Optimizing Self-management COPD Treatment Through the American Lung Association Helpline
Phase: NA
Conditions: Copd
Sponsor: Rush University Medical Center

PROTOCOL TITLE: COPD Helpline study
Page 1 of 17
PROTOCOL TITLE:
Optimizing self-management COPD treatment through the American Lung Association Helpline
PRINCIPAL INVESTIGATOR:
Amanda R. Mathew, PhD
Department of Preventive Medicine
(312) 563-1273
Amanda_Mathew@Rush.edu
VERSION DATE:
2/20/2023
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PROTOCOL TITLE: COPD Helpline study
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1.0 Purpose of the Study: 
Chronic Obstructive Pulmonary Disease (COPD) is an increasingly prevalent and costly chronic health 
condition, and is the third major cause of morbidity and mortality in the United States. Self-management 
treatment programs for COPD are shown to improve health-related quality of life and prevent COPD-related 
hospitalizations. Despite their clinical benefits, these programs are typically multi-component and time- and 
resource-intensive. To date, no study has been conducted to isolate the role of individual self-management 
treatment components in contributing to improved COPD outcomes. The proposed research will establish the 
feasibility of using the Multiphase Optimization Strategy (MOST) framework to optimize COPD self-
management treatment delivered by the American Lung Association (ALA) Helpline. Treatment components to 
be evaluated include duration of self-management education, ground-based walking training, inhaler training, 
and caregiver support. The primary outcome is health-related quality of life, with secondary outcomes of COPD 
symptom burden, self-management behaviors, and hospitalization. Specific aims are:
Aim 1: Design a factorial experiment and develop operational procedures. We will design a factorial 
experiment with the same number of experimental conditions and length of follow-up as the planned 
optimization trial. In collaboration with the ALA COPD Helpline, we will develop operational procedures (i.e., 
recruitment, screening, randomization, and database management) for successful implementation.
Aim 2: Establish feasibility and acceptability by pilot testing the study design. We will deliver treatment to 
three participants per experimental condition (N=48) with good fidelity, and will remotely assess baseline, 
mediator, and outcome variables. We will conduct qualitative interviews at end-of-treatment with 15-20 
participants. Resulting values will provide estimates of recruitment and retention rates, treatment fidelity, 
acceptability of treatment components, and outcome measure variability to inform a subsequent, fully-powered 
optimization trial. The primary outcome is health-related quality of life, with secondary outcomes of COPD 
symptom burden, self-management behaviors, and hospitalization. 
2.0 Background / Literature Review / Rationale for the study:
Chronic Obstructive Pulmonary Disease (COPD) is an increasingly prevalent and costly chronic 
health condition. COPD is a chronic, progressive disease that is the third major cause of morbidity and 
mortality in the United States.1 Whereas mortality from most common causes of death such as cardiovascular 
disease and cancer has declined over the past 40 years, mortality attributable to COPD has doubled.2 COPD is 
responsible for more than 2.7 million deaths and 50 billion dollars of healthcare expenditure in the U.S. every 
year.3,4
Self-management treatment improves COPD functioning. A recent Delphi process has resulted in the 
conceptual definition for COPD self-management treatment as structured but personalized and often multi-
component, with goals of motivating, engaging, and supporting patients to positively adapt health behaviors and 
develop skills to better manage their disease.5 COPD self-management treatment has a dual focus on reducing 
current symptoms and reducing future exacerbation risk.6 Programs typically include components focused on 
COPD education, recognition and treatment of exacerbations, dyspnea management, correct device use, 
smoking cessation, physical activity, nutrition, social support, and treatment of comorbidities.7 
Over the past 20 years, numerous randomized clinical trials (RCTs) have shown self-management 
treatment to have robust effects on improving health-related quality of life in COPD.6,8-12 Self-management 
treatment also improves dyspnea,10,13 decreases emergency department visits,11,14,15 and prevents up to 40% of 
COPD-related hospitalizations.6,8,10,12,14,16,17 Findings on mortality are mixed; two recent high-quality trials have 
demonstrated decreased mortality risk,13,18 while a 2017 Cochrane review detected a small, but statistically 
significant, higher respiratory-related mortality rate in the self-management group as compared to usual care.6 
Authors suggest caution in interpreting this finding, as the overall effect was dominated by two studies,19,20 
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PROTOCOL TITLE: COPD Helpline study
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misclassification in cause of death is common, and no effect on all-cause mortality was seen in the overall 
analysis. Given the overarching evidence of treatment benefit, self-management treatment is proposed in a 
chronic care model of COPD and recommended in international COPD guidelines.1,21
