Effectiveness of Telemedicine Home Assessments for Identification and Reduction of Asthma Triggers
Phase: NA
Conditions: Asthma in Children
Sponsor: University of Arkansas

 
Title: Efficacy of Telemedicine Home Assessments for Identification and Reduction of 
Asthma Triggers 
PI: Robert Pesek, MD 
Institution: University of Arkansas for Medical Sciences (UAMS) and Arkansas Children’s Hospital/Research Institute 
(ACH/ACRI) 
Sponsor: UAMS Translation Research Institute (UAMS TRI) 
 
Protocol v8  5/27/2021 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Page 1 
  
Principal Investigator:   
Robert D. Pesek, MD 
University of Arkansas for Medical Sciences 
Arkansas Children’s Hospital 
13 Children’s Way, Slot 512-13 
Little Rock, AR 72202 
Telephone: (501) 364-1606  
Email: rdpesek@uams.edu    
                                              
Sub-Investigators:       
Erhan Ararat, MD 
 
 
 
 
University of Arkansas for Medical Sciences 
Arkansas Children’s Hospital 
1 Children’s Way, Slot 512-17 
Little Rock, AR 72202 
Telephone: (501) 364-1006 
Email: eararat@uams.edu  
 
Tamara T. Perry, MD 
University of Arkansas for Medical Sciences 
Arkansas Children’s Hospital 
13 Children’s Way, Slot 512-13 
Little Rock, AR 72202 
Telephone: (501) 364-1060 
Email: perrytamarat@uams.edu  
  
Study Location:                 
Arkansas Children’s Research Institute 
                                             13 Children’s Way 
                                             Little Rock, AR 72202 
 
Version: 
 
 
8 
 
Date:  
 
 
May 27, 2021 
 

 
Title: Efficacy of Telemedicine Home Assessments for Identification and Reduction of 
Asthma Triggers 
PI: Robert Pesek, MD 
Institution: University of Arkansas for Medical Sciences (UAMS) and Arkansas Children’s Hospital/Research Institute 
(ACH/ACRI) 
Sponsor: UAMS Translation Research Institute (UAMS TRI) 
 
Protocol v8  5/27/2021 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Page 2 
Background and Rationale 
Asthma is the most common chronic disease of childhood. Characterized by airway 
inflammation and bronchial hyper-reactivity, affected patients can experience symptoms 
such as cough, shortness of breath, exercise limitation, and wheezing.1 Affected 
children are also at risk of developing acute exacerbations requiring healthcare 
utilization such as emergency department visits and/or hospital admission. An estimated 
26 million Americans currently have asthma, including over 7 million children.2 This 
leads to over 14 million outpatient visits, nearly 2 million emergency department visits, 
and over 400,000 hospitalizations each year with a disproportionate number of these 
coming from low-income and minority populations.3-4 The estimated economic impact 
each year includes over $50 billion in direct costs with an additional $5.9 billion in 
indirect costs due to lost earnings.5-8 Uncontrolled asthma is associated with higher 
medical expenditures and health care utilization, decreased work productivity, and 
missed school days.9 There are multiple environmental factors that can trigger 
exacerbations including infections, weather changes, allergens, and airway irritants.10-11  
Several of these triggers can be found in the home environment and when identified, 
reduction or removal leads to improvements in asthma morbidity.12 Current asthma 
guidelines recommend home environmental assessment and intervention as an 
important aspect of asthma management.1   
 
The majority of research in asthma trigger reduction has focused on inner-city 
populations with less work done in rural populations. While there may be a similar rate 
of asthma between these two populations, rural children may have a higher rate of 
undiagnosed asthma and asthma morbidity, often due to lack of available care.13-14  
Nearly 50% of families living in rural areas have income less than 200% of the federal 
poverty level compared to 27% of those living in non-rural areas.15 Approximately 20% 
of these families lack insurance and as a result are less likely to receive preventive 
medical care.16 Less than 10% of physicians practice in rural areas and access to 
subspecialists is particularly difficult. When combined with the lack of insurance, rural 
populations are woefully underserved. Arkansas is a primarily rural state and also has 
large African American and other minority populations. In certain regions of the state, 
especially the Delta region, minority children with asthma suffered twice the mortality 
rate compared to the national average (45.0 vs 22.2 per 100,000) and had higher rates 
of asthma morbidity.13 
 
