iTRACC (Improving Technology-Assisted Recording of Asthma Control in Children)
Phase: NA
Conditions: Asthma
Sponsor: Dr. Deneen Vojta

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Title of Project: iTRACC (Improving Technology-Assisted Recording of Asthma Control in Children) 
 
Principal Investigator: Ruchi Gupta, MD MPH 
Co-Investigator: Deneen Vojta, MD 
Co-Investigator: Mary Nevin, MD  
Co-Investigator: Waheeda Samady, MD 
Research Manager: Kathy Boon, MPH 
 
Background 
Asthma Epidemiology 
An estimated 8-10% of children under 18 years of age in the United States (6.3 million) have 
asthma, although the actual number of children affected is probably higher, as pediatric asthma is often 
under diagnosed and/or underreported.1,2 It has been shown that the prevalence of asthma is higher 
among children living in urban inner-city environments, children with low socioeconomic status, and 
children with poor access to primary care.3  In Chicago, prevalence of asthma is substantially higher, with 
13.9% of children living with asthma.4,5 Furthermore, the distribution of asthma in Chicago is highly 
variable by neighborhood ranging from 2% in some neighborhoods to 44% in others.4 Asthma rates also 
vary by race in Chicago, with rates among Africa Americans (21.2%) roughly double those of Whites 
(9.7%) and Hispanics (11.8%).6 Children affected by asthma may have impaired health-related quality of 
life, frequent emergency hospitalizations and school absences, and even death if the disease is not 
managed appropriately.7  In addition to emergency department visits, children with asthma are at 
increased risk of inpatient hospitalization. Asthma is the third-ranking cause of hospitalizations, with 
more than 200,000 per year,8 for children under 15 years of age9 and is the cause of almost 5 million 
doctor visits.8 The estimated total annual cost for treating asthma is $56 billion.10 This huge cost affects 
not only hospitals but insurers and families as well, as the average cost per child is $1,042.11 
Furthermore, there are other costs to families, such as the indirect costs of decreased productivity and 
reduced quality of life among both asthmatic children and their parents.12 Reducing unnecessary costs 
associated with poorly-controlled asthma is therefore essential to having a significant financial impact 
on both the healthcare system and affected families. 
Asthma Management 
For most children with asthma a cornerstone of asthma management is daily use of inhaled 
corticosteroids (ICS) to prevent exacerbations. Regular use of these “controller” medications, as 
prescribed, have been demonstrated to reduce airway inflammation and improve asthma outcomes.13 
However, adherence to these preventive therapies has been repeatedly demonstrated to be suboptimal 
which has led to reduced asthma control in pediatric populations.14-16 A landmark study in the New 
England Journal of Medicine found that regular use of controller meds by asthma patients ages 5-44 
may reduce asthma-related hospitalization risk by up to 80% and that a patient’s risk of death is reduced 
21% for each ICS canister used in the prior year.16 Evidence suggests that Short-acting Beta Antagonist 
(SABA) “rescue” medications typically prescribed as-needed to patients for treatment of exacerbations, 
are also occasionally not used as prescribed, leading to suboptimal outcomes.18  
Most children between 4 and 17 years of age rely on their parents or caregivers for the 
management of their asthma. Besides ensuring their child’s asthma therapies are administered as 
prescribed, successful asthma management entails knowledge and avoidance of asthma triggers, 
establishment of an asthma action plan, and the ability to reference it effectively in the event of an 
exacerbation.20 This management is often multidimensional, involving the interaction of family, 
healthcare, and school systems,21 with the family system having the largest influence on daily asthma 
management decisions. It may be significantly difficult for families to acquire management skills and 
adhere to treatment plans, depending on the severity of their child’s asthma.22, 23 One study found that 

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caregivers who report their child’s asthma as more burdensome may find it more difficult to effectively 
manage, which may in turn increase the risk of unnecessary asthma-related emergency department (ED) 
visits.24 
Technology 
In recent years, advances in health technology have facilitated the development of various 
electronic monitoring devices, which aim to improve asthma control by providing objective, detailed, 
and accurate information about day-to-day patient adherence.25 Propeller Health utilizes telehealth 
concepts, including an FDA-approved sensor, mobile apps, predictive analytics, and feedback to help 
patients and providers better manage asthma.26,27 The sensor monitors the use of inhaled medications 
(both rescue inhaler and controller inhaled corticosteroid), capturing the date, time, and number of 
uses. The sensor transmits this information via Bluetooth to a paired smartphone or hub and securely 
uploads all data to the cloud. Location data is captured if the sensor is connected and within range to 
the smartphone at the time the sensor is used. Data is transmitted back to the caregiver’s smartphone 
app or to a web portal and to the their physician and care team to help facilitate improved asthma 
management by both the caregiver and health care team.28   
Preliminary Work 
Our team has a long-standing history of asthma work, including assessing asthma prevalence 
and factors associated with described disparities in Chicago. After surveying over 40,000 Chicago 
schoolchildren, we found asthma prevalence to be 9.7% for white children and 21.2% for Black children.6  
We also found that asthma varies by the child’s neighborhood, spanning from 2% to 44%, even in 
adjacent neighborhoods.4 We have also published on asthma management and barriers to adherence of 
guidelines by physicians. Our team members also lead the Asthma Clinical Care Guideline Committee at 
Lurie Children’s Hospital. The interventions put into place by this team have led to hospital-wide 
decreases in length of stay without increases in readmissions. Furthermore, we developed an inpatient 
pediatric asthma scoring system that demonstrated good predictive ability, inter-rater agreement, and 
severity correlation. This scoring system allows for objective evaluation of patients both during initial 
presentation and for continued assessments as patients receive treatment in the urgent care, 
emergency department, and inpatient settings.   
Our team has worked on many technology-integrated projects in the past focusing on childhood 
chronic diseases. A successful patient-focused intervention called SMART (Student Media-based Asthma 
Research Team) was implemented in three separate schools throughout Chicago.29-31 In these 
interventions, we partnered with adolescents with documented asthma to learn more about their 
communities and the factors that negatively or positively affect their asthma. Technology, including 
photo cameras and video cameras, were used with the goal to empower the student participants to 
ultimately improve their asthma knowledge and self-efficacy while also promoting asthma awareness in 
the surrounding community.  
We have also developed and tested a low-health literacy Visual Asthma Action Plan to improve 
physician care, and to bridge the gap between the management counselling received in the primary care 
setting improve control and management at home.32  Our team members also utilized a multidisciplinary 
team of providers to create an electronic asthma action plan available in Epic that can be used in both 
inpatient and outpatient centers, improving communication between these two arenas. Also within the 
inpatient arena, our team members have developed best practice alerts to ensure patients are being 
appropriately weaned on their medications based on reported exam findings.  
Finally, we have also worked in Epic to create a clinical decision support tool for primary care 
physicians to effectively diagnose and treat food allergy. The tool incorporated NIAID guidelines to 
direct physicians to improve documentation and management of food allergies.33 

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The goal of this study is to determine whether a sensor-enabled, clinically integrated, mobile 
health asthma program can improve asthma outcomes among 4-17 year old children with moderate-
to-severe asthma.  
 
