Enhanced Community-Based Asthma Monitoring Through Novel Technology
Phase: NA
Conditions: Asthma in Children
Sponsor: Nemours Children's Clinic

PROCEDURE MANUAL 
 
 
 
Enhanced Community-Based Asthma Monitoring Through Novel Technology 
 
 
 
Protocol version # 1 
01.11.23 

Study Site Contact Information 
 
 
Nemours Children’s Hospital, Delaware 
Division of Pediatric Pulmonology 
1600 Rockland Road 
Wilmington, DE 19803 
 
PI 
Abigail Strang, MD 
astrang@nemours.org 
 
(302) 651-6400 
Co-I 
Aaron Chidekel, MD 
Aaron.Chidekel@nemours.org 
 
(302) 651-6400 
 
 

Overview of the Study 
 
 
The primary objective of the proposed study is to pilot test implementation of a protocol for enhanced asthma 
monitoring using novel technology, including mobile spirometry and remote study visits, for rural and medically 
underserved children with persistent asthma in Delaware and to determine its feasibility, acceptability, and 
accessibility. Additionally, the proposed study aims to explore patient and family demographic characteristics 
and social factors associated with successful completion of the program and to explore the preliminary effect of 
the enhanced asthma monitoring program on asthma control and sleepiness as a measure of daytime 
functioning. 
Scientific Rationale 
 
 
Asthma is the most common chronic disease of childhood with significant morbidity, mortality, and 
economic burden in the United States and in Delaware. Asthma affects up to 6 million children in the United 
States (US) with estimated healthcare costs of $81 billion annually.1,25 Despite the significant financial resources 
utilized for asthma and despite advances in preventative medications, asthma-related deaths continue to occur 
with over 3,000 deaths annually in the US.1 DE, in particular, is a national asthma hotspot with a higher than 
average prevalence of childhood asthma (12%).2 Over 25% of DE high school students report a lifetime diagnosis 
of asthma, with even higher rates for racial and ethnically minoritized children. Of those children with asthma in 
DE, 65% experienced an asthma-related visit to their doctor in the past year.2,26  
 
Asthma disproportionally affects minoritized and underserved children who are also less likely to 
receive specialty care and routine lung function measurements.  In the US, asthma burden disproportionally 
affects minoritized and economically disadvantaged children with higher rates among non-Hispanic Black 
children (14.5%) compared to non-Hispanic White (8.2%) children.1 There are also higher rates of asthma among 
individuals of lower socioeconomic status1  and children who live in rural areas.27 Rates of asthma-related deaths 
are twice as high for Black Americans compared to White Americans (21.8 v. 9.5 deaths per million). 1 Among 
children with asthma in DE with near-fatal asthma requiring ECMO support, 100% were Black and utilized 
Medicaid as insurance.28 The reasons for these disparities are multifaceted, but include reduced access to 
specialty asthma care,29,30 financial and transportation constraints,31 and beliefs about medications and self-
management.30  Specialty care is associated with better outcomes for youth with asthma.32,33  NHLBI guidelines 
recommend both specialty care and spirometry, a type of lung function testing, as standard components of the 
diagnosis and management of asthma.10 Spirometry provides objective measures of lung function and is 
necessary to monitor asthma control and response to therapy, especially in children, who may not perceive or 
report ongoing asthma symptoms.34 Although guidelines recommend routine measurements of lung function,10 
current devices available for home use are peak flow meters, which may be inaccurate or even underestimate 
asthma symptoms.35,36 
 
Chronic and uncontrolled asthma causes daytime and nighttime symptoms and increases risk for severe 
exacerbations that may be life-threatening. These chronic symptoms are associated with missed school and 
work days,3-5 decreased quality of life,3, 36 and daytime sleepiness.6-9 Improving asthma control has the potential 
to improve daytime sleepiness and quality of life in children with asthma.9 Therefore, novel and innovative 
approaches to enhance asthma monitoring and access to specialty care, in ways that are acceptable and 
convenient to families, may be transformative for youth with asthma.  
 
