familiarize him/her with the intervention expectations and protocol. The AE-C 
may start delivery of intervention before obtaining formal AE-C certification as long as they have 
completed a training course and the study-specific training.  
6.4.2 AE-C Intervention Protocol: The AE-C will receive contact information and have access to 
the clinical chart for participants randomized to the AE-C arm. The AE-C will schedule the 
participant’s family to come in for an educational session in the clinic. At this visit, the AE-C will 
assess and educate on asthma symptoms, control, triggers, medication technique, adherence, 
presence of a written asthma plan, and he/she will address caregiver/child concerns. The AE-C 
will call the family on the telephone in 2-4 weeks to discuss self-monitoring of symptoms and 
medication and answer any questions. The AE-C will schedule the participant’s family again to 
come in for a similar visit at 6-months. A follow-up telephone call will occur 2-4 weeks later. 
6.5 Standard and Research Procedures 
The AE-C is considered “best practice” but is not routine care at Erie due to funding. For this 
study, the AE-C condition is subsidized by the research budget making it a research procedure 
that will not be offered to intervention arm participants. CHW intervention is a research 
procedure. Both interventions will be documented in the medical record; support staff regularly 
document patient encounters in the record, making this standard procedure. The data collection 
is a research procedure. 

 _____________________________________________________________________________________________  
Asthma Action at Erie Trial 
 Version 11 
Page 12 of 26 
  February 28, 2018 
 
 
6.6 Fidelity and Process Measures:  Training: The CHWs will be assessed at the end of the 
trainings using role plays to determine that they have adequate knowledge and intervention 
delivery skills. The AE-C will have passed the National Asthma Education Certification Board 
(NAECB) examination. Delivery: CHWs and the AE-C will complete documentation after every 
encounter to record curriculum topics covered, resources utilized, and issues encountered after 
home and clinic visits. These will be reviewed monthly by unblinded staff to ensure fidelity and 
also to inform the study team on areas of focus and challenge. The data will also be used in 
final analyses to determine “dose” of intervention and to assess the influence of specific 
topics/skills on outcomes. Additionally, CHW and AE-C documentation in the EMR will be 
reviewed quarterly to capture frequency of interactions between clinicians, CHWs and AE-C, 
behavioral health providers, and case management, and the topics covered. Home visits and 
clinic visits will be randomly tape recorded and reviewed by unblinded staff to ensure 
intervention fidelity and accuracy of CHW/AE-C documentation.   
6.7. Retention: Participants will be contacted by UIC research staff monthly to verify contact 
information. We will obtain multiple alternative contacts at the time of enrollment – friends, 
family, or others likely to keep in touch with the participant and know their whereabouts. We can 
also search the clinic records for changes in address or telephone number. Incentive payments 
for data collection aid in retention. The one source that will not be utilized will be the CHWs as 
this approach could lead to differential ascertainment of outcomes between the arms and 
introduce bias into the study. 
6.8. Outcomes:  
6.8.1. General Procedures 
Individual outcomes will be collected in the homes by UIC RS. Results will not be returned to 
participants or their clinicians in order to simulate routine clinical care as much as possible. 
Emergency plans will be implemented if outcomes are in critical ranges. For example, endorsing 
a suicide plan will receive immediate intervention and appropriate referrals.   
6.8.2. Instruments 
The instruments and data domains are in the following table. All instruments have been 
validated, most with official Spanish validations as well. All instruments will have both English 
and Spanish translations. Before the study begins, the RSs will receive training sessions which 
will cover the procedures involved in data collection. The RSs will perform several “test” data 
collections in both English and Spanish, where they will perform data collection with volunteers. 
The data collection process and instruments will be reviewed by study staff and then compared 
to determine intra- and inter-rater reliability. Problems with question accuracy and translations 
will be fixed.  
6.8.3. Salivary Cotinine Protocol: 
The salivary cotinine assay will be performed by staff in the UIC Department of Pediatrics 
laboratory of Dr. Sekhar Reddy and UIC Research Resource Center – Dr. Balaji Ganesh. 
Equipment: bioquant ELIZA assay.  360/kit (96 wells), capped test tubes. 
Procedure:  
1. 
Nothing to drink for 1 hour before 
2. 
Spit into tube (If dry mouth, have them not swallow for a minute and then try.) 
4. 
Need 1 ml  

 _____________________________________________________________________________________________  
Asthma Action at Erie Trial 
 Version 11 
Page 13 of 26 
  February 28, 2018 
 
 
5. 
Cap tube 
6. 
Transport to UIC within 24 hours 
7. 
Store at -20 degrees Celsius until transport to lab for analysis 
 
OUTCOME ASSESSMENTS 
Domain 
Questions 
# of 
items 
Pre-base 
line 
(phone or 
in person) 
0mo 
Base 
line 
6mo 
 
12mo 
18mo 
(phone 
or in 
person) 
24mo 
Screening 
Erie pre-screen 
 
 
 
 
 
 
 
UIC screen 
21,17,10 
 
 
 
 
 
 
Asthma Control 
Activity limitation over 14 days42-43 
1 
 
 
 
 
 
 
ACQ14-17 
6 
 
 
 
 
 
 
cACT/ACT20-24 
5-7 
 
 
 
 
 
 
Oral steroids* 13,20 
1 
 
 
 
 
 
 
Asthma functional severity scale 25 
6 
 
 
 
 
 
 
Asthma  
Medicines 
Caregiver self-report 10 
5 
 
 
 
 
 
 
Child self-report 10 
3 
 
 
 
 
 
 
Observed medicines 10 
2 
 
 
 
 
 
 
Observed technique 10 
11, 12, 10 
 
 
 
 
 
 
Adherence 10 
5 
 
 
 
 
 
 
Triggers 
Home assessment (self-report + 
observed)11,19 
167 
 
 
 
 
 
 
Salivary cotinine11,26 
1 
 
 
 
 
 
 
Health Services  
Utilization 
Urgent care visits* 
1 
 
 
 
 
 
