Comparing Effectiveness of Self-management and Peer Support Communication Programs Amongst Chronic Obstructive Pulmonary Disease (COPD) Patients and Their Family Caregivers
Phase: NA
Conditions: COPD
Sponsor: Johns Hopkins University

 
 
 
 
 
 
 
 
 
 
 
Comparing Effectiveness of Self-Management and Peer Support Communication Programs 
amongst Chronic Obstructive Pulmonary Disease Patients and Family Caregivers 
 
Study Protocol 
 
NCT#02891200 
 
Version Date: June 28, 2019 
 
IRB Approval Date: 7/24/2019 
 
 
 
 

 
 
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Date:  06/28/2019    
Principal Investigator: _Hanan Aboumatar 
Application Number: IRB00114571 
 
 
 
JHM IRB - eForm A – Protocol 
 
 
 
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each. If a section is not applicable, leave heading in and insert N/A. 
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the top of JHM IRB eForm A. 
 
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1. 
Abstract 
a. Provide no more than a one-page research abstract briefly stating the problem, the research 
hypothesis, and the importance of the research. 
             Chronic Obstructive Pulmonary Disease (COPD) is a prevalent global condition that results in high 
mortality, morbidity, symptom burden, and functional limitations that impact the quality of life. COPD is 
the third leading cause of death in the US and a leading cause of hospitalizations. COPD patients report 
unmet needs in regards to information about their disease and how to manage and cope with it at an 
intellectual, emotional, and social level. Many COPD patients lack the information and skills that they need 
to correctly use their inhaled medications, manage ‘breathlessness episodes’, and detect early signs of a 
COPD exacerbation. Pulmonary rehabilitation programs are established to help COPD patients increase 
their exercise capacity and reduce fatigue and dyspnea with daily activity. While clinical trials testing these 
programs have demonstrated significant improvements in health-related quality of life, and reduced 
dyspnea and fatigue amongst participants, it remains unclear how best to engage and motivate patients to 
participate in them.  
Self-management support interventions which involve “collaboratively helping patients acquire and 
practice the skills needed to carry out disease-specific medical regimens, change their health behavior to 
adjust their roles for optimal function, improve day-to-day control of their disease, and improve their well-
being”, have been demonstrated in several trials to improve health-related quality of life, and reduce 
symptom burden, hospitalizations, and ED visits amongst COPD patients. However, it is still unclear which 
self–management support strategies employed in ‘real world’ settings are most effective in engaging, 
motivating, and enabling patients to successfully follow recommended treatments, adopt desired health 
behaviors, and thus achieve the desired improvements in their health outcomes.  
Studies that involve ‘expert patients’ or ‘peer mentors’ in delivering self- management support to other 
patients who have a similar health condition have shown significant benefit to participants including: 
increased motivation; enhanced self-efficacy; and improvements in self-care behavior, disease control, 
clinical outcomes, and quality of life. Using peer-to-peer communications to help advance self-
management amongst patients is particularly promising as peer mentors possess ‘credibility’ and can serve 
as ‘role models’, as people ‘who understand, have been there, and done that’. These elements are key to 
achieving behavior change, according to Social Learning Theory.  
The overall goal of this proposal is to compare the effectiveness of two health communication and 
dissemination strategies that are designed to engage patients and family caregivers in successfully 
managing COPD in ‘real-world’ settings. Both strategies aim to; advance patient understanding of COPD, 
its treatment options, and self-care tasks; support them in coping with the disease; and enable them to adopt 
a variety of positive behaviors, including adherence to treatment plans, smoking cessation, joining 
pulmonary rehabilitation programs, and assuming an active, healthy lifestyle. One strategy relies on the 

 
 
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healthcare professional (HCP) as the primary communicator about COPD self-management (Health Care 
Professional Arm), whereas the other uses a dual approach that involves both healthcare professionals and 
peer mentors delivering such communication (Health Care Professional PLUS Peer support Arm). Peer 
mentors are COPD patients and caregivers who have successfully managed COPD and have received 
foundational training on peer mentoring. Specifically we aim to: 1) Conduct a randomized controlled trial 
in which the ‘HCP’ and ‘HCP PLUS Peer Support’ strategies are tested in ‘real-world’ healthcare settings; 
2) compare the impact of these strategies on patient satisfaction, experience, activation, self- efficacy, self-
care behavior, health status, quality of life, use of Emergency Department (ED) and hospital services, and 
survival; and, 3) compare the impact of these strategies on caregiver satisfaction, experience, self-efficacy, 
stress, and coping skills. Study participants will be adult patients with moderate to severe COPD and their 
caregivers. Three hundred and twenty five patient participants will be recruited in ‘real world’ clinical 
settings from one urban and one suburban hospital and their specialty and primary care practices. Each 
patient will have the opportunity to include one family-caregiver with them in this study. The primary study 
outcome is the change in health-related quality of life at 6 months post-intervention compared to baseline. 
Secondary outcomes include: Combined number of COPD-related hospitalizations and ED visits, patient 
experience and satisfaction, patient–reported health status for physical, mental, and social well–being; 
symptom burden; patient activation and self- efficacy; medication adherence; smoking cessation rates; 
participation in pulmonary rehabilitation; physical activity levels; caregiver stress, coping skills, and self-
efficacy. We hypothesize that the ‘HCP PLUS Peer Support’ strategy will achieve superior results 
compared to the HCP strategy.  
 
2. 
Objectives (include all primary and secondary objectives) 
           The overall goal of this proposal is to compare the effectiveness of two health communication and 
dissemination strategies that are designed to engage patients and family caregivers in successfully 
managing COPD in ‘real-world’ settings. Both strategies aim to advance patient understanding of COPD, 
its treatment options, and self-care tasks; support them in coping with the disease; and enable them to 
adopt a variety of positive behaviors, including adherence to treatment plans, smoking cessation, joining 
pulmonary rehabilitation programs, and assuming an active, healthy lifestyle. One strategy relies on the 
healthcare professional (HCP) as the primary communicator about COPD self-management (HCP Arm), 
whereas the other uses a dual approach that involves both healthcare professionals and peer mentors 
delivering such communication (HCP PLUS Peer Support Arm). Peer mentors are COPD patients and 
caregivers who have successfully managed COPD and have received foundational training on peer 
mentoring. Specifically we aim to: 1) Conduct a randomized controlled trial in which the ‘HCP’ and ‘HCP 
PLUS Peer Support’ strategies are tested in ‘real-world’ healthcare settings; 2) compare the impact of 
these strategies on patient satisfaction, experience, activation, self- efficacy, self-care behavior, health 
status, quality of life, use of Emergency Department (ED) and hospital services, and survival; and, 3) 
compare the impact of these strategies on caregiver satisfaction, experience, self-efficacy, stress, and 
coping skills.  
 
The proposed study will answer the research question: Amongst COPD patients and their caregivers, 
would a dual strategy that combines healthcare professional and peer mentor delivery of COPD self- 
management education and support result in greater improvements in health status and quality of life, and 
reductions in acute healthcare services’ utilization, compared to relying on healthcare professionals alone 
in these communications? Would such dual strategy result in reduced caregiver stress and improved 
coping and satisfaction? 
 
3. 
Background (briefly describe pre-clinical and clinical data, current experience with procedures, 
drug or device, and any other relevant information to justify the research) 
 
Chronic Obstructive Pulmonary Disease (COPD) is a prevalent global condition that results in high 
mortality, morbidity, symptom burden, and functional limitations that impact the quality of life. In year 
2000, around 2.75 million people died from COPD worldwide1 with 119,000 of those deaths occurring in 

 
 
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the U.S. In that year in the US , COPD resulted in 1.5 million ED visits and  726,000 hospitalizations.2 In 
year 2010, COPD continued to be amongst the top 10 causes of hospitalizations in the United States 
accounting for 703,000 hospitalizations that year.3 According to the 2011 Behavioral Risk Factor 
Surveillance System (BRFSS), 6.3% of U.S. adults ( about 15 million individuals ) reported being told that 
they have COPD by their health-care provider4 and about 12% of the U.S. population ≥65 years have 
COPD.4 COPD is the third leading cause of death in the US and a leading cause of hospitalizations.3 A 
recent analysis of age standardized death rates in the US between 1969-2013, showed that whereas death 
rates from most common killers such as cardiovascular disease and cancer have decreased, the death rates 
from COPD have doubled.5 About 75% of total costs for treating COPD are spent treating acute 
exacerbations mostly in the hospital setting, 3 and about 20 % of hospitalized patients get re-hospitalized 
within 30 days of their discharge.6 Significant disparities in hospitalization rates exist among COPD 
patients, with patients residing in low income areas and blacks experiencing higher number of re-
hospitalizations than patients residing in high income areas and white patients, respectively.3 Psychosocial 
distress, single marital status, and the need for social services intervention are all associated with higher re-
hospitalization rates among COPD patients.7  
COPD results in significant functional limitations and reductions in the quality of life, with 64.2% of 
COPD patients reporting shortness of breath that impaired their quality of life.4 Depressive symptoms 
among COPD patients are associated with higher mortality and symptom burden and poorer physical and 
social functioning.8 COPD results in increased burden, stress, and affects the health and professional life 
for family-caregivers of COPD patients.9  
 
Patients with COPD report unmet needs in regards to information about their disease and how to manage 
and cope with it at an intellectual, emotional, and social level. 10-13 More than half of COPD patients lack 
the skills required for proper inhaler use.14, 15 This has been associated with increased symptoms and 
functional limitation; treatment with steroids and antibiotics; and, emergency room and hospital visits.16 
COPD patients lack the necessary information and skills for how to manage ‘breathlessness episodes’ and 
how to detect early signs of an acute COPD exacerbation.17, 18 Pulmonary rehabilitation programs have 
been established to help COPD patients increase their exercise capacity and experience less fatigue and 
dyspnea with daily activities. While clinical trials testing pulmonary rehabilitation programs have 
demonstrated significant improvements in health-related quality of life, and reduced dyspnea and fatigue, 
amongst participants, 19 it remains unclear how to engage and motivate patients to participate in pulmonary 
rehabilitation.20, 21 Pulmonary rehabilitation remain largely underused as treatment option , despite medical 
guidelines recommendations and healthcare insurance plans coverage, with as little as 1-14% of COPD 
patients being  referred to these programs.22 Self- management support interventions which involve 
“collaboratively helping patients acquire and practice the skills needed to carry out disease-specific medical 
regimens, change their health behavior to adjust their roles for optimal function, improve day-to-day 
control of their disease, and improve their well-being”,23  have been demonstrated in multiple clinical trials 
to result in significant improvements in health related quality of life , reduced symptom burden, and 
reduced hospitalizations and ED visits amongst COPD patients.24 However, it is still unclear how to 
provide self –management support in real world settings so that patients are engaged, motivated, and 
enabled to successfully follow recommended treatments, adopt desired health behaviors, and thus achieve 
the desired improvements in their health outcomes. 23, 25 Studies that involve ‘expert patients’ or ‘peer 
mentors’ in delivering self- management education and support to other patients who have a similar health 
condition have shown significant benefits to participants including increased motivation, self-efficacy, and 
self-care behaviors; as well as, improved disease control, clinical outcomes, and quality of life.26-40 Such 
‘peer to peer’ programs have been successfully implemented and sustained in real world settings to help 
patients suffering from many different conditions including weight problems/obesity, mental health and 
addiction problems, chronic disease, pulmonary disease, and cancer.   Examples of these programs include 
peer-led support groups, dyadic peer-to-peer mentorship or ‘buddy’ programs, and online peer support 
groups. Peer support benefits are attributed to the provision of emotional, informational, and appraisal 
support (peer affirmation of the “appropriateness of one’s emotions, cognitions, and behaviors”).41 Benefits 

