My Lung Health Coach-A Virtual COPD Self-management Support Program Integrated Into the Electronic Patient Record
Phase: NA
Conditions: Copd
Sponsor: Women's College Hospital

 
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Study Protocol:  
 
My Lung Health Coach – A virtual COPD self -
management support program integrated into 
the electronic patient record
 
 
Principal Investigator:
 Dr. Andrew Kouri  
Version Number:  1.1 
Version Date: 28-May-2024 
 
 
 
 
 
 
 
 
 
 

 
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Principal 
Investigator:  
Andrew Kouri 
Staff physician, Division of Respirology, WCH 
Scientist, Women’s College Research Institute 
Co-
Investigators:  
Chandra Farer 
Quality Manager 
Women’s College Hospital 
 
 
Study Site(s):  Women’s College Hospital 
 
Funded By:  
Women’s College Hospital Foundation: Women’s College 
Healthcare Breakthrough Challenge 

 
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TABLE OF CONTENTS  
 
STATEMENT OF COMPLIANCE  .................................................................................................................. 6 
LIST OF ABBREVIATIONS  .......................................................................................................................... 7 
CLINICAL TRIAL SUMMARY  ....................................................................................................................... 8 
1.0 INTRODUCTION ................................................................................................................................. 10 
1.1 
BACKGROUND............................................................................................................................... 10 
1.2 
STUDY INTERVENTION ................................................................................................................... 10 
1.3 
PRECLINICAL DATA TO DATE ......................................................................................................... 10 
1.4 
CLINICAL DATA TO DATE ............................................................................................................... 11 
1.5 
RISKS/BENEFITS ........................................................................................................................... 11 
2.0 CLINICAL TRIAL OBJECTIVES  ....................................................................................................... 12 
2.1 
PRIMARY OBJECTIVE ..................................................................................................................... 12 
2.2 
SECONDARY OBJECTIVE ............................................................................................................... 12 
3.0 CLINICAL TRIAL DESIGN  ................................................................................................................. 12 
3.1 
OVERALL DESIGN ......................................................................................................................... 12 
3.2 
PRIMARY ENDPOINTS .................................................................................................................... 12 
3.3 
SECONDARY ENDPOINTS ............................................................................................................... 12 
4.0 PARTICIPANT SELECTION AND WITHDRAWAL  ........................................................................... 13 
4.1 
TARGET POPULATION .................................................................................................................... 13 
4.2 
PARTICIPANT RECRUITMENT AND SCREENING ................................................................................ 13 
4.3 
EQUITY, DIVERSITY AND INCLUSION CONSIDERATIONS.................................................................... 13 
4.4 
ELIGIBILITY CRITERIA .................................................................................................................... 14 
4.4.1 
Inclusion Criteria .................................................................................................................... 14 
4.4.2 
Exclusion Criteria ................................................................................................................... 14 
4.5 
LIFESTYLE CONSIDERATIONS ......................................................................................................... 14 
4.6 
SCREEN FAILURES ........................................................................................................................ 14 
4.7 
PARTICIPANT WITHDRAWAL CRITERIA ............................................................................................ 14 
4.7.1 
When and How to Withdraw Participants .............................................................................. 14 
4.7.2 
Follow-up for Withdrawn Participants .................................................................................... 15 
5.0 STUDY INTERVENTION .................................................................................................................... 16 
5.1 
DESCRIPTION................................................................................................................................ 16 
5.2 
TREATMENT REGIMEN ................................................................................................................... 16 
5.3 
METHOD FOR ASSIGNING PARTICIPANTS TO TREATMENT GROUPS .................................................. 16 
5.4 
ADMINISTRATION OF STUDY INTERVENTION .................................................................................... 16 
5.5 
PARTICIPANT COMPLIANCE MONITORING ....................................................................................... 16 
5.6 
CONCOMITANT THERAPY ............................................................................................................... 17 
5.7 
PACKAGING .................................................................................................................................. 17 
5.8 
BLINDING OF STUDY INTERVENTION ............................................................................................... 17 
5.9 
RECEIVING, STORAGE, DISPENSING AND RETURN .......................................................................... 17 
5.9.1 
Receipt of Study Intervention Supplies .................................................................................. 17 
5.9.2 
Storage ................................................................................................................................... 17 
5.9.3 
Dispensing of Study Intervention ........................................................................................... 17 
5.9.4 
Return or Destruction of Study Intervention ........................................................................... 17 
6.0 RESEARCH PROCEDURES.............................................................................................................. 17 
6.1 
RESEARCH VISITS ......................................................................................................................... 17 
6.2 
SCHEDULE OF EVENTS .................................................................................................................. 19 

