BREATHES: Bringing Respiratory Education for Improved Adherence and Technique Home Through E-interventions for Self-management
Phase: NA
Conditions: COPD
Sponsor: University of Chicago

 
 
 
 
 
 
BREATHES:  
Bringing Respiratory Education for Improved 
Adherence and Technique Home Through E-
Interventions for Self-management 
 
Document date: September 27, 2019 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

BACKGROUND 
Chronic obstructive pulmonary disease (COPD) results in nearly 750,000 hospitalizations 
annually and is the third leading cause of 30-day hospital readmissions in the United States.1,2 
Improving the quality of care for hospitalized COPD patients has recently become a national 
priority through the Centers for Medicare and Medicaid Services’ Hospital Readmissions 
Reduction Program.3,4 A key element of improving care quality is translating existing evidence 
into improved practice.5,6 Extensive evidence exists to support the efficacy of inhaled 
medications to control and reduce COPD symptoms and to improve patient outcomes.7–17 
However, the real-world effectiveness of these medications is often limited due both to poor 
inhaler technique and to insufficient adherence to treatment plans.10,11,18–26 Most interventions for 
hospitalized patients with COPD focus on medication reconciliation, treatment optimization, and 
inhaler technique education prior to being discharged home.27–29 However, after discharge 
home, patients quickly lose inhaler technique skills, have difficulty adhering to complex 
regimens, and lack tools to aid adherence, such as lung function response to their treatment 
regimen.8,10,11,30,31 Interventions to reinforce skills and support adherence are needed across 
care transitions to reduce the risk of deleterious health outcomes. 
Simple and feasible at-home interventions to provide skills training and adherence support are 
needed. Our novel idea is to pair at-home inhaler skill training with at-home spirometry 
measurements to comprehensively support both medication skill and adherence. I propose 
testing a novel at-home self-management support program called “BREATHES” (Bringing 
Respiratory Education for improved Adherence and Technique Home through E-interventions 
for Self-management) Program. BREATHES will include two main components: first, self-
directed inhaler skill training sessions through the virtual Teach-To-Goal (V-TTG) intervention I 
developed and tested during my K2332,33 and, second, a handheld lung function device to 
provide physiologic feedback and capture medication adherence called SpiroPD.34,35 TTG is a 
patient-centered strategy that uses cycles of assessment and demonstration tailored to patients’ 
self-management needs; my research shows in-person TTG is effective for teaching inhaler 
technique and reduces acute care utilization.10,11,18,31,36 Virtual-TTG delivers the key features of 
TTG using virtual patient-directed lessons through novel adaptive technology that provides 
tailored self-assessment and training.32,33 My studies demonstrate participants’ willingness to 
use V-TTG at-home for post-discharge booster education and show that V-TTG is effective and 
may be non-inferior to in-person TTG in significantly reducing inhaler misuse among 
hospitalized patients.32-33 However, it remains unknown whether at-home V-TTG sessions will 
maintain self-management skills over the longer term and how direct physiologic lung 
monitoring support can impact medication adherence. The proposed studies will determine 
whether combining at-home skill training with objective measurements of lung function and 
adherence monitoring through the BREATHES Program improves self-management skills and 
medication adherence in the first 30 days after hospitalization for COPD. 
PURPOSE & HYPOTHESIS 
Our central hypothesis is that patients hospitalized for COPD who subsequently complete the 
at-home BREATHES Program with V-TTG skill training and SpiroPD adherence support will 
retain increased medication knowledge, skill, self-efficacy, and adherence that otherwise decays 
substantially by 30 days post-discharge. To test this hypothesis, I propose the following specific 
aims: 
SA1. Determine the feasibility of, adherence to, and efficacy of at-home V-TTG for 
ongoing inhaler skill training. Hypothesis: Participants who complete both in-hospital and at-
home V-TTG will have a significantly increased likelihood of demonstrating effective respiratory 
inhaler technique within 30 days after hospital discharge compared to in-hospital technique.  
 