 
 
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have been demonstrated for both people providing and receiving peer support. Using peer to peer 
communications to help advance self-management amongst patients is particularly promising as peer 
mentors bring in the ‘credibility’ and ‘role modelling’ as people ‘who understand, been there, and done 
that’. These elements are key to achieving behavior change, according to the Social Learning Theory. 42, 43 
Peer support also strengthens the social support structure that patients have and reduces their isolation. The 
latter is particularly relevant to patients with COPD whose medical illness often makes them reluctant to 
‘go out’ with family and friends given their functional limitations and need for portable oxygen. In persons 
with COPD, receiving positive social support is associated with reduced hospitalizations, fewer 
exacerbations and better health status.44, 45 There is evidence that the number of interpersonal relationships 
in the COPD patient’s social network has important implications for their health outcomes.46  
Studies show a significant role that family caregivers play in caring for COPD patients especially when 
they become more dependent,47,48 and that this role can positively impact patients’ healthcare behaviors 
(e.g. improved adherence),49 or negatively influence it ( for example, when a caregiver is overprotective 
which leads to patient becoming more dependent and less active ).50  Studies also show that caregivers 
experience distress and increased burden when caring for COPD patients and that can negatively influence 
their emotional wellbeing, professional life, and quality of life overall . 48, 50- 51 Findings from a survey 
administered to participants in support groups for COPD revealed positive impacts with 90% of 
participants reporting that they have a better understanding of COPD, 72% feeling less lonely, and 61% 
feeing less anxious. Survey patient respondents (N=347) reported that the group definitely help them with 
health decision making (76% of participants); communication with doctors (61% of participants); 
communication with family, friends, peers, and neighbors  (41%); and adjusting their activities so they can 
do more at home ( 50%) and outside it ( 44%). Participants reported making positive changes in behaviors 
with 50% becoming more active, 31% taking medicines more regularly, 23% joining pulmonary 
rehabilitation, and 9% stopping smoking. Seventy one percent of respondents reported that they have taken 
steps that have resulted in keeping them out of the hospital. Ninety percent of participants encouraged 
other COPD patients to join a COPD peer support group.52 Caregivers participating in COPD peer support 
groups also reported similar benefits, with 100% having better understanding of COPD, 78% gaining 
confidence in managing COPD, 71% feeling less lonely as a COPD caregiver; 64% feeling more 
supported in their caregiving responsibilities activities; and, 78% reporting that participation in the peer 
group helped them keep their loved one out of the hospital.52 
 
4. 
Study Procedures 
a. Study design, including the sequence and timing of study procedures   
(distinguish research procedures from those that are part of routine care). 
 
Study Phases  
The study will be conducted in two phases: Phase 1 starts with intervention development (phase 
1a), followed by peer mentor recruitment and training (phase 1b). Phase 2, randomized 
controlled trial and assessment of experience with study intervention, implementation barriers, 
and lessons learned. Phases 1a and 1b are already underway (IRB application is # 
IRB00103197). The current application is for Phase 2 of this study. 
 
Summary of Phases 1a and b: Phase 1a involves development of study intervention, materials, 
and protocol with a joint study team that includes patients, caregivers, 
interdivisional/multidisciplinary professional team (physicians, nurses, respiratory therapists, 
case managers, social workers), and healthcare leaders.  
Phase 1b involves partnering with COPD patients and caregivers who are ‘candidates’ for peer 
mentor role to co-develop the peer support intervention materials and pilot test the peer mentor 
training. In this phase, the peer mentors will receive foundational training on peer mentoring 
and provide feedback on it.  Candidate peer mentors are COPD patients and family- caregivers 
who have successfully managed COPD and who will be nominated by their healthcare team as 

 
 
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successful COPD self-managers. All patient peer mentors will be graduates of pulmonary rehab 
and current non-smokers thus serving as positive role models. Specifically, the peer mentors 
will be 1) moderate-severe COPD patients who have successfully stopped smoking, participated 
in a pulmonary rehabilitation program, and have been nominated by pulmonary rehabilitation 
center staff or their pulmonologist for this role; or 2) a family- caregiver of a COPD patient who 
meets above criteria, is not a current smoker, and is nominated by the pulmonary rehabilitation 
program staff or pulmonologist for this role.  
 
To recruit the peer mentors we are collaborating with the pulmonary staff program teams at the 
Johns Hopkins Bayview Medical Center and the Howard County General Hospital, and the 
pulmonologists at both study sites (JHBMC and HCGH). The peer mentors will receive training 
on how to mentor other people who have COPD. This training includes both general peer 
mentoring skills, as well as discussion about COPD –specific topics. Training topics include 
listening, empathy, motivational interviewing, telling own story, as well as discussion of 
common questions and challenges with COPD. The training will take about 10 hours, and its 
format, number of sessions etc. will be determined based on feedback from the participants. 
 
Participants in phase 1b who successfully complete all training activities and the requirements 
for serving as a volunteer at Johns Hopkins will be offered the opportunity to participate as peer 
mentor (also called BREATHE Pal) in phase 2 of this study. In their role as BREATHE Pals, the 
peer mentors would help provide peer support to other patient and caregiver study participants.     
 
Phase 2 involves conducting a randomized controlled trial to compare the effectiveness of two 
strategies to support COPD patients and improve their quality of life. Both strategies aim to 
advance patient understanding of COPD, its treatment options, and self-care tasks; support them 
in coping with the disease; and enable them to adopt a variety of positive behaviors, including 
adherence to treatment plans, smoking cessation, joining pulmonary rehabilitation programs, 
and assuming an active, healthy lifestyle. One strategy relies on the healthcare professional 
(HCP) as the primary communicator about COPD self-management (HCP Arm), whereas the 
other uses a dual approach that involves both healthcare professionals and peer mentors in 
delivering such communication (HCP PLUS Peer Support Arm). Phase 2 specific aims are : 1) 
Conduct a randomized controlled trial in which the ‘HCP’ and ‘HCP PLUS Peer Support’ 
strategies are tested in ‘real-world’ healthcare settings; 2) compare the impact of these strategies 
on patient satisfaction, experience, activation, self- efficacy, self-care behavior, health status, 
quality of life, use of Emergency Department (ED) and hospital services, and survival; and, 3) 
compare the impact of these strategies on caregiver satisfaction, experience, self-efficacy, stress, 
and coping skills.  
 
Study Population and Setting 
The study participants are adults receiving treatment for COPD and their family caregivers. The 
patient participants must be older than 40 years, with no significant cognitive dysfunction, 
severe mental illness, or active substance abuse. Family caregivers must be 18 years or older 
and chosen by the patient participant to get enrolled with them into the study. The reason for 
these requirements is the nature of the proposed intervention (group-based with active 
engagement and participation).   
 
We will conduct this study at Johns Hopkins Bayview Medical Center (JHBMC) and Howard 
County General Hospital (HCGH), and their affiliated pulmonary and primary care clinics 
(some of these clinics are part of Johns Hopkins Community Physicians). JHBMC is an 
academic center in Baltimore, Maryland that serves an urban, inner-city population with a large 
percentage of low-income and ethnic minority patients, as well as patients from the Baltimore-

 
 
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Washington DC region. JHBMC has a 550-bed hospital, a nationally recognized pulmonary 
center, pulmonary specialty clinics, a pulmonary rehabilitation center, and multiple primary care 
clinics. HCGH is a community hospital in Columbia, Maryland that serves a suburban 
population with a large percentage of middle class patients, as well as patients from the 
Baltimore-Washington DC region. HCGH is a 300 bed community hospital, and includes 
pulmonary specialty clinics, a large pulmonary rehabilitation center (about 2000 people 
complete the acute rehabilitation program), and multiple primary care clinics. Both hospitals 
and their affiliated clinics are part of the Johns Hopkins Health System.  
 
Study structure 
 
We will conduct a randomized controlled trial (RCT) to implement and test study interventions 
at two study sites, recruiting COPD patient participants from an urban academic hospital (Johns 
Hopkins Bayview Medical Center) and its affiliated hospital based clinics and a suburban 
hospital (Howard County General Hospital) and its affiliated clinics. Participants will be 
recruited from both hospital and ambulatory service settings.  
 
Below is a schematic depicting Phase 2 trial design: 
 
   
 
In the HCP Arm, we will employ a healthcare professional delivered, clinic-based approach for 
engaging patients and families. It involves delivery of self-management education and support 
on an individual basis to individual patients (and their family caregivers, if applicable).   
In the HCP PLUS Peer Support Arm, a dual strategy will be followed where HCP support is 
provided as in the first arm, and a peer support program is added.  
 
This strategy employs a partnership model, is co-led by peer mentors and healthcare 
professionals, and brings together groups of patients and family caregivers to discuss COPD and 
chronic disease management topics, and share tips on how to cope with COPD and manage it. 
The peer mentors (called ‘BREATHE pals’ in this study) are COPD patients and caregivers who 
have successfully managed COPD, and have received foundational training on peer mentoring 
and facilitation of peer conversations. Peer mentors will be nominated by their medical 
providers as successful COPD self-managers and all patient peer mentors will be graduates of 
pulmonary rehab and current non-smokers thus serving as positive role models. The peer 
mentors are also formal ‘volunteers’ within Johns Hopkins Bayview and HCGH and have thus 
met the requirements for interacting with patients within these healthcare facilities.  
 
Study conceptual model 
The conceptual model (see below) clarifies the different mechanisms by which healthcare 
professionals and peers can help enable and support COPD patients and caregivers in adopting 

 
 
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the recommended self- management strategies that will lead to improvements in patient 
outcomes and caregiver experiences.  
 
 
The traditional medical expert model involves healthcare professionals (HCPs) from various 
disciplines ( doctors, nurse educators, respiratory therapists, etc.. ) providing the necessary 
medical/ technical information about COPD; the instrumental help in regards to referring 
patients to the necessary treatment services and recommended programs (e.g. pulmonary 
rehabilitation, smoking cessation programs etc..) ; and, the encouragement and support that 
would help enable them to gain confidence in their ability to implement recommended self-care 
practices and desired behaviors. Though all of the above healthcare professional contributions 
are essential to caring for COPD patients, they may not be sufficient to induce and maintain 
positive behavior changes particularly amongst patients who are less engaged and motivated and 
who have low self-efficacy. These patients often fail to adopt the desired evidence-based 
behaviors that would lead to achieving improvements in patient-centered outcomes such as 
improved health related quality of life and reduced need for frequent use of emergency room 
and hospital services.  
 
According to the Social Cognitive Theory, self- efficacy mediates behavior change and 
achieving the former requires practice and mastery of the necessary skills, modeling of desired 
behaviors (also referred to as vicarious or observational learning), and social persuasion. 
(Bandura, 1986) Patients who are successfully managing COPD ( for example, those who have 
stopped smoking, participated in pulmonary rehabilitation, maintain activity, and use available 
COPD treatment options effectively) are very well positioned to help other COPD patients and 
their caregivers learn from their practical knowledge on managing COPD in their daily living. 
More importantly those ‘successful COPD self-managers’ are capable of offering COPD 
patients what no other healthcare professional can offer, mainly the role modeling of desired 
behaviors and the persuasive message that these behaviors are indeed achievable by other 
people with a similar health condition. In addition to helping provide experiential knowledge, 
role modeling, and social persuasion, peers can help provide emotional and appraisal support 

 
 
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and therefore facilitate success in adopting recommended behaviors and reducing feelings of 
isolation.41  Caregivers who have successfully supported family members with COPD can 
similarly provide informational, social, emotional, and appraisal support for other caregivers 
and help them in learning about how they can support someone with COPD and cope with the 
burdens of caregiving for someone with this health condition. The attached conceptual model 
depicts key contributions that healthcare professional support provides to COPD patients and 
their caregivers (blue arrow), and the additive contributions that peer support would introduce 
(the green arrow). A dual approach which involves pairing expert healthcare professional 
services with peer support, allows patients to receive (1) the technical information that they 
need, and the referrals to services that will enable them to adopt recommended behaviors; and 
(2) the peer support that increase the likelihood that they will become more motivated, 
activated, and achieve the self- efficacy needed to successfully manage COPD. Those areas that 
peer support is most likely to positively impact amongst both COPD patients and caregivers are 
highlighted in green in the model. 
 