Objective: To improve overall asthma control and asthma management among children 4-17 years old 
with moderate-to-severe asthma. 
 
Study Aims: For children 4-17 years old with moderate to severe asthma we will: 
 
1) Determine factors influencing clinical and psychosocial outcomes.   
We will use clinical chart review data, as well as parent report of the following clinical asthma-
related outcome measures: 
1) Asthma-related oral corticosteroid use; 2) Asthma-related  ED visits 3) Asthma-related 
hospitalizations; 4) Asthma symptom control, as measured by the Asthma Control Test (ACT) for 
adults and childhood Asthma Control Test for children. In addition, patient demographics, co-
morbidities, and parent and physician management factors (measured in in aim 2 and 3) will be 
assessed.   
 
We will use parent-report surveys of the following psychosocial outcome measures: 
1) Days missed from school due to asthma; 2) Pediatric Asthma-Related Quality of Life 
(PACQLQ); and 3) Parental Asthma Management Self-Efficacy (PAMSE). 
 
2) Enhance parental management through improved inhaler use. 
We will use the Propeller Sensor Platform (referenced as Remote Health Management Platform) 
to allow parents to track their child’s ICS and SABA inhaler use daily (please see the appendices 
for a list of inhalers that are compatible). The Platform also will have specific educational 
messaging to help parents and their children achieve adherence to their prescribed plan. This 
constant feedback and reinforcement may lead to improved asthma control therefore reducing 
frequency and severity of asthma exacerbations. We will also be assessing the factors associated 
with the feasibility and sustainability of the Propeller Sensor Platform by observing trends in 
utilization.  Utilization and drop-off will be measured by monitoring use of the inhalers and 
periodic surveys of families. 
  
3) Improve management by the healthcare team.   
We will use the Remote Health Management Platform to integrate inhaler use data into a web 
portal that the physician’s office can access. Through the development of this interface, the 
Propeller Sensor Platform will be able to provide inhaler use feedback to healthcare teams.  
Types of feedback: 
• 
Emergency Management: data on ICS and SABA use 
• 
Long-term Management: data on ICS and SABA use 
This interface will include data on both ICS and SABA inhaler use. The interface will also have 
flags to notify the office of under or overuse of inhalers, with a protocol in place to reach out to 
patients. We will also be assessing the factors associated with the feasibility and sustainability of 
the Remote Health Management Platform by the healthcare team. This will be done by weekly 
contact with the healthcare team, rapid cycle improvement of the web portal, and written 
assessments. Follow-up assessments through interview will be conducted at the end of the trial 
with health providers.  
 

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Participant Sites 
The participant sites will be pediatric clinics in the Chicagoland Area. Each site in this proposed study has 
a strong history of research collaborations with Dr. Gupta, which includes the ability to recruit and retain 
patients in research studies.  
We will be recruiting from at least four of the following sites: 
• 
Children’s Healthcare Associates 
• 
Chicago Family Asthma and Allergy 
• 
Clark/Deming Resident Clinic (Lurie Children’s) 
• 
Pulmonary Clinic (Lurie Children’s) 
• 
Lurie Children’s Uptown Clinic 
 
Study Design and Procedures 
1. Design: We will conduct a randomized controlled trial comparing asthma inhaler use and 
asthma-related outcomes between children who either receive the Remote Health Management 
Platform (intervention) or Standardized Education (control) for asthma management. We will 
use a prospective cohort design to determine the effect of the intervention on the 
aforementioned outcomes. 
 
We will enroll patients from Chicago pediatric clinics, as well as inpatient units at Lurie 
Children’s Hospital. At enrollment, we will randomize children to either the Remote Health 
Management Platform (intervention) group or the Standardized Education group (control).  
 
Children in the Standardized Education group will receive education about NAEPP guideline-
based asthma management, including asthma action plans and appropriate and effective inhaler 
use. During the initial visit, the child participants will get ImmunoCAP allergen testing to 
ascertain their environmental allergens. This is a simple blood draw that can help further guide 
the knowledge and overall management of the child’s asthma. Allergen testing is not mandatory 
to participate in this study. They will also receive education on the benefits of an active lifestyle 
on asthma control and other health outcomes, appropriate physical activity types for asthma 
control (e.g., aerobic, moderate-intensity physical activities), setting goals for physical activity 
(e.g., daily step counts, one-hour of moderate-intensity physical activity per day), and 
recommendations for self-monitoring physical activity levels. 
252 Children 
125 Children: 
Propeller Sensor 
Group 
127 Children: 
Standardized 
Education Group 
Randomization 
Figure 1. Study Arms 

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At the enrollment visit, children in the intervention group and their families will receive all 
devices and software needed to track inhaler use and physical activity, as well as the education 
that the Standardized Education group receives. The Remote Health Management sensor will be 
enabled so that both caregivers and healthcare team will be able to track the child participants’ 
inhaler use. The software platform will provide participant families with tailored educational 
material via a mobile device-based app. A research assistant will provide the education on how 
to use the sensor device and the app, as well as the standardized education as described above. 
The child participants will also obtain allergen testing via ImmunoCAP. 
 
All participants will be assigned a study ID number prior to the collection of baseline 
measurements. Data will be de-identified and linked only by their study ID number. Data from 
the sensor will be uploaded to a cloud-based storage facility for analysis.  
 
2. Inclusion Criteria: 
a. English-speaking parents of:  
i. Children 4-17 years of age. Using both NHLBI (National Heart, Lung, and Blood 
Institute) guidelines and based off of a physician expert panel, the research 
team has limited the ages to 4-17 years old. It has been shown to be difficult to 
properly diagnose individuals less than 4 years of age with asthma. Usually, they 
are diagnosed with reactive airway disease or bronchial virus.  
ii. Moderate-to-severe persistent asthma, defined by the National Heart, Lung, 
and Blood Institute. This will be done by a physician-trained RA who will be able 
to identify potential participants prior to recruitment. 
iii. At least one asthma exacerbation that required a course of oral corticosteroids 
in the past year 
iv. Prescription and utilization of an ICS inhaler for at least the past year. 
v. Who are seen at: Clark and Deming Resident Clinic, Lurie Children’s Pulmonary 
Clinic, Lurie’s Uptown Clinic or Chicago Healthcare Associates  
b. Exclusion criteria: 
i. Non-English speaking parents/families 
ii. Patients seen in the hospital who receive primary care outside of the study’s 
clinics 
iii. Children with any comorbid conditions, which interfere with appropriate 
assessment of asthma symptoms: Chronic Lung Disease, Broncho-Pulmonary 
Dysplasia, Cystic Fibrosis, Pulmonary Hypertension, Interstitial Lung Disease, 
Immunodeficiency, Bronchiectasis, Primary Ciliary Dyskinesia, Chronic 
Respiratory Insufficiency, Neuromuscular Weakness, Sickle Cell Lung Disease, 
Restrictive Lung Disease,  and Tracheostomy or Ventilator-dependence 
iv. Child-patients who are participating in any other research studies that would 
interfere with our ability to use and track the inhaler sensor  
 
3. Pilot Phase 
a. 10 children and their families will be recruited by their healthcare provider to join this study 
for 30 days. After enrollment, participants in the pilot phase will receive the Remote Health 
Management device, as well as the same training and education that the Intervention group 
will receive, including the allergen testing.  