SA2. Determine the feasibility of, adherence to, and efficacy of at-home SpiroPD for 
COPD medication adherence support. Hypothesis: Participants’ use of SpiroPD (PMD 
Healthcare) will significantly improve their COPD medication adherence.  
METHODS OVERVIEW 
We will voluntarily enroll 70 inpatients admitted to the University of Chicago Medicine over the 
course of 12 months into the at-home BREATHES Program.  After obtaining informed consent, 
participants will complete in-hospital skills, lung function, and medication adherence 
assessments followed by the BREATHES at-home V-TTG inhaler learning program with self-
monitoring and adherence support through the SpiroPD device. Participants will be trained on 
V-TTG and SpiroPD use in the hospital. The V-TTG intervention uses novel adaptive learning 
features that allow learners to participate in tailored educational sessions. They will begin every-
other-day lung function assessments using the SpiroPD device in the hospital and continue on 
discharge. At 48-72 hours after discharge, participants will receive  a unique username and 
password to complete the at-home V-TTG sessions on any of their own desktop or handheld 
devices; they will complete the V-TTG session at least one time in the first 30 days. Participants 
will receive reminders for completion of the V-TTG inhaler training and daily lung function 
monitoring via text messaging Adherence to the at-home V-TTG session (captured through the 
Smart Sparrow platform), lung function monitoring (captured via the SpiroPD device), and 
objective inhaler medication adherence (captured via Propeller Health Bluetooth objective 
monitoring; only 30 of these 70 patients will have objective medication adherence captured) will 
be assessed throughout the 30-days after discharge via the HIPAA compliant interface. 
Participants will return at 30 days post-hospital discharge for an in-person evaluation of their 
inhaler skills, lung function, and acute care utilization.  
RECRUITMENT 
Admission logs (EPIC) at the University of Chicago will be examined each day to screen for 
potentially eligible inpatients. The treating physician will be contacted for verbal assent using 
standardized text.  Among patients whose physician provides assent, medical records will be 
reviewed to ascertain eligibility and informed consent will be sought from eligible patients. 
Approximately 70 patients will be recruited at the University of Chicago Medicine over 12 
months. 
Study Schema  
 
Table 1: Data Collection Tools 
 
Hospital 
Home 
30-day  
V-TTG adherence 
Smart Sparrow platform data capture 
- 
X 
- 
Inhaler technique 
Validated inhaler checklists 
X 
- 
X 
Inhaler 
knowledge, 
efficacy, skills 
Inhaler step knowledge, applied inhaler use skill, and attitudes for inhaler self-
efficacy assessed through short-answers.  
 
X 
 
X 
 
X 
Lung function 
KoKo® portable spirometer: lung function (FEV1 %predicted). 
Handheld SpiroPD device (up to daily, at home)  
X 
X 
- 
X 
X 
X 
Treatment 
Adherence 
 
Self-reported: Medication adherence report scale (MARS); dose-counter on 
applicable devices; optional medication diary on the SpiroPD device 
Objective: Propeller Health© Bluetooth devices.  
X 
 
- 
- 
 
X 
X 
 
X 
Self-efficacy 
 “I am confident that I know how to use [inhaler] correctly, (5-point scale).  
X 
X 
X 
Quality of life 
(QOL) 
The Airway Questionnaire (AQ-20) 20-item tool assesses effect of current 
symptoms in everyday life for patients with COPD.  
 
X 
 
- 
 
X 
Symptoms  
Modified Borg Dyspnea Scale; COPD Severity Score.  
X 
- 
X 
Health Literacy 
Short Test of Functional Health Literacy in Adults: 36 item tool.  
X 
- 
X 