 
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7.0 STATISTICAL CONSIDERATIONS  ................................................................................................... 20 
7.1 STATISTICAL HYPOTHESES  ........................................................................................................... 20 
7.2 SAMPLE SIZE DETERMINATION  ..................................................................................................... 20 
7.3 POPULATIONS FOR ANALYSES  ..................................................................................................... 20 
7.4 STATISTICAL ANALYSES  ................................................................................................................ 20 
7.4.1 GENERAL APPROACH  ..................................................................................................................... 20 
7.4.2 ANALYSIS OF THE PRIMARY ENDPOINT(S)  ................................................................................. 20 
7.4.3 ANALYSIS OF THE SECONDARY ENDPOINT(S)  ........................................................................... 20 
7.4.4 SAFETY ANALYSES  ......................................................................................................................... 21 
7.4.5 BASELINE DESCRIPTIVE STATISTICS  ........................................................................................... 21 
7.4.6 PLANNED INTERIM ANALYSES  ...................................................................................................... 21 
7.4.7 SUB GROUP ANALYSES  .................................................................................................................. 21 
7.4.8 TABULATION OF INDIVIDUAL PARTICIPANT DATA ..................................................................... 21 
7.4.9 EXPLORATORY ANALYSES  ............................................................................................................ 21 
8.0 SAFETY AND ADVERSE EVENTS  ................................................................................................... 22 
8.1 
DEFINITIONS ................................................................................................................................. 22 
8.2 
RECORDING OF ADVERSE EVENTS ................................................................................................. 22 
8.3 
REPORTING OF SERIOUS ADVERSE EVENTS ................................................................................... 23 
8.3.1 
Investigator Reporting: Notifying the Sponsor ....................................................................... 23 
8.3.2 
Investigator Reporting: Notifying the REB ............................................................................. 23 
8.3.3 
Sponsor Reporting of SUADRs: Notifying Health Canada .................................................... 23 
8.3.4 
Sponsor Reporting of SUADRs: Notifying Sites .................................................................... 23 
8.4 
REPORTING OF DEVICE DEFICIENCIES ........................................................................................... 23 
8.5 
SAFETY MANAGEMENT PLAN ......................................................................................................... 23 
8.6 
UNBLINDING PROCEDURES ............................................................................................................ 24 
8.7 
DATA AND SAFETY MONITORING BOARD ........................................................................................ 24 
9.0 CLINICAL TRIAL DISCONTINUATION AND CLOSURE  ................................................................. 24 
9.1 
CLINICAL TRIAL DISCONTINUATION ................................................................................................ 24 
10.0 DATA HANDLING AND RECORD KEEPING  ................................................................................... 24 
10.1 
SOURCE DOCUMENTS & CASE REPORT FORMS ............................................................................. 24 
10.2 
PROTOCOL DEVIATIONS ................................................................................................................ 25 
10.3 
RECORD RETENTION ..................................................................................................................... 25 
10.4 
CLINICAL TRIAL REGISTRATION ...................................................................................................... 25 
11.0 STUDY MONITORING, AUDITING, AND INSPECTING ................................................................... 25 
11.1 
STUDY MONITORING PLAN ............................................................................................................ 25 
11.2 
AUDITING AND INSPECTING ............................................................................................................ 25 
12.0 ETHICAL CONSIDERATIONS  ........................................................................................................... 25 
12.1 
RESEARCH ETHICS BOARD (REB) APPROVAL ................................................................................ 25 
12.2 
INFORMED CONSENT PROCESS & DOCUMENTATION ....................................................................... 26 
13.0 PRIVACY AND CONFIDENTIALITY  .................................................................................................. 26 
14.0 CLINICAL TRIAL FINANCES  ............................................................................................................ 27 
14.1 
FUNDING SOURCE ........................................................................................................................ 27 

 
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14.2 
CONFLICT OF INTEREST ................................................................................................................. 27 
15.0 PUBLICATION POLICY/DATA SHARING  ........................................................................................ 27 
15.1 
FUTURE SECONDARY USE OF DATA ............................................................................................... 45 
16.0 REFERENCES .................................................................................................................................... 27 