 
Description of Study Arms 
 
HCP Arm- employs a healthcare professional delivered approach for engaging patients and 
families. It involves delivery of self-management education and support on an individual basis 
to individual patients and their family caregivers if applicable.  The program will aim to deliver 
COPD education and support services per ATS/ ERS guidelines for treatment of COPD. The 
program will include provision of patient-centered self-management education materials, a 
community resources guide, and follow-up phone support by a respiratory care practitioner 
(RCP). The RCP will explain the provided materials, answer any questions that the 
patients/caregivers may have, and discuss any challenges that they are having in managing their 
health.   
 
HCP PLUS Peer Support Arm –employs a dual strategy where HCP support is provided as in 
the HCP Arm and a peer support component is added. The peer support is provided via 
participating in a peer support program that uses groups and 1:1 conversations to provide peer 
support. In this program COPD patients and family caregivers will be connected with ‘expert’ 
patients and caregivers also referred to as ‘peer mentors’/’BREATHE Pals’. These mentors are 
COPD patients and caregivers who have successfully managed COPD and have received 
foundational training on peer mentoring. Peer mentors are nominated by their medical providers 
as successful COPD self-managers and all patient peer mentors have completed an acute 
pulmonary rehabilitation program and are current non-smokers thus serving as positive role 
models. Peer mentors are trained to listen and share their experiences with having COPD and 
overcoming its challenges, without provision of any medical advice. They are also trained about 
HIPPA and keeping all their conversations with program participants confidential. The peer 
support is provided using multiple channels including group and 1:1 conversations. All program 
participants will be invited to 8 group sessions over 6 months period. The sessions will be led by 
1-2 peer mentors and discuss COPD self-management topics. At each of these sessions, a social 
worker would be present to support the peer mentors and facilitate any ‘difficult conversations’ 
that may arise. The group leaders will be trained to promote a friendly and non-hierarchal group 
environment. The program will encourage all participants to use group formats as often as 
possible to maximize benefits of peer and social support. Participants in the peer support 
program will also receive 1:1 peer support via having phone conversations with the peer 
mentors.  
The peer mentors/Breathe Pals will have their own support structure to ensure continued 
participation, interest, and reciprocal benefits. Based on earlier studies we anticipate that the 

 
 
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BREATHE Pals will also benefit from participating in the peer support program via connecting 
with others peers in general and peer mentors in particular. The figure below depicts the 
BREATHE Pals (referred to in the visual as peer leaders) support structure. A Peer Support 
Program Coordinator will provide support and guidance for the BREATHE Pals. The 
coordinator is a licensed clinical social worker who will help train the BREATHE Pals and hold 
regular peer leader meetings in which they get to discuss their current efforts and any challenges 
that they may be facing. The social worker will be available to also provide support for 
BREATHE Pals on individual basis as needed.  
 
                   
Study procedures 
i. 
Recruitment and Consent Procedures  
       
There are four types of participants in this study: 1) Patient participants (patients receiving 
treatment for COPD at the hospital or clinic setting); 2) Caregiver participants ( family members 
or friends helping the patient participant with their healthcare ); 3) Patient peer mentors ( COPD 
patients who have completed phase 1 of this study and indicated interest in participating in this 
trial as a peer mentor/BREATHE Pal in the Peer Support Program); 4) Caregiver peer mentors ( 
COPD family caregivers who have completed phase 1 of this study and indicated interest in 
participating in this trial as a peer mentor/BREATHE Pal in the Peer Support Program).  
The Patient Participants will be asked if they are interested in inviting a family caregiver to join 
in them in this study; however, they can enroll without a family-caregiver. The patient 
participants will be randomized to one of the two study arms in this trial (HCP or HCP PLUS 
Peer Support) and their respective Caregiver Participant, if they have one enrolled, would 
participate with them in that study arm.  The Patient and Caregiver Peer mentors will only 
participate in the HCP PLUS Peers study arm serving as ‘BREATHE Pals’ in the Peer Support 
Program. 
 
Below we detail the recruitment and consent approaches for each of these types of participants.  
 
Patient and Caregiver Participants 
 

 
 
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Step 1- Patient identification and discussion about the study  
Multiple approaches will be used to recruit patient participants from the hospital and clinic 
settings. We will start with recruitment from JHBMC and HCGH hospital medical units, as well 
as the pulmonary clinics at both hospitals, and the JHCP primary care clinics. For the latter, we 
will start with clinics that are on either of the hospital sites or the closest to these hospitals and 
additional clinics may be added as need be. We will collaborate with the healthcare providers to 
identify patients who are receiving care at the hospital or clinic, who have been diagnosed with 
COPD by a physician, are receiving treatment for it, and are at least 40 yrs old. The recruitment 
process will likely vary by setting and site, depending on logistical considerations (i.e. setting, 
space, staff) and healthcare team preferences.  
 
At the hospitals, we will use patient census and diagnosis lists that are maintained by the 
hospital nursing and case management teams to identify in a timely manner admitted patients at 
the two study sites who have COPD early during their hospital stay.  We have utilized this 
recruitment approach successfully in an earlier study to help streamline the process of hospital 
based recruitment and reduce recruitment time demands on clinical staff (IRB00054456). For 
patients who have COPD and are receiving treatment for it at one of 4 Bayview medical units ( 
MedA, MedB, PCU, Bridgeview) or at one of the HCGH med-surg units, a study team member 
will contact the patient’s provider to determine whether the patient’s  clinical status allows them 
to talk about the study. Patients who are clinically stable will then be approached by a study 
team member who will share materials about the study (Brief study video; Patient Hospital 
Flyer; Caregiver Hospital Flyer), and inquire about their interest in participating in the privacy 
of their own room. 
 
At the outpatient clinics, we will use multiple approaches to ensure successful recruitment based 
on the clinic set up and patient flow: 
(1) Recruitment materials will be available in clinic waiting areas, and for healthcare team 
members to provide to their patients (Brief study video; Patient Brochure; Caregiver Brochure). 
Contact information for the research study team will be provided on the recruitment materials. 
Interested patients have the option to fill in a contact information card (tear out part of the 
Patient Brochure) with times that they would like to be contacted and leave it in a sealed 
envelope with their healthcare provider at the clinic site. A study team member will then pick up 
their card and contact them via phone. This approach will be particularly helpful at clinic sites 
where the clinic lacks a private space for the study team member to discuss the study with 
interested patients.  
(2) A study team member will be available at select sites to approach any patients who are 
referred by their healthcare provider to the study. To reduce burden on providers and streamline 
the recruitment process, we will collaborate with the healthcare providers to identify COPD 
patients who are coming for a clinic visit on that day and a study team member will then provide 
these patients with study recruitment materials and check on their interest to learn more about 
the study.  
(3) Furthermore, at select clinic sites, we will collaborate with experienced data analysts at 
ICTR’s Center for Clinical Data Analysis (CCDA) following applicable data trust privacy and 
security regulations, to identify patients with diagnosis of COPD in EPIC who have visited these 
clinics in the past 6 months, and contact these patients via  mailed letter (See Study Notification 
Letter; this approach will be used at sites where medical director is a study team member) . 
 
 
 
Step 2- Screening for Eligibility  

 
 
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Once the study team member talks with the interested patients about the study, s/he will check 
whether they meet basic eligibility criteria and if so s/he would describe the study in detail, and 
if the patient is interested to join the study, they will proceed to step 3 if in the hospital and not 
being discharged soon. Otherwise, the patient will be scheduled for a study enrollment visit. 
(Initial Contact Eligibility - In Person Script; Initial Contact Eligibility - Telephone Script). The 
patient will be asked if they have a family caregiver who is 18 years or older whom they would 
like to include with them in the study.  and if so they are invited to ask that caregiver to come 
with them to the study enrollment visit or enroll with them while at the hospital. The patient will 
be informed that they can still participate in the study even if they don’t have or don’t want to 
include a family caregiver with them in the study. The study team member will also provide the 
patient, as needed, with a caregiver brochure or flyer to share with their caregiver (Caregiver 
Hospital Flyer; Caregiver Brochure). These materials will be provided in person or via mail. If 
the patient is enrolled in the hospital but family-caregiver is unavailable, a separate enrollment 
visit will be scheduled for the family- caregiver. 
 
Step 3: Patient and Caregiver Study Visit, Written Consent, and Randomization 
At the study Enrollment Visit (or during enrollment in the hospital) , additional eligibility data 
will be collected and if patient meets those, written consent, baseline assessment, and 
randomization will occur. A trained study team member will: 
1) Conduct a spirometry test and confirm that results meet criteria for enrollment into the study 
2) Obtain written consent and conduct the baseline interview  
3) Tell the participant their randomization results 
4) Refer the participant to the healthcare professional for their in- person education session 
To start with the study team member will describe the study in more detail to the patient and 
caregiver ( if applicable), the two study arms will be described, and the patient and caregiver 
will be told what will happen in either arm of the study. After written informed consent is 
obtained, (Patient Consent Form) all patients will complete the baseline assessment (REDCap 
Survey- Patient section). The caregiver, if applicable, will also provide written consent 
(Caregiver Consent Form) and complete a baseline assessment (REDCap Survey – Caregiver 
section).   All assessments will be obtained using structured interview format and participant 
responses will be directly entered by the study team member using an electronic device into a 
redcap database. After assessment is completed, a study team member will open a sealed 
envelope that would have the patient’s randomization assignment. They will inform the patient 
of their random assignment and inform the family caregiver (if applicable) that they are 
assigned to that same study arm with their loved one. Both patient and caregiver, if applicable, 
will then be invited to their in- person session with the Respiratory Care Practitioner therapist 
(RCP) which will take place right after their Enrollment Visit for participant convenience, 
unless the participant had expressed their interest in alternative date and time. (If patient is 
enrolled at the hospital, the RCP session will be scheduled to take place while at the hospital or 
soon after their discharge.)    
 
 
Patient and Caregiver Peer Mentors  
Few COPD patients and caregivers will be recruited to perform peer mentor roles as BREATHE 
Pals in this study (N= 12- 36). To be eligible for this role, these participants must have: 
(1) Successfully completed Phase 1 of this study in which they receive special training for this 
role (Peer Mentor Training Outline)  
(2) Have applied for and met the requirements for becoming a Johns Hopkins volunteer at the 
respective study site (Johns Hopkins Volunteer Requirements). As part of these 
requirements, the peer mentors are asked to sign a confidentiality agreement 
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(3) Be willing to participate in phase 2 of this study as BREATHE Pals for at least 6 months 
Eligible candidates will participate in a group meeting in which the BREATHE Pal role will be 
described in detail, and if still interested will have an individual follow up conversation (in 
person or via phone depending on candidate preference) to go over the written consent for Peer 
mentor participants in this study. (Peer Mentor Consent Form)  
 
 
ii. 
Intervention procedures  
 
All study participants will receive a HCP support intervention in this study. Those randomized 
to the “HCP PLUS Peer support” Arm will also have the opportunity to participate in a Peer 
Support Program. Below we describe the procedures for both study interventions.  
                   