Telemedicine (TM) has recently evolved to address some of these concerns. TM 
involves the use of telecommunication systems to deliver health care at a distance 
which can improve access to care while reducing costs. In studies of heart failure, TM 
led to similar outcomes as in-person or phone visits, while in diabetes, TM led to 
improved blood sugar control.17-18 In asthma, TM programs have led to reductions in 
daily asthma symptoms and health care utilization.19 To date, TM has not been utilized 
in asthma home assessment programs. As with clinical care, TM could improve the 
access to this important aspect of asthma care while decreasing the costs associated 
with in-person programs. In this project, we aim to determine the effectiveness of TM 
asthma home assessments/interventions in reducing triggers in a cohort of underserved 

 
Title: Efficacy of Telemedicine Home Assessments for Identification and Reduction of 
Asthma Triggers 
PI: Robert Pesek, MD 
Institution: University of Arkansas for Medical Sciences (UAMS) and Arkansas Children’s Hospital/Research Institute 
(ACH/ACRI) 
Sponsor: UAMS Translation Research Institute (UAMS TRI) 
 
Protocol v8  5/27/2021 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Page 3 
asthmatic children. Approximately 1500 children each year receive care at Arkansas 
Children’s Hospital (ACH) for acute exacerbations of asthma. The majority of these 
children are African American and nearly 25% of these patients live below the federal 
poverty level. Given the burden of asthma in minority populations living in Arkansas, 
targeted home interventions could lead to significant reductions in asthma morbidity.  
Hypothesis and Specific Aims: 
Specific Aim 1: Compare the effectiveness of TM home 
assessments/interventions versus standard of care education for the 
reduction of asthma related triggers. 
 
Hypothesis 1: TM home assessments/interventions will lead to greater reductions 
in asthma-related triggers compared to standard of care education.  
Specific Aim 2: Determine changes in asthma morbidity as a result of asthma 
home  assessments and related interventions.   
Hypothesis 2: TM assessments/interventions will lead to greater reductions in 
asthma symptoms and healthcare utilizations related to acute asthma compared 
to standard of care trigger education. 
Study Design and Procedures 
Design Overview: We will conduct a 6 month randomized pilot trial of 40 pediatric 
patients, ages, >5 and <18 years, with persistent asthma to compare trigger reduction 
performed through TM home assessments/interventions versus standard of care 
education. (Figure 1) For the proposed study, participants will be randomized to receive 
TM home assessments/interventions performed by a trained home visitor (HV) or 
standard of care asthma trigger education by the HV. Those who are randomized to TM 
home assessments/interventions will complete a baseline home assessment and two 
follow-up visits, occurring 2 months apart. Visits will assess the presence of potential 
asthma triggers in the home and frequency of asthma symptoms/exacerbations. TM 
participants will be provided education and materials necessary to reduce asthma 
triggers in the home. Follow-up visits will assess the interval change in presence of 
asthma triggers, change in daily asthma symptoms/exacerbations, and 
participant/family retention of education. For subjects randomized to receive standard of 
care asthma education, written and verbal information will be provided regarding 
identification and removal of potential asthma triggers in the home but no formal 
assessment of the home will be performed, nor will participants in this arm receive 
trigger reduction supplies. The overarching hypothesis is that utilization of 
telemedicine asthma home assessments/interventions will result in higher efficacy for 
trigger reduction, asthma outcomes, patient/family satisfaction, and retention of trigger 
education compared to standard of care asthma education.  
 
Figure 1. Summary of Study Design 

 
Title: Efficacy of Telemedicine Home Assessments for Identification and Reduction of 
Asthma Triggers 
PI: Robert Pesek, MD 
Institution: University of Arkansas for Medical Sciences (UAMS) and Arkansas Children’s Hospital/Research Institute 
(ACH/ACRI) 
Sponsor: UAMS Translation Research Institute (UAMS TRI) 
 
Protocol v8  5/27/2021 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Page 4 
 
Study population: We will recruit 40 children (ages >5 and <18 years) with persistent 
asthma to participate in a prospective, randomized trial. Participants will be recruited 
from ACH locations including the emergency department, inpatient services, general, 
and/or asthma specialty (Allergy/Immunology, Asthma, Pulmonary) clinics. 
 