 
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STATEMENT OF COMPLIANCE 
 
This clinical trial will be carried out in accordance with the following:  
• International Conference on Harmonisation Good Clinical Practice (ICH GCP) 
• Tri-Council Policy Statement 2018 (TCPS 2) 
• Personal Health Information Protection Act (PHIPA), 2004; Chapter 3 Schedule A 
(PHIPA) and applicable regulations 
• Institutional and REB policies and procedures 
 
 
 
 
 
  
 
 
May 6th, 2024 
________________________________  
_____________________________ 
Signature of PI 
 
 
 
 
Date 
 
 
 
 
 
 
 
 
 
 
 
 
 

 
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LIST OF ABBREVIATIONS 
Include a list of abbreviations used within the research protocol. A sample list is 
included below: 
 
AE 
 
Adverse Event 
CRE  
Certified Respiratory Educator 
COPD  
Chronic Obstructive Pulmonary Disease 
CRF   
Case report form(s) 
DSMB  
Data Safety & Monitoring Board 
GCP   
Good Clinical Practice 
ICF  
 
Informed consent form 
MLHC  
My Lung Health Coach 
PHI 
 
Personal Health Information 
PHIPA 
Personal Health Information Protection Act 
PI 
 
Principal Investigator 
QI 
 
Qualified Investigator 
SAE  
Serious Adverse Event 
SUSAR  
Suspected unexpected serious adverse reaction 
TCPS 2 
Tri-Council Policy Statement  
 
 
 
 
 
 
 
 

 
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CLINICAL TRIAL SUMMARY 
 
Short Title  
MLHC clinical study 
Phase 
Pilot study 
Methodology  
Single arm pilot study 
Clinical trial  
Duration  
12 months 
Participating site(s)  
Single site – Women’s College Hospital   
Objectives  
To evaluate the feasibility and effectiveness of MLHC, a 
COPD self-management and education support program 
delivered virtually with an electronic patient-record integrated 
companion app 
Number of 
Participants  
50 
Study Intervention  
Reference 
Therapy/Comparator  
The intervention will be enrollment in the MLHC program (a 
COPD self-management and education support program 
delivered virtually), and access to the Epic Care Companion 
MLHC companion app. There will not be a control group for 
this pilot study. 
Duration of 
Intervention  
12 weeks intervention duration, 6 months total follow-up 

 
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Statistical 
Methodology  
Feasibility  outcomes (system use): 
o Number of patients who started program over total 
offered 
o Number of patients who completed program over 
total started 
o Number of providers who referred patients to the 
program over total 
o App use metrics over duration of study participation 
Effectiveness  outcomes (clinical outcomes): These 
outcomes will be collected prior to program commencement, 
at program completion (3 month), and at 6-month follow-up. 
Outcomes will be collected by MLHC certified respiratory 
educators (CREs) using a standardized form in Salesforce, 
as well as a research assistant based on Epic electronic chart 
review. For continuous variables, difference in the mean (SD) 
will be calculated at 3 months and 6 months compared to 
baseline. For dichotomous variables, difference in proportions 
at 3 and 6 months compared to baseline will be calculated. 
o Healthcare system utilization: number of COPD-
related outpatient visits, hospital admissions, ED 
visits, ICU admissions (at baseline will be over the 
previous 12 months) 
o COPD severity: CAT and mMRC scores, and 
number of COPD exacerbations  
o Health-related quality of life: CAT score 
o Medication, smoking, vaccination status: COPD 
controller medication use, oxygen therapy, oral 
corticosteroid use, antibiotic use, rescue inhaler 
use, packs per year smoking, smoking cessation 
attempts, routine vaccinations 
o Knowledge of COPD: Adapted COPD-Q score 
o Self-efficacy: Adapted COPD Self-Efficacy Scale 
(COPD SES) score 
o Self-management: Partners in Health Scale (PIHS) 
score 
o Referrals: pulmonary rehab, smoking cessation 
counseling, specialist care 
 
  
 

 
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1.0 INTRODUCTION 
1.1 
Background  
Chronic Obstructive Pulmonary Disease (COPD) is a highly prevalent chronic airways 
disease that affects 1 in 9 adults in Ontario. COPD can cause significant symptoms of 
dyspnea, chronic cough, and wheezing, and lead to important reductions in health-
related quality of life. People with COPD can also experience repeated acute 
exacerbations of their chronic disease, where symptoms worsen for days to weeks, 
leading to further loss of lung function and quality of life, increased healthcare resource 
utilization, and mortality. Up to 50% of people with COPD will have an exacerbation 
within the first year of follow-up, and among those who experience exacerbations, >50% 
have 2 or more each year. In Canada, COPD exacerbations are one of the leading 
causes of emergency room visits and hospitalizations nationally (~90,000 hospital 
admissions yearly, with >25,000 in Ontario alone), and COPD costs the healthcare 
system $1.5B annually. As COPD prevalence is increasing yearly, these numbers are 
unfortunately projected to further grow over time.  
 