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Enrollment: Informed consent will be obtained at the time of enrollment. Families in the 
Intervention arm will receive Remote Health Management sensors. Data collected at the time of 
enrollment will include the following for each participant: 
a. Basic demographic and clinical history data (obtained by a review of medical 
records) 
a. Include: name, date of birth, date of asthma diagnosis, zip code, history of a 
course of oral corticosteroid, current medications, phone call/email history 
to the clinic, asthma exacerbation history, and history of asthma-related ED 
visits and hospitalizations.  
b. Parent questionnaires, including the Asthma Control Test (ACT), Parental Asthma 
Management Self Efficacy (PAMSE) scale, intervention survey, and the Pediatric 
Asthma Caregiver’s Quality of Life Questionnaire (PACQLQ). 
b. A member of the research team will go in person to each clinic once per week to ensure that 
the pilot phase is running smoothly and optimally.  
c. A member of the research team will conduct telephone interviews with these families one 
week after enrollment. These phone calls will determine how the device is working, if 
participants foresee any obstacles to the use of the device, and to answer any other 
questions participants might have.  
d. A member of the research team will reach out to enrolled parents via phone, text, or email 
once a week (4 times in total) to inquire about how well the device is working, and if this is a 
feasible Platform to use. 
e. After 30 days, a member of the research team will again conduct interviews to get feedback. 
This pilot group will continue to use the device for one full year and will assist us with 
trouble shooting throughout the intervention. 
 
4. Enrollment/Visit 1/Baseline Measurements 
Informed online consent will be obtained at the time of enrollment. The consent form will be 
stored utilizing REDCap, which is a secure, online software. Families in the Intervention arm will 
receive Remote Health Management sensors. Data collected at the time of enrollment will 
include the following for each participant: 
c. Basic demographic and clinical history data (obtained by a review of medical 
records) 
a. Include: name, date of birth, date of asthma diagnosis, zip code, history of a 
course of oral corticosteroid, current medications, phone call/email history 
to the clinic, asthma exacerbation history, and history of asthma-related ED 
visits and hospitalizations.  
d. Parent questionnaires, including the Asthma Control Test (ACT), Parental Asthma 
Management Self Efficacy (PAMSE) scale, and the Pediatric Asthma Caregiver’s 
Quality of Life Questionnaire (PACQLQ). 
 
All enrolled children, regardless of study arm, will have allergen testing via ImmunoCAP. This is a 
simple blood draw that can help further guide the knowledge and overall managements of 
child's asthma. This will be incorporated into the Remote Health Management software for the 
intervention group and be disclosed to the control group as well. The volume of the blood to be 
drawn for the assessment is 1.3 mL of serum or plasma is required to process the allergen panel 
we intend to use in the study. 
 
5. Daily Inhaler Use Management 

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The Remote Health Management team (Propeller Health) utilizes telehealth concepts, including an 
FDA-approved sensor, mobile apps, predictive analytics, and feedback to help patients and providers 
better manage asthma.11,12 The sensor monitors the use of inhaled medications (ICS and SABA), 
capturing the date, time, and number of uses. The sensor transmits this information via Bluetooth to 
a paired smartphone or hub. The location of the event is also securely uploaded to the cloud if the 
sensor is connected to the Smartphone at the time the sensor is used.  Data can be uploaded to the 
caregiver’s smartphone and to the patient’s web portal, which their healthcare team will have 
access to help overall management.13   
 
The sensors will be distributed to participants by the study team. We will aim for participants to 
engage with the study team before going to the clinic or hospital so the device is ready to use at the 
time of their appointment. This will require the participants to call the research team and the 
consent being described over the phone to the participants. At their appointment and when the 
device is given, the participants will sign the consent. 
 
6. Randomization 
After recruitment, participants will be stratified by age, sex, and insurance status. They will then be 
randomly assigned to one of the two study arms.  
 
After recruitment, participants will be stratified by age (4-7 vs 8-17), sex (M vs F), and insurance type 
(private vs. public), resulting a total of eight strata (stratum1: 4-7, M, Private, stratum2: 4-7, M, 
Public, stratum3: 4-7, F, Private, etc.). Since this is not a double-blind study and no centralized 
randomization system will be implemented, one randomization schedule will be generated for each 
site. Each randomization schedule will contain all eight strata. To ensure balanced treatment 
allocations within each stratum, 20 randomization blocks will be generated within each stratum. 
Each block has a block size of 4 with a random permutation of treatments A and B (eg, block 
1=AABB, block2=ABBA, etc). Each site’s randomization schedule will begin with a distinct 
randomization sequence number which is different from the subject ID number. For example, site 
1’s randomization schedule will begin with randomization sequence number 100001, site 2’s 
randomization schedule will begin with randomization sequence number 2000001, etc.  
 
The site investigator will assign the randomized treatment to a patient in the sequential order, 
based on the stratum the patient belongs to.   
 
7. Intervention 
a. After enrollment, participants in the Remote Health Management Sensor group will have 
the full Remote Health Management Sensor Platform (i.e. mobile application, physician 
access to inhaler use data, etc.). Research staff will review uploaded sensor data on a daily 
basis. If participants are enrolled into the control group, they will only receive Standard 
Asthma Education. The Standard Asthma Education follow the NAEPP (National Asthma 
Education and Prevention Program) guidelines for asthma management. This will include 
the following list of topics: 1. What is Asthma (Explanation of symptoms); 2. Asthma triggers 
(what those are and how to avoid them); 3. Using medications (how to use prescribed 
asthma medications, the difference between controller medications and rescue inhalers, 
how to appropriately use a spacer, how to appropriately use a mask); and 4. Managing 
asthma control (purpose of asthma control test and how to complete it, purpose of an 
asthma action plan and how to read and complete it, how to appropriately use a peak flow 
meter). 

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b. All participants will receive allergen testing, done by their physicians to ascertain their 
environmental triggers. This will be incorporated into the Remote Health Management 
software for the intervention group. 
c. If uploaded data reveals elevated SABA use, healthcare team staff will be expected to 
contact caregivers if needed to ascertain the context of the elevated use and schedule 
appointments as needed. Information regarding this contact will be documented in the 
patient’s EMR and available to researchers. 
d. The Remote Health Management Platform will send education, based on management plan 
and identified asthma triggers, to participant in the intervention group.  
 
8. 1 month from start of enrollment 
a. Control Arm- Caregivers will take the ACT, PAMSE, iTRACC survey, and PACQLQ. Caregivers 
will also be asked about acute exacerbations, ED visits, and hospitalizations as visits to out-
of-network healthcare facilities may not be visible in the EMR. This information will be 
collected via email or phone for both groups utilizing a REDCap survey link for each 
participant. 
b. Intervention Arm- Caregivers will take the ACT, PAMSE, intervention survey, and PACQLQ. 
Caregivers will also be asked about acute exacerbations, ED visits, and hospitalizations as 
visits to out-of-network healthcare facilities may not be visible in the EMR. This information 
will be collected via email or phone for both groups utilizing a REDCap survey link for each 
participant. 
 