Screening and Eligibility: A partial HIPAA waiver will be obtained to allow for access 
to identifiable health information in order to screen and recruit for this study. Patients will 
be pre-screened to determine age and persistent asthma diagnosis eligibility. The pre-
screening process will involve the research staff reviewing the recruitment clinics, 
emergency department, and inpatient services daily EPIC schedules, to capture the 
age, diagnosis and potential participant’s name, parent name, phone number and zip 
code. This information will be logged into a screening log in Excel. The screening log 
will be password protected and the research coordinator, study respiratory therapist and 
principal investigator will have access to this screening log. The research staff will call 
the potential participant/caregiver to provide a brief introduction (approximately 2 
minutes) about the study. No additional PHI will be obtained during the introduction call. 
The purpose of the call is informative and to provide the potential participant/caregiver 
the opportunity to learn more about the research study during their scheduled clinic 
visit.     
 
Patients identified as eligible for the study will be contacted and if interested in study 
participation, will be scheduled for a screening, enrollment, and initial demographic 
assessment visit to occur at the ACH campus.   
 
Inclusion Criteria:  
 
1) Age ≥ 5 years and ≤ 18 years 
2) Have a diagnosis of persistent asthma as defined by national guidelines 
criteria1 
 
3) Patient receives care in ACH primary care, in patient and/or specialty clinics 
 
1:1 Randomization 
 
Telemedicine 
Home 
Assessment 
Standard of 
care as 
asthma 
education  
Children with 
persistent 
asthma seen in 
ACH 
subspecialty 
clinics  
Telemedicine 
Follow-Up 
Home 
Assessment  
Telemedicine 
Final Home 
Assessment  
Follow-Up 
asthma 
education 
Assessment  
Follow-Up 
asthma 
education 
Assessment 
4 months 
2 months 
End of study 
phone 
assessment  
End of study 
phone 
assessment  
6 months 

 
Title: Efficacy of Telemedicine Home Assessments for Identification and Reduction of 
Asthma Triggers 
PI: Robert Pesek, MD 
Institution: University of Arkansas for Medical Sciences (UAMS) and Arkansas Children’s Hospital/Research Institute 
(ACH/ACRI) 
Sponsor: UAMS Translation Research Institute (UAMS TRI) 
 
Protocol v8  5/27/2021 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Page 5 
4) Patient has had at least one or more acute exacerbations of asthma within the 
12 months prior to enrollment that led to an emergency department visit, hospital 
admission, or prescription for systemic steroids   
5) English speaking participants/parents 
6) Access to WIFI, smartphone or mobile device (tablet) 
  
 
Exclusion Criteria:  
 
1) Age <5 or >18 years  
 
2) Non-English speaking participants/parents 
 
  
 
3) Patients not receiving primary and/or asthma specialty care or inpatient 
 
services at ACH  
4) Inability of patient or family to participate in TM evaluation due to lack of 
access to WiFi or smartphone or mobile device 
 
Rationale for only enrolling participants with persistent asthma: Only children with 
persistent asthma will be recruited to participate in the proposed study because they 
require regularly scheduled, follow-up to monitor asthma control and prevention of 
future exacerbations.1 Patients with intermittent asthma will not be recruited for 
participation because they typically are not at high risk of acute exacerbation nor require 
specialty care. 
 
Recruitment: Potential participants will be recruited from ACH primary care or asthma 
subspecialty clinics through direct patient contact and advertising. These patients may 
also receive care in other ACH settings such as the emergency department, inpatient 
services or may be registered in institutional research participant databases, so we will 
recruit from these locations if needed to meet recruitment goals. Only one child per 
household who meets eligibility criteria will be enrolled.  
 
We will utilize flyers, ACH/ACRI Intertube, and electronic signage to advertise the study. 
We will advertise via ACH/ACRI social media (i.e. Facebook, Twitter, and YouTube). 
The study will also be advertised via word of mouth. The advertisements will provide the 
contact information allowing parents/caregivers/potential adult participants to directly 
contact research staff. The clinics will be provided the study coordinator/respiratory 
therapist contact information to address any questions.  
Screening, initial demographic assessment and informed consent: The informed 
consent/assent process will be carried out by trained research staff. All potential 
participants will be screened to ensure they meet inclusion and exclusion criteria as 
outlined above. After pre-screening, at or before the time of the potential participant’s 
scheduled clinic visit, the research team will ask the parent/caregiver more detailed 
screening questions to determine eligibility prior to enrollment.  The detailed screening 
may occur in person or via phone conversation from the research team’s office or from 
a private, quiet area different from the research team’s office.  If eligible, informed 
consent/assent will be obtained from interested parents/caregivers/legal authorized 