 
Emergency dept visits* 
1 
 
 
 
 
 
 
Hospitalizations* 
1 
 
 
 
 
 
 
Missed school* 
1 
 
 
 
 
 
 
Missed work* 
1 
 
 
 
 
 
 
Demographics 
Height/weight 
2 
 
 
 
 
 
 
Demographics 
27 
 
 
 
 
 
 
Psychosocial 
Caregiver depression PHQ-9 
9 
 
 
 
 
 
 
Child depression (CDI-2 short or parent 
PROMIS parent proxy)27-29 
6 
13 
 
 
 
 
 
 
Perceived Stress Scale 4-item35-37 
4 
 
 
 
 
 
 
Caregiver trauma38-40 
6 
 
 
 
 
 
 
Child trauma PROPS/CROPS41 
26 
 
 
 
 
 
 
Asthma-Related Trauma Event Items 
9 
 
 
 
 
 
 
Social Support PROMIS Scale29-34 
8 
 
 
 
 
 
 
CHAOS 44-45 
15 
 
 
 
 
 
 
Implementation 
Intervention tracking 
19 
 
 
 
 
 
 
 
 
 
 
 

 _____________________________________________________________________________________________  
Asthma Action at Erie Trial 
 Version 11 
Page 14 of 26 
  February 28, 2018 
 
 
 
 
 
6.8.4. Mental Health Protocol: 
Part 1: In the home – Research Specialists 
A mental health services list will be prepared that explains how to get mental health services at 
Erie, as well as other local resources. This will be given to all families. 
The UIC research specialist (RS) will administer all depression and trauma instruments either 
via a computer (handing the computer to the participant to complete) or via a paper version with 
pen/pencil. All instruments will be in the preferred language. They will be instructed to complete 
the questionnaire on their own but they can ask questions.  
The RS will give the caregiver the PHQ-9 and Short Form of the PTSD Checklist - Civilian 
Version. In addition, if the child is unable to complete the CDI-2 Brief, the research specialist will 
give the caregiver the PROMIS Parent Proxy questionnaire. The RS will give the child the CDI2 
Brief and the CROPS. There is no immediate scoring of these instruments. When the participant 
finishes completing the PHQ-9, the RS should check to see if they answered 1, 2, or 3 on 
question 9.  If yes, then implement Suicide Protocol.  
Suicide Protocol: The RS will tell the participant the following statement: “I feel that you may 
need to speak to someone immediately and I am going to make a phone call so that you can 
speak to a professional about how you are feeling.”  The RS will call the National Suicide 
Prevention Lifeline and ask the participant to talk with them: 1-800-273-TALK (8255). If they are 
English-speaking, can call locally 630-482-9696. Wait while participant completes call, but try to 
give privacy. Give hotline card.  Give family mental health services list. If further assistance is 
needed, the RS should do what they feel is appropriate or contact the PI if unsure how to 
proceed.  If participant refuses to talk with the hotline, leave them the mental health services list.  
Call them back 24 hours later to reinforce that we feel they need to contact this number.   
Part 2: After data collection – Research Specialists 
The mental health instruments should be scored within 7 days of collection. The following are 
abnormal scores. If participants score in these ranges, the RS is responsible for trying to call 
back the participant within 24 hours of noting an elevated score using the below script as a 
guide.  The RS must inform Dr. Weinstein of the scoring and action within 24 hours of noting an 
elevated score. 
• 
PHQ-9: >=10   
• 
Short Form of the PTSD Checklist - Civilian Version: If score >= 14,  
• 
CDI2: If the scoring puts the child in the Elevated to Very Elevated range 
 “This is from the Asthma Action at Erie Trial.  I was at your house a few days ago.  Some of the 
information we collected tells us that you have [your child has] been feeling somewhat sad and 
anxious.  Everyone fells sad or anxious sometimes but this usually only lasts a short time.  We 
are concerned that your [your child’s] feelings of sadness and anxiety are lasting too long and 
may be interfering in your [his/her] life.  Sometimes professional help from a counselor or a 
doctor can help a person feel happier about life.  We recommend that you call one of the people 
listed on the mental health services list we gave you. The people there can talk to you more 
about this and get you help if you need it.” 

 _____________________________________________________________________________________________  
Asthma Action at Erie Trial 
 Version 11 
Page 15 of 26 
  February 28, 2018 
 
 
For enrolled children in elevated range: All enrolled children are patients at Erie (see inclusion 
criteria) and therefore qualify for behavioral health services at Erie. If children are already 
receiving behavioral health services per caregiver report, the caregiver should be advised to talk 
with their provider about the results of this screen. If children are not already receiving services, 
the caregiver should be advised to ask at Erie about receiving services. 
For caregivers in the elevated range: If caregivers are patients at Erie, they will be advised to 
seek behavioral health services from Erie. If they are already receiving services, they will be 
advised to talk with their provider about the results of this screen. If they are not patients at Erie, 
they will be referred to other providers on the mental health services list. 
Part 3: Interventionists – AE-C and CHWs 
The AE-C and CHWs will not have access to the mental health screening results and they will 
not conduct formal mental health screening. If they develop concerns for the children or their 
caregivers in regards to mental health, they will encourage them to seek services using the 
mental health services list. If they already receive services, they will encourage them to talk with 
their provider. If the AE-C or CHW has strong concerns regarding an enrolled child, they will 
notify the child’s primary care provider to refer the child to the Erie Behavioral health program. 
6.8.5. Participant and Staff Safety 
Working with CHWs poses multiple unique challenges since the CHWs are lay people that 
interact with participants in their homes. This study proposes the following:   
Mandatory reporting: UIC and Erie staff are mandatory reporters of domestic abuse, child abuse 
and suicidal ideations.  If a CHW or RS witness or suspect any of these situations, they will call 
911 if they have concerns for the immediate safety of the person involved. If they feel safe 
leaving without calling 911 but have suspicions of abuse or suicidal ideation, they will bring the 
concern directly to their supervisor.  The supervisor will review the situation, confer with the PI if 
needed, and determine if the police or Child Protective Services need to be notified.  If the 
supervisor decides the situation requires reporting, the supervisor or PI will perform the 
reporting and also inform the participant of the decision to do so.  This process will be stated in 
the consent form. 
Staff safety: CHWs and RSs will usually visit homes alone but they will always have the option 
of being accompanied by a “sentry” for safety reasons.  If they feel threatened or unsafe, they 
will not enter the home or they will leave the home.  They will then notify the PI or their 
supervisor and home visits for that participant will be suspended until the home is determined to 
be safe.   
Participant safety: Participants will be informed at the start of the study that if they do not feel 
comfortable with their RS or CHW, they can refuse them entrance into their home.  Participants 
will be encouraged to notify the RS or project manager if they are uncomfortable with their RS or 
CHW.  If this occurs, they will be offered the option of changing RSs or CHWs, or withdrawing 
from the study.   
Asthma safety: CHWs and RSs will be trained in the danger signs of asthma:  using albuterol 
inhaler more than every four hours, inability to speak, severe cough, and severe wheeze. If they 
witness a participant with any of these danger signs, they will call 911 or have the participant’s 
family bring them to seek medical attention immediately.  CHWs and RSs will always have 