                  HCP support intervention 
In this intervention a HCP (trained respiratory care practitioner) would hold a 1 hour individual 
session with each study participant and their caregiver (if applicable). The session will be held 
at the site where the participant usually receives their care. The respiratory care practitioner will 
discuss with the participants COPD self-management, review medication use, and provide 
them with informational materials and resources. The RCP will ensure that the patient 
participant is demonstrating proper inhaler use technique. The RCP will go over COPD self-
management following a written guide that will be provided to each participant (COPD Patient 
Education Guide). This guide has been developed by the study co-investigators in an earlier 
study and covers areas recommended by the American Thoracic Society and European 
Respiratory society (ATS/ERS) for COPD patient education. The RCP and the participant will 
decide together on the areas of the guide that they would like to spend more time on during this 
session. In addition, the participant will be provided with a resource guide for various local 
services and programs that COPD patients may find helpful (BREATHE Resource Guide). 
Caregivers will also be provided with Tips on Being a Caregiver (Caregiver Tips) and a 
caregiver frequently asked questions resource document that has been developed by the COPD 
foundation (FAQ for caregivers). The RCP will provide her contact information to the patient 
and their caregiver, if applicable, in case they wanted to meet and discuss the provided materials 
further. In this intervention, the RCP will not provide any medical advice or treatment services. 
Instead they will refer the participant to their medical provider for any specific questions on 
changes in their treatment plan.  The RCP session will take place in person within 2 months of 
participant enrollment into the study. If the patient missed one appointment for RCP visit, they 
will be scheduled for another. If they missed the second appointment the RCP will reach out to 
them and offer to hold that session via phone.  
 
                  Peer support program intervention 
The Peer support program will offer patient and caregiver participants who are randomized to 
the “HCP PLUS Peer support” Arm, peer support services that will be delivered via multiple 
channels including 1:1 and group conversations.  In this program, the patient and caregiver 
participants will have the option to connect with other peers. Each patient and caregiver 
participant in this study arm will be ‘matched’ with a peer mentor (referred to as BREATHE 
Pal). The Breathe pal will talk with the participant at regular intervals at peer group ‘Get 
together’ events and/ or via phone (based on participant preference and their attendance of 
group events). The group events will take place at the study sites and will be co-led by 2 
BREATHE Pals in presence of a social worker. At these events, select topics about COPD self-
management will be discussed, and the messages delivered by the RCP will be reinforced.   
 

 
 
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The BREATHE Pals are people who have COPD, who have successfully stopped smoking and 
completed acute pulmonary rehabilitation program, and/or their family-caregivers. They are 
identified via nomination from a pulmonologist or a pulmonary rehab team member for this 
role, have successfully completed phase 1 of this study that includes receiving training on 
becoming a COPD peer mentor, and have applied to and met the requirements for becoming a 
volunteer at JHBMC or HCGH.  The BREATHE Pals will receive ongoing support from a 
Johns Hopkins licensed clinical social worker who will provide guidance and support to the peer 
mentors and coordinate peer support program services. The social worker will attend the ‘Get 
together ‘events, to provide support for the BREATHE Pals without taking over the leadership 
of these events. The social worker will ensure that the BREATHE Pals are following study 
protocol and not engaging in provision of medical advice. They would also help facilitate any 
difficult conversations that the group may have. The social worker will help match the 
BREATHE pals with patient and family- caregiver participants who are in the HCP PLUS Peer 
Support Arm. The matching will occur based on preset criteria, aiming to match participants 
with BREATHE Pals based on gender, patient or caregiver status, and oxygen therapy use to the 
extent that may be possible.  Matching will also occur within study sites to the extent possible.  
 
Peer support group conversations will be orchestrated at 8 ‘Get Together’ events spanning a 6 
months period. All participants who miss an event or were not interested/able to attend an event 
( based on preference, life circumstances, or health status), will be offered the option of 
attending a similarly themed ‘BREATHE group call’ to catch up on missed event conversations  
and their ‘matched’ BREATHE Pal will also contact him/her via phone to check in on them, 
answer any questions they have,  and encourage them to attend the next Get together event. At 
end of these phone calls, the peer mentor has the option of talking about their call with the social 
worker. If a patient or a family caregiver expressed the need for additional healthcare or social 
support services, or if the peer mentor felt that they need it, they would inform the social worker 
who will facilitate the patient or family-caregiver access to these services.  
 
At the group events (in person or group call), the group participants led by the BREATHE Pals 
will discuss COPD and its challenges, and share their experiences in coping with and managing 
it. See summary table below on general topics for discussion.  The topics pertain to advancing 
patient understanding of COPD and its treatment options, introducing effective coping skills, 
and reinforcing a variety of positive behaviors including adherence to treatment plans, smoking 
cessation, joining pulmonary rehabilitation programs, and assuming an active, healthy lifestyle. 
The Breathe pals will use the COPD Patient Education guide and a set of commonly asked 
questions and answers (Commonly Asked Questions and Answers) as their content 
guide/reference for the group conversations and follow up phone conversations. Each meeting 
will include: 1) Education about COPD management strategies based on the themes in table 
below; 2) discussion of patient experiences and challenges related to using these strategies; and, 
3) encouragement to set goals and problem solve challenges. The sessions will follow a 
sequence of themes from 1-8 and then repeat. A study participant may thus join the sessions 
sequence at any time point and continue for 8 sessions thus getting to participate in all 8 themes. 
If at any point the number of participants attending the sessions exceeded 20 people, the group 
will be split into two and new participants may join either group according to their preferred 
group meeting time.  
 
 
 
The table below depicts the session themes and sample opening questions for group discussion:  

 
 
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Theme 
Session Topic 
Topics to be Discussed 
Corresponding 
pages in the 
COPD Patient 
Education 
Guide 
Theme#1 
 Ways to Breathe 
Easier 
 
 
 
Family-caregivers 
I 
Ways to perform daily activities with less shortness of 
breath 
 
  Pursed-lip breathing  
 
Small group activity (in separate patient and caregiver 
groups) –discussion of general experiences with COPD 
and providing/ receiving help and support 
p. 21-26, 47-50 
 
 
Addendum- 
Tips and 
resources for 
caregivers 
Theme #2 Recognizing Signs 
of a Flare-Up 
COPD exacerbations or flare-up and how to manage 
those 
 
“Action plans” and how to use  
p. 31-34 
Review Action 
Plan 
Theme #3 
Coping with 
COPD 
 
 
 
Family Caregivers 
II 
COPD impact on life 
 
Managing feeling out of breath 
 
Managing feelings of anxiety and depression 
Small group activity (in separate patient and caregiver 
groups)  
p. 23-26, 39, 
47-50 
 
Breathless-ness 
cycle 
Theme #4 
Getting the Most 
of your COPD 
Medications  
COPD treatments 
 
Inhaler use  
 
Rescue vs. Maintenance Inhalers vs. Nebulizers 
 
Managing medication costs 
p. 7-12 
Theme #5 
Getting 
Acquainted with 
Oxygen Usage 
Oxygen therapy- when is it needed and how to use safely 
 
Traveling with oxygen 
 
Getting comfortable using 
 oxygen in public 
p. 13-20, 53-55 
Theme#6 
Becoming More 
Active 
Importance of staying active 
 
Becoming more active 
 
Pulmonary rehabilitation and its benefits  
p. 39-46 
Theme#7 
Lifestyle 
Modifications 
with COPD 
Diet Changes 
 
Planning a Daily Routine/Pacing Yourself 
 
Support for Smoking Cessation 
 
Prevention/Being Proactive about COPD 
p. 47-52 

 
 
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The BREATHE Pals will use the COPD education guide as a ‘content reference’ and review its 
contents as applicable in the group meetings.  
 
The BREATHE Pals will have a set of suggested ice breaker activities to choose from for use at the 
various in-person sessions. Examples of those include sharing a personal story related to the topic of 
the meeting or sharing coping strategies such as pursed lip breathing or mindfulness to start the 
discussion. Additionally, time will be reserved that allows for socializing among group participants 
at the end of each meeting (approximately 30 mins). Any individual participant concerns can be 
discussed at that time between the participant and their BREATHE Pal and/or the social worker.  
 
The Get together events will provide an open forum for COPD patients and their caregivers to share 
their experiences with COPD, and how they have managed its various impacts on their lives. These 
events will have a set of engagement rules for the participants (referred to as ‘group agreement’) 
that will be revisited periodically and posted in the room. Those include: “What is said in the group 
stays in the group; we listen to, support, and learn from each other; everybody’s opinion is 
important; when someone is talking, we allow the person to complete what they are saying before 
we speak; there are no right or wrong questions; we will reduce distractions (cell phones, 
computers, IPads, notebooks are not permitted- necessary calls may be made outside the room); we 
will start and end on time” . The social worker, who will also be attending the Get-togethers, will 
help support the BREATHE Pals in making sure that these rules are observed.  
 
The Breathe pals will use ice breaker activities such as sharing a personal story related to the topic 
of the meeting or sharing coping strategies such as pursed lip breathing or mindfulness to start the 
discussion at each of the Get togethers. Additionally, time for socializing among group meeting 
participants will be allotted for people to talk with other participants at the end (approximately 30 
mins). 
 
Given that the patient and caregiver participants may wish to discuss some topics pertaining to how 
they relate to and support each other without the presence of their loved one, at least two 
opportunities will be provided where the group will be divided into a patient and a caregiver 
subgroup for part of the Get Together and time will be taken to discuss patient-caregiver matters 
separately.  
As a quality control measure, we will audio-record a sample of the peer group conversations and 
those audio-recordings will be reviewed for adherence to guidelines protocol. The patients and 
family-caregivers will be reminded at the start of each conversation/session that it will be audio-
recorded and will be informed that they may choose not to have the audio-recorder on or ask that it 
be stopped anytime during the session. The audio files will be saved on a secure password protected 
Hopkins drive directly after session conclusion. The drive will only be accessible to the PI and 
designated team members and stored files will be kept for 7 years in accordance with the DHHS 
regulations and would then be destroyed.  
 
 
 
                    
Theme #8 
Preventing 
Breathlessness 
Irritants you should avoid  
 
Protecting yourself from infections 
p. 27-30 

 
 
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iii. 
Safety Management 
 
The interventions employed in this study are minimal risk interventions where no medical 
treatments or advice will be provided. All treatment services will remain under the control of the 
study participants and their healthcare providers. The RCP who will be delivering the HCP 
intervention, and the social worker who will facilitate the Peer Get-togethers and provide oversight 
and support for the BREATHE Pals, are both licensed Healthcare professionals who are employed 
within Johns Hopkins. The roles they will perform in delivering the study interventions are well 
within their professional scope of practice. These professionals will be trained on intervention 
procedures and if a study participant requires additional medical treatment or social support 
services, they will not provide treatment services themselves but rather facilitate the study 
participant’s access to these services at the respective sites where the participants receive their care.  
 
The peer mentors will be specifically trained not to provide any medical advice and to refer study 
participants who request such advice or report on specific healthcare or social needs to the social 
worker. The peer mentors, in addition, will be instructed to turn to the social worker with any 
concerns that they may personally have about any participants, or if they feel distressed or burdened 
by their BREATHE Pal role. All peer mentors will have the opportunity to regularly meet with the 
social worker to discuss their volunteer efforts and any needs or concerns that they may have.  
 