Technology-enhanced interventions have the potential to empower families to monitor asthma more 
closely and reduce disparities in asthma care. The use of telehealth for specialty care visits and mobile 
spirometry for monitoring asthma symptoms has the potential to improve outcomes among children from rural 
and underserved areas by reducing the burdens of time and travel to specialty care centers. The use of telehealth 
has been studied in children with asthma with some studies showing non-inferiority to standard in-person visits 
and high patient satisfaction.38 Additionally, small, uncontrolled studies have shown improved symptom control;39, 
40 however, lack of objective measurements of lung function, typically gathered during in-person visits, may 
reduce the effectiveness of telehealth visits. This limitation of telehealth care, however, may be surmounted by 

the increased availability of hand-held, mobile spirometers that allow for monitoring of airway function in the 
home setting and provide objective data to both patients and care teams. Preliminary data show positive 
acceptance and feasibility of using this novel technology with children with asthma and CF.17-21 However, there 
are limited data regarding the use of mobile spirometers in children. In particular, there is little data regarding 
their use in children from rural and underserved areas, a group at higher risk for asthma-related morbidity and 
mortality due to decreased access to care. The utilization of technology-enhanced monitoring for asthma in the 
home setting is a novel approach to engaging patients and families in specialty care without the excessive burden 
of travel and time.  Prior to large-scale interventional studies, it is imperative to assess the feasibility, accessibility, 
and acceptability of this approach as well as any unique concerns regarding the use of such technology specific 
to this population. 
 
Recruitment and Enrollment 
 
Study Eligibility 
• Children with persistent asthma (defined as using at least one controller medication or asthma) ages 12-
17  
• Followed by Nemours Pulmonology and by a primary care practice which meets HRSA criteria as rural 
or medically-underserved 
• Participants must be able to speak and read English.  
• Access to a mobile device with internet connectivity 
• Ability to follow directions to perform study measures 
 
Exclusion criteria   
• 
Significant cardiopulmonary disease other than asthma (Examples: Cystic Fibrosis, complex congenital 
heart disease) 
• 
Non-English Speaking 
 
Enrollment targets 
• 
15 participants  
Identifying and Recruiting Participants 
 
A member of the research team will contact eligible participants by telephone and provide a brief summary of 
the study after review of EMR.  
 
If the potential participant expresses interest in participation, the initial research visit (including consent/assent 
discussion and documentation and completion of initial study measures) will be scheduled at the Milford or 
Wilmington outpatient pulmonology office.  
 
Study Procedures 
 
 
 
 
 
This technology-enhanced asthma pilot study will be completed over 24 weeks using a hybrid approach with 
remote and in-person research visits. Participants with persistent asthma ages 12-17 will be recruited from 
Nemours DE Healthcare System Pulmonology Division.  
 
The initial (week 0) and final (week 24) visits will be completed as in-person visits in the Wilmington or Milford, 
DE, Nemours outpatient pulmonology office. At the initial visit, study measures will be completed, and 

participants will be trained on the use of technology for future remote visits (mobile spirometry device connected 
to mobile application for reporting of results and the use of the telehealth platform). At the initial study visit, in -
office (gold standard) spirometry will be completed as well as mobile spirometry. Interval monthly visits at weeks 
4, 8, 12, 16, and 20 will be completed using remote study procedures with completion of mobile spirometry and 
measures of asthma control and sleepiness. See Table 1 for study timeline. The final study visit at week 24 will 
include similar procedures as week 0, including in-office spirometry. 
 
After completing consent/assent procedures during study visit 1, baseline study procedures including standard 
spirometry using clinic-based pulmonary function equipment (Carefusion Vitalmax™), mobile spirometry (using 
the MIR Spirobank Smart™ spirometer with the Zephyrx Breath Easy® mobile application) will be completed, as 
well as training on the mobile spirometry device and telehealth application. If participants are unable to complete 
reliable spirometry (either standard or mobile after 8 attempts and meet standard ATS criteria for acceptable 
technique), are unable to understand study measures, or if there are any other concerns about participation, the 
participant will be considered a screen failure and the reasons for screen failure recorded.  
 
At the time of the initial study visit, participants will receive the mobile spirometry unit and will be instructed on 
the use of a mobile application for results report generation for future visits. The initial study visit will take 
approximately 2 hours for baseline testing, training, and collection of data. Subsequent study visits will be 
completed at 4-week intervals using a remote video platform with a member of the research team available to 
help complete study measures and, if needed, “coach” the participant during completion of mobile spirometry 
(see Table 1). The participants will be instructed to complete mobile spirometry using the mobile spirometer and 
the application for generation of results. The participant will be given 8 attempts to complete successful mobile 
spirometry. Although the remote application does provide instruction and some immediate feedback to the user, 
the research team member will be available on video for the remote visit for immediate feedback and guidance 
if there are difficulties obtaining the correct technique or technical concerns. If the participant is unable to achieve 
reliable results within 8 attempts, the participant will be instructed to stop testing at that time, and additional 
participant-specific re-training/education will be completed. Time for mobile spirometry completion is expected 
to be 5-10 minutes. Reasons for inability to complete the mobile spirometry (e.g. technical concerns, patient 
effort) will be recorded at each visit.  
 