There is a need to optimize COPD self-management treatment. To date, there have been several 
attempts to characterize the effective elements of COPD self-management treatment; 11,22-24 however, findings 
have been greatly limited due to program heterogeneity. Jonkman and colleagues (2016) conducted an 
individual patient data meta-analysis which identified intervention duration as the sole effect modifier.22 This 
study design was unable to assess whether negative findings were due to methodological limitations of the 
meta-analysis, lack of fidelity of intervention delivery, heterogeneous groups of studies being compared, or 
other sources of variability. Raymond and colleagues (2019) determined that attempts to identify beneficial 
components were confounded by intervention complexity and heterogeneity, such that the optimal content of 
COPD self-management treatment cannot be defined from the currently published literature.23 
Novel experimental approaches could help to address this critical research gap and optimize the 
effectiveness of multi-component COPD self-management interventions on health-related quality of life. The 
Multiphase Optimization Strategy (MOST) framework is an innovative, engineering-inspired methodological 
framework for intervention development (Figure 1) that uses highly efficient randomized experimentation to 
assess the performance of individual intervention components and their interactions on clinically-relevant 
outcomes.25 The MOST framework can be used to systematically identify the most promising intervention 
components, and interactions of components, 
that drive the effect of self-management 
treatment on COPD outcomes. The MOST 
framework can also identify any treatment 
component, or combination of components, 
with unintended harmful effects (i.e., 
inappropriate management strategies for an 
exacerbation), 26,27 so that these components can 
be eliminated from future treatment programs. 
Thus, MOST is ideally suited to address the 
significant clinical problem of heterogeneity 
among self-management programs,1 and has 
strong potential to advance the field of self-
management treatment for COPD. In the 
proposed project, we seek to establish the 
feasibility of using the MOST framework to 
optimize treatment delivered by the American 
Lung Association (ALA) Helpline. 
3.0  Inclusion and exclusion criteria:
Study eligibility will be determined as follows: Inclusion criteria: Eligible participants will be males and 
females who are 1) 40 years or older, 2) report a physician diagnosis of COPD, 3) use an inhaler for COPD at 
least once a week, 4) able to walk at least one block without assistance, 5) able to identify a caregiver, and 6) 
have access to a connected device (i.e., smart phone, tablet, and/ or computer). Participants will be excluded in 
the presence of any of the following. Exclusion criteria: 1) cognitive dysfunction impairing ability to provide 
informed consent and follow study procedures, 2) terminal illness (i.e. less than 6 months life expectancy) that 
is non-COPD related, 3) living at a chronic care facility (i.e. nursing home, assisted living), or 4) inability to 
speak and read English.
We will not include adults unable to consent, pregnant women, prisoners, or individuals under the age of 
18. Socioeconomically disadvantaged persons will be included in this study, but not targeted for recruitment.
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4.0  Procedures Involved:
Overall Study Design 
In the proposed project, we seek to establish the feasibility of using the Multiphase Optimization 
Strategy (MOST) framework to optimize treatment delivered by the American Lung Association (ALA) 
Helpline. MOST is an innovative, engineering-inspired methodological framework for intervention 
development that uses highly efficient randomized experimentation to assess the performance of individual 
intervention components and their interactions on clinically-relevant outcomes. 
Factorial study design. We will conduct a randomized factorial experiment to examine the effects of 
four interventions components 
(Figure 2), in preparation for a 
full-scale optimization trial. 
Randomization will be stratified 
by current smoking status. Each 
treatment condition corresponds 
to a factor with two possible 
levels, resulting in a total 16 
experimental conditions (Table 
1). 
Participants. The 
randomized factorial experiment will consist of 48 participants. We will partner with the American Lung 
Association (ALA) Illinois chapter team and recruit participants from the ALA COPD Helpline for this study, 
following recruitment procedures described below. The PI has collaborated with the ALA-Illinois chapter team 
since 2015, and the proposed research is a natural extension of this partnership. As the ALA Living Well with 
COPD programs reaches over 800 callers per year, we believe that accrual targets (4 participants/ month; 
planned N=48) will be feasible in the grant period.
Procedures. We will conduct a 
pilot randomized factorial trial in which 
participants will be randomized to one of 
two levels for each of the four intervention 
components. This will result in a total of 
16 study conditions, 3 participants per 
condition (N=48).
Length of participation. As shown 
in Figure 4, participants will be enrolled in 
the study for approximately 4 months (14 
weeks).