Given that many of our study participants will have severe COPD and other co-morbidities, and that 
frequent hospitalizations and occasional deaths are anticipated in this patient population, we will 
establish a Data Safety and Monitoring Board (DSMB).  The primary responsibilities of the DSMB 
will include monitoring of participant safety, data quality, and adverse events tracking. The DSMB 
will meet regularly, either in person, or via conference call.  They will receive data reports prior to 
the meeting that contain information about participant recruitment, retention, participant 
characteristics and adverse events.  In addition to the DSMB members, meeting attendees will also 
include the study Principal Investigator and the study Biostatistician.  
 
We will follow the following procedures to ensure safety and track adverse events in this study: 
Adverse Events in this study will be identified and assessed for severity and tracked whether or not 
they are related to the study treatments. For the purposes of this study, serious adverse events 
include: death, hospitalization, or fall due to intervention related activities. These events will be 
assessed during routine data collection calls at 3, 6 and 9 months post enrollment. A log will be kept 
for unanticipated problems. Any participant deaths that occur within 30 days of receiving a study 
intervention, whether expected or unexpected, will be promptly reported in accordance with JHM 
policies. All pertinent adverse events will be included in the data reports to DSMB and to the IRB at 
continuing review time.   
      
 
             Study Measures and Outcomes  
 
 
The primary outcome measure is change in health-related quality of life as measured by the Saint 
George’s Respiratory Questionnaire (SGRQ) total score at 6 months post-intervention compared to 
baseline. Additional secondary patient outcomes that we will measure in this study include overall 
patient experience and satisfaction; patient activation; patient–reported health status; PROMIS 
informational support, emotional support, and social isolation domain measures; loneliness; anxiety 
and depression; and symptom burden. We will also measure the combined number of COPD-related 
and all cause hospitalizations and ED visits per patient at 6 months post-intervention start. Other 

 
 
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process/impact measures will include patient self- efficacy, and medication adherence; joining 
pulmonary rehabilitation; smoking cessation; caregiver stress, coping skills, and self-efficacy.  
 
We will collect data on patient demographic characteristics, disease severity, co-morbidities, health 
literacy, history of healthcare utilization, anxiety and depression, mental health. Similarly, we will 
collect caregiver participants’ age, gender, employment, relationship to patient, caregiving 
responsibilities, health status, and distance from patient home, and transportation means.  
 
Below is a description of main patient study measures with comments on validity.  
1. Disease-specific health-related quality of life will be measured with the St. George’s Respiratory 
Questionnaire; 76 items, 3 subscales (symptoms, activity, and impacts), each with score 0-100. The 
minimum clinically important difference is 4; 8 units reflect moderate change; and 12 units very 
efficacious treatment.   
2. Combined # of COPD- related ED and hospital visits per patient from enrollment to 3, 6, and 9 
months (also calculated separately for hospital and for ED visits).  
3. Patient activation measure Pam -13 item. This instrument has been widely tested with patients 
with various medical conditions. It has been psychometrically tested and used in multiple research 
studies.  The 13-item measure has similar psychometric properties to the original 22-item version 
which shows good precision and validity.  
4. Understanding COPD questionnaire: Will use the sections on ‘understanding of COPD’ and ‘self-
efficacy and use of key self-management skills”. Good test-retest reliability (ICC range: 0.87 to 
0.96) and internal consistency (Cronbach's Alpha range: 0.78 to 0.95). The instrument has been 
shown to be responsive to in studies of pulmonary rehabilitation. We will also use an adapted 
version of this questionnaire to measure self-efficacy among caregivers.  
5. Medication adherence – Morisky scale. This is an 8-item scale that has been validated and used in 
multiple studies. The instrument was initially tested with hypertension patients but has since been 
used with different patient populations. 
6. Social and other support- The Patient-Reported Outcomes Measurement Information System 
(PROMIS) item bank - four validated domains will be used: Social isolation; Informational support; 
Emotional support. . 
7. Ways of Coping Questionnaire. Validated questionnaire with reliability of .76 - .88 and 
established construct validity. 
 
Caregiver outcomes include self-efficacy, stress and coping, informational and emotional support, 
and experience with the intervention.  
 
Please refer to ‘Study Outcomes Table’ attachment for full list of Patient and Caregiver outcomes 
and time points of data collection.   
 
 
Data collection and outcomes assessment 
It is not possible to ‘blind’ the patients, their families, or the healthcare professionals to the study 
assignment in this type of intervention. However, we will have the study research coordinators and 
any other personnel who are involved in outcome assessment blinded to the study participants’ arm 
assignment.  
 
All participants will be interviewed in person, upon enrollment , prior to randomization, by a trained 
study team member. They will then be interviewed via phone by a research team member, who is 
blinded to their study arm assignment at 3, 6, and 9 months post enrollment. Six attempts will be 
made to reach patient/caregiver at each data collection period. At the enrollment visit, baseline data 
will be collected on demographics, bio-psychosocial status, as well as COPD knowledge, self-

 
 
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management skills, patient activation, and health literacy levels (BREATHE2 REDCap survey; 
BREATHE2  Outcomes Table). At their last follow up call, patient and caregiver participants will 
be asked if willing to share their perspective about study interventions, their experience with those, 
and suggestions for improvement. If interested, a future 30-60 min interview will be scheduled to 
take place via phone or at the healthcare facility per participant preference. (See ‘Exit Interview 
Questions’ attachment)   
 
Information will be collected post enrollment on whether the patient has visited the ED or been re-
hospitalized. If so, the name of ED or hospital will be collected and patient’s permission to check 
the medical records from that hospital /ED will be obtained. The medical record will then be 
reviewed to determine whether the visit was COPD-related. This determination will be carried out 
by two physician reviewers. A third physician will adjudicate any unresolved conflicts.  
 
Patients will receive a small monetary incentive for participation in the study at each data collection 
time point. Data will be directly entered using a tablet device into a secured research database 
(Research Electronic Data Capture- REDCap) 
 
We will similarly collect data from caregiver participants who will be surveyed upon enrollment, 
and at 3,6, and 9 months follow up post enrollment.  
 
Peer mentor patient and caregiver participants will complete mentor specific assessment pertaining 
to their experiences as a peer mentor at the end of study. We will also conduct interviews with 
patient and caregiver peer mentor participants to better understand their experiences in this study 
and recommendations for improvement and future dissemination.  
 
 
 
b. Study duration and number of study visits required of research participants.                            
 
Study duration for all participants is 9 months. Peer mentor participants will be invited to extend 
their participation in this study beyond 9 months, if interested and approved by study social worker 
to do so.  
 
One visit will be required from patient and caregiver participants at the enrollment time to obtain 
baseline assessment and meet the respiratory care practitioner, except for hospitalized patients 
whose hospital length of stay allows for those to be conducted prior to their discharge.  This visit 
will occur at the study site where the participants receive their medical care.  
 
Patient and caregiver participants randomized to the HCP PLUS Peer Support Arm will be invited 
to also attend 8 Get together events at the study site where they receive their healthcare.  
 
Peer mentors will be asked to also attend the 8 Get together events as well as monthly peer mentor 
meetings or conference calls with the Peer support program coordinator (clinical social worker.  
 
c. Blinding, including justification for blinding or not blinding the trial, if applicable.  
 
Blinding for intervention arm assignment is not possible for this study’s interventions. Outcomes 
assessors, however, will be blinded to the participants’ arm assignment. 
 
d. Justification of why participants will not receive routine care or will have current therapy 
stopped. N/A 

 
 
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e. Justification for inclusion of a placebo or non-treatment group. N/A 
f. Definition of treatment failure or participant removal criteria. N/A 
g. Description of what happens to participants receiving therapy when study ends or if a 
participant’s participation in the study ends prematurely. N/A 
 
5. 
Inclusion/Exclusion Criteria 
 
           Peer Mentor (PM) Participants 
 Inclusion criteria: 
1) Having moderate- severe COPD or being a family-caregiver for one 
2) AGE >/= 40 YEARS if patient PM and >/= 18 YEARS if family-caregiver. 
3) Never smoked or have successfully stopped smoking for at least 3 months 
4) If patient PM, completed an acute pulmonary rehabilitation program 
5) Nominated by pulmonary rehab staff member or pulmonologist 
6) Successfully completed Phase 1 of the BREATHE2 study (IRB application is # IRB00103197) 
7) Consented to participate as peer mentor in Phase 2 of BREATHE2 study ( RCT phase) 
Exclusion criteria for peer mentors are: Non- English speaking; planning to move from area, unable 
to attend group meetings at study site. 
 
           Patient Participants 
Inclusion Criteria: 
1) Receiving a physician diagnosis of COPD AND treatment for it (defined as receiving treatment 
at hospital or clinic for COPD)  
2) Age > or = to 40 years 
 
Exclusion criteria for patient participants are: Non- English speaking; cognitive dysfunction 
impairing ability to provide informed consent and follow instructions; active substance abuse or 
unstable psychiatric condition; terminal illness (i.e. less than 6 months life expectancy) that is non-
COPD related; planning to move from area;  living at a facility, such as Hospice or nursing home; 
unable to provide contact information.  
 
Caregiver participant: 
Inclusion Criteria: Invited by an enrolled patient participant to join them as caregiver (person 
involved in their healthcare); 18 yrs or older 
Exclusion Criteria: Non-English speaking; Unable to provide contact information 
 
 
6. 
Drugs/ Substances/ Devices 
a. The rationale for choosing the drug and dose or for choosing the device to be used. N/A 
b. Justification and safety information if FDA approved drugs will be administered for non-FDA 
approved indications or if doses or routes of administration or participant populations are 
changed. N/A 
c. Justification and safety information if non-FDA approved drugs without an IND will be 
administered. N/A 
 
7. 
Study Statistics   
a. Primary outcome variable.  

 
 
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Change in Health-related Quality of Life at 6-month follow up compared to baseline, as 
measured by Total score on the St. George Respiratory Questionnaire. 
 
b. Secondary outcome variables 
Please see table below 
 
 
 
Outcome 
 Baseline 
 3 months post 
 6 months post 
 9 months post 
Measure/Instrument description 
Patient Outcomes 
Age, Gender, Marital Status, Race/Ethnicity, 
Living alone Y/N 
✔  
 
 
 
Spirometry : FEV1 % predicted and FEV1/FVC 
✔  
 
 
 
Addiction to drugs or alcohol, mental health 
dx. 
✔  
 
 
CAGE questionnaire; Drug use coded diagnosis at the 
time of baseline assessment 
Education, Income, Occupation 
✔  
 
 
 
Health Literacy 
✔  
 
 
One item question on ease of filling of medical forms 
mMRC Dyspnea Scale 
✔ ✔ ✔ 
✔ 
One item 
Medical hx. (Ht, Wt, previous PFTs, oral 
steroid use, class of inhaler treatments) 
✔  
 
 
Medical record 
Number of hospitalizations in prior 1 year to 
enrollment 
✔  
 
 
Patient/Caregiver self-report 
Time since last hospitalization 
 (in mons) 
✔  
 
 
Patient/Caregiver self-report 
No. of years since receiving COPD diagnosis 
✔  
 
 
Patient/Caregiver self-report 
Smoking Status 
✔ ✔ ✔ 
✔ 
Yes/No, pack-years 
Readiness to quit using 4 stages 
Home oxygen use 
✔  
✔ 
✔ 
No oxygen/oxygen continuously/oxygen with activity 
and/or sleep 
Depression treatment 
✔  
 
 
One item on receiving treatment for depression: 
currently/during past 2 years/never 
Health status 
✔ ✔ ✔ 
✔ 
Patient self-report 
Functional status 
✔  
✔ 
✔ 
Katz Index of Independence in Daily Living 
Patient anxiety and depression   
✔  
✔ 
 