 
9. 3 months from start of enrollment  
a. Control Arm- Caregivers will take the ACT, PAMSE, iTRACC survey, and PACQLQ. Caregivers 
will also be asked about acute exacerbations, ED visits, and hospitalizations as visits to out-
of-network healthcare facilities may not be visible in the EMR. This information will be 
collected via email or phone for both groups utilizing a REDCap survey link for each 
participant. 
b. Intervention Arm- Caregivers will take the ACT, PAMSE, intervention survey, and PACQLQ. 
Caregivers will also be asked about acute exacerbations, ED visits, and hospitalizations as 
visits to out-of-network healthcare facilities may not be visible in the EMR. This information 
will be collected via email or phone for both groups utilizing a REDCap survey link for each 
participant. 
 
10. 6 months from start of enrollment  
a. Control Arm- Caregivers will take the ACT, PAMSE, iTRACC survey, and PACQLQ. Caregivers 
will also be asked about acute exacerbations, ED visits, and hospitalizations as visits to out-
of-network healthcare facilities may not be visible in the EMR. This information will be 
collected via email or phone for both groups utilizing a REDCap survey link for each 
participant. 
b. Intervention Arm- Caregivers will take the ACT, PAMSE, intervention survey, and PACQLQ. 
Caregivers will also be asked about acute exacerbations, ED visits, and hospitalizations as 
visits to out-of-network healthcare facilities may not be visible in the EMR. This information 
will be collected via email or phone for both groups utilizing a REDCap survey link for each 
participant. 
 
11. 9 months from start of enrollment  

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a. Control Arm- Caregivers will take the ACT, PAMSE, iTRACC survey, and PACQLQ. Caregivers 
will also be asked about acute exacerbations, ED visits, and hospitalizations as visits to out-
of-network healthcare facilities may not be visible in the EMR. This information will be 
collected via email or phone for both groups utilizing a REDCap survey link for each 
participant. 
b. Intervention Arm- Caregivers will take the ACT, PAMSE, intervention survey, and PACQLQ. 
Caregivers will also be asked about acute exacerbations, ED visits, and hospitalizations as 
visits to out-of-network healthcare facilities may not be visible in the EMR. This information 
will be collected via email or phone for both groups utilizing a REDCap survey link for each 
participant. 
 
12. Final Visit at 12 Months 
a. A second clinic visit will occur one year after enrollment. This visit will aim to coincide with 
participants’ annual asthma clinic visits.  
b. Control Arm- Caregivers will take the ACT, PAMSE, iTRACC survey, and PACQLQ. Caregivers 
will also be asked about acute exacerbations, ED visits, and hospitalizations as visits to out-
of-network healthcare facilities may not be visible in the EMR. This information will be 
collected via email or phone for both groups utilizing a REDCap survey link for each 
participant. 
c. Intervention Arm- Caregivers will take the ACT, PAMSE, intervention survey, and PACQLQ. 
Caregivers will also be asked about acute exacerbations, ED visits, and hospitalizations as 
visits to out-of-network healthcare facilities may not be visible in the EMR. This information 
will be collected via email or phone for both groups utilizing a REDCap survey link for each 
participant. 
d. During this final study visit, a member of the research team will make sure that that the 
caregivers have completed the all the study surveys via Propeller or via text, email, or 
telephone. 
 
13. Semi-structured interviews (After Participant Completion of Trial) 
a. From the intervention arm alone, caregivers who responded that they were interested in 
further contact from the study team on the exit survey will be contacted. 
b. Caregivers will be interviewed about their experience with the intervention (sensor/app) 
and about how caregiving for their child’s asthma is affected by their experiences of family, 
community, school, and the health care system.  
c. Caregivers will be informed that the in-person, or telephone, interview will be audio-
recorded. In-person interviews will be conducted at Northwestern Medical Campus in 
private, research rooms.  
d. Interviews will last approximately 60 minutes and conducted by research staff. 
 
14. Semi-structured interviews (Health providers at the end of the trial) 
a. Health providers (e.g., nurses and physicians), who were involved in the trial, will be invited 
to participate in exit interviews 
b. Health providers will be interviewed abou their experience using the web portal (Study Aim 
3), using the data generated by the sensors, and managing pediatric asthma patients and 
their interaction with parents 
e. Health providers will be informed that the in-person, or telephone, interview will be audio-
recorded. In-person interviews will be conducted at their clinic location in a private office. 
f. 
Interviews will last approximately 60 minutes and conducted by research staff. 

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Study Extension 
Data analysis will begin 12 months after a participant is enrolled (beginning January 2018.). During the 
analysis period, we will also determine the feasibility of implementing the intervention more broadly 
throughout the healthcare system.  
 
Study Subjects: 
Eligible participants will be children 4-17 years old with moderate or severe persistent asthma, as 
diagnosed by their pediatrician, who are primarily seen for their asthma care at one of the participating 
clinical sites, and who have parents/caregivers willing to participate in this study. Participants will also 
be required to have received oral corticosteroids in the past year.  
 
Study Enrollment: 
Recruitment will occur by a research assistant at all sites. Scheduling of recruitment and participant 
screening will require the healthcare team to identify potential participants and then the RA either 
calling or mailing an informational pamphlet to the parents prior to their next appointment. Participants 
may also be recruited in the clinic by the RA, but will require the RA to follow-up with them via the 
telephone to properly install and utilize the Remote Health Management Platform. Participants may also 
be recruited through Lurie Children’s Hospital Inpatient service after an asthma exacerbation. Only 
children who receive their primary care from one of the 5 study clinics will be permitted to be in the 
study. A member of the research team will work with hospitalists to recruit these individuals. 
 
For the post-trial semi-structured interviews, only those participants who had previously responded that 
they were interested in further contact by the research team will be recruited. Study staff will contact 
potential participants for interviews by telephone and only schedule a time if participants remain 
interested after the interview study has been explained to them.  
 
For post-trial interviews of health providers, all health providers who were in the trial will be invited to 
participate. Study staff will email health providers for interviews and only schedule time if health 
providers are interested after the study has been explained to them.  
 
Participant Engagement 
Members of the study team will communicate with participants about issues and/or questions 
throughout the study period via text, email, or phone. Participants will also receive calls from their 
healthcare provider’s office if necessary. 
Figure 2. Participant Burden 
The healthcare team will comprise of physicians, nurses, nurse practitioners, and respiratory therapists 
at participating sites. They will have regular contact with the research team. A member of the research 
team will make frequent in-person appearances in each clinic to make sure that the intervention is 
running smoothly from a clinical perspective.  