Managing COPD and preventing exacerbations can be extremely challenging, as 
disease progression is often heterogeneous, and symptoms can fluctuate significantly 
over time. There are also several important patient-level barriers to reducing COPD 
exacerbations, including lack of medication adherence, limited participation in smoking 
cessation counseling, low health literacy levels, and poor COPD action plan use. Many 
of these barriers are related to a lack of effective self-management, a crucial part of 
holistic COPD care. Self-management refers to the skills and behaviours required for 
people with COPD to cope with their disease and preserve their quality of life and 
function. This can include knowledge and skills related to medication adherence and 
inhaler technique, smoking cessation, physical activity and exercise, managing 
symptoms and self-recognition of exacerbations, healthy diet, and stress 
management.18,20  
 
Interventions to improve COPD self-management are an essential part of COPD care. 
However, many patients with COPD do not have access to self-management 
interventions, and poor self-management behaviour (including low adherence to 
medications and action plans, lack of exercise maintenance, and low health literacy 
levels) remains an important care gap in COPD. In Ontario, there is currently no 
uniformly available pathway for patients with COPD to access evidence-based self-
management interventions, and individual providers lack the time and resources 
necessary to provide effective self-management support to all of their patients.  
1.2 
Study  Intervention  
My Lung Health Coach (MLHC) is a freely available evidence-based and person-
centered COPD self-management program that connects people virtually with 
experienced certified respiratory educators (CREs) to provide structured COPD 
education and self-management support. MLHC was jointly developed by the Lung 
Health Foundation (a charitable organization focused on lung health advocacy) and 
academic Respirologist Dr. Andrew Kouri, with input from community members living 

 
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with COPD. MLHC links community members living with COPD with certified respiratory 
health educators, using a person-centered approach to provide COPD education and 
self-management support. It is delivered virtually through one-on-one meetings offered 
over multiple sessions over 12 weeks. The topics covered in the program include: 
general COPD knowledge, smoking cessation, COPD medications (inhalers, oxygen), 
physical activity counseling, mental health and wellness, vaccinations, symptom self-
management skills (breathing, energy management, symptom monitoring), nutrition, 
travel, and long-term planning (including end-of-life care).  
 
In order to improve the patient experience using MLHC, we have integrated the MLHC 
program into the Epic Care Companion app at Women’s College Hospital, an interactive 
patient facing app designed as an extension of the Epic electronic health record system. 
Using Care Companion, patients will be able to track their progress through MLHC, 
accomplish session specific educational and self-management tasks, and share their 
progress with their Women’s College healthcare teams.  
1.3 
Preclinical Data  to Date  
We are currently testing the MLHC Care Companion app through a rapid cycle design 
process, to optimize app usability and acceptability. This is being accomplished using 
an iterative end-user testing process with patient focus groups and qualitative and 
quantitative assessments. This process is approved as a quality improvement project 
(APQIP # 2024-0015-P) 
1.4 
Clinical Data to Date  
n/a 
1.5 
Risk s/Benefits  
The intervention being offered is patient education and self-management support 
program, developed in line with international COPD guidelines. A recent Cochrane 
review of COPD self-management and support programs (Schrijver et al. 2022) 
reported that these types of interventions are unlikely to cause harm. However, potential 
harms that may occur could include poor management of care by CREs (however this is 
unlikely as the CRE is a licensed and regulated clinical professional), risk of data breach 
through the use of the Care Companion smartphone app (again this is unlikely given the 
app is operated through high security protocols within Women’s College), and risk of 
embarrassment if personal health information is inappropriately released. 
 
The virtual format of this program is unlikely to confer any additional risk, as the format 
of self-management and education support is not specified in international and national 
guidelines, only the content delivered.  
 
In terms of benefits, the same review found that these types of interventions were 
associated with improved health-related quality of life and a reduction in respiratory-
related hospital admissions in COPD. These types of interventions also reduced anxiety 
and depression levels.   
 