PROMIS anxiety (8 questions) and depression (4 
questions) measures 
Response options: 
Never/rarely/sometimes/often/always
Cognitive status 
✔  
 
 
Minicog 

 
 
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Patient participation in study interventions 
 
 
 
✔ 
HCP and Peer support program participation 
Participation in other programs 
Co-morbidities 
✔  
✔ 
 
Charleson co-morbidity index based on coded 
diagnosis from medical record at baseline 
Patient self-report at 6 months on new heart 
conditions or cancer 
Major life events  
 
 
✔ 
 
Loss of caregiver, change in living status, new health 
conditions or terminal diagnosis, other 
Patient Activation  
✔ ✔ ✔ 
✔ 
Patient Activation Measure (PAM 13) 
Self-efficacy 
✔ ✔ ✔ 
✔ 
Understanding COPD Questionnaire- Select questions) 
Self- care behaviors: Physical activity, smoking 
status, etc. 
✔ ✔ ✔ 
✔ 
Select questions from Understanding COPD 
questionnaire, change in smoking status, physical 
activity
Medication Adherence 
✔  
✔ 
 
Morisky Medication Adherence Scale (4 items) 
Patient perceptions of caregiving 
✔  
✔ 
✔ 
Perceptions of caregivers’ support and their 
preparedness to assist with COPD management; 
caregiving activities received 
PROMIS support measures 
 
✔ ✔ ✔ 
✔ 
PROMIS item bank- 4 domains will be used (each 
domain has 4 items):  
1) Social isolation; 2) Informational support;  
3) Emotional support; 4) Instrumental support.  
There are 5 response options: 
Never/rarely/sometimes/usually/always 
Hope 
✔ ✔ ✔ 
✔ 
Herth Hope index ( 12 item instrument ) with 3 
subscales
Participation in pulmonary rehabilitation 
✔ ✔ ✔ 
✔ 
Percentage of patients enrolled in pulmonary 
rehabilitation; Mean number of sessions attended per 
week 
Post hospitalization ED visits and readmissions 
( COPD - related and all cause)  
✔ ✔ ✔ 
✔ 
Measure: Average number of visits per patient in the 
6 months post enrollment (calculated as Combined ED 
and hospitalizations; ED only; Hosp. only).  
Based on patient self-report (Y/N ;  
circumstances/reasons for seeking these services) 
followed by medical records confirmation  
COPD - specific quality of life : Total score; 
domain scores 
✔  
✔ 
✔ 
St. George’s Respiratory Questionnaire (SGRQ)  
 Mortality 
 
✔ ✔ 
✔ 
Mortality data collected from caregivers, hospital and 
ED records, and vital Statistics records 
Caregiver Outcomes 
Family – caregiver preparedness for 
caregiving 
✔ ✔ ✔ 
✔ 
Preparedness for Caregiving Scale adapted from 
Understanding COPD questionnaire  
Caregiver stress 
✔ ✔ ✔ 
✔ 
Zarit stress index, Ways of Coping Questionnaire  
PROMIS measures 
✔ ✔ ✔ 
✔ 
PROMIS item bank- 2 domains will be used (each 
domain has 4 items):  
1) Informational support;  
2) Emotional support. There are 5 response options: 
Never, rarely, sometimes, usually, or always. 
Patient and Caregiver Satisfaction and 
Experience 
 
 
✔ 
 
Adapted from CAHPS plus additional intervention 
specific items  
 
c. Statistical plan including sample size justification and interim data analysis. 

 
 
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We hypothesize that the dual strategy of using ‘HCP PLUS Peer Support’ to engage and support 
COPD patients and caregivers will have superior outcomes to the ‘HCP only’ strategy in the 
following areas: a) Improved health- related quality of life and survival, and reduced numbers of 
COPD-related hospital and ED visits; b) improved patient activation, self-efficacy, and self-care 
behaviors; c) improved self- efficacy and coping skills. These improvements will be noted at 3, 
6, and 9 months compared to baseline.  
 
The main analysis approach for assessing the change in the primary outcome measure from 
baseline, as well as changes in secondary outcome measures from baseline, will consist of 
performing analyses of the treatment effect between the two study groups under intention to 
treat, adjusted for baseline measure, site, and recruitment setting. The health- related quality of 
life in hypothesis (a) will be measured using the SGRQ. For Hypothesis (b) patient activation 
will be measured using PAM, self- efficacy and self- care behaviors will be measured using the 
‘Understanding COPD questionnaire’, Morisky scale, and additional items on physical activity, 
smoking cessation, and participation in pulmonary rehabilitation. For hypothesis (c), caregiver 
self- efficacy will be measured using ‘Preparedness for caregiving’ scale and an adapted 
‘Understanding COPD questionnaire’ items for caregivers; and, coping skills will be measured 
using the ‘Ways of Coping Questionnaire’. 
 
The primary outcome of this study (hypothesis a) will be evaluated with a linear mixed random-
effects (RE) model. The primary hypothesis about change in HRQOL from baseline to 6 
months, will be evaluated by a hypothesis test of the interaction term between study group and 
the 6-month time variable. The mixed RE model reflects the study’s interest in comparisons of 
change at the individual level, where the changes may be subject-specific and reflective of 
potentially unmeasured variables. 
 
For secondary outcomes, we will fit appropriate generalized mixed RE models based on the type 
of outcome variable. Differences in change in outcome from baseline between study groups will 
be assessed by including interaction terms between the time variables and study group. Initially, 
models will be adjusted only for baseline measure, site, and recruitment setting. We will also 
consider adjusting for patient characteristics such as age, gender, presence of caregiver, home 
oxygen use, and prior hospitalization. For a more detailed description of the statistical analysis 
please refer to the statistical analysis plan in the supplemental study documents section 
(SAP_BREATHE2_2019Jun26). 
 
Given the nature of the HCP PLUS Peer Support intervention, it is not possible to guarantee full 
adherence from all of the patients. As a result, traditional ITT statistical methods might be bias 
due to the effects from non-adherent participants. To correct for this bias, we would implement 
an instrumental variable approach to estimate the effect of the intervention on the change in the 
HRQOL. For this analysis we will divide the group of patients assigned to the HCP PLUS Peer 
Support group into adherent and non-adherent participants.  
 
We will define as adherent participants all those patients who experienced at least 4 or more 
encounters with their peer mentor either by attending to a get-together, participated in a 
BREATHE call, or by having a phone conversation with their BREATHEpal.  For this analysis, 
we will instrument patient adherence with the patient’s randomized assignment to either the 
control or the treatment group. Additional sensitivity analysis will be performed using different 
definitions of intervention adherence: (1) those participants with at least 2 encounters with 
their peers (get—togethers, BREATHE calls, or phone conversations) and (2) those participants 
who experienced at least 4 or more encounters with their peers either by attending to a get-

 
 
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together, participated in a BREATHE call, or by having a phone conversation with their 
BREATHE pal containing discussion of COPD-related issues (determination based on BREATHE 
pal notes.)  For a more detailed description of our complier-average causal effect analysis and 
IV approach, please refer to the statistical analysis plan in the supplemental study documents 
section (SAP_BREATHE2_2019Jun26). 
 
The sample size calculation will be based on an overall comparison of the change between the 
baseline and 6-month measurements of the patients on the St. George scale (primary outcome) 
in the two arms (interaction term). The unadjusted per-arm sample size is based on a power of 
0.80, alpha of 0.05, a minimally clinical significant difference in change scores of 4 points and a 
meta-analysis estimate of variability. The estimated sample size is 145 patients per arm, after 
accounting for a 15% attrition rate, assuming a within-patient correlation between 
measurements of 0.8.  
 
Heterogeneity of Treatment Effects (HTE) HT-1 
 
The goal of the HTE analyses in this study is to consider the difference in treatment effect 
between the two arms, taking into consideration differences in the arms that are not obviously 
accounted for in the balance created by the randomization scheme. Patient characteristics such 
as disease severity or caregivers’ presence may show differences in the intervention’s effect and 
thus are important avenues to explore for hypothesis generation. In this hypothesis generating 
HTE analysis, we will consider the following subgrouping variables: age (4 categories), gender, 
disease severity, baseline PAM score, and caregiver presence. Within the HCP PLUS Peer 
Support group, we will also consider subgrouping by the propensity for adherence to treatment.  
 
HT-2, HT-3 
 
Subgroup treatment effects will be estimated by including a three-way interaction between the 
subgroup variable, the study assignment variable, and the 6-month time variable in a generalized 
linear mixed RE model.  We will test for a difference in treatment effect between subgroups by 
a hypothesis test of the overall three-way interaction in this model. We will report estimates of 
subgroup treatment effects with corresponding 95% confidence intervals (CIs). For a more 
detailed description of the heterogeneity of treatment effect, please refer to the statistical 
analysis plan in the supplemental study documents section (SAP_BREATHE2_2019Jun26). 
 
d. Early stopping rules. 
No early stopping rules.  
 
8. 
Data Management Plan 
 
Blinded team members will perform follow-up data collection by telephone 3, 6, and 9 months after a 
participant enrollment in the program. Authorized team members will collect the necessary study 
instruments using the secure web-based application, REDCap. This application is equipped to satisfy HIPAA 
requirements, and allows mechanisms to maintain the blinding requirements of the study. In addition, 
REDCap has the ability to export all data in different formats to be analyzed by different statistical 
software such as Stata, R, and Excel, while also providing with an updated data dictionary and other 
metadata from all the collected instruments. The team will also rely on internal Access databases for event 
tracking and logistics.  
Once the data is collected, the research team member in charge of data management will monitor the 
quality and consistency of the data collected. All study data, raw data and analytic files, will be kept for 

 
 
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seven years in a Secure Analytic Framework Environment (SAFE) desktop. SAFE is a virtual desktop that 
provides JHM investigators with a secure environment to analyze and share sensitive data such as PHI and 
PII. This virtual environment complies with federal and institutional requirement to protect patient data. 
With respect to data recovery and preservation, the SAFE environment takes a snapshot of all data stored 
3 times a day. Two of these are kept for 2 days, while one is retained for 6 weeks. 
Study findings will be reported at trials.gov along with the study protocol and SAP. Study results we would 
also be shared with the scientific community  in presentations and peer-reviewed publications. Results will 
also be shared with the study partners and recruitment site leaders.  
 
 
9. 
Risks 
This is a minimal risk study. Patients who participate in either study arm will not have any change 
made to the medical treatments that they receive. Patients will not have any procedures or receive 
any medications.  
As part of their training the peer mentors in this study will learn the difference between sharing 
their experiences as peers and providing medical advice. We will also record a select set of 
meetings and those will be reviewed to ensure that conversations do not constitute medical advice 
but rather good exchange of information and practical advice from peers about how to address day 
to day challenges of living with COPD.  
 
a. Medical risks, listing all procedures, their major and minor risks and expected frequency. 
Medical risks are minimal as the study participants will be in control of the treatment plan. No 
procedures or medical treatments will be provided to the study participants. 
 
The risks associated with the intervention are negligible and mainly pertain to patient 
confidentiality. It is possible that the intervention may lead to few patients/ family members 
demanding more ‘face time’ from their clinicians to answer questions/address concerns about 
COPD,  and that this demand while an encouraging sign of patient engagement and activation may 
on few occasions not be welcomed by some clinicians. 
 
 It is also possible that a patient may not feel comfortable with the peer mentor leading their group 
and in that event, we’ll make accommodations so that they can get connected with another peer 
mentor. The peer mentors may get attached to a particular participant who is very sick or dies. In 
that case the peer mentors are instructed to turn to the clinical social worker leading the program 
who will provide grief counseling and be there for ongoing support.  The monthly meetings that the 
peer mentors will have will also provide another ongoing source of support. 
 