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Figure 3. Web Portal for Healthcare Team
 
Figure 4. Web Portal-At a Glance 

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Figure 5. Web Portal-at a glance 
 
 
 
 

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Figure 6. ImmunoCAP Allergy Profiles for IL 
 
 

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Figure 7. ImmunoCAP Allergy Profiles, Study Timeline (Intervention): 

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Tasks 
 
Year 1 
 
 
 
Aug 
Sept 
Oct 
Nov 
Dec 
Jan 
Feb 
Mar 
Apr 
May 
Jun 
Jul 
Aug 
Preparation 
Phase 
 
 
 
 
 
 
 
 
 
 
 
 
 
Web Portal 
X 
X 
 
 
 
 
 
 
 
 
 
 
 
Pilot Phase 
 
 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
x 
Adapt Protocol  
 
 
X 
X 
 
 
 
 
 
 
 
 
 
Study Phase 
 
 
 
 
 
 
 
 
 
 
 
 
 
Recruitment 
 
 
 
 
 
X 
X 
X 
X 
X 
X 
X 
X 
Baseline Surveys 
 
 
 
 
 
X 
X 
X 
X 
X 
X 
X 
X 
Remote Health 
Management 
Device 
Distribution 
 
 
 
 
 
X 
X 
X 
X 
X 
X 
X 
X 
Weekly 
Calls/Emails to 
Clinic 
x 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
Retention Phase 
 
 
 
 
 
 
 
 
 
 
 
 
 
1 month surveys 
 
 
 
 
 
 
X 
X 
X 
x 
X 
X 
X 
3 month surveys 
 
 
 
 
 
 
 
 
x 
x 
X 
X 
X 
Half-Yearly 
Surveys 
 
 
 
 
 
 
 
 
 
 
 
X 
X 
9 month surveys 
 
 
 
 
 
 
 
 
 
 
 
 
 
Phone/email 
Follow-up 
 
 
 
 
X 
X 
X 
X 
X 
 
 
 
 
Epic Data Pull 
 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
 
Tasks 
Year 2 
 
 
 
Sept 
Oct 
Nov 
Dec 
Jan 
Feb 
Mar 
Apr 
May 
Jun 
Jul 
Aug 
Retention Phase 
 
 
 
 
 
 
 
 
 
 
 
 
9  month surveys 
x 
x 
x 
X 
X 
X 
X 
X 
X 
X 
X 
X 

Version: 04/06/2020 
 
 
Study Timeline (Control): 
 
Tasks 
 
Year 1 
 
 
 
Aug 
Sept 
Oct 
Nov 
Dec 
Jan 
Feb 
Mar 
Apr 
May 
Jun 
Jul 
Aug 
Preparation 
Phase 
 
 
 
 
 
 
 
 
 
 
 
 
 
Web Portal 
X 
X 
 
 
 
 
 
 
 
 
 
 
 
Pilot Phase 
 
 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
x 
Adapt Protocol  
 
 
X 
X 
 
 
 
 
 
 
 
 
 
Study Phase 
 
 
 
 
 
 
 
 
 
 
 
 
 
Recruitment 
 
 
 
 
 
X 
X 
X 
X 
X 
X 
X 
X 
Baseline Surveys 
 
 
 
 
 
X 
X 
X 
X 
X 
X 
X 
X 
Remote Health 
Management 
Device 
Distribution 
 
 
 
 
 
X 
X 
X 
X 
X 
X 
X 
X 
Weekly 
Calls/Emails to 
Clinic 
x 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
Retention Phase 
 
 
 
 
 
 
 
 
 
 
 
 
 
1 month surveys 
 
 
 
 
 
 
X 
X 
X 
x 
X 
X 
X 
3 month surveys 
 
 
 
 
 
 
 
 
x 
x 
X 
X 
X 
End of the Study 
Surveys 
x 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
Remote Health 
Management  Data 
Pull 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
Web Portal Data Pull 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
Feasibility 
Assessment 
 
X 
X 
X 
X 
X 
X 
 
 
 
 
 
Analysis Phase 
 
 
 
 
 
 
 
 
 
 
 
 
Data Analysis 
 
X 
X 
X 
X 
X 
X 
X 
X 
x 
 
 
Publications and 
Presentations 
 
 
 
X 
X 
X 
X 
X 
X 
X 
X 
X 

Version: 04/06/2020 
 
Half-Yearly 
Surveys 
 
 
 
 
 
 
 
 
 
 
 
X 
X 
9 month surveys 
 
 
 
 
 
 
 
 
 
 
 
 
 
Phone/email 
Follow-up 
 
 
 
 
X 
X 
X 
X 
X 
 
 
 
 
Epic Data Pull 
 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
 
 
 
 
 
Clinical Outcomes 
Source 
Outcome 
Time Point 
Remote Health Management  
Application 
ICS and SABA use 
Monthly download 
Web Portal/Epic 
Asthma-related ED visits, 
hospitalizations, and oral 
corticosteroid 
prescriptions/courses  
Monthly Epic data pull 
Web Portal/Epic 
Patient demographics pulled 
Baseline 
Parent report (Survey) 
Patient age, family income, race, 
family makeup (single parent, two-
parent household, etc) 
Baseline 
Tasks 
Year 2 
 
 
 
Sept 
Oct 
Nov 
Dec 
Jan 
Feb 
Mar 
Apr 
May 
Jun 
Jul 
Aug 
Retention Phase 
 
 
 
 
 
 
 
 
 
 
 
 
9  month surveys 
x 
x 
x 
X 
X 
X 
X 
X 
X 
X 
X 
X 
End of the Study 
Surveys 
x 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
Remote Health 
Management  Data 
Pull 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
Web Portal Data Pull 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
Feasibility 
Assessment 
 
X 
X 
X 
X 
X 
X 
 
 
 
 
 
Analysis Phase 
 
 
 
 
 
 
 
 
 
 
 
 
Data Analysis 
 
X 
X 
X 
X 
X 
X 
X 
X 
x 
 
 
Publications and 
Presentations 
 
 
 
X 
X 
X 
X 
X 
X 
X 
X 
X 

Version: 04/06/2020 
 
Asthma Control Test (ACT) (ages 12 and 
older Or  
Childhood Asthma Control Test (ages 4-
11) 
Parent report of their child’s 
asthma control 
5 times in total (baseline, 3 
months, 6 months, 9 months, 
study completion) 
Parent-reported Values (un-validated) 
Asthma-related oral corticosteroid 
prescription/use/courses; number 
of asthma-related hospitalizations; 
number of asthma-related ED visits 
5 times in total (baseline, 3 
months, 6 months, 9 months, 
study completion) 
ImmunoCAP Allergen Testing  
Environmental Allergens 
Baseline 
 
Psychosocial Outcomes 
Source 
Outcome 
Time Point 
Parental Asthma Management Self-
Efficacy (PAMSE) 
Parental self-efficacy survey to 
assess parent’s ability to manage 
and/or prevent acute 
exacerbations 
5 times in total (baseline, 3 
months, 6 months, 9 months, 
study completion) 
Parent-reported values (un-validated) 
School days missed due to asthma 
5 times in total (baseline, 3 
months, 6 months, 9 months, 
study completion) 
Pediatric Caregiver Asthma-related 
Quality of Life Questionnaire (PACQLQ) 
Parent form of how their child’s 
asthma is affecting both their lives 
and the life of their child 
5 times in total (baseline, 3 
months, 6 months, 9 months, 
study completion) 
 
Parental Management Outcomes  
Source 
Outcome 
Time Point 
Parent report (Survey) 
Feasibility and acceptability of 
Platform 
5 times in total (baseline, 3 
months, 6 months, 9 months, 
study completion) 
Remote Health Management Platform 
Frequency of use of the application 
(synching) 
Monthly data pull 
 
Physician and Clinical Team Outcomes 
Source 
Outcome 
Time Point 
Remote Health Management Platform 
ICS and SABA use 
Monthly download 
Web Portal/Epic 
Asthma-related ED visits, 
hospitalizations, and oral 
corticosteroid 
prescriptions/courses  
Monthly Epic data pull 
Clinician Survey 
Feasibility and acceptability of the 
Platform 
1 month into the study, 6 
months and study completion 
Physician Survey  
Feasibility and acceptability of the 
Platform 
1 month and study completion 
Remote Health Management Platform 
Frequency of use of the web portal 
Monthly data pull 
 
 
 
 

Version: 04/06/2020 
 
 
Data Analysis: 
Primary Outcomes  
 
• 
ACT: Parent-reported test on their child’s asthma control 
• 
Asthma-related hospitalizations: Data will be obtained from the EMR and parent report. 
• 
Asthma-related ED visits: Data will be obtained from the EMR and parent report. 
• 
Asthma-related oral corticosteroid use: Prescription/course data will be obtained from the EMR 
and parent report. 
 