 
Title: Efficacy of Telemedicine Home Assessments for Identification and Reduction of 
Asthma Triggers 
PI: Robert Pesek, MD 
Institution: University of Arkansas for Medical Sciences (UAMS) and Arkansas Children’s Hospital/Research Institute 
(ACH/ACRI) 
Sponsor: UAMS Translation Research Institute (UAMS TRI) 
 
Protocol v8  5/27/2021 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Page 6 
representative and patients. Adolescents who reach the age of maturity (turn 18 years 
of age) while enrolled during the study period will be re-consented. The research staff 
will contact the parent/caregiver/legal authorized representative prior to the participant's 
age of maturity and a time will be scheduled to re-consent the participant using the IRB 
approved Informed Consent document. In addition to survey and home assessment 
data, we will obtain consent from caregivers and adult participants to access 
participants’ health record to assess and monitor healthcare utilization for asthma. In the 
event a parent/potentially eligible participant agrees to participation at a later time after 
the eligibility screening, the informed consent interview and initial demographic 
assessment can be completed at an ACH campus location. During the consent/assent 
process, the participant will be given a copy of the consent document and asthma 
trigger education materials.  Participant identification and enrollment will take place until 
we meet our enrollment goal.  
 
Randomization: Subjects will be randomized 1:1 into 2 groups. One group will receive 
TM home assessments/interventions for identification and reduction of asthma triggers 
in the home while the other group will receive standard of care asthma trigger 
education. Randomization will occur at the time of enrollment visit after consent and 
assent is obtained and initial demographic assessment is complete. All participants will 
receive the same asthma education and trigger reduction materials. For those 
randomized to TM, participants will receive TM assessment of their home as well as an 
Asthma Home-Assessment kit that will provide supplies to reduce asthma triggers in the 
home.    
 
The Role, Qualifications, and Expectations of the Home Visitor (HV): The Home 
visitor (HV) is a frontline public health worker who is a trusted member of and/or has an 
unusually close understanding of the community served. The HV is in a unique position 
to partner with families due to living in the area they are serving or having similar 
cultural backgrounds. The person acting in this role will be responsible for performing 
standard of care trigger education and asthma TM home assessments to aide in the 
identification and reduction of exposure to indoor asthma triggers. The goal is to 
establish a trusting partnership with participants and family members by providing 
education and tools to maximize asthma control and management as well as model 
appropriate behavior standards and core values as exemplified by Arkansas Children’s 
mission and vision statement.  For the purpose of this pilot project, the HV will enter into 
a contract agreement with UAMS or the Arkansas Children’s Research Institute (ACRI) 
for the period of the pilot project. A minimum of a high school education, with a Bachelor 
degree in a health or social science related field preferred. In addition, one year of 
experience in some type of home visiting related to health care. Asthma specific training 
will be provided in the amount of 10 hours by a Certified Asthma Educator. The HV will 
receive CITI training as well. The education materials are provided by the Association of 
Asthma Educators and a certificate of completion is awarded after post testing. The HV 
will be expected to carry out the asthma home assessment via TM consistent with the 
procedures listed below.  
 

 
Title: Efficacy of Telemedicine Home Assessments for Identification and Reduction of 
Asthma Triggers 
PI: Robert Pesek, MD 
Institution: University of Arkansas for Medical Sciences (UAMS) and Arkansas Children’s Hospital/Research Institute 
(ACH/ACRI) 
Sponsor: UAMS Translation Research Institute (UAMS TRI) 
 
Protocol v8  5/27/2021 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Page 7 
Study Procedures, Outcome Measures, and Longitudinal Assessments: For the 
proposed study, participants will receive home assessments for identification and 
reduction of asthma triggers via TM or standard of care asthma trigger education.  
Eligible subjects will undergo a total of 4 visits including an initial, in person 
screening/enrollment and initial demographic assessment visit, lasting approximately 1-
2 hours. After enrollment and randomization, each TM participant will receive three 
home assessments including an initial baseline home assessment and two follow-up 
assessments, each 2 months apart (+/- two weeks). The home assessment visits will 
last approximately 90 minutes. During the TM home assessment, a home environmental 
asthma trigger assessment checklist (heat) will be utilized to identify potential asthma 
triggers in the subject’s home. TM participants and their household will receive 
education and supplies, at the time of enrollment, for reduction of any identified triggers 
as well as education and supplies for general cleaning of the home. The Asthma Home 
Kit supplies provided to participants will include: Quickie 45TRI automatic sponge mop, 
child resistant roach and mice bait stations, zippered mattress covers, zippered pillow 
covers, trash can with lid, trash bags, anti-microbial sponges, rubber gloves, non-toxic 
all-purpose cleaner, Borax powder, scrubbing pads, Quickie home pro cleaning cloths, 
broom/dust pan, dusting spray, and paper towels. Each kit will contain labeled 
instructions on the proper use and/or storage of each item. 
 