 _____________________________________________________________________________________________  
Asthma Action at Erie Trial 
 Version 11 
Page 16 of 26 
  February 28, 2018 
 
 
immediate access to a supervisor via cell phone when in the field whom can call if they have 
concerns or questions.   
6.8.6. Missing Data 
Missing data will be dealt with in the analysis. See Section 9. 
 
6.9 Data Management: See Sections 8 and 11. 
 
6.10 Timeline 
 
Year 1 
Year 2 
Year 3 
Year 4 
Year 5 
Instrument/staff preparation 
Recruitment 
CHW initial training 
Baseline data collection 
Active intervention 
6 month partial data collection 
12 month data collection 
Observation period 
18 month data collection 
24 month data collection 
Data analysis 
Manuscript preparation 
 
7.0 
Expected Risks/Benefits 
 
Children and caregivers will be subject to only minimal risks throughout this trial. They 
may include inconvenience or embarrassment involved in completing questionnaires or 
demonstrating self-management skills, or permitting the CHW (or research specialist) to conduct 
home visits for interventions (or for assessments). The caregivers and children will not be 
required to answer any questions (or conduct any part of the study) that they are reluctant to 
discuss/conduct. There is also a risk of loss of confidentiality. The CHWs will not provide 
children or caregivers with any type of medical advice, but will have direct access to health care 
providers to address any child/caregiver clinical questions or concerns. If the CHW is 
accidentally contacted with clinical questions, the CHW will connect the child/caregiver with a 
health care provider familiar with the participant’s medical condition immediately. On enrollment, 
caregivers will be instructed to call their health care provider or seek emergency services in 
case of worsening symptoms, as opposed to directing questions to the CHW. All participants will 
be informed in advance that they may withdraw from the study at any time without negatively 
affecting their medical care or any other benefits they might receive. 
 
We do not know if participants will benefit directly from the research process and we will 
not indicate there is a benefit to participating. One potential benefit is to the communities served 
by Erie Family Health Center. Erie is very connected to the communities they serve. They are 
involved in local schools, events, and organizations. Promotion of research and asthma within 
Erie translates into promotion of research and asthma in the community at large. The support of 
this grant and Erie will increase awareness and visibility for research and asthma. 
 
 
8.0 
Data Collection and Management Procedures 
Data Coordinating Center 

 _____________________________________________________________________________________________  
Asthma Action at Erie Trial 
 Version 11 
Page 17 of 26 
  February 28, 2018 
 
 
Data management for this project will be provided by the Data Coordinating Center (DCC), 
which is comprised of staff and investigators from the Methodology Research Core in the 
Institute for Health Research and Policy at UIC. The DCC also serves as the Design and 
Analysis Core of the University of Illinois at Chicago Center for Clinical and Translational 
Science (CCTS) which is supposed by NIH funding through a Clinical and Translational Science 
Award as well as strong institutional commitment. The DCC has extensive experience in the 
acquisition, maintenance, and analysis of both large and small clinical trial databases. It is 
directed by Michael Berbaum who is a co-investigator on this proposal. The DCC faculty and 
staff are located in same offices as the other UIC investigators. Specific activities of the DCC 
include: collaborating with the study team to develop a comprehensive, yet efficient, set of case 
report forms to capture participant data, developing web and direct data capture systems, 
processing data, implementing and maintaining an effective study database and its associated 
query system, maintaining a computer environment sophisticated enough to efficiently, 
effectively, and securely manage the study database, and developing regular reports as to the 
accuracy and completeness of the study database, participant follow-up, and intervention 
delivery.  The DCC is part of the research team which supports the ready exchange of any 
needed resources. The DCC will also implement the randomization processes. Access to 
randomization assignment data will be limited to pertinent DCC staff, intervention staff, and 
investigators as needed. Outcomes assessors are to remain blind to study arm.  
Data acquisition and maintenance 
All interviewer administered questionnaire data will be collected on computers (by outcomes 
assessors and CHWs) with the possible exception of the mental health instruments. The mental 
health instruments are to be self-administered for privacy; families will be offered the computer 
but they will be collected on paper case report forms if caregivers and/or children are 
uncomfortable answering the questions on the computers. Electronic data collected in the field 
will be on encrypted computers (see below). Paper forms will be transported to the Institute for 
Health Research and Policy where outcomes assessors will enter them into the computer data 
collection program and then store the paper forms in a locked storage cabinet.  
All data will be kept confidential, and no subject will be identifiable from research records or 
published data. We will employ procedures used in other studies to maintain anonymity. All 
identifying information will be removed from the provider self-report data and all data sheets will 
be coded with ID numbers only. Tracking information will be stored separately from data files, 
and access to tracking information will be limited to the PI and research staff. The master list of 
ID code numbers and corresponding names will be kept in a locked file cabinet or in a password 
protected file on an internal server, with close scrutiny of access maintained by the PI. The 
master list is used only to coordinate data collection.  
Data will be entered using REDCap (Research Electronic Data Capture). REDCap is a secure, 
web-based application for building and managing online databases for the collection and entry 
of research data. It is a valuable resource that allows for the creation of web-based databases 
quickly and securely, with special features like ad-hoc reporting and scheduling. It is fast and 
flexible with an easy to use design environment to create data capture forms. The program was 
developed by staff at Vanderbilt University in 2004 in order to help researchers manage data for 
small/medium sized projects in a systematic manner (metadata defined, secure, audit trails, 