Secondary Outcomes  
• 
Inhaler Use: Use data, including frequency of both SABA and ICS inhalers, will be obtained via 
the sensor throughout the study period. 
• 
PAMSE: Parental Asthma Management Self-Efficacy; self-report survey that measures parental 
self-efficacy for the management and prevention of acute exacerbations of asthma.   
• 
PACQLQ: Paediatric Asthma Caregiver’s Quality of Life Questionnaire; will assess the impact of 
their child’s asthma on their lives, the lives of their children with asthma, and the family as a 
whole.  
• 
Clinical management:  To compare clinical management, data on physician-patient 
communication and rates of follow up will be obtained from the web portal for all patients for a 
year for each intervention participant. This will be measured via the number of tasks have been 
completed. Additionally, in the Intervention group, we will work with physicians to conduct 
rapid-cycle improvements to the web portal interfaces, through conversations the RA and the PI 
have with clinicians. We will also follow up with healthcare team to ensure follow-up calls are 
occurring. Finally, a four-question survey of members of the healthcare team about the 
acceptability and feasibility of the sensor will be conducted periodically.  
 
 
Statistical Analysis: 
Demographic and baseline characteristics: 
Demographic and baseline characteristics including gender, age, race, ethnicity,  and co-morbidities will 
be summarized for each treatment group and overall. The demographic and baseline characteristics 
summary will be based on all randomized subjects. 
Baseline values for efficacy parameters (ACT, quality of life score, PAMSE) will also be presented for each 
treatment group and overall based on all randomized subjects. 
 
For continuous variables, non-missing will be used to calculate the mean, median, SD, IQR, minimum 
and maximum by treatment group and overall. For categorical variables, the count and percentages of 
each possible value will be tabulated by treatment group and overall. 
 
All comparisons of baseline characteristics between treatment groups will be adjusted for potential 
household clustering using robust standard errors. For continuous variables, comparability of treatment 
groups will be assessed using general linear models. For discrete variables, comparability will be 
assessed using the Cochran-Mantel-Haenszel general association test. P-values will be displayed as 
descriptive statistics of comparability in order to identify potential baseline imbalances with an alpha 
level of 0.05. 

Version: 04/06/2020 
 
 
AIM 1. Determine factors influencing clinical and psychosocial outcomes. 
Clinical and psychological outcomes of interest include the 12-month rate of asthma-related oral 
corticosteroid use, ED visits, and hospitalizations, as well as change in mean ACT scores (range of 0 to 
27) from baseline to end line (12 months). Psychological outcomes of interest include quality of life 
score (range of 1 to 7), parental self-efficacy score, and the number of school days missed due to 
asthma. Potential predictors of outcomes include age (4 to 7 years vs. 8 to 17 years), gender (M vs. F), 
race/ethnicity (non-Hispanic white, non-Hispanic Black, Hispanic, vs. others), insurance status 
(private/public), and co-morbidities. 
 
Each count variable (asthma-related oral corticosteroid use, ED visits, and hospitalizations) will be 
analyzed by mixed negative binomial regression analysis adjusting for treatment, all potential predictors, 
and including maximal random effect structures (i.e., slope and intercept as allowed by the model) of 
family and clinic. VIFs (variance inflation factors) will be computed for each predictor.  Highly correlated 
predictors (i.e. predictors that can be well-explained by other predictors) will be dropped from the 
model to avoid multicollinearity issues. Model fit criteria, parameter estimates, and precision of 
parameter estimates will all be evaluated to select the most parsimonious model.  
 
For each continuous primary outcome variable (i.e., ACT score), change-from-baseline score at each visit 
will be analyzed using mixed linear regression models, adjusting for treatment , time point, baseline 
score, all potential predictors, and including random effects (i.e., both slope and intercept) of family and 
clinic. A treatment by time interaction will be included to evaluate whether the effect of the treatment 
on the primary outcome varies by time point. VIFs will be investigated for each predictor, and those with 
high VIFs (VIF>=10) will be dropped from the model to avoid multicollinearity issues.  An unstructured 
covariance (UN) matrix will be assumed. Model fit criteria, parameter estimates, and precision of 
parameter estimates will also be used to select the most parsimonious model.   
 
Model diagnostics will be performed to check model assumptions.  All analyses will be performed using 
statistical analytic software Stata Version 15.1.      
 
AIM 2. Enhance parental management through improved inhaler use. 
After the patient’s enrollment visit, parents will be contacted via email or phone at 1, 3, 6, 9, and 12 
months to complete a REDCap survey. Each quantitative survey item will be summarized using 
descriptive statistics such as frequencies and percentages along with any corresponding measures of 
spread. Qualitative data will be coded and analyzed by theme analysis. 
The following questions will be asked: 
Quantitative Questions: 
1. How often do you check the sensor system? 
• 
More than once a daily  
• 
Daily 
• 
Once a week 
• 
More than once a week 
• 
Every other week 
• 
I don’t check the Propeller Sensor (If selected, participants will only answer question 1 
and 5) 
2. How often in the past week did you receive useful asthma information through the sensor 
system? 

Version: 04/06/2020 
 
• 
Once 
• 
Twice 
• 
Three or more times 
• 
I did not receive useful asthma information through the sensor system 
3. How helpful is the sensor system in managing your child’s asthma? 
• 
Extremely helpful 
• 
Very helpful 
• 
Helpful 
• 
A little helpful 
• 
Not helpful 
• 
I have not checked the sensor system  
4. What do you enjoy most about the sensor system? 
 Easy to use 
 Ability to track inhaler use 
 Asthma Education cards 
 Other: fill in the blank 
 Nothing 
5. Do you have any issues regarding the sensor system?  
• 
Comment Box 
 
AIM 3. Improve management by physician and clinical team. 
On a biweekly basis, we will collect quantitative data from clinics on the number of time physicians’ 
follow-up with patients and the follow-up outcome. The research team will know exactly how many 
alerts physicians are receiving, and how physicians are following-up with patients from the Propeller 
dashboard. The data from the Propeller dashboard will be summarized  with descriptive statistics. 
Clinicians will also be contacted at 1, 3, 6, 9, and 12 months through REDCap surveys to determine if the 
data is helping them with management and aspects of the platform they like and dislike. Qualitative 
data will be coded and analyzed by theme analysis. 
The following questions will be asked: 
Quantitative Questions: 
1. In the past week, how many times did you check the propeller dashboard? 
 Once time 
 Twice  
 3 or more times 
 Zero 
2. Are the Propeller Dashboard flags useful to you?  
 Yes 
 No 
3. In the past week, how many times did you have to follow-up with patients due to alerts you 
received regarding the over use of Albuterol? 
 Once 
 Twice 
 3 or more times  
 Zero 
4. In the past week, how many alerts did you receive due to patients overusing albuterol? 
 One 
 Two  