A Data Safety and Monitoring Board has been established for the study.  The Board has 3 
researchers and a patient advocate. The researchers have many years of experience in clinical 
management of COPD, research methodology, and community based research. The patient advocate 
has COPD and has participated in advocacy efforts led by the COPD Foundation. The board will 
meet twice a year during the study period. The Board has the responsibility for monitoring study 
data for evidence of adverse effects attributable to study interventions. 
 
b. Steps taken to minimize the risks. 
None of the patient information will be released to their physician, health care organization, or any 
other party without the patient's permission.  Phone contacts to locate the study subject will not 
suggest the content of the study.  All study data will be stored in locked file cabinets at Johns 

 
 
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Hopkins Armstrong Institute for Safety and Quality (not the clinical sites) .  Personal identifiers will 
be removed as soon as possible.  
 
c. Plan for reporting unanticipated problems or study deviations. 
Unanticipated problems will be reported to the IRB per IRB specified guidelines and a log will be 
kept for unanticipated problems and study deviations. Any participant deaths, whether expected or 
unexpected, will be promptly reported in accordance with JHM policies, except when the death 
meets one of the exceptions to prompt reporting criterion. 
 
d. Legal risks such as the risks that would be associated with breach of confidentiality. 
There are minimal risks for breach of confidentiality that we would address by taking all possible 
measures to secure study participants personal health information and restrict access to it.  All 
collected data will be kept in a secure database and secured shared drive. No PHI will be saved on 
personal devices.  
 
e. Financial risks to the participants. 
 
No financial risks.  
 
 
10. 
Benefits  
 
a. 
Description of the probable benefits for the participant and for society. 
 
All patients in this study may experience benefits from having an in person meeting with a 
healthcare professional to learn about COPD and evidence based recommendations for their 
condition, double check their inhaler use technique, and receive educational materials and a 
community resource guide. They may also benefit from having the opportunity during their 9 month 
study period to call the RCP and ask questions about COPD and discuss any difficulties in 
managing it.   
Study participants randomized to the HCP PLUS Peer Support arm may benefit from meeting other 
peers and gaining new knowledge about management of COPD.  
This study may bring societal benefits if the developed study intervention was demonstrated later to 
result in improved outcomes for COPD patients and their caregivers.  
 
 
11. 
Payment and Remuneration  
 
 
a. 
Detail compensation for participants including possible total compensation, proposed bonus, 
and any proposed reductions or penalties for not completing the protocol. 
 
 1) 
PATIENT PARTICIPANTS: Participants will receive a total of $80 over the 9 months study 
period for his/her time and participation.  The compensation will be given as follows: $20 for the 
Enrollment visit.  The participant will receive $15 each for completing a phone interview at 3 
months, and then at 6-month follow-up. S/he will also receive $30 for completing the 9-month final 
follow-up interview. 
 
2) 
PEER MENTOR PARTICIPANTS: Peer mentor participants (both patient and caregiver 
peer mentors) will receive a total of $500 over the 9 months study period in appreciation of his/her 
service as a BREATHE Pal in this study. The peer mentors will receive $ 50 after each Get-together 

 
 
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and then $100 at the end of study period. Parking will be covered and meals will be provided at the 
group meetings.  
 
3) 
CAREGIVER PARTICIPANTS: Caregiver participants will receive a total of $60 over the 9 
months study period for his/her time and participation.  S/he will receive $15 for the first scheduled 
study visit during which researchers will go over the study consent form and ask him/her questions 
about his/her health. S/he will receive $15 each for completing a phone interview at 3 months, and 
then at 6-month follow-up. S/he will also receive $15 for completing the 9-month final follow-up 
phone call. 
 
 
12. 
Costs  
 
a. 
Detail costs of study procedure(s) or drug (s) or substance(s) to participants and identify 
who will pay for them. 
There will be no costs associated with study participation.   
 
 
 
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Supplemental Document 
 
Statistical Analysis Plan 
 
NCT#02891200 
 
Version Date: June 26, 2019 
 
IRB Approval Date: 7/24/2019 
 
 

Statistical Analysis Plan (SAP) for BREATHE2 Study 
Study Description 
The overall goal of this study is to compare the effectiveness of two health communication and 
dissemination strategies that are designed to engage patients and family caregivers in 
successfully managing COPD in real-world settings. Both strategies aim to (1) advance patient 
understanding of COPD, its treatment options, and self-care tasks and (2) support them in coping 
with the disease; and enable them to adopt a variety of positive behaviors, including adherence 
to treatment plans, smoking cessation, joining pulmonary rehabilitation programs, and assuming 
an active, healthy lifestyle. One strategy relies on the healthcare professional (HCP) as the 
primary communicator about COPD self-management (HCP Group), whereas the other uses a 
dual approach that involves both healthcare professionals and peer mentors delivering such 
communication (HCP PLUS Peer Support Group). 
 
The study will compare the impact of these strategies on the outcomes of health-related quality 
of life, mortality, and use of Emergency Department (ED) and other hospital services, as well as 
intermediate measures such as patient activation, self- efficacy, and self-care behavior, as 
described in the BREATHE2 Study Conceptual Model shown in Figure 1 below.    At the same time, 
the study will compare the impact of these strategies on caregiver self-efficacy, stress, and coping 
skills. We will also assess both patient and caregiver experience and satisfaction within the HCP 
PLUS Peer Support Group. 
 

 
Figure 1. BREATHE2 Study Conceptual Model 
 
Study Design (PCORI Standard IR-1)  
Phase 1 of this study involved intervention development followed by peer mentor recruitment 
and training.  Phase 2 of this study, which is addressed by this SAP, involves rigorous testing of 
the study intervention in a randomized controlled trial (RCT) at two study sites: (1) Johns Hopkins 
Bayview Medical Center (JHBMC) and affiliated pulmonary and primary care clinics and (2) 
Howard County General Hospital (HCGH) and affiliated pulmonary and primary care clinics.  
(some of these clinics are part of Johns Hopkins Community Physicians).  Thus within each study 
site, patients were recruited from two clinical settings: (1) inpatient recruitment within the 
hospital and (2) outpatient recruitment from the affiliated clinics.  
 
We consented and enrolled 290 persons who met the initial eligibility criteria of receiving a 
physician diagnosis of COPD and treatment for it. Patient participants were randomized to one 
of the two study groups in this trial (HCP or HCP PLUS Peer Support) and their respective 
Caregiver Participant, if they have one enrolled, participated with them in that study group.  Then 
patients were randomized 1:1 to the HCP or the HCP PLUS Peer Support. 
 
Our primary study outcome is the change in quality of life (QOL) over the 6 months post 
discharge.  Other patient measures include patient activation self-efficacy, self-care behavior, 

health status, used of Emergency Department (ED) and other hospital services, and survival. 
Caregiver measures include caregiver self-efficacy, stress, and coping skills. 
 
Intervention Description  
All study participants will receive a Health Care Professional (HCP) support intervention in this 
study, which involves a 1 hour session with the respiratory care practitioner (RCP), and the ability 
to follow up with them with any questions.  They would also receive the BREATHE binder with 
educational materials on COPD self-management and a resource guide.  
 
Those randomized to the HCP PLUS Peer Support group of the study will also have the 
opportunity to participate in a Peer Support Program. This program will offer patients and their 
caregiver support services to be delivered via multiple channels including one-on-one and group 
conversations.  In this program, the patient and caregiver participants will have the option to 
connect with other peers. Each patient and caregiver participant in this study group will be 
matched with a peer mentor (referred to as BREATHE Pal). The BREATHE pal will talk with the 
participant at regular intervals at peer group Get together events and/ or via phone. The group 
events will take place at the study sites, and will be co-led by two BREATHE Pals in the presence 
of a social worker. At these events, select topics about COPD self-management will be discussed, 
and the messages delivered by the respiratory care practitioner will be reinforced.  Participants 
who are unable to attend these in-person events have the option to participate in BREATHE calls, 
where the same topics are discussed via a conference call. 
 
 Study Objectives 
We hypothesize that the dual strategy of using HCP PLUS Peer Support to engage and support 
COPD patients and caregivers will have superior outcomes to the HCP only strategy at 3-, 6-, and 
9-months post enrollment compared to baseline in the following areas: 
a) Improved health- related quality of life measured with the St. George’s Respiratory 
Questionnaire. 
b) Improved survival and reduced numbers of COPD-related hospital and ED visits. 

c) Improved patient activation, self-efficacy, and self-care behaviors 
               
Data Collection for Phase 2 
All participants will be interviewed in person, upon enrollment, prior to randomization, by a 
trained study team member. At the enrollment visit, baseline data will be collected on 
demographics, bio-psychosocial status, as well as COPD knowledge, self-management skills, 
patient activation, and health literacy levels. Participants will then be interviewed via phone by a 
research team member, who is blinded to their study group assignment at 3-, 6-, and 9-months 
post enrollment. Similarly, we will collect data from caregiver participants who will be surveyed 
upon enrollment, and at 3-, 6-, and 9-months follow up post enrollment.  Due to the study end 
date, it will not be possible to collect 9-month follow-up data for participants who enrolled later 
in the study. 
 
Additionally, information will be collected post enrollment on whether the patient has visited the 
ED or been re-hospitalized via Chesapeake Regional Information System for our Patients (CRISP). 
CRISP will be used determine whether the visit was COPD-related using a set of pre-determined 
discharge diagnoses.  
 
Study Outcomes and Hypotheses 
The study groups will be compared for the following outcomes: 
 
Primary Outcome for Patient Participants: 
1. Change in health-related quality of life (HRQOL) as measured by the St. George 
Respiratory Questionnaire (SGRQ) total score, from baseline to 6 months post-
enrollment. 
Hypothesis: Patients in the HCP PLUS Peer Support group will have a larger improvement 
in HRQOL (larger negative change in SGRQ score) at 6 months post discharge compared 
to baseline, than patients in the HCP only group. 
 

Secondary Outcomes and Intermediate Measures for Patient Participants:   
Secondary Outcomes: 
1. Change in HRQOL based on SGRQ total score at 9 months post enrollment.  
Hypothesis: Patients in the HCP PLUS Peer Support group will have larger improvement 
in HRQOL (larger negative change in SGRQ score) compared to baseline, than patients in 
the HCP only group. 
 
2. Total number of COPD-related hospitalizations and ED visits at 3, 6, and 9 months post-
enrollment. 
Hypothesis: Patients receiving the HCP PLUS Peer Support will have a lower rate of  COPD-
related hospitalizations and ED visits than patients in the HCP only group. 
 
3. Total combined number of all cause hospitalizations and ED visits at 3, 6, and 9 months 
post-enrollment. 
Hypothesis: Patients receiving the HCP PLUS Peer Support will have a lower rate of 
hospitalizations and ED visits than patients in the HCP only group. 
 
4. Total combined number of all cause hospitalizations and ED visits at 3, 6, and 9 months 
post-enrollment. 
Hypothesis: Patients receiving the HCP PLUS Peer Support will have a lower total number 
of all cause hospitalizations and ED visits than patients in the HCP only group. 
 
5. Change in HRQOL based on SGRQ domain scores at 3, 6, and 9 months post-enrollment. 
Hypothesis: Patients receiving the HCP PLUS Peer Support will have larger improvement 
in HRQOL (larger negative change in SGRQ score) compared to baseline, than patients in 
the HCP only group. 
 
6. Mortality rate at 3, 6, and 9 months post-enrollment.  
Hypothesis: Patients receiving the HCP PLUS Peer Support will have a lower mortality rate 
compared to patients in the HCP only group. 