 
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2.0 CLINICAL TRIAL OBJECTIVES  
2.1 
Primary Objective  
The primary objective is to evaluate the feasibility of delivering the MLHC program 
accompanied by the Epic Care Companion application. This will be evaluated by 
assessing system use over the study period, including the number of patients who start 
the program (over total number referred/offered), the number of patients who complete 
the program over the total number started, and the number of providers who refer 
patients to the program over the total number of eligible providers. We will also evaluate 
app use metrics by patients (number of interactions with the app, number of tasks 
completed, app features activated, time spent using the app) 
2.2 
Secondary Objective  
The secondary objective is to assess for potential clinical benefits of participating in the 
MLHC program accompanied by the Epic Care Companion application. To assess this 
we will evaluate healthcare system utilization, COPD severity, health related quality of 
life, COPD medication use, smoking status, vaccination status, COPD knowledge, self-
efficacy scores, self-management scores, and healthcare provider referrals prior to 
using the program vs. after program completion. 
 
 
3.0 CLINICAL TRIAL DESIGN 
3.1 
Overall  Design  
This pilot study will be a single center, single arm, pilot trial. There will not be a control 
group. Each participant will complete the 12-week MLHC virtual program, during 
which time they will also interact with the Care Companion app. Clinical outcomes 
will then be reassessed at 6 months after study initiation. The trial is expected to last 
12 months.  
3.2 
Primary Endpoints  
Feasibility endpoints:  
- 
MLHC program participation 
o Number of patients who started program over total offered 
o Number of patients who completed program over total started 
o Number of providers who referred patients to the program over total 
- 
MLCH Care Companion app use 
o Number of times app opened 
o Number of sessions accessed within the app 
o Number of session tasks marked completed 
o Use of other app features (ex: medication reminder notifications) 
o Time spent using the app each time used 
3.3 
Secondary Endpoints  
Clinical endpoints: 

 
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▪ Assessed prior to study start, at 3 months (end of MLHC program) and at 6 months 
(follow-up after program completion). Outcomes will be collected by MLHC CREs 
using a standardized form in Salesforce, as well as a research assistant based on 
Epic electronic chart review. For continuous variables, difference in the mean (SD) 
will be calculated at 3 months and 6 months compared to baseline. For dichotomous 
variables, difference in proportions at 3 and 6 months compared to baseline will be 
calculated. 
 
- 
Healthcare system utilization (number of COPD-related outpatient visits, hospital 
admissions, ED visits, ICU admissions (at baseline will be over the previous 12 months) 
- 
COPD severity (CAT and mMRC scores, and number of COPD exacerbations) 
- 
Health related quality of life (CAT score) 
- 
COPD medication use (COPD controller medication use, oxygen therapy, oral 
corticosteroid use, antibiotic use, rescue inhaler use) 
- 
Smoking status (packs per year, quit attempts) 
- 
Vaccination status (routine guidelines recommended vaccines received) 
- 
COPD knowledge (Adapted COPD-Q score) 
- 
Self-efficacy score (Adaptd COPD Self-efficacy scale score) 
- 
Self-management score (Partners in Health Scale score) 
- 
Healthcare provider referrals prior to using the program (pulmonary rehab, smoking 
cessation counseling referrals 
4.0 PARTICIPANT SELECTION AND WITHDRAWAL 
4.1 
Target Population  
Patients with physician diagnosed COPD will be the target patient population.  
4.2 
Participant Recruitment and Screening
 
We will target a recruitment of 50 patients with physician diagnosed COPD. The 
patients will be recruited from the WCH Respirology Program clinics (as patients must 
be followed at WCH in order to use the Epic Care Companion app component). 
Recruitment will be accomplished through: advertisement posters in the Respirology 
clinic directing patients to discuss participation with their WCH Respirologist, and 
referrals from clinicians/circle of care. The potential participant’s respirolgist will be the 
one to determine interest/consent in the participant being contacted for the study. 
 
Participants who have expressed interest in the study will be contacted by study 
personnel (for example, a research assistant) to discuss potential participation in the 
study. Patients will not be compensated for their participation. 
4.3 
Equity, Diversity  and Inclusion  Considerations  
We will consider patient gender during study recruitment, and collect this information on 
study enrollment. As this is a small pilot study, it will likely not be possible to 
meaningfully analyze study results in a disaggregated manner based on gender.  