Version: 04/06/2020 
 
 3 or more  
5. In the past week, how many times did you have to follow-up with patients regarding their 
underuse of their controller medication? 
 Once  
 Twice  
 3 or more times 
6. In the past week, how many alerts did receive due to patients underusing their controller 
medication? 
 One 
 Two  
 3 or more  
 Zero 
7. On a scale of 1-5 (1 being the least helpful, and 5 being the most helpful), how helpful do 
you feel calls to patients improve asthma management? 
 1 
 2 
 3 
 4 
 5 
8. On a scale of 1-5 (1 being the least useful, and 5 being the most useful) how much do you 
think the parents found your call useful? 
 1 
 2 
 3 
 4 
 5 
Qualitative Questions: 
1. What do you find useful about the Propeller dashboard? 
2. What changes do you think are needed to improve the Propeller dashboard? 
3. How are you currently using the Propeller dashboard? Please describe. 
4. Would you utilize the Propeller health management platform for your current 
practice in the future? 
 
Sample Size Determination: 
Assuming asthma exacerbation rate of 0.545 for the intervention arm, and asthma exacerbation rate of 
0.75 for the standard treatment arm, resulting odds ratio (OR) equal to 0.3992674, and log(OR)=-
0.9181239. Assuming 20% patient drop-out rate, two-sided significance level alpha=0.05, a total of 250 
patients (125 per arm) is needed in order to achieve a statistical power of 85%. The sample size 
calculation was computed using SAS procedure PROC SEQDESIGN. 
 
Qualitative Analyses of Semi-Structured Interviews: 
Data will be analyzed systematically using a constant comparative approach; and four analysts (i.e., 
coders), including Dr. Shaunfield (qualitative methods expert), Dr. Kan, and 2 research team members, 
will meet to discuss initial thoughts, insights, and observations for the development of initial coding 
categories (e.g., themes). Through a systematic analysis process, themes will be continually refined by 
collapsing redundant themes and removing irrelevant themes. Once no new categories have emerged, a 

Version: 04/06/2020 
 
codebook will be developed for the remaining analysis. We will construct a saturation grid, to track 
themes as they emerge and determine when no new information is obtained 
 
 Study Staff: 
Dr. Ruchi Gupta will oversee study operation at participating sites and will be responsible for the 
acquisition and handling of study data according to the procedures outlined in this protocol. The 
research team will be comprised of a research managerr, research assistants, research coordinators, a 
data analyst, and a biostatistician. A member of the research team, along with Propeller Health will be 
responsible for the web portal integration of sensor data in the web portal. A Lurie Children’s Epic 
personnel will be responsible for extracting EMR data. United Health Care Group will be involved or 
consulted in every aspect of the study. 
   
Data Privacy and Human Subject Consideration: 
Direct benefit: 
Remote Health Management Group (Intervention): Children will have use of an inhaler sensor that may 
improve asthma management by tracking ICS and SABA use. The sensor software also sends tailored 
education materials to caregivers and alerts primary care physicians of increased SABA use. This 
enhanced care may lead to fewer asthma exacerbations, resulting in fewer school and/or work days 
missed, fewer ED visits, and fewer hospitalizations. 
 
Standardized Education Group: Children in this group will have standardized education (proper inhaler 
technique and a visual action plan), which may lead to better asthma outcomes as well.  
 
Indirect benefit: Eventual development of an insurance-wide program for children to better manage 
their asthma. 
 
Risks: The primary risk to participants in this study is discomfort related to getting blood drawn for the 
ImmunoCAP allergen testing. We will teach participating families to properly use all applications before 
the intervention begins. There is also a risk of confidentiality. 
 
To protect personal health information (PHI), each child will be given a study ID number, which will be 
kept separate from sensor and questionnaire data on a secure, password-protected database at 
Northwestern University. All sensor data will be securely downloaded from the cloud by the Remote 
Health Management provider, and sent securely to Northwestern to store on secure servers. All EMR 
data will be de-identified and saved in the same manner. 
 
Patient Safety Monitoring Plan:  
The patient safety monitoring plan for this study will include:  
- Standard clinical management of the enrolled children, which includes in each practice that the 
families are provided with contact information for the practice. As part of enrollment in this study, each 
family will be reminded that their child’s practice continues to be their resource for any questions or 
concerns about their child’s condition. Each family will be informed that the study does NOT substitute 
for their child’s physician. 
- The investigators do not anticipate any safety issues related to the monitoring device itself. However, if 
a parent or guardian raises any questions about the safety of the monitoring device, the study team will 
respond promptly to the parent’s/guardian’s concern. All parent's/guardian's will have contact 
information of the study coordinator. 
 