 _____________________________________________________________________________________________  
Asthma Action at Erie Trial 
 Version 11 
Page 18 of 26 
  February 28, 2018 
 
 
etc). The system is continually updated and enhanced by the Project REDCap team at 
Vanderbilt. REDCap is maintained by the staff in the DCC.  
REDCap is designed to minimize data errors. The DCC will develop quality assurance checks 
that will be implemented at the time data are entered as an assurance of data accuracy.  
Erroneous and/or inconsistent values will prompt generation of an entry to a query report that 
will be developed for this study.  Query reports will be generated weekly and distributed to study 
staff for resolution.  Once generated, a query will remain part of the weekly report until it is 
resolved.  
The RedCap Survey website and database is hosted by the Institute for Health Research and 
Policy (IHRP). RedCap is an IRB approved web data collection tool. The REDCap server is 
behind a firewall, has virus protection, uses Secure Socket Layer authentication to encrypt 
communication between a user and the server, and has been configured to meet campus 
HIPPA rules. This means that the Internet connection between a user’s browser and REDCap is 
encrypted, but REDCap is not encrypted on the server on which it resides, nor is any data 
downloaded and saved to a computer or other storage device encrypted unless a user takes 
steps to encrypt the stored file using third party software.  All data collected through RedCap is 
stored on a secured MySQL database server. The database server does not have an externally 
translatable IP address and access to the server is controlled by Microsoft Active Directory. 
Permission controls and passwords will assure that only authorized personnel will have the 
ability to access study data.  Account creation to the Redcap web server is managed by the 
Center for Clinical and Translational Sciences, project access is controlled by the project 
manager. The DCC will work with study staff to ensure accurate transfer of data to the DCC.   
Additional data collection procedures are described in Section 6.8. Data instruments are in the 
table in Section 6.8. Biologic specimens (saliva) will be stored in a freezer at UIC until they are 
sent to the allergy lab for analysis. After analysis, the samples will be destroyed.  
 
9.0 
Data Analysis 
 
All analyses will be performed by the investigators and analysts in the Institute for Health 
Research and Policy using SAS version 9.4. We will compare key population descriptors in the 
two treatment groups as patient recruitment progresses (at N=100 and N=150) to ensure that 
the randomization process is achieving reasonable balance, being careful to protect operational 
staff from bias. Basic summary statistics will be calculated for outcome variables and covariates. 
Continuous variables will be assessed for normality using Q-Q plots and compared using 2-
sample t-tests. If distributions are sufficiently non-normal, then a suitable transformation or non-
parametric test will be used. Categorical variables will be compared using chi-square tests. 
Significance tests will be two-sided at level α=0.05.  
Specific Aim 1: To assess the efficacy of the integrated CHW home asthma intervention 
relative to the AE-C intervention at 12-months post-randomization as demonstrated by asthma 
control. This study will employ two primary measures of asthma control: number of days with 
activity limitation over the previous 14 days and the Asthma Control Test/childhood Asthma 
Control Test (ACT/cACT). The mean total number of days with activity limitation over the 
previous 14-day period will be assessed at 12-months between the two treatment arms using 
the two-sample t-test or Mann-Whitney test. If the mean days with activity limitation in the 
intervention arm is at least 30% lower than that of the AE-C arm and p < 0.05, we will conclude 
that the CHW intervention is more effective. The ACT/cACT will be analyzed using similar 
methods; a MID of 0.2 will be used to determine intervention efficacy. Linear mixed models will 

 _____________________________________________________________________________________________  
Asthma Action at Erie Trial 
 Version 11 
Page 19 of 26 
  February 28, 2018 
 