 For those receiving standard of care education, each subject will receive the same 
education given to TM subjects for identification and reduction of asthma triggers, but 
will not receive TM home assessments or trigger reduction kits.  Standard of care 
subjects will be contacted again at 2 months and 4 months (+/- 2 weeks) to assess 
retention of education materials and to provide additional asthma education and trigger 
reduction info.  All participants will then receive a phone follow-up at 6 months (+/- two 
weeks) from the time of enrollment.  
 
Dust samples will be collected from all subjects in both study arms. We will use the 
Dustream collector (Indoor Biotechnologies) to collect the dust specimens. Subjects will 
receive a dust collector kit that attaches to a vacuum cleaner. All participants will 
receive written instructions at the time of enrollment but will also be contacted by TM to 
assist with proper collection of the dust samples. These samples will be mailed to the 
study team using pre-paid postage and packaging through the USPS.  One sample will 
be collected from the main living area and another sample will be collected from the 
participant's sleeping area during the baseline visit. A second set of dust samples will be 
collected at the 4 month visit for both groups.  
 
Each participant will be contacted by phone at 6 months for an end of study visit. This 
phone conversation should last approximately 15-30 minutes. In the event the 
participant is no longer available on the day of the scheduled follow-up visits or 6-month 
phone contact, three attempts will be made to complete study procedures/ end of study 
phone call. If the research staff are unsuccessful after the third scheduled visit or phone 
call attempt, an email will be sent to the parent/caregiver asking that he/she contact the 
research staff via return phone call.  

 
Title: Efficacy of Telemedicine Home Assessments for Identification and Reduction of 
Asthma Triggers 
PI: Robert Pesek, MD 
Institution: University of Arkansas for Medical Sciences (UAMS) and Arkansas Children’s Hospital/Research Institute 
(ACH/ACRI) 
Sponsor: UAMS Translation Research Institute (UAMS TRI) 
 
Protocol v8  5/27/2021 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Page 8 
 
Telemedicine Home Assessment: 
Interactive Video (IAV) will be utilized to complete the TM home assessment. This mode 
of communication allows for real-time audio and visual interaction between individuals in 
two different locations. The participant will be located in their primary resident, while the 
HV will be at an office location that allows for patient privacy. This would include a room 
with IAV set up and the ability to close the door for privacy. The interaction will be in 
real-time interactive video via a secure link with ACH. The research staff will provide the 
participant/parent written instructions on how to connect via IAV. Participants may use 
their own smart phone, tablet, or lap top that has Wi-Fi/data capability. The device must 
be mobile so the HV can see all parts of the home that are being assessed.  The 
participant/parent/caregiver will use the ACH secure link: 
asthma.research.space@archildrens.org to connect with the HV via teleconference.  
The participant/parent/caregiver will also be given a second means of a secure 
connection. He/she can click to join the link for audio/video using Chrome browser only 
at:https://telehealth.archildrens.org/invited.sf?secret=0BpuE4x3LrLOFIAS5mlN2Q&id=1
38052178.  
 
At the start of the TM assessment, the HV will review the home assessment process 
and answer any questions posed by the participant/parent. The steps for the TM home 
assessment 1st Visit include: 
1. Ask the participant/parent to remove and inspect items in the kit. These items 
should be visible to the HV. In addition, the HV will have a sample kit to help 
participants/parent find and visualize each item. The HV will review 
recommendations for use and storing of all items, emphasizing those that 
should be kept away from children. 
2. Device positioning to allow performance of the home assessment 
3. All data to be collected during the assessment will be reviewed and 
participants will verbalize understanding prior to collection. 
4. Each visit will cover the following topics and items: 
 Education topics: basic facts of asthma, triggers, medication/inhaler 
technique 
 Environmental Assessment 
 Asthma Control Test (ACT) and other surveys 
 Reduction strategies for identified asthma triggers 
 
Standard of Care Asthma Education:  
At each visit, the participant/parent will be contacted to cover the following topics and 
items: 
 Education topics: basic facts of asthma, triggers, medication/inhaler 
technique 
 Asthma Control Test (ACT) and other surveys 
 Reduction strategies for identified asthma triggers 
 