Version: 04/06/2020 
 
References: 
1. Centers for Disease Control. (2016). Asthma. Summary health statistics for U.S. children: 
National health interview survey, 2012. Retrieved from 
http://www.cdc.gov/nchs/fastats/asthma.htm. 
2. Center for Disease Control. (2016). Most recent asthma data: National Current Asthma 
Prevalence (2014). Retrieved from http://www.cdc.gov/asthma/most_recent_data.htm.  
3. Halterman, J., Rieker, K., Bayer, A., Fagnano, M., Tremblay, P., Blaakman, S., Borrelli, B. (2011). A 
pilot study to enhance preventive asthma care among urban adolescents with asthma. Journal 
of Asthma. 48(5). 
4. Gupta, R., Zhang, X., Sharp, L., Shannon, J., Weiss, K. (2008). Geographic variability in childhood 
asthma prevalence in Chicago. J Allergy Clin Immunol. 123(6).  
5. Centers for Disease Control. (2015). Data, Statistics, and Surveillance: Asthma Surveillance Data. 
Asthma. Retrieved from http://www.cdc.gov/asthma/asthmadata.htm 
6. Shalowitz, M., Sadowski, L., Kumar, R., Weiss, K., Shannon, J. (2007). Asthma burden in a 
citywide, diverse sample of elementary schoolchildren in Chicago. Ambul Pediatr. 7(4).  
7. Al-sheyab, N., Gallagher, R., Crips, J., Shah, S. (2012). Peer-led education for adolescents with 
asthma in Jordan: a cluster-randomized controlled trial. Pediatrics. 129(1). 
8. Akinbami LJ. “State of Childhood Asthma, United States, 1980-2005.” Advance Data from Health 
and Vital Statistics, 381: 1-24, December 2006. 
9. Asthma's Impact on Children and Adolescents. Atlanta: National Center for Environmental 
Health, Centers for Disease Control and Prevention. (No authors given.) 8 June 2005. 
10. United States Environmental Protection Agency. Asthma Facts. March 2013. 
http://www.epa.gov/asthma/pdfs/asthma_fact_sheet_en.pdf 2013.  
11. Wang LY, Zhong Y, Wheeler L. “Direct and Indirect Costs of Asthma in School-Age 
Children.” Preventing Chronic Disease , 2(1): [serial online], January 2005. 
12. Bhaumik U, Norris K, Charron G, Walker S, Sommer S, Chan E, Dickerson D, Nethersole S, Woods 
E. (2013). A cost analysis for a community-based case management intervention program for 
pediatric asthma. Journal of Asthma. 50(3). 
13. Fong E, Levin R. (2007). Inhaled corticosteroids for asthma. Pediatr Rev. 28(6): e30-35. 
14. Burgess S, Sly P, Devadason S. (2011). Adherence with preventive medication in childhood 
asthma. Pulm Med. Epub. 
15. Bender B, Zhang L. (2008). Negative affect, medication adherence, and asthma control in 
children. J Allergy Clin Immunol. 122(3): 490-495. 
16. Barnes C, Ulrik C. (2015). Asthma and adherence to inhaled corticosteroids: current status and 
future perspectives. Respir Care. 60(3): 455-468. 
17. Suissa S, Ernst P, Benayoun S, Baltzan M, Cai B. (2000). Low-dose inhaled corticosteroids and the 
prevention of death from asthma. N Engl J. Med. 343(5): 332-336. 
18. Labrecque M, Laurier C, Champagne F, Kennedy W, Pare M, Cartier A. Effect of Age on the 
Conformity Rate to Short-Acting Beta-Agonist Use Criteria in Asthma. Journal Of Asthma [serial 
online]. October 2003;40(7):829-835.  
19. NIH. (2011). Asthma Care Quick Reference: Diagnosing and Managing Asthma. Guidelines from 
the National Asthma Education and Prevention Program. Accessed here: 
https://www.nhlbi.nih.gov/files/docs/guidelines/asthma_qrg.pdf 
20. McQuaid E, Kopel S, Klein R, Fritz G. (2003). Medication adherence in pediatric asthma: 
Reasoning, responsibility, and behavior. Journal of Pediatric Psychology. 28(5): 323-333. 
21. Fiese B, Wamboldt F, Anbar R. (2005). Family asthma management routines: Connections to 
medical adherence and quality of life. The Journal of Pediatrics. 146(2): 171-176. 

Version: 04/06/2020 
 
22. Schreier H, Chen E. (2010). Longitudinal relationships between family routines and biological 
profiles among youth with asthma. Health Psychology. 26(1): 82-90. 
23. Everhart R, Fedele D, Miadich S, Koinis-Mitchell D. (2015). Caregiver quality of life in pediatric 
asthma: Associations with beliefs and concerns about medications and emergency department 
use. Clinical Pediatrics. 54 (3).  
24. Chan A, Reddel H, Apter A, Eakin M, Riekert K, Foster J. (2013). Adherence monitoring and e-
health: How clinicians and researchers can use technology to promote inhaler adherence for 
asthma. J Allergy Clin Immunol Pract. (5): 446-454. 
25. Van Sickle D, Magzamen S, Truelove S, Morrison T. Remote monitoring of inhaled 
bronchodilator use and weekly feedback about asthma management: An open-group, short-
term stud of the impact on asthma control. PLoS One 2013; 8:e55335. 
26. Van Sickle D, Maenner M, Barrett M, Marcus J. Monitoring improving compliance and asthma 
control: Mapping inhaler use for feedback to patients, physicians and payers. Respir Drug 
Delivery Europe 2013;1:1-12. 
27. Merchant R, Inamdar R, Quade R. (2015). Effectiveness of population health management using 
the propeller health asthma platform: A randomized clinical trial. Journal of Allergy and Clinical 
Immunology: In Practice.  
28. Gupta, R., Lau, C., Springston, E., Warren, C., Mears, C., Dunford, C., Sharp, L., Holl, J. (2013). 
Perceived factors affecting asthma among adolescents: Experiences and findings from the 
student asthma research team pilot study. J Asthma Allergy Educ. 
29. Yarbrough M, Blumenstock J, Warren C, Dyer AA, Wilson J, Smith BM, Gupta RS. SMART 
(Student Media-based Asthma Research Team): Engaging Adolescents to Understand Asthma in 
their Communities. Progress in Community Health Partnerships: Research, Education, and 
Action. 2016. Accepted 
30. Chris’ paper 
31. Yin, H. S., Gupta, R. S., Tomopoulos, S., Mendelsohn, A. L., Egan, M., van Schaick, L., ... & Dreyer, B. P. 
(2016). A Low-Literacy Asthma Action Plan to Improve Provider Asthma Counseling: A Randomized 
Study. Pediatrics, peds-2015.  
32. Otto A, Dyer A, Walkner M, Smith B, Gupta R. Characterizing Pediatricians’ Management of Food 
Allergy to Improve Coordination of Care. Poster Presentation, Pediatric Academic Society 
Conference; Baltimore, MD: April 30-May 3, 2016. 
 
 
Appendices: 
1. Parent questionnaires 
a. ACT 
b. Quality of Life 
c. PAMSE 
d. Intervention Feasibility questionnaire (Intervention Arm) 
e. iTRACC Survey (Control Arm) 
2. Physician questionnaires 
a. Technology questionnaire/script 
b. Post-intervention survey 
3. Email contact script 
4. Randomization Schedule 
5. Thermofisher ImmunoCAP Allergy Profiles 
 

Version: 04/06/2020 
 
Compatible Inhalers (retrieved from: https://www.propellerhealth.com/support/compatible-
medications/)  
Supported Rescue/Relief Medications: 
• 
Albuterol HFA 
• 
ProAir HFA 
• 
Proventil HFA 
• 
Ventolin HFA 
• 
Xopenex 
Supported Controller/Daily Medications:  
• 
Advair HFA 
• 
Advair Diskus 
• 
Asmenex 
• 
Combivent Respimat 
• 
Dulera 
• 
Flovent Diskus 
• 
Flovent HFA 
• 
QVAR 
• 
Serevent Diskus 
• 
Spiriva Respimat 
• 
Striverdi Respimat 
 
Timeline 
Pilot: November 2016 
• 
Pilot group of 8-10 families 
 
Phase 1: Enrollment  
• 
December 2016-December 2017 
• 
Collect EMR data from the previous year 
• 
Randomization 
 
Phase 2: Intervention  
• 
December 2016-December 2018 
• 
Intervention Group will have the Remote Health Management device for 1 year 
• 
Standardized Group will receive enhanced, standardized asthma education 
• 
Each group will fill out the following surveys 5x during the study period: 
o ACT 
o PAMSE 
o PACQLQ 
o iTRACC Survey (Control Arm) or Intervention Survey (Intervention Arm) 
o Number of hospitalizations, ED visits, exacerbations 
• 
We will pull information from the EMR to determine oral corticosteroid use 
 
Phase 3: Analysis 
• 
January 2018- December 31, 2018 
• 
All data analyzed 
• 
Preparation and submission of academic abstracts and papers 

Version: 04/06/2020 
 
• 
Help to prepare for full scale rollout, if applicable 
• 
Semi-structured interviews of subsample of participants 
• 
Semi-structured interviews of health providers in the trial