 
then be employed to analyze primary outcomes at twelve months. To test the CHW 
intervention's efficacy on these outcomes, we will first conduct per protocol analyses limited to 
those patients who received CHW intervention. We will correct potential selection bias by 
including covariates found to be differentially related to nonadherence. Under the missing at 
random (MAR) assumption, this ensures unbiased estimates from linear mixed models. 
Additionally, to test the intervention's effectiveness in clinical practice we will conduct intention-
to-treat analyses that include outcomes for all patients randomized. Nonadherent and other 
subgroups of patients can be expected to exhibit differentially higher rates of missing data. We 
will therefore examine the sensitivity of inferences to multiple imputation rule using the SAS 
macros of Little and Yau (1996), including last observation carried forward (LOCF), return to 
baseline, and continuing on apparent trajectory. The fixed-effects part of the model will be 
Daysij= β0 + β1Timeij + β2Txi + β3(Txi*Timeij) + εij, for subject i at visit j. Candidate covariance 
structures will be assessed using the data’s correlation structure and Akaike’s Information 
Criterion (AIC). A random intercept will be included in the model if it significantly improves the 
model fit as determined by the likelihood ratio test. Standardized residuals and Cook’s distance 
will be used to assess the influence of outliers and individual observations and residual plots will 
be used to check the multivariate normal distribution assumption. These analyses will be 
conducted in SAS PROC MIXED (and PROC GLIMMIX for categorical outcomes), and will be 
followed by an exploratory variable selection analysis in PROC GLMSELECT. Potentially 
confounding covariates will be considered for model inclusion using the least absolute shrinkage 
and selection operator (LASSO) model selection method. This method identifies a significant 
subgroup of covariates that will form a more parsimonious model. The LASSO method avoids 
problems typically encountered using stepwise procedures. To accommodate potential age-
specific effects, heterogeneity of treatment effects by age will be examined as an exploratory 
analysis. 
Specific Aim 2: To assess maintenance of intervention efficacy, at 18 and 24 months after 
randomization. The asthma control measures will be compared between the two treatment 
groups at 18- and 24-months post-randomization as described above for Specific Aim 1. An 
indicator variable, to be named “Phase”, will be added to the models to allow distinction 
between the time during intervention periods. The model will be: Yit = β0 + β1Timeij + β2Txi + 
β3(Txi * Timeij) + γ1Phasej * (Timeij – 12) + γ2Txi * Phasej * (Timeij – 12) + ϵij. We will conclude 
that any intervention effect is sustained if the slope for γ2Time after 12-months continues to be 
positive in the CHW arm. 
Specific Aim 3 compares the costs and cost effectiveness of the interventions.  The analysis 
will be conducted from the societal perspective, including the costs borne by the program, 
individual participant and family, and healthcare system. 1) Cost and resource use information 
will be collected for the program, participant, and healthcare utilization. 2) Efficacy will be 
measured as asthma control as described for Specific Aim 1. 3) Cost effectiveness will be 
evaluated by combining the mean total cost per participant with change in asthma control. We 
will calculate the ICER for the CHW home intervention compared to AE-C services, such that 
ICERt = (C1 – C0) / (E1t – E0t), where C is cost and E is effectiveness. Subscript 1 denotes CHW 
home intervention and subscript 0 denotes usual asthma care. t denotes the time period: 12 
months, 18 months and 24 months. 95% confidence intervals for the ICERs will be calculated to 
evaluate the uncertainty in these results. 4)  We will conduct one-way and multi-way sensitivity 
analyses for the key parameters to evaluate whether the ICERs are sensitive to plausible 
changes in their values. The sensitivity analysis is a check on the robustness and will determine 
the key parameters impacting the ICERs. 

 _____________________________________________________________________________________________  
Asthma Action at Erie Trial 
 Version 11 
Page 20 of 26 
  February 28, 2018 
 
 
Specific Aim 4: To assess the efficacy of the integrated CHW home asthma intervention 
among those experiencing depression, stress, and/or PTSD. Interaction terms between 
treatment indicators for depression, stress, and PTSD will be examined to test for heterogeneity 
of treatment effects.  
 
10.0 
Quality Control and Quality Assurance 
Intervention fidelity procedures are described in Section 6.6. The MRC will develop quality 
assurance checks that will be implemented at the time data are entered as an assurance of data 
accuracy.  Erroneous and/or inconsistent values will prompt generation of an entry to a query 
report that will be developed for this study.  Query reports will be generated weekly and 
distributed to study staff for resolution.  Once generated, a query will remain part of the weekly 
report until it is resolved.   
 
11.0 
Data and Safety Monitoring 
11.1. Data Safety Monitoring Board 
A Data Safety Monitoring Board (DSMB) has been created to provide oversight for the proposed 
trial. We have a 6 member DSMB.  At its first meeting, the DSMB elected one of the members to 
serve as the Chair and another to serve as Executive Secretary. DSMB members and their 
expertise are as follows: 
- 
Marissa Feldman, PhD; Medical Psychologist, Ann & Robert H. Lurie Children’s 
Hospital of Chicago (health psychologist)  
- 
Saria Awadalla, PhD: University of Illinois at the School of Public Health 
(Biostatistician)  
- 
Brad Appelhans, PhD, Associate Professor, Rush University Medical Center 
(behavioral intervention researcher and health psychologist) 
- 
Kameron Matthews, MD, JD; Chief Medical Officer, Mile Square Health Center 
(federally-qualified health center administrator) 
- 
Geisel Collazo, MD, Mile Square Health Center (community pediatrician)  
- 
Cortland Lohff, MD, Medical Director, Public Health and Safety Division, Department 
of Public Health, City of Chicago, Illinois (local health expert) 
 
The data management team will report directly to the DSMB chairperson at their request 
or every 12 months. The DSMB will make an affirmative decision at each meeting whether to 
continue or terminate the study. Early termination is an option for the DSMB, particularly if there 
are serious concerns about patient safety or there is evidence of futility or sufficient evidence of 
efficacy; decisions regarding early termination will be made by the DSMB. No interim analyses 
of outcomes for efficacy or futility are planned. In general, the DSMB will be provided data 
grouped by treatment without identified treatment groups (i.e., masked to treatment 
assignment). If the DSMB requests, for the purpose of competent deliberation, to see the 
treatment assignments (by group or individual), these will be provided by the lead biostatistician. 
The investigators will remain masked to the treatment assignments of individual patients unless 
it is judged that it is in the best interests of an individual patient. 
11.2. Adverse events (AEs) and Unanticipated Problems (UPs) 
The Data Coordinating Center (DCC) will work with study staff to monitor any AEs and UPs that 
occur among participants of the proposed study. The two primary risks are: 1) confidentiality 
(protection of data, especially sensitive data collected in home); and 2) mental health risk (not 