Pre-Screening and Baseline 
Assessment. The flow of participants 
through study procedures is summarized 
in Figure 3. Following initial recruitment 
by ALA counselors, potential participants 
will be contacted by research staff for a 
full study description and eligibility 
screening. The pre-screening questionnaire will be administered by phone. Those who remain interested and 
eligible, will complete informed consent remotely via a secure REDCap link sent by text message or email. 
Study staff will discuss the consent form while on the phone with the participant following the screening 
process. If the participant does not have time for this discussion, a second phone call will be arranged. 
Table 1. Study Conditions
Condition
Education
Walking 
training
Inhaler 
training
Caregiver 
support
1
SHORT
ON
ON
ON
2
SHORT
ON
ON
OFF
3
SHORT
ON
OFF
ON
4
SHORT
ON
OFF
OFF
5
SHORT
OFF
ON
ON
6
SHORT
OFF
ON
OFF
7
SHORT
OFF
OFF
ON
8
SHORT
OFF
OFF
OFF
9
LONG
ON
ON
ON
10
LONG
ON
ON
OFF
11
LONG
ON
OFF
ON
12
LONG
ON
OFF
OFF
13
LONG
OFF
ON
ON
14
LONG
OFF
ON
OFF
15
LONG
OFF
OFF
ON
16
LONG
OFF
OFF
OFF
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PROTOCOL TITLE: COPD Helpline study
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Consenting procedures will follow Rush IRB guidance for the use of electronic informed consent, described 
below.
Following consent, participants will be sent a baseline survey link by text message or email, or given the 
option to complete the baseline survey by phone interview format. After baseline survey completion, 
participants will be randomized to treatment following a randomization scheme programmed in REDCap. 
Participants will be mailed study materials specific to their treatment condition, consisting of the “Living Well 
with COPD” booklet and treatment material for up to three other treatment components.
Participants will be assigned to one of 16 possible experimental conditions, consisting of self-
management education (either short or long duration) and up to three additional treatment components. The 
study schedule for each treatment condition is depicted in Figure 4. Self-management education will be 
delivered by an ALA Helpline counselor who is a certified COPD educator. Inhaler education will be delivered 
by a trained interventionist (advanced Respiratory Therapy student), overseen by the PI. Ground-based walking 
training and caregiver support will be delivered by a trained study staff member. All questionnaire assessments 
will be administered remotely through the REDCap data management system. Study staff will follow up with 
the participant to ensure all measures are completed, and address any questions or technical issues. Lastly, a 
subset of 15-20 participants will be invited to participate in a qualitative interview at end-of-treatment. 
Baseline Assessment (Week 0). Prior to randomization, participants will complete a questionnaire 
battery of socio-demographic information, COPD-related measures, potential treatment mediators, and 
smoking-related measures, if 
applicable, as described 
below. 
Mid-treatment 
Assessment (Week 5). 
Participants will complete a 
questionnaire battery of 
potential treatment mediators 
and adverse events, as 
described below.
End-of-treatment 
Assessment (Week 8). 
Participants will complete a questionnaire battery of COPD-related measures, potential treatment mediators, and 
smoking-related measures, if applicable, as described below. Participants who were invited to participate in a 
qualitative interview will complete it at this stage. 
90-day follow up (Week 14). Approximately 90 days after treatment start date, participants will 
complete a final questionnaire battery of COPD-related measures and smoking-related measures, if applicable, 
as described below.
Intervention components. Our selection of intervention components is based on recent, high-quality 
meta-analyses6,10-12,24 and international expert group panels,5,28 while also incorporating practical 
considerations: intervention components must be distinct, robust, and have appropriate comparison levels to be 
considered for inclusion in an 
optimized treatment package.29 
Although patient education 
forms the ‘core’ of self-
management treatment, 
education alone is insufficient to 
foster health behavior change.1 
Instead, self-management 
treatment should be individually 
tailored and employ structured 
behavior change techniques.7 
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Within multi-component programs, treatment components targeting physical activity are uniquely associated 
with improved health-related quality of life.24 Additionally, provision of social support is a critical component 
of COPD self-management treatment.30 Receiving positive social support from caregivers is consistently 
associated with improved health-related quality of life and self-efficacy among individuals with COPD.31,32 
Overall, the four intervention components to be tested in the current study are supported by rigorous scientific 
evidence, relevant to a range of COPD stages,28 and can be combined with no conflict or redundancy in an 
optimized self-management intervention. 