Data Collection Time Points 
1. In-Hospital Baseline Assessments. Research Assistant (RA) will assess participants’ baseline 
inhaler technique, inhaler self-efficacy, lung function, and self-reported adherence to their 
treatment regimen.  
2. In-Hospital Education: Research Assistant (RA) provides in-person TTG inhaler training and 
training on how to use the V-TTG and lung function monitoring at home.  
3. In-Hospital Post-Education Assessments. RA will obtain post-education assessments.10  
4. Post-Discharge At-Home BREATHES Program with V-TTG education and lung function 
monitoring. The participant will complete up to daily lung function (goal of every other day) and 
medication adherence diaries using the SpiroPD device.  The RA will give a unique username 
and password to each participant to access the V-TTG inhaler training after they have been 
discharged home. The V-TTG should be completed at least once within the first 30 days after 
discharge. The RA will send up to three reminders for completion of the lung function monitoring 
and V-TTG via text messaging. Participants will use their own device (tablet, laptop or desktop 
computer, or smartphone) for V-TTG use at home. For some patients, data will be collected 
each time they use their inhaled medication as prescribed. This data will be collected 
automatically when medication is utilized via a Propeller Health device attached to the inhaler. 
Patients should use their medication as they are instructed by their provider; no specified usage 
will be provided by the research team. Only data from regular use will be collected for this 
portion of the study. 
5. Post-Discharge Assessments. Thirty days (+/-7 days) after discharge, participants will return 
for an in-person study visit to assess inhaler technique, adherence measures, lung function, and 
other assessments.  
Device Data Collection 
The SpiroPD device will record participant use and lung function scores. These measurements 
are stored in a HIPAA compliant server over wifi and are available to the participant and 
research team. Data from the V-TTG educational modules will be collected via the Smart 
Sparrow platform. For a subset of approximately 30 patients, a device by Propeller Health will 
measure  objective medication use and adherence. This device will collect only use of an inhaler 
medication and does not require the participant to use their treatment any differently than 
prescribed by the clinician. This data will be stored in a HIPPA compliant server only available to 
the research team. 
Survey Data Collection 
Trained research staff will assess the following at the initial enrollment and the 30-day follow-up 
visit: 
- 
Demographics 
- 
Self-reported treatment adherence 
o MARS 
- 
Self-reported self-efficacy (5-point Likert scale) 
- 
Quality of Life 
o The Airway Questionnaire (AQ-20) 20-item tool assesses effect of current 
symptoms in everyday life for patients with COPD 
- 
Symptoms 
o Modified Borg Dyspnea Scale  

o COPD Severity Tool 
- 
Health Literacy 
o Short Test of Functional Health Literacy in Adults: 36 item tool. 
Spirometry  
Spirometry will be performed during the initial visit and during the follow up visit using the 
portable KoKo spirometer and the SpiroPD device. 
DURATION 
Participants will be enrolled in the at-home BREATHES Program for 30 days after discharge 
from the hospital. They will be in the study for 30 days (with a window of +/- 1 week for the 30 
day visit) from the time of enrollment. 
LOCATION 
The study will take place at the University of Chicago Medicine as well as at patient homes.  
TYPE AND NUMBER OF EXPERIMENTAL SUBJECTS 
We will enroll 70 study participants from patients admitted to the University of Chicago 
Medicine. Only 30 of these 70 subjects will utilize the Propeller Health device to objectively 
measure medication adherence. This subset of 30 patients will be chosen based on the 
patients’ prescription of a Propeller-compatible inhaler device (as not all inhalers will be 
compatible with this technology) as well as their willingness to verbally assent to this portion of 
the study.  
Inclusion Criteria 
1. Age 18 years and older 
2. Physician-diagnosed COPD (prior to or during hopsitalization) 
3. Owns a wifi-enabled device (desktop, laptop, tablet, smartphone, etc.) 
4. Discharged with a rescue and/or controller MDI 
5. Visual acuity of at least 20/50 in at least one eye (with or without corrective lens provided 
by the reseach team for study purposes) 
Exclusion Criteria 
1. Currently in an intensive care unit 
2. Physician declines to provide consent 
3. Patient unable to provide consent (e.g., history of cognitive impairment, unable to 
understand English) or declines to provide consent 
STATISTICAL ANALYSES 
We will use means, medians, proportions, scatterplots, and histograms to describe the data. We 
will test for group differences using the t-test, the Wilcoxon rank sum test, Pearson’s chi-
squared test, or Fisher’s exact tests, as appropriate. The primary outcomes for Aim 1 are at-
home V-TTG adherence and inhaler technique and for Aim 2, at-home lung function testing 
adherence and medication adherence. McNemar’s chi-squared tests will be used to compare 30 
day post-discharge vs. pre-discharge adherence to the devices, prevalence of inhaler misuse 
(≤10/12 steps correct), and medication adherence. Secondary outcomes will include change in 