 _____________________________________________________________________________________________  
Asthma Action at Erie Trial 
 Version 11 
Page 21 of 26 
  February 28, 2018 
 
 
from the intervention, but assessments query for risks of harm to self or others). Confidentiality 
risks are managed by the procedures described in Data Acquisition and Maintenance Section. 
Mental health risks are managed as indicated on the Mental Health Protocol (See section 
6.8.4).Adverse events will be reported immediately to the Safety Officer (Dr. Mosnaim).  When 
indicated, the Safety Officer will inform the Principal Investigator, IRB, DSMB, Compliance 
Office, and/or NIH.  Action to protect participant safety and privacy will be taken. Serious and 
non-serious AEs will be reported by the Principal Investigator to the IRB and NHLBI within 14 
calendar days of initial receipt of information.   UPs that are not serious AEs will be reported by 
the Principal Investigator to the IRB and NHLBI within 14 calendar days of when the investigator 
becomes aware of the problem. 
11.3. Data Management  
Data management for this project will be provided by the Methodology Research Core (MRC) in 
the Institute for Health Research and Policy at UIC. The MRC also serves as the Design and 
Analysis Core of the University of Illinois at Chicago Center for Clinical and Translational 
Science (CCTS) which is supported by NIH funding through a Clinical and Translational Science 
Award as well as strong institutional commitment. The MRC has extensive experience in the 
acquisition, maintenance, and analysis of both large and small clinical trial databases. It is 
directed by Michael Berbaum who is a co-investigator on this proposal. The MRC faculty and 
staff are located in same offices as the other UIC investigators. Specific activities of the MRC 
include: collaborating with the study team to develop a comprehensive, yet efficient, set of case 
report forms to capture participant data, developing web and direct data capture systems, 
processing data, implementing and maintaining an effective study database and its associated 
query system, maintaining a computer environment sophisticated enough to efficiently, 
effectively, and securely manage the study database, and developing regular reports as to the 
accuracy and completeness of the study database, participant follow-up, and intervention 
delivery.  The MRC is part of the research team which supports the ready exchange of any 
needed resources. The MRC will also implement the randomization processes. Access to 
randomization assignment data will be limited to pertinent MRC staff (who have no interaction 
with participants) and designated study personnel who are responsible for ensuring participant 
safety. 
11.4. Data Storage 
See Section 8.0. 
11.5 Data Release 
A well-documented and appropriately accessible archive of study data is an important resource 
that will result from this study. The research team recognizes the need to share final data from 
the study with the larger scientific community.  The Asthma Action at Erie Trial recognizes the 
requirements of data sharing set forth by the NIH. Three years after the end of clinical activity or 
two years after the main paper of the trial has been published (whichever comes first), data will 
be publically released. Data sets from the Trial will be stripped of all protected personal health 
information (PHI) to allow sharing of data without compromising participant confidentiality, 
privacy, and safety.  All identification covered under HIPAA will be removed.  All remaining 
variables not covered under HIPAA will be evaluated in terms of the risk of deductive disclosure 
of identity, and appropriate measures will be taken to protect confidentiality. The striped data, in 
partnership with the community clinical partner, will be sent to the NIH Program Officer for public 
release. In order to ensure responsible usage of study data, user registration will be required in 
order to access or download data files.  Registered users will receive technical assistance with 

 _____________________________________________________________________________________________  
Asthma Action at Erie Trial 
 Version 11 
Page 22 of 26 
  February 28, 2018 
 
 
questions or problems from the Methodology Research Core at the University of Illinois at 
Chicago’s Institute for Health Research and Policy.  A data sharing agreement will be required 
that will describe the conditions and restrictions of their use; limited data access will be made 
available only to users who successfully complete a rigorous approval process by both the 
investigators and the community partners.  Data sets will be encrypted for transfer to approved 
investigators. 
 
12.0 
Statistical Considerations 
Statistical analysis is described in Section 9.0. The sample size for the study was determined to 
allow assessment of the relative efficacy of the proposed interventions with respect to asthma 
control. While a strong clinical definition of asthma control has been in place for some time, 
there is no gold standard for assessing asthma control. The Asthma Control Questionnaire 
(ACQ) has been validated in diverse, large samples but currently there is an absence of 
substantive data on this test (data such as variability and reasonable effect sizes within this 
target population) upon which statistical power and sample size estimates can be based. 
Therefore we have conducted two calculations to ensure adequate power. Using the ACQ, a 
sample size of 100 per group (total N=200) had power 0.87 to detect the minimally important 
difference (MID) of 0.5 established for this test.14 We performed a separate power calculation 
using number of days with activity limitation (over the past 14-days) as Zeiger et al.42 found 
“activity limitation” to be a strong determinant of the composite asthma control score. In a multi-
site inner-city (including Chicago) randomized trial of a home CHW asthma intervention, Morgan 
et al. reported activity limitations over the previous 14 day period.43 Based on their data, we 
hypothesize a mean of 3.9 “activity limitation” days at baseline in both groups (SE 0.22) and, in 
the AE-C comparison group, a mean at 12 months of 2.84 days (SE 0.10). We anticipate the 
proposed CHW intervention will be more potent than that tested by Morgan et al. because it 
involves a higher dose and more physician involvement. Within the proposed CHW home 
intervention group, we anticipate a mean of 2 “activity limitation” days over a 14-day period at 12 
months (SE 0.10), representing a 30% reduction from the AE-C comparison group (and 50% 
reduction from the baseline mean). Further assuming an attrition rate of 15% and 80% power, 
the standard two-group t-test for comparing means (at 12 months) requires a sample size of 
about 111 per group, for a total of 223 participants. Analyses to examine heterogeneity of 
treatment effects by age, race, or other groups have more limited power but results will be 
considered suggestive for further research. 
 
13.0 
Regulatory Requirements 
 
13.1 
Informed Consent  
Written informed consent will be obtained by UIC RS from caregivers in the home 
before randomization. Before signing the consent, the RS will review the entire 
document and study protocol. They will answer all questions and ensure the caregiver 
understands the protocol and consent document. The RS will be bilingual in English and 
Spanish and all documents will be available in both languages. The protocol for informed 
consent for Spanish-speakers is the same therefore as for English-speakers.  
Assent will be obtained from all children capable of reading and understanding 
the written assent document. The RS will explain the study protocol using the assent 
document to ensure the child understands what the document says and what the 
protocol entails. The caregiver will be present during this process. 

 _____________________________________________________________________________________________  
Asthma Action at Erie Trial 
 Version 11 
Page 23 of 26 
  February 28, 2018 
 
 
The RS will complete human subjects training using the online Citi course at UIC. 
They will practice obtaining informed consent with volunteers/study staff under the 
observation of the project manager and/or investigators unless mastery of the process is 
confirmed.  
Signed informed consent/assent documents will be stored in locked cabinets in 
the Institute for Health Research and Policy. The RS, the project manager, and the PI 
will have access to the documents.  
 