 
Title: Efficacy of Telemedicine Home Assessments for Identification and Reduction of 
Asthma Triggers 
PI: Robert Pesek, MD 
Institution: University of Arkansas for Medical Sciences (UAMS) and Arkansas Children’s Hospital/Research Institute 
(ACH/ACRI) 
Sponsor: UAMS Translation Research Institute (UAMS TRI) 
 
Protocol v8  5/27/2021 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Page 9 
Outcome Measures: 
Outcomes of patients receiving home assessments/interventions via TM will be 
compared to patients receiving standard of care trigger education. (Table 1) The 
primary outcome will be the mean difference in dust mite levels found in home dust 
samples at 4 months compared to baseline and between TM and standard of care 
groups. Other outcomes will be any change in the home environmental asthma trigger 
assessment score (heat) as a result of trigger mitigation performed at each home visit 
(TM group), changes in ACT score, comparison in number of exacerbations requiring a 
healthcare utilization or prescription for systemic steroids, and patient/household family 
retention of education provided during visits (both groups). We will measure study 
satisfaction among all participants and telemedicine-specific satisfaction among TM 
participants.  
 
Table 1. Summary of Outcome Measures 
 
 
Baseline 
 
2months 
 
4months 
  
6months 
Dust Mite Levels 
X 
 
X 
 
Asthma Control Test (ACT) 
X 
X 
X 
X 
Healthcare Utilization 
X 
X 
X 
X 
Satisfaction Survey 
X 
X 
X 
X 
Information Recall Survey 
 
X 
X 
X 
 
Primary Outcome Measure: The primary outcome measure will be the mean 
difference in dust mite levels found in home dust samples at 4 months compared to 
baseline and between TM and standard of care groups. Dust mites (Dermatophagoides 
farina and Dermatophagoides pteronyssinus) are one of the most common triggers for 
asthma and are commonly found throughout homes. ELISA testing can be utilized to 
quantify household dust mite levels with levels ≥ 2 mcg/g considered positive.20 
Prolonged reductions in household dust mite concentrations are associated with 
improved asthma outcomes.21   
 
Secondary Outcome Measures: 
Asthma Control Test (ACT): The ACT is a validated 5-question (≥ 12 years of age) or 
7-question (<12 years of age) survey used to assess asthma control. ACT is used for 
symptoms monitoring as per guidelines1 and has been identified as an appropriate 
asthma control composite score in clinical research.22  
Healthcare Utilization: At baseline, participants will be surveyed to determine the 
number of acute exacerbations he/she has experienced in the past 12 months resulting 
in hospitalization, emergency room/sick visits, or systemic steroid use. At each study 
time point, participants will record acute exacerbations resulting in hospitalization, 
emergency room or sick visits, or systemic steroid use since the previous asthma 
education session/TM home assessment visit. 
Visit Satisfaction: We will administer ACH’s outpatient satisfaction survey, supplied by 
National Research Corporation, at the completion of each visit for both groups. For TM 

 
Title: Efficacy of Telemedicine Home Assessments for Identification and Reduction of 
Asthma Triggers 
PI: Robert Pesek, MD 
Institution: University of Arkansas for Medical Sciences (UAMS) and Arkansas Children’s Hospital/Research Institute 
(ACH/ACRI) 
Sponsor: UAMS Translation Research Institute (UAMS TRI) 
 
Protocol v8  5/27/2021 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Page 10 
participants, we will administer the telemedicine patient satisfaction survey23 that will 
ask respondents to assess four areas regarding the effectiveness and quality of care 
received via TM: 1) risk and benefits, 2) effectiveness, 3) efficiency, and 4) future 
adoption.  
Education Recall: Participants and household parents/caregivers will be administered 
a questionnaire at each follow-up visit and again via phone call at 6 months to assess 
recall of education provided during each home assessment.  
 
The ACT, healthcare utilization, visit satisfaction and education recall questionnaires will 
be completed via a mobile link and take approximately a total of 20 minutes to 
complete. 
  
Participant Withdrawal 
Since participation is strictly voluntary, participants may withdraw at any time. 
Participants will only be replaced if withdrawal occurs prior to the beginning of the first 
home assessment. Participants may be withdrawn due to non-compliance with study 
related procedures. Data from the baseline assessment or the subsequent data 
collection time points for participants who withdraw or who are lost to follow-up will be 
analyzed. 
 