self-efficacy for inhalers, symptom burden, self-reported utilization of health care services, and 
QOL. A two-tailed p-value less than 0.05 will define statistical significance. 
POTENTIAL RISKS AND BENEFITS 
The subject may be uncomfortable answering some interview questions. All subjects will be told 
that they can refuse to answer any question.  
Loss of confidentiality. To help ensure that patients’ health information remains private, we will 
restrict access to data collected for our study to study personnel only (via use of password-
protection and locked cabinets for study documents).  Study ID numbers will be generated and 
will be used when discussing and/or reviewing data at study meetings.  Also, study reports will 
report results in aggregate and not contain information that can be used to identify individual 
patients. 
Spirometry is safe and is commonly used to measure disease severity but can cause some 
minor chest soreness or lightheadedness. 
DATA SAFETY MONITORING PLAN  
A Data and Safety Monitoring Board will be formed to protect the safety of study subjects to 
ensure that they are not exposed to undue risk and to assure that the quality of the research 
data generated is acceptable and protected. The DSMB will operate without any conflicts of 
interest and/or undue influence from interested parties including the study investigators and 
funder.. The DSMB members’ primary responsibilities will be to ensure sufficient progress and 
implementation of the project and to ensure safety of the participants. This work will include 
evaluations of patient accrual rates during the recruitment period, patient safety including 
adverse and/or unplanned events, and the integrity of the data collection and management 
during this study. All serious adverse events will be forwarded to the IRB and DSMB within 48 
hours of being recognized by study staff. The DSMB will have authority to recommend 
modifications to the clinical investigations or to stop these investigations if there are concerns 
with patient safety or the integrity of the study.  
Study investigators will communicate with the DSMB members about the study only as needed 
to make decisions related to meetings and meeting materials. Communication between DSMB 
members will be initiated by the DSMB chair. Communication with NHLBI will led by the DSMB 
chair and/or PI depending on the circumstances of the required communication such as 
communication regarding the DSMB report. This DSMB will consist of 3 members, including two 
faculty at the University of Chicago and one from Northwestern, who will be involved with the 
safety and monitoring of this study: Kenzie Cameron, PhD, Peter O’Donnell MD, and Matthew 
Churpek MD, PhD. All board members will meet our institution’s requirements for declaring 
conflicts of interest. The DSMB will convene initially to review, provide feedback on, and 
ultimately approve the data safety monitoring plan prior to beginning enrollment. The board will 
then meet half way through the enrollment period or when we reach 50% enrollment, whichever 
comes first. The NHLBI Program Office will be notified of scheduled meeting in advance should 
the program manager and/or delegate wish to monitor the meeting. A report of these minutes 
will be forwarded to the PI and to NIH NHLBI staff. A summary of DSMB deliberations and 
recommendations will be submitted to the IRB. Additional DSMB meetings may be scheduled as 
needed. 
POTENTIAL BENEFITS OF THE PROPOSED RESEARCH TO THE PARTICIPANTS AND 
OTHERS  
Although we do not believe that participants will directly benefit from this study, beyond potential 
improved aderence, self-monitoring, and inhaler technique skills, the risks are reasonable in 

relation to the benefits because the proposed studies could help us learn about better ways to 
patients to self-assess their lung function and continue to learn self-management skills after 
they transition home post-discharge. 
 
CONFIDENTIALITY 
We understand the importance of protecting the confidentiality of information from our research 
participants. We will use unique alphanumeric identifiers for the data collection process. These 
unique codes will link all related participant information. All case report forms will be stored in 
locked file cabinets.  All electronic data will be secured using password-protected files. Access 
to these data will be restricted to the research staff only. Analytic files will not contain any 
identifying information. All reports/manuscripts will be prepared in such a way that individual 
patients will not be identifiable.  Additonal specific details are described above. 
 
COMPENSATION 
Participants will receive compensation for their time ($25 inpatient, $50 30-day in-person visit). 
Additionally, study participants will receive the SpiroPD for use during the study and will be able 
to keep this device for their personal use upon completion of the study; this device is valued at 
$500. 
 
INFORMED CONSENT 
Medical records at the University of Chicago will be examined each day to screen for potentially 
eligible patients. The treating physician will be contacted for verbal or written assent using 
standardized text. To reduce the burden on busy clinicians of individual pages/phone calls for 
assent, we will also provide additional options for assent ahead of clinical rotations (see X). 
Among patients whose physician provides assent, medical records will be reviewed to ascertain 
eligibility and written informed consent will be sought from eligible patients.  
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