13.2 
Subject Confidentiality  
Details for study access, data storage, and data release are described in Sections 8.0, 
11.3, and 11.5. These procedures will ensure subject confidentiality will be maintained. 
No Certificates of Confidentiality will be required. 
 
14.0 
References 
 
1. Lara M, Akinbami L, Flores G, Morgenstern H. Heterogeneity of childhood asthma among 
Hispanic children: Puerto Rican children bear a disproportionate burden. Pediatrics. 
2006;117(1):43-53. 
2.  Moorman JE, Akinbami LJ, Bailey CM, et al. National Surveillance of Asthma: United States, 
2001–2010. National Center for Health Statistics. Vital Health Stat 3(35). 2012. 
3.  Canino G, McQuaid EL, Rand CS. Addressing asthma health disparities: a multilevel 
challenge. J Allergy Clin Immunol.  2009;123(6):1209-17 
4.  Canino G, McQuaid EL, Alvarez M, Colon A, Esteban C, Febo V, Klein RB, Mitchell DK, 
Kopel SJ, Montealegre F, Ortega AN, Rodriguez-Santana J, Seifer R, Fritz GK.  Issues and 
methods in disparities research: the Rhode Island-Puerto Rico asthma center. Pediatr 
Pulmonol. 2009;44(9):899-908. 
5.  Whitman S, Williams C, Shah A. Sinai health system's community health survey:  Report 1. 
Chicago, IL: Sinai Health System; 2004. 
6.  Postma J, Karr C, Kieckhefer G.  Community health workers and environmental interventions 
for children with asthma: a systematic review.  J Asthma. 2009;46(6):564-76. 
7.  Viswanathan M, Kraschnewski J, Nishikawa B, Morgan LC, Thieda P, Honeycutt A, Lohr KN, 
Jonas D. Outcomes of Community Health Worker Interventions. Evidence Report/Technology 
Assessment No. 181 (Prepared by the RTI International–University of North Carolina Evidence-
based Practice Center under Contract No. 290 2007 10056 I.) AHRQ Publication No. 09-E014. 
Rockville, MD: Agency for Healthcare Research and Quality. June 2009.   
8.  Viswanathan M, Kraschnewski JL, Nishikawa B, Morgan LC, Honeycutt AA, Thieda P, Lohr 
KN, Jonas DE.  Outcomes and costs of community health worker interventions: a systematic 
review.  Med Care. 2010 Sep;48(9):792-808. 
9.  Krieger JW, Philby ML, Brooks MZ.  Better home visits for asthma lessons learned from the 
Seattle-King County Asthma Program. Am J Prev Med. 2011;41(2 Suppl 1):S48-51.   

 _____________________________________________________________________________________________  
Asthma Action at Erie Trial 
 Version 11 
Page 24 of 26 
  February 28, 2018 
 
 
10.  Martin MA, Olson D, Mosnaim GS, Ortega DA, Rothschild SK.  Recruitment, Asthma 
Characteristics, and Medication Behaviors in Midwest Puerto Rican Youth: Data from Project 
CURA.  Ann Allergy Asthma Immunol. 2012;109:121-127.   
11.  Martin MA, Thomas AM, Mosnaim GS, Greve M, Swider SM, Rothschild SK.  Home 
Asthma Triggers: Barriers to Asthma Control in Chicago Puerto Rican Children.  J Health Care 
Poor Underserved.  2013 May;24(2):813-27.  
12. Martin MA, Mosnaim GS, Olson D, Swider S, Karavolos K, Rothschild S. Results from a 
community-based trial testing a community health worker asthma intervention in Puerto Rican 
youth in Chicago. Journal of Asthma. 2014 Aug 27:1-12.  
13. National Heart, Lung, and Blood Institute. Expert Panel Report 3. Guidelines for Diagnosis 
and Management of Asthma.  National Asthma Education and Prevention Program, 2007. 
Available from: www.nhlbi.nih.gov/guidelines/asthma. Accessed 6/24/14. 
14. Juniper EF, Gruffydd-Jones K, Ward S, Svensson K. Asthma Control Questionnaire in 
children: validation, measurement properties, interpretation. Eur Respir J. 2010;36(6):1410-6. 
15. Juniper EF, Svensson K, Mork AC, Stahl E. Measurement properties and interpretation of 
three shortened versions of the asthma control questionnaire. Resp Med. 2005;99:553–558. 
16. Nguyen JM, Holbrook JT, Wei CY, Gerald LB, Teague WG, Wise RA; on behalf of the 
American Lung Association Asthma Clinical Research Centers. Validation and psychometric 
properties of the Asthma Control Questionnaire among children. J Allergy Clin Immunol. 2013 
Aug 6. [Epub ahead of print] 
17. Picado C, Badiola C, Perulero N, Sastre J, Olaguíbel JM, López Viña A, Vega JM; Covalair 
Investigator Group.  Validation of the Spanish version of the Asthma Control Questionnaire. Clin 
Ther. 2008 Oct;30(10):1918-31 
18. Viswanathan M, Ammerman A, Eng E, Gartlehner G, et al.  Community-based participatory 
research:  Assessing the evidence.  Evidence Report/Technology Assessment No. 99 
(Prepared by RTI-University of North Carolina Evidence-based Practice Center under Contract 
No. 290-02-0016).  AHRQ Publication 04-E022-2.  Rockville, MD: Agency for Healthcare 
Research and Quality.  July 2004.   
19. Krieger JW, Takaro TK, Song L, Weaver M. The Seattle-King County Healthy Homes 
Project: A randomized, controlled trial of a community health worker intervention to decrease 
exposure to indoor asthma triggers. Am J Public Health. 2005;95(4):652-9. 
20.  Cloutier MM, Schatz M, Castro M, Clark N, Kelly HW, Mangione-Smith R, Sheller J, 
Sorkness C, Stoloff S, Gergen P.  Asthma outcomes: composite scores of asthma control.  J 
Allergy Clin Immunol. 2012;129(3 Suppl):S24-33. 
21.   Vega JM, Badia X, Badiola C, López-Viña A, Olaguíbel JM, Picado C, Sastre J, Dal-Ré R. 
Validation of the Spanish version of the Asthma Control Test (ACT). J Asthma.  
2007;44(10):867-72. 
22. Schatz M, Sorkness CA, Li JT, Marcus P, Murray JJ, Nathan RA, Kosinski M, Pendergraft 
TB, Jhingran P. Asthma control test: Reliability, validity, and responsiveness in patients not 
previously followed by asthma specialists. J Allergy Clin Immunol. 2006;117(3):549-56. 