 Self-management education duration (short vs. long). The self-management education condition is 
based on the Living Well with COPD program, which has been researched extensively.9,13,16,33-35 The program 
consists of a mailed booklet and structured phone counseling delivered by certified COPD educators. Topics 
include disease information, breathing retraining, action planning, medication use, energy conservation, and 
following good health habits. The ALA has offered the Living Well with COPD program to over 5700 callers 
with COPD since 2016. 
The duration/ intensity of self-management education programs within the research literature is highly 
heterogeneous, ranging from a single session36,37 to 12 or more treatment contacts over up to 24 months.14,16,38 
Although one meta-analysis found longer treatment duration to predict lower hospitalization risk,22 low-
intensity treatments have demonstrated clinically significant effects on health-related quality of life39,40 and 
reduced hospitalization.36,39 Highly intensive treatment programs may also result in substantial treatment burden 
for individuals with COPD41 and limited scalability for population health. Thus, identifying optimal parameters 
of treatment intensity is critical. We will test a 2-session (short) versus 5-session (long) version of the self-
management education program, in combination with the mailed booklet. The short condition consists of two 
calls (30-45 minutes each) to introduce patient education topics and refer to the booklet for further information. 
The long condition consists of five, weekly calls (30-45 minutes each) following a structured curriculum of 
patient education topics. 
Ground-based walking training (GBWT; on vs. off). GBWT is a well-established, safe, and feasible 
physical activity program in COPD.42,43 As walking is the most common form of exercise undertaken in daily 
life, this modality allows for light to moderate intensity physical activity without the need for specialized 
equipment or professional supervision. Although long-term results are mixed,44,45 GBWT is associated with 
increased daily step count, exercise capacity, and quality of life and at 2- to 3-months.42,43,46,47 Participants  
randomized to this condition will be mailed a pedometer (3DFitBud Simple Step Counter) and instructed on its 
use to establish baseline steps/ day for 7 days. They will then receive a booklet with instructions to establish a 
walking program and three brief (10-15 minute), bi-weekly calls from a trained staff member to review step 
count values and engage in setting personal activity goals over the course of 6 weeks,46 following established 
exercise guidelines for individuals with COPD.48 Sessions will be conducted by phone or videoconference via a 
Zoom meeting hosted on a secure, HIPAA-compliant Rush Zoom account. 
Inhaler education (on vs. off). Inhaled medications are commonly prescribed to manage COPD and 
prevent exacerbations. However, inhaler misuse is common,49 and errors in use are associated with worse 
symptoms and increased hospitalizations.50 Inhaler training with direct observation is shown to improve 
technique,51 but often not addressed in routine clinical care, representing a critical unmet need. Participants 
randomized to this condition will receive two sessions of inhaler technique education using a virtual teach-to-
goal (TTG) method,51,52 in which individuals are observed using their inhaler, provided feedback, and then 
observed again. Sessions will be conducted by videoconference via a Zoom meeting hosted on a secure, 
HIPAA-compliant Rush Zoom account.
Caregiver support (on vs. off). Caregivers play a critical role in supporting quality of life among those 
with COPD, but frequently report unmet needs for support, disease information, and effective management 
strategies.58 Participants randomized to this condition will identify an informal caregiver who is involved in 
their healthcare (i.e., spouse, family member, or friend), who will receive a mailed copy of the Respiratory 
Health Association’s COPD Caregiver’s Toolkit, a comprehensive informational resource to support the care of 
the person living with COPD. Caregivers will receive two brief (10-15 minute) check-in calls from a trained 
staff member. The structured content of these sessions will include providing an overview of toolkit content, 
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identifying goals for sections(s) to review and incorporate into caregiving activities, and addressing any 
questions. Sessions will be conducted by phone or videoconference via a Zoom meeting hosted on a secure, 
HIPAA-compliant Rush Zoom account.
Treatment fidelity. The ability to deliver each intervention component, and combination of 
components, to fidelity is a key aspect of study feasibility. Checklists for each treatment condition will be 
created to describe both the necessary, and proscribed, elements of treatment. Following established 
procedures,53 we will use a rigorous database with embedded protocols to guide study activities and specify the 
order of implementation, such that participants receive all the intervention components to which they are 
assigned and only the intervention components to which they are assigned. Our study database will also include 
a scheduling program that tracks when research contacts occur and when visits or calls need to be scheduled 
based on the participants’ condition. 
Measures.
Baseline characteristics. 