Risks and Benefits  
A potential risk to study participants is the potential for loss of confidentiality. Measures 
to protect confidentiality will be implemented according to UAMS/ACH/ACRI policies. 
There are no significant risks to participants regarding the home assessment products 
being used. All products utilized in cleaning of the home or with the reduction in asthma 
triggers are non-toxic. The pesticides in the bait traps should not be handled by young 
children or pregnant individuals during their first trimester. We recommend the 
participant/household family member read all labeled warnings prior to opening the 
package. There are no significant risks associated with use of telemedicine as the 
connection is via secure link with ACH.   
 
There could be no direct benefits to the study participants. Potential benefits to 
participation include improved education of participating subjects and family members in 
regards to identification and removal of asthma triggers. Participants in the TM group 
will be provided supplies to assist with reduction in home asthma triggers throughout the 
study period. This may improve the participant’s asthma morbidity leading to decreased 
healthcare utilization. Knowledge gained from the study could also potentially benefit 
patients in the future. 
 
Participant Incentives 
Participants will receive $25 for each completed visit for a total of $75 during the 
enrollment period. The monetary incentives will be issued via ClinCard. ClinCard is an 
electronic debit card method that allows participants to have access to their study 
incentives immediately at the conclusion of the home assessment. The participant pays 

 
Title: Efficacy of Telemedicine Home Assessments for Identification and Reduction of 
Asthma Triggers 
PI: Robert Pesek, MD 
Institution: University of Arkansas for Medical Sciences (UAMS) and Arkansas Children’s Hospital/Research Institute 
(ACH/ACRI) 
Sponsor: UAMS Translation Research Institute (UAMS TRI) 
 
Protocol v8  5/27/2021 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Page 11 
no fees to access funds that are securely loaded to their unique debit card. The 
research staff will assist the participant to create a username and the participant is 
navigated via www.myclincard.com to select their unique 4-digit PIN.  ClinCard is used 
for in-store and online purchases. It’s accepted at ATM locations. The use of ClinCard 
eases the administrative cost and burden associated with incentive processing. In the 
event a debit card is lost or damaged, it can be replaced at no cost to the participant. 
Any existing balance on the previously issued card will automatically transfer to the 
newly issued debit card. UAMS ClinCard administrator will conduct the research staff 
ClinCard training prior to study enrollment. The initial debit card will be issued to the 
parent/adult participant during the consent interview. At the conclusion of each visit, the 
research staff will load the $25 incentive onto the debit card. 
 
An alternate incentive payment method will utilize UAMS accounts payable. The 
research staff will submit the participant incentive via invoice or Workday to UAMS 
accounts payable. Accounts payable will approve the invoice/requisition and submit a 
paper check to the participant via the address listed on his/her W9. This process could 
take upwards of three weeks to process and USPS mail the participant his/her check.   
Data Handling and Recordkeeping 
The Principal Investigator will carefully monitor study procedures to protect the safety of 
research subjects, the quality of the data and the integrity of the study. All study 
participant material will be assigned a unique identifying number. Only study staff will 
have access to the code and information that identifies the participants in this study. 
Questionnaires, consent and assent forms will be stored in a binder in a locked 
protected file in a locked office on ACH campus. Only study personnel will have access 
to these forms. All participant materials will be recorded in a REDCap database utilizing 
the unique subject identifier to protect the confidentiality of the individuals.  Maintaining 
a link to identifiers until after data analysis is complete allows for rechecking of data to 
ensure data integrity and improved study design. For dust samples, only the unique 
identifying number will be used to identify subject samples during shipping to the 
processing lab.  Samples will be discarded after lab analysis. At the end of the study, 
documents will be archived according to UAMS/ACH/ACRI policies regarding 
destruction of research records. Electronic records will be stored on the ACRI/UAMS 
servers which are password protected.  
 
Data Analysis 
Sample size:  
Analysis for the primary endpoint: The primary outcome measure is level of dust mite 
allergens as measured by the MARIA™ test data. Using a one-way analysis of 
covariance, we estimated that a sample size of 20 in each of the two groups will yield at 
least 96% power to detect a 4 µg/g difference between group means assuming a 
common standard deviation of 2 and a two-sided significance level of 5%. 
 