 _____________________________________________________________________________________________  
Asthma Action at Erie Trial 
 Version 11 
Page 25 of 26 
  February 28, 2018 
 
 
23. Liu AH, Zeiger R, Sorkness C, Mahr T, Ostrom N, Burgess S, Rosenzweig JC, Manjunath R. 
Development and cross-sectional validation of the Childhood Asthma Control Test. J Allergy 
Clin Immunol. 2007;119(4):817-25. 
24. Rodríguez-Martínez CE, Melo-Rojas A, Restrepo-Gualteros SM, Sossa-Briceño MP, Nino 
G. Validation of the Spanish version of the childhood asthma control test (cACT) in a population 
of Hispanic children. J Asthma. 2014 Oct;51(8):855-62. 
25. Rosier MJ, Bishop J, Nolan T, Robertson CF, Carlin JB, Phelan PD.  Measurement of 
functional severity of asthma in children. Am J Respir Crit Care Med  1994;149:1434-1441.  
26.  Kumar R, Curtis LM, Khiani S, Moy J, Shalowitz MU, Sharp L, Durazo-Arvizu RA, Shannon 
JJ, Weiss KB.  A community-based study of tobacco smoke exposure among inner-city children 
with asthma in Chicago. J Allergy Clin Immunol. 2008;122(4):754-759. 
27.  Kroenke K, Spitzer RL. The PHQ-9: A new depression diagnostic and severity measure. 
Psychiatric Annals. 2002;32(9):509-15. 
28.  Kovas M. 2003.Children’s depression inventory (CDI): Technical manual update. North 
Tonawanda, NY: Multi-health systems.  
29. http://www.assessmentcenter.net/documents/InstrumentLibrary.pdf 
30. Pilkonis PA, et al; PROMIS Cooperative Group. Item banks for measuring emotional 
distress from the Patient-Reported Outcomes Measurement Information System (PROMIS®): 
depression, anxiety, and anger. Assessment. 2011 Sep;18(3):263-83. 
31. Hahn EA, et al. New English and Spanish social health measures will facilitate evaluating 
health determinants. Health Psychology. 2014; May;33(5):490-9. 
32. Ross A, et al. National survey of yoga practitioners: Mental and physical health benefits. 
Complementary Therapies in Medicine. 2013; 21(4), 313-23.  
33. http://www.nihpromis.org/measures/translations 
34. http://www.nihpromis.org/Documents/PROMISStandards_Vers2.0_Final.pdf? 
AspxAutoDetectCookieSupport=1 
35. Cohen, S; Kamarck T, Mermelstein R. A global measure of perceived stress. J Health Soc 
Behav. 1983; 24(4):385–396.  
36. Lee EH. Review of the psychometric evidence of the Perceived Stress Scale. Asian Nursing 
Research. 2012;6:121-127. 
37. Gonzalez Ramirez MT, Landero Hernandez R.  Factor Structure of the Perceived Stress 
Scale (PSS) in a Sample from Mexico. Span J Psychol.  2007;10:199-206. 
38. Lang AJ, Stein MB. An abbreviated PTSD checklist for use as a screening instrument in 
primary care. Behav Res Ther. 2005;43(5):585-94. 
39. Miles JN, Marshall GN, Schell TL. Spanish and English versions of the PTSD Checklist - 
Civilian Version (PCL-C): Testing for differential item functioning.  J Trauma Stress. 
2008;21(4):369-76. 
40. Marshall GN. Posttraumatic stress disorder symptom checklist: Factor structure and 
English-Spanish measurement invariance. J Trauma Stress. 2004;17(3):223-23 

 _____________________________________________________________________________________________  
Asthma Action at Erie Trial 
 Version 11 
Page 26 of 26 
  February 28, 2018 
 
 
41. Ziegler MF, Greenwald MH, DeGuzman MA, Simon HK. Posttraumatic stress responses in 
children: awareness and practice among a sample of pediatric emergency care 
providers.Pediatrics. 2005 May;115(5):1261-7. 
42. Zeiger RS, Yegin A, Simons FE, Haselkorn T, Rasouliyan L, Szefler SJ, Chipps BE; TENOR 
Study Group.  Evaluation of the National Heart, Lung, and Blood Institute guidelines impairment 
domain for classifying asthma control and predicting asthma exacerbations.  Ann Allergy 
Asthma Immunol. 2012;108(2):81-7. 
43. Morgan WJ, Crain EF, Gruchalla RS, O'Connor GT, Kattan M, Evans R 3rd, Stout J, 
Malindzak G, Smartt E, Plaut M, Walter M, Vaughn B, Mitchell H; Inner-City Asthma Study 
Group.  Results of a home-based environmental intervention among urban children with 
asthma.  N Engl J Med. 2004;351(11):1068-80. 
44. Matheny A, Wachs T, Ludwig J, Phillips K. Bringing order out of chaos: psychometric 
characteristics of Confusion, Hubbub and Order Scale. J Appl Dev Psychol. 1995;16:429-444.   
45. Dumas JE, Nissley J, Nordstrom A, Phillips Smith E, Prinz RJ, Levine DW. Home chaos: 
Sociodemographic, parenting, interactional, and child correlates. Journal of Clinical Child and 
Adolescent Psychology. 2005;34:93–104.