Variables assessed at 
baseline include socio-
demographics (i.e., age, 
gender, race/ ethnicity, 
employment status, and 
household income), 
medical history, and 
medication use. Health 
literacy will be assessed 
with the Calgary 
Charter on Health 
Literacy scale.54 COPD 
functioning will be 
assessed with the 
PROMIS Dyspnea-
Activity Motivation 
scale;55 comorbid 
conditions will be 
assessed with the 
Charlson Comorbidity 
Index.56 For current 
cigarette smokers, we 
will assess baseline 
smoking characteristics 
with the Smoking 
History Questionnaire 
and nicotine 
dependence with the 
Heaviness of Smoking 
Index (HSI)57 and 
PROMIS-Nicotine 
Dependence scale.58 
Outcomes. The 
primary outcome of health-related quality of life will be measured by the Chronic Respiratory Disease 
Questionnaire (CRQ),59 a 20-item questionnaire yielding a total score and subscale scores for mastery, fatigue, 
emotional functioning, and dyspnea. The total score ranges from 20-140, with 10 points considered to be a 
minimal clinically important difference.60 Secondary outcomes include COPD symptom burden, self-
Table 2. Measures
Timepoint Assessed
Baseline
Mid-
treatment
End-of-
treatment
90-day 
follow-
up
COPD-related measures
Chronic Respiratory Disease 
Questionnaire
X
X
X
COPD Assessment Test
X
X
X
Patient Activation Measure-13
X
X
X
Hospitalization history
X
X
X
PROMIS Dyspnea-Activity 
Motivation
X
Charlson Comorbidity Index
X
Medication Use
X
Calgary Charter on Health Literacy 
scale
X
Adverse events
X
X
X
X
Potential treatment mediators
Bristol COPD Knowledge 
Questionnaire
X
X
X
International Physical Activity 
Questionnaire
X
X
X
Inhaler Confidence Scale
X
X
X
PROMIS Informational Support
X
X
X
Treatment acceptability
Client Satisfaction Questionnaire
X
Qualitative Interviews (subset of 15-
20 ppts)
X
Smoking-related measures, if 
applicable
Smoking History Questionnaire
X
Heaviness of Smoking Index
X
X
X
PROMIS Nicotine Dependence
X
X
X
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management behaviors, and hospitalization. COPD symptom burden will be assessed with the COPD 
Assessment Test (CAT),61 an 8-item questionnaire measuring the global impact of dyspnea on health status. 
Self-management behaviors will be assessed with the Patient Activation Measure (PAM-13),62 a 13-item 
questionnaire measuring patient knowledge, skill, and confidence for self-management. Self-reported 
hospitalization history will be assessed by asking participants if they have been hospitalized for their COPD 
(i.e., respiratory-related hospitalization) or other medical conditions (i.e., all-cause hospitalization) since 
enrolling in the study. Lastly, we will monitor for adverse events at all assessment timepoints, as described in 
the Data and Safety Monitoring Plan. 
Treatment mediators. COPD knowledge will be assessed with the Bristol COPD Knowledge 
Questionnaire.63 Physical activity will be assessed with the International Physical Activity Questionnaire 
(IPAQ). Inhaler confidence will be assessed with the Inhaler Confidence Scale. Informational support will be 
assessed with the PROMIS Informational Support scale.64 
 Treatment acceptability. We will assess treatment acceptability with the 8-item Client Satisfaction 
Questionnaire (CSQ-8), with adequate acceptability indicated by a total score of 24/30 or greater.65 To 
complement the CSQ-8, we will conduct qualitative interviews at end-of-treatment with a subset of 
approximately 15-20 participants, until thematic saturation is reached (i.e., the point at which each subsequent 
interview provides no new information).66 Qualitative interview content will focus on perceived benefits of 
treatment, treatment burden and other negative aspects of treatment, and suggestions for improving COPD self-
management treatment. We will use a purposive sampling approach to ensure the sample is balanced by gender, 
race/ ethnicity, and exposure to each of the four treatment components. Following independent reviews of 
transcripts by the PI and trained research staff, and identification of a priori and in-vivo themes,67 initial codes 
will be assigned with content and comparative analysis68 using QSR NVivo version 11 software.69
Analytic Strategy. Three main areas will be examined: 1. Feasibility of recruitment and outcome 
procedures. Feasibility will be evaluated via enrollment ratios, monthly recruitment rates, retention rates, and 
data completeness 2. Feasibility and acceptability of the treatment components. Treatment feasibility will be 
assessed by treatment fidelity ratings. Treatment acceptability will be assessed with the CSQ-8 in the full 
sample, and qualitative interviews in a subset of participants. 3. Explore the variability and acceptability of trial 
outcomes and treatment. We will examine the variability of the change in the COPD-related outcomes and 
treatment mediator measures. We will examine the proportion of hospitalization events over the course of the 
study, as well as the proportion of participants who endorse clinically meaningful change from baseline to 90-
day follow-up on the CRQ and CAT. We will assess all questionnaires for good measurement properties (i.e., 
good internal consistency and sensitivity to treatment-related change) prior to selection in the planned 
optimization trial. 