The estimated time for the remote visit is estimated to be 20-30 minutes. The study-specific Satisfaction and 
Usability Questionnaire will be completed at each visit, which will take approximately 5 minutes to complete. The 
study-specific demographic and psychosocial assessment tool will be completed at the baseline visit, which will 
take approximately 5-10 minutes to complete.  The asthma history questionnaire will be completed at the 
baseline and final visit, which will take 5 minutes to complete. The 5-time asthma control test (ACT®)23 will be 
completed at each study visit as well as the 10-item Epworth Sleepiness Scale for Children and Adolescents 
(ESS-CHAD).24  Participants will receive a pre-paid gift card at the time of study consent, which will be loaded 
with $25 after each in-person study visit and $10 after each remote visit ($100 total for completion of all visits). 
 
All paper forms used in the study (e.g., questionnaires) will be kept in a locked file cabinet. Only members of 
the research team will have access to the human subjects’ data and identifying information. All data will be 
identified only by Subject ID and the master list linking the subjects’ identities to the code numbers, as well as 
consent forms with participant names, will be kept in a password protected excel sheet on the Nemours secure 
server. All electronic study data will be stored in a folder on the Nemours secure shared drive, separate fr om 
the document linking participants to subject IDs, and only study personnel will have access to this folder. 
 
 
 

Table 1. Study Timeline  
 
 
Statistical Considerations 
 
The primary outcome of feasibility will be evaluated by calculating recruitment and retention rates at each study 
time point (e.g. percent of approached individuals who consent to participant, percent of enrolled participants 
who complete each study visit). The percent of patients who are successful at producing mobile spirometry 
results at each study visit will be calculated. The percentage of participants who require additional training 
sessions due to difficulty using the device will be calculated. To measure acceptability, the Satisfaction and 
Usability Survey will be reviewed at the item-level, and specifically, responses of “agree” or “strongly agree” will 
be used as benchmarks of acceptability and feasibility of each item. Responses to the open-ended questions 
will be analyzed for consistent themes across participants. Finally, to measure accessibility, the investigators 
will measure the length of time required to complete all visits and the frequency of any technical or connectivity 
issues. The investigators will meet regularly to review data management procedures and discuss any errors. 
Prior to beginning analyses, the investigators will examine the distribution of the data and identify any potential 
outliers. The investigators will consult closely with the REACH Center biostatistician in analyzing the data. 
 
Descriptive and comparative statistics will be employed to characterize patient factors associated with successful 
study completion (completion of ≥80% of study measures). Categorical variables will be summarized by 
frequencies and percentages, and continuous variables summarized by mean and standard deviation. 
Correlations will be utilized to determine whether any patient factors (e.g. age, grade in school, severity of 
asthma) are associated with successful completion of the pilot (completion of ≥80% of study measures). For 
specific Aim 3, changes in asthma control and sleepiness will be examined longitudinally for each participant. 
Data distributions and change over time will be evaluated. Mean differences will be tested for statistical 
significance using ANOVA.  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Outcome measure 
*Baselin
e 
**Study 
visit 2 
**Study 
visit 3 
**Study 
visit 4 
**Study 
visit 5 
**Study 
visit 6 
*Final 
Time (Weeks) 
0 
4 
8 
12 
16 
20 
24 
Demographic and Psychosocial  
Assessment tool 
X 
 
 
 
 
 
 
Asthma history questionnaire  
X 
 
 
 
 
 
X 
Standard Spirometry 
X 
 
 
 
 
 
X 
Mobile Spirometry 
X 
X 
X 
X 
X 
X 
X 
Asthma Control Test®  
X 
X 
X 
X 
X 
X 
X 
Epworth Sleepiness Scale (ESS-CHAD) 
X 
X 
X 
X 
X 
X 
X 
Satisfaction and Usability 
Questionnaire  
 
X 
X 
X 
X 
X 
X 
*Visit and Measures will be completed in-person  
**Remote study visit using telehealth platform and mobile spirometry device 

 
 
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