 
Intermediate Measures: 
7. Change in PROMIS support domain scores (Instrumental, Informational, Depression, 
Anxiety, Social Isolation, and Emotional Support) at 3, 6, and 9 months post-enrollment. 
Hypothesis: Patients receiving the HCP PLUS Peer Support will have larger positive change 
in PROMIS scores compared to baseline, than patients in the HCP only group.  
 
8. Change in Herth Hope Index total score at 3, 6, and 9 months post-enrollment. 
Hypothesis: Patients receiving the HCP PLUS Peer Support will have larger positive change 
in Hearth Hope Index scores compared to baseline, than patients in the HCP only group.  
 
9. Change in Patient Activation Measure (PAM) scores at 3, 6, and 9 months post-
enrollment. 
Hypothesis: Patients receiving the HCP PLUS Peer Support will have larger positive change 
in PAM scores compared to baseline, than patients in the HCP only group. 
 
10. Change in patient’s understanding and self-efficacy, as measured by the Understanding 
COPD questionnaire’s three components (About COPD, Symptom Management, and 
Accessing Help and Support)  at 3, 6, and 9 months post-enrollment. 
Hypothesis: Patients receiving the HCP PLUS Peer Support will have larger positive change 
in understanding and self-efficacy levels compared to baseline, than patients in the HCP 
only group. 
 
11. Morisky adherence levels at  6 months post-enrollment.  
Hypothesis: Patients receiving the HCP PLUS Peer Support will have a higher level of 
adherence compared to patients in the HCP only group. 
 

12. Participation in pulmonary rehabilitation at 3, 6, and 9 months post-enrollment. 
Hypothesis: Patients receiving the HCP PLUS Peer Support will have greater level of 
participation in pulmonary rehabilitation than patients in the HCP only group. 
 
13. Change in smoking status at 3, 6, and 9 months post-enrollment.  
Hypothesis: Patients receiving the HCP PLUS Peer Support will have a higher smoking 
cessation rate than patients in the HCP only group. 
 
Handling of Missing Data (PCORI Standards MD-2, MD-4) 
There are two types of missing data, at the respondent level (unit non-response) and at the 
specific question level (item non-response). At the respondent level, missing data occurred 
because of patient death, withdrawal from study, or inability to be reached via phone for an 
interview. Comparisons of missingness by several patient characteristics at baseline will be 
performed with Fisher’s exact or Chi-Square tests to examine any potential systematic pattern to 
the missing data. For the specific case of the SGRQ instrument, values of 100 (the worst possible 
QoL score) will be imputed for any assessment in which a patient was not available because of 
death. 
 
With respect to data at the specific question level, missing data will be handled according to each 
instrument collection manual. In some cases, for example the SGRQ,1 PAM,2 and PROMIS-
anxiety,3 -depression,4 -emotional,5 and –instrumental support index6 score will be prepared in 
instrument specific calculators, provided by the instrument’s authors, and accounted for any 
assignments of missing scores based on the availability of item responses. Missing data for other 
instruments such as PROMIS-social isolation7 and –informational support index8, understanding 
COPD9, and Morisky measure,10 will be handled according to the instrument’s author’s direction.  
 
When no information is available for handling missing item responses on a particular instrument, 
a rule, allowing no more than 25% of the items for the scale/domain to be missing, was used.  If 
less than 25% of the item responses were missing, the mean of the non-missing item responses 

was calculated and was used to replace the value of the missing item responses before 
calculation of the scale/domain score. This approach weights the scale/domain score towards 
the respondent’s mean response and is balanced by requiring a large majority of item responses 
to be available. If more than 25% of the item responses were missing, the scale/domain score 
was considered missing. 
 
Statistical Analysis (PCORI Standard IR-1, RC-4) 
Statistical summaries and distributions of patient characteristics will be reviewed by study site 
(JHBMC and HCGH) and by recruitment setting (inpatient and outpatient). Statistical summaries 
and distributions of patient and clinical characteristics will also be reviewed across study groups. 
Randomization of the patients to the study groups expects that on average the groups were 
balanced on characteristics that might affect the study results, such as socio-demographic and 
health status.  Thus, no statistical tests to compare the groups on patient characteristics will be 
performed. 11 
Exploratory analyses will be performed cross-sectionally at baseline, 3, 6, and 9 months post-
discharge for each of the outcomes across the two study groups. This will provide an assessment 
of the outcomes’ distributions, missingness patterns and the need for additional data review and 
quality assurance.  
 
The main analysis approach for assessing the change in the primary outcome measure from 
baseline, as well as changes in secondary outcome measures from baseline, will consist of 
performing analyses of the treatment effect between the two study groups under intention to 
treat (ITT) adjusted for baseline measure, site, and recruitment setting. 
 
Repeated outcomes in this study will be evaluated using generalized linear mixed random-effects 
(RE) models.  The generalized linear mixed RE model reflects the study’s interest in comparisons 
of change at the individual level, where the changes may be subject-specific and reflective of 
potentially unmeasured variables.  This model also fits well with the approaches related to 

missing data and heterogeneity of treatment effects discussed below.  In particular, this approach 
will help us handle the missing 9-month data for participants who enrolled later in the study.  
 
The primary repeated outcome (SGRQ) will be evaluated using a linear mixed RE model.  Within 
this model, the primary hypothesis about change in HRQOL from baseline to 6 months, will be 
evaluated by a hypothesis test of the interaction term between study group and the 6-month 
time variable. 
 
For secondary outcomes, we will fit appropriate generalized linear mixed RE models based on 
the type of outcome variable.  Continuous measures, such as for HERTH Hope Index or PROMIS 
support domain scores, will be assessed using linear mixed RE models.  Binary outcomes, such as 
Morisky adherence to medication, will be assessed using logistic mixed RE models.  Outcomes 
that are cumulative counts, such as number of hospitalizations and ED visits, will be assessed 
using Poisson or negative binomial mixed RE models, as appropriate.  Differences in change in 
outcome from baseline to 3, 6, and 9-months between the study groups will be assessed by 
including interaction terms between the time variables and study group.  We will assess 
significance by first testing the overall interaction between time and group.  If the overall 
interaction is significant for an outcome measure, we will then estimate and test individual time 
differences accounting for multiple testing using a Bonferroni correction. Initially models will be 
adjusted only for baseline measure, site, and recruitment setting.   We will also consider adjusting 
for patient characteristics such as age, gender, presence of caregiver, home oxygen use, and prior 
hospitalization. 
 
Unadjusted survival analyses using Kaplan-Meier and log rank tests will be performed for time to 
death or first COPD-related hospitalization or ED visit. Statistical significance will be considered 
for p < 0.05. 
 
Complier-Average Causal Effect (CACE) using Instrumental Variable Estimation 
 

CACE: Primary Outcome 
Given the nature of the HCP PLUS Peer Support group, it is not possible to guarantee full 
adherence from all of the patients. As a result, traditional ITT statistical methods might be bias 
due to the effects from non-adherent participants. To correct for this bias, we would implement 
an instrumental variable approach to estimate the effect of the intervention on the change in the 
HRQOL as measured by the SGRQ total score from baseline to 6-months post-enrollment. 12 
One of the requirements for this analysis is to divide the group of patients assigned to the HCP 
PLUS Peer Support  group into adherent and non-adherent participants.  For our main analysis, 
we define as adherent participants all those patients who experienced at least 4 or more 
encounters with their peer mentor either by attending to a get-together, participated in a 
BREATHE call, or by having a phone conversation with their peer-pal.  Phone conversations with 
peer-pals include both check-in conversations as well as conversations about the COPD related 
issues discussed at the get togethers. For this analysis, we will instrument patient adherence with 
the patient’s randomized assignment to either the control or the treatment group. Additionally, 
we will conduct sensitivity analyses by defining adherent participants to be (1) those participants 
with at least 2 encounters with their peers (get—togethers, BREATHE calls, or phone 
conversations) and (2) those participants who experienced at least 4 or more encounters with 
their peers either by attending to a get-together, participated in a BREATHE call, or by having a 
phone conversation with their BREATHE pal containing discussion of COPD-related issues 
(determination based on BREATHE pal notes.) 
 
CACE: Secondary Outcomes 
In order to analyze the effect of the Peer Support intervention on secondary outcomes such as 
the level of acute health care utilization (hospitalizations and ED visits), patient-reported 
outcomes (PROMIS scores), patient’s activation measure, and HERTH hope index we will 
implement a CACE approach to control for the bias produced by not-fully adherent patients. 
Just as with the case of our primary outcome, we will use a patient’s randomization assignment 
as an instrument for HCP PLUS Peer Support group adherence. For this analysis we will define as 

adherent participants all those patients who experienced at least four or more encounters with 
their peer mentor. We will also conduct sensitivity analyses in the same manner as for the 
primary outcome. 
Intervention Implementation Analysis 
In addition to assessing the primary and secondary outcomes for patients we intend to 
investigate which patient characteristics determine participation in the HCP PLUS Peer Support.  
That is, we will investigate which patient characteristics are related to attendance at BREATHE 
get togethers, participation in BREATHE calls, and phone interactions with BREATHE pals.  As in 
the CACE analysis, we will define overall participation in the HCP PLUS Peer Support group as 
experiencing at least 4 or more encounters with a peer mentor either by attending a get-
together, participating in a BREATHE call, or having a phone conversation.  We will define 
participation in group support via attendance at 4 or more BREATHE get togethers or BREATHE 
calls.  We will define participation in individualized 1:1 support by 4 or more encounters with a 
BREATHE pals over the phone.  We will use multivariable logistic regression to predict overall 
participation, as well as participation in group or 1:1 support , from baseline characteristics such 
as age, gender, education level, distance from patient’s home to meeting location, oxygen use, 
whether patient lives alone, whether patient reports they have a caregiver, self-reported health 
status, PAM level, and baseline assessments of hope, support, anxiety and depression from Herth 
Hope Index and PROMIS measures.  
 
Heterogeneity of Treatment Effect (HTE) (PCORI Standard HT-1, HT-2, and HT-3) 
HT-1, HT-3:  
The goal of the HTE analyses in this study is to consider the difference in treatment effect 
between the two groups, taking into consideration differences in the groups that are not 
obviously accounted for in the balance created by the randomization scheme. Patient 
characteristics such as disease severity or caregivers’ presence may show differences in the 
intervention’s effect and thus are important avenues to explore for hypothesis generation. In 
these hypothesis generating HTE analyses, we will consider the following subgrouping variables 
for the primary outcome of change in SGRQ from baseline to 6 months: age (4 categories), 

gender, disease severity (whether they are on continuous home oxygen), baseline PAM score 
(collapsed into low vs high levels), and caregiver presence (caregiver vs no caregiver).  Within the 
HCP PLUS Peer Support group, we will also consider subgrouping by the propensity for adherence 
to treatment (collapsed into low vs high levels), with propensity for adherence to treatment as 
the estimated probability of adherence to treatment from our intervention implementation 
analysis described above.   
 
HT-2, HT-3:  
Subgroup treatment effects will be estimated by including a three-way interaction between the 
subgroup variable, the study assignment variable, and the 6-month time variable in a generalized 
linear mixed RE model.  We will test for a difference in treatment effect between subgroups by a 
hypothesis test of the overall three-way interaction in this model. We will report estimates of 
subgroup treatment effects with corresponding 95% confidence intervals (CIs).  For the 
comparison of propensity for adherence groups within the HCP PLUS Peer Support group, we will 
include an interaction between the subgroup variable and the 6-month time variable, test this 
interaction, and estimate subgroup effects with corresponding 95% CIs. 
 
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