5.0 Multiple sites: 
N/A
6.0 Incomplete Disclosure or Deception:
N/A
7.0 Recruitment:
Participants will be recruited from the Departments of Internal Medicine, Pulmonary Medicine, and 
Family Medicine at Rush University Medical Center. We will post study recruitment materials in each clinic, 
and will ask providers to refer interested and potentially eligible patients to the study team. We will also create 
an audio hold recording to be played on the Rush on-hold line. Potential participants will be asked to call the 
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ALA Lung Helpline and ask about the ‘Rush COPD Management study;’ they may also choose to provide their 
contact information to receive a phone call from an ALA Lung Helpline counselor. 
Study recruitment will be supplemented by partnerships with Rush University organizations such as the 
Tobacco Oversight Committee and Lung Cancer Screening Program, and community partners who serve 
individuals with COPD, including the American Lung Association, Respiratory Health Association, and local 
COPD support groups and Pulmonary Rehabilitation programs. Dr. Mathew will share IRB-approved 
recruitment materials with community partners through multiple communication channels (i.e., community 
events, newsletters, e-newsletters, website postings, tweets) to reach potentially eligible individuals with COPD. 
We will also advertise our study and recruit participants through Researchmatch.org, a nonprofit program 
funded by the National Institutes of Health (NIH) that allows researchers to connect with people interested in 
research studies.
All study procedures are conducted remotely, precluding any cost or burden associated with travel to the 
research center. The ALA Helpline counselors will provide a brief study description and assess the caller’s 
interest in participating at the time of their initial telephone intake. They will share contact information of 
interested callers through a brief REDCap form. Interested callers will be contacted by the research team for a 
full study description and eligibility screening. If eligible, callers will complete informed consent remotely via a 
secure REDCap link sent by text message or email, and will be randomized to treatment.
8.0 Consent Process:
Trained study staff members will obtain electronic consent via REDCap following standardized 
procedures. Specifically, after completing the phone screener, those who remain interested and eligible 
for the study will be immediately emailed or texted a link to the appropriate IRB-approved online 
consent form in REDCap. Study staff will discuss the consent form while on the phone with the 
participant following the screening process. If the participant does not have time for this discussion, a 
second phone call will be arranged. Individuals who remain interested will provide an online signature 
on the REDCap consent form. We will attempt to conduct the signature process in one continuous 
session with the participant. If this is not possible (e.g., the participant uses a cell phone as their only 
connected device, and is unable to simultaneously talk on the phone and view the REDCap e-consent), 
study staff will follow the consent process below to obtain verbal consent. Study staff will then follow 
up with the participant by email/ text to obtain an electronically signed copy of the consent form as soon 
as possible after the phone call has ended. 
Consenting procedures will follow Rush IRB guidance for the use of electronic informed consent 
to ensure best practices are followed in remotely obtaining informed consent. Study staff will first verify 
that: 1) the form the participant received is the currently approved version, 2) all pages of the consent 
were received, and 3) the participant can read all pages of the consent. Study staff will verify the identity 
of the participant by asking their date of birth. Study staff will then review all information in the consent 
form, similarly to how this discussion would be conducted in an in-person format. Participants will be 
provided with ample time to review the consent and ask any questions they may have. Those who 
remain interested will provide an online signature on the REDCap consent form.  A PDF version of the 
consents will be saved on the secure network drive and emailed or texted to the participant. Informed 
consent will be obtained prior to any data collection or study procedures. There is no waiting period 
between informing the prospective subject of their eligibility and obtaining the consent. Non-English 
speaking individuals, individuals under the age of 18, cognitively-impaired adults, and adults unable to 
consent will not be included in the current study. 
9.0  Process to Document Consent: 
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Documentation of the consent process will occur within the REDCap e-consent project (i.e., eConsent 
form with electronic signature for each study participant, Consent Collection Form, and Consent Process 
Documentation Form).