 
Title: Efficacy of Telemedicine Home Assessments for Identification and Reduction of 
Asthma Triggers 
PI: Robert Pesek, MD 
Institution: University of Arkansas for Medical Sciences (UAMS) and Arkansas Children’s Hospital/Research Institute 
(ACH/ACRI) 
Sponsor: UAMS Translation Research Institute (UAMS TRI) 
 
Protocol v8  5/27/2021 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Page 12 
Analysis for the secondary endpoint: To evaluate the secondary outcome variables, the 
distribution for each outcome (i.e. home environmental asthma trigger score (heat), ACT 
score, healthcare utilization, visit satisfaction, and education recall) will be first assessed 
with summary statistics and graphical measures. It is anticipated that the distribution for 
some of these variables will be positively skewed. In cases of non-normal data, a 
logarithmic or square root transformation will be applied to normalize the distribution of 
the data. Secondary outcomes will be assessed for significant differences between 
groups and from baseline to 4 months and 6 months using a univariate repeated 
measure analysis of variance that will include a time x group interaction. 
 
All tests will be two-sided and assume a significance level of 5%.  All statistical analyses 
will be performed using SAS software version 9.4 (SAS Institute Inc., Cary NC, USA). 
Missing data and general considerations: All reasons for drop out and missing data will 
be documented and reported. Subjects will be replaced if the dropout rate exceeds the 
estimate of 10%.   
 
Ethical Considerations 
This study will be conducted in accordance with all applicable government regulations 
and UAMS research policies and procedures. This protocol and any amendments will 
be submitted and approved by the UAMS Institutional Review Board to conduct the 
study.  
 
At the time of the detailed screening, the parent/caregiver/adult participant will indicate 
“Yes” on the eligibility document acknowledging verbal consent to complete the 
eligibility screener. The formal consent of each subject, using the IRB-approved consent 
form, will be obtained before the participant is submitted to any study procedures. All 
participants for this study will be provided a consent form describing the study and 
providing sufficient information in language suitable for participant to make an informed 
decision about their participation in this study. The person obtaining consent will 
thoroughly explain each element of the document and outline the risks and benefits, 
alternate treatment(s), and requirements of the study.  
 
The consent process will take place in a quiet, private room and participants may take 
as much time as needed to make a decision about their participation. Participant privacy 
will be maintained and questions regarding study participation will be answered. No 
coercion or undue influence will be used in the consent process. Assent will be obtained 
from capable participants 7-17 years of age. This consent form must be signed by the 
participant or legally authorized representative, and the individual obtaining the 
consent. A copy of the signed consent will be given to the participant, and the informed 
consent process will be documented in each participant’s research record.   
 
CONFIDENTIALITY: The participant’s records will be kept confidential with the 
exception of the Office for Human Research Protection (OHRP), UAMS IRB and other 
institutional oversight offices.  The participant will be made aware that the Investigator 

 
Title: Efficacy of Telemedicine Home Assessments for Identification and Reduction of 
Asthma Triggers 
PI: Robert Pesek, MD 
Institution: University of Arkansas for Medical Sciences (UAMS) and Arkansas Children’s Hospital/Research Institute 
(ACH/ACRI) 
Sponsor: UAMS Translation Research Institute (UAMS TRI) 
 
Protocol v8  5/27/2021 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Page 13 
and HV are considered mandated reporters.  As a mandated reporter the investigator 
and HV might be required to report any child abuse or neglect, as well as any intention 
of study participants for self-harm or harm of others. The Investigator and HV, if ordered 
to do so by a court of law, may also be required to disclose information the participant 
has provided. 
 
Dissemination of Data 
We will protect the rights and privacy of all human subjects who participate in this 
research. The proposed research will include data from 40 children participating in the 
trial. The final dataset from the trial will include demographic, medical, and survey data 
from participants. The final dataset will be stripped of identifiers prior to release for 
sharing.  Sharing of data will be accomplished by publication in the scientific literature, 
presentation at national scientific meetings, as well as communicating our findings to 
the public through the ACRI and UAMS Translational Research Institute websites. 
 
 

 
Title: Efficacy of Telemedicine Home Assessments for Identification and Reduction of 
Asthma Triggers 
PI: Robert Pesek, MD 
Institution: University of Arkansas for Medical Sciences (UAMS) and Arkansas Children’s Hospital/Research Institute 
(ACH/ACRI) 
Sponsor: UAMS Translation Research Institute (UAMS TRI) 
 
Protocol v8  5/27/2021 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Page 14 
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Title: Efficacy of Telemedicine Home Assessments for Identification and Reduction of 
Asthma Triggers 
PI: Robert Pesek, MD 
Institution: University of Arkansas for Medical Sciences (UAMS) and Arkansas Children’s Hospital/Research Institute 
(ACH/ACRI) 
Sponsor: UAMS Translation Research Institute (UAMS TRI) 
 
Protocol v8  5/27/2021 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Page 15 
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