10.0  Risks to Participants:
This is a minimal risk study. Study procedures do not involve any medical procedures or medication 
use; participants will be informed that this is a non-medical study and will not involve any changes to their 
usual medical care. All study procedures are conducted remotely, precluding any risks associated with in-person 
study visits. Potential risks include psychological distress and loss of confidentiality. First, participants will be 
asked to report on their COPD symptoms, health habits such as cigarette smoking and physical activity, and 
adjustment to disease/ quality of life. As a result, they may experience discomfort or distress from providing 
self-report of private, potentially embarrassing information. Second, while we will make every effort to protect 
privacy and keep data confidential, a risk for loss of confidentiality also exists. 
Potential study participants will be informed regarding alternative treatments, including the ALA COPD 
Helpline, which remains available to callers who opt out of the research study. Callers who are ineligible or 
choose not to participate will be referred back to the ongoing ALA COPD Helpline and Tobacco Quitline 
services. 
11.0  Potential Benefits to Participants: 
Participants may not directly benefit from the proposed research, but will contribute to the research 
literature on improving self-management treatment for individuals with COPD. Study participants may benefit 
from self-management treatment content focused on understanding COPD, engaging in a healthy lifestyle, and 
increasing social support. The risk/benefit ratio is seen as highly favorable, as the potential benefits of improved 
health-related quality of life, COPD symptom burden, and self-management skills greatly outweigh the 
potential risks.
12.0  Financial Compensation:
Participants will be provided with financial compensation for completing study assessments, with an 
additional compensation to participants who complete a qualitative interview, as shown in Table 3 below. 
Participants are only eligible for payment if all study procedures at a given assessment are completed. Payments 
will be provided in the form of a mailed check, gift card to Amazon or Target, mailed debit card, or reloadable 
debit card (Greenphire ClinCard). Participants will not be responsible for any costs associated with participating 
in the research.
Participants will be compensated up to $100 for completing all study procedures, with an additional $20 
provided to participants who complete a qualitative interview.
Table 3. Study Compensation
Study Assessment Timepoint
Payment
Baseline Assessment
$20
Mid-Treatment Assessment
$20
End-of-treatment assessment
$20
90-day follow-up assessment
$40
Qualitative interview (optional)
$20
TOTAL
Up to $120
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13.0  Provisions to Protect the Privacy Interests of Participants:
The risk of potential loss of confidentiality will be minimized through training and ongoing supervision 
of study staff as well as storage of all private health information on a secure network drive (detailed in section 
14.0 below). 
14.0  Confidentiality and Data Management:
Data Acquisition and Maintenance
Data will be collected using REDCap (Research Electronic Data Capture) electronic data capture tools 
hosted at Rush University. REDCap is a secure, web-based software platform designed to support data capture 
for research studies. REDCap provides 1) an intuitive interface for validated data capture; 2) audit trails for 
tracking data manipulation and export procedures; 3) automated export procedures for seamless data downloads 
to common statistical packages; and 4) procedures for data integration and interoperability with external 
sources.
The data manager will be responsible for maintaining the security of the data stored both in REDCap 
and on the DMC server, and will set permissions on an as needed basis. All data will be stored on the 
Department of Preventive Medicine’s MS SQL server relational database. Rush data network security and 
availability on DMC servers is supported by Rush Information Services servers. Rush University has two data 
centers on our Chicago campus at 1700 W. Van Buren St. and 711 S. Paulina St. All servers are located in the 
locked data centers, with access limited to authorized personnel via a biometrics access system. Data centers 
each have Sinorix™ 227 and Ecaro-25™ Clean Agent Chemical Fire Suppression Systems, redundant backup 
diesel generator and uninterruptible power supply (UPS) systems, and redundant chillers for cooling.
The Rush data network is segmented and protected from the internet by a Palo Alto Networks® firewall. 
Access to the network from the internet requires multi-factor authentication. All network users are required to 
have a unique login and password. The passwords must be changed every 180 days and must be complex (i.e., 
must have: a capital letter, small letter, number, special character, and be at least 8 characters in length). Change 
management policies and procedures are in place to protect the integrity of the systems. A Change Management 
Review Board meets once each week to review all proposed software and hardware changes. Systems are 
backed-up nightly and the data is duplicated and sent to an offsite storage facility. 
Monitoring of Data Quality
The REDCap database will contain embedded protocols to guide study activities and specify the order of 
implementation, such that participants receive all the intervention components to which they are assigned and 
only the intervention components to which they are assigned. Quality assurance checks (i.e., required items, 
allowable ranges of response values) will be built into each REDCap survey to ensure data accuracy at the time 
of entry. Erroneous and/or inconsistent values will be flagged and entered into a recurring query report 
specifically developed for this study. Reports will be generated weekly and distributed to designated study staff 
for resolution. Once generated, a query will remain part of the weekly report until it is resolved. The PI will 
receive weekly aggregated reports on study recruitment and follow-up status and study intervention fidelity by 
treatment component. We will monitor the fidelity to the treatment protocol timeline and percentage of 
components delivered in each treatment condition. Our study database will also include a scheduling program 
that tracks when research contacts occur and when visits or calls need to be scheduled based on the participants’ 
condition.
15.0  Data Monitoring Plan to Ensure the Safety of Participants:
Dr. Mathew has developed a data safety and monitoring plan that is commensurate with the risks, size, 
and complexity of the current study. Potential risks of the self-management treatment are considered minimal. 
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Monitoring will be provided by the PI, an independent safety officer (ISO), and the Rush University 
Institutional Review Board (IRB). A detailed data and safety monitoring plan is described below.
Monitoring of Safety Data 
Overall framework. The PI is responsible for safety oversight, in coordination with an independent 
safety officer with relevant expertise in this clinical population (i.e., individuals with COPD). The PI will ensure 
the study is conducted according to the approved protocol. She will ensure all study staff have completed 
Collaborative Institutional Training Initiative (CITI) and Good Clinical Practice training, as required by the 
IRB, and are thoroughly trained on study procedures. The PI will develop standardized procedures for 
identifying, reviewing, and reporting adverse events (including serious adverse events) and unanticipated 
problems to the independent safety officer, Rush University IRB, and the appropriate offices at NHLBI, as 
noted in Table 4. 
Adverse events. Adverse events are defined as any untoward or unfavorable medical occurrence in a 
human subject, including any abnormal sign (e.g., abnormal physical exam or laboratory finding), symptom, or 
disease, temporally associated with the subject’s participation in the research, whether or not considered related 
to the subject’s participation in the research. During protocol-designated study contacts, which occur at mid-
treatment, end-of-treatment, and 90-day follow-up, research staff will ask participants to report all adverse 
events that have occurred since the previous study contact. However, participants will be advised to report any 
adverse event to research staff at any time. Adverse events to be assessed include COPD exacerbation, defined 
as an acute worsening of symptoms of COPD requiring new or increased doses of systemic corticosteroids, 
antibiotics, and/or emergency treatment or hospitalization. Adverse events will be reported quarterly to the 
independent safety officer for review, and will also be reported annually for IRB continuing reviews and NIH 
progress reports. 
Serious adverse events. A serious adverse event is defined as follows: death, a life-threatening adverse 
event, inpatient hospitalization or prolongation of existing hospitalization, a persistent or significant 
disability/incapacity, a congenital anomaly/birth defect, or a medically significant event that may require 
medical or surgical intervention. Risks of participation will be continually monitored and appropriate measures 
implemented in cases of unforeseen adverse events. If a serious adverse event occurs, the study PI will notify 
the independent safety officer and the IRB within 24 hours. The serious adverse event will be reported 
regardless of whether it appears to be related to study procedures. The PI will consult with the independent 
safety officer to determine appropriate action, including whether a corrective action plan is needed. The full 
summary of the SAE and resolution, if applicable, will be reported to the appropriate NHLBI program officials 
in an expedited manner. 
Unanticipated problems. The PI will notify the Rush University IRB and the appropriate NHLBI 
program officials within five (5) business days of discovering any unanticipated problems involving risks to 
participants and others.
Table 4. Adverse event reporting time periods.
Event
Reporting Window
Adverse Event
< 3 months (i.e., in quarterly ISO reports and annual 
reports to IRB and NHLBI)
Serious Adverse Event
< 24 hours
Unanticipated Problem
< 5 days
Trial Registration
This project includes an applicable trial which requires registration on ClinicalTrials.gov. The PI will be 
responsible for compliance of registration and reporting of trial outcomes. 
16.0  Data and if applicable, Specimen Banking: 
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N/A
17.0  Qualifications to Conduct Research and Resources Available:
The primary investigator, Dr. Mathew, is a licensed clinical psychologist with expertise in human 
laboratory-based and clinical research within the field of smoking cessation. All study staff will be directly 
supervised by Dr. Mathew and have been trained in human subjects research and current study procedures. 
The study interventionist, Amanda Kallinikos, is an advanced standing student in the Rush University 
Master of Science in Respiratory Care program. She has completed specialized training in COPD self-
management and inhaler use, as well as training in human subjects research. She will be directly supervised by 
Dr. Mathew. 
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