 
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4.4 
Eligibility Criteria
 
4.4.1 
Inclusion Criteria  
The participant must meet all of the inclusion criteria to eligible for this clinical trial: 
1. Must be deemed to have capacity to provide informed consent; 
2. Must sign and date the informed consent form; 
3. Stated willingness to comply with all study procedures; 
4. Be diagnosed with COPD as per a WCH Respirologist  
5. Be 40 years or older 
6. Be a current or ex-smoker 
7. Have a history of at least 1 COPD exacerbation (requiring prednisone or antibiotic 
use, or an urgent healthcare visit of any kind) in the previous 12 months 
4.4.2 
Exclusion Criteria  
An individual who meets any of the following criteria will be excluded from participation 
in this clinical trial: 
1. Experienced a COPD exacerbation in the 4 previous weeks to study enrollment 
2. Co-diagnosis of asthma by a WCH Respirologist 
3. Significant co-morbidities that could interfere with program participation, or terminal 
illness 
4. Willing to download and use the Epic Care Companion app and has a suitable 
mobile device to do this 
5. Pregnancy 
4.5 
Lifestyle Considerations
 
None 
4.6 
Screen Failures  
We will collect screen failures demography, screen failure details, eligibility criteria, and 
any serious adverse events (SAE).  
4.7 
Participant Withdrawal Criteria
 
4.7.1 
When and How to Withdraw Participants  
Participants are free to withdraw from participation in the clinical trial at any time.  
An investigator may discontinue or withdraw a participant from the clinical trial for the 
following reasons: 
• Pregnancy; 
• If any adverse event (AE), laboratory abnormality, or other medical condition or 
situation occurs such that continued participation in the clinical trial would not be in 
the best interest of the participant; 
• Disease progression which requires discontinuation of the study intervention; 
• If the participant meets an exclusion criterion (either newly developed or not 
previously recognized) that precludes further study participation 

 
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The reason for participant discontinuation or withdrawal from the study will be recorded      
within the participant’s research record, and/or legal health record. 
4.7.2 
Follow -up for Withdrawn Participants  
If a participant withdraws consent, they can also request the withdrawal of their data 
and/or biological specimens subject to any research-specific restrictions, if applicable.  
Once withdrawn from the clinical trial, no further research procedures or evaluations will 
be performed, or additional research-specific data collected on the participant. 
Reasonable effort will be made to obtain permission to document the reason for 
withdrawal.  
4.7.3 
Early Termination Visit
 
If a participant withdraws from the clinical trial, an Early Termination Visit will be 
arranged if possible with study staff. This will include: 
 
• Assessment of new and ongoing AEs; 
• Assessment of any complications following the study intervention; 
• Performance of other relevant study-related procedures. 
 
The PI and/or QI will ensure the participant is appropriately transitioned/followed for any 
additional care as required. 
4.7.4 
Participants who are Lost to Follow
-up 
A participant will be considered lost to follow-up if they fail to return for 2 scheduled 
visits and is unable to be contacted by the research team.  
 
The following actions will be taken if a participant fails to attend a required study visit: 
• The research team will attempt to contact the participant and reschedule the missed 
visit within 2 weeks, counsel the participant on the importance of maintaining the 
assigned visit schedule, and reconfirm whether the participant wishes to and/or 
should continue in the clinical trial.  
• Before a participant is deemed lost to follow-up, the research team will make every 
effort to regain contact with the participant (where possible, three telephone calls 
and, if necessary, a certified letter to the participant’s last known mailing address or 
local equivalent methods). These contact attempts should be documented in the 
participant’s research record and/or legal health record.   
• Should the participant continue to be unreachable, they will be considered to have 
withdrawn from the clinical trial with a primary reason of lost to follow-up. 
 

 
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5.0 STUDY INTERVENTION  
5.1 
Description  
MLHC is delivered virtually through one-on-one meetings with the CRE offered over 
multiple sessions. The full program consists of 6 sessions across 12 weeks, covering all 
topics (geared towards new COPD diagnosis). The topics covered in the program 
include: general COPD knowledge, smoking cessation, COPD medications (inhalers, 
oxygen), physical activity, mental health and wellness, vaccinations, symptom self-
management skills (breathing, energy management, symptom monitoring), nutrition, 
travel, and long-term planning (including end-of-life care). As participants complete their 
virtual MLHC program with CREs, they will also have access to the Epic Care 
Companion app developed as a companion app to MLHC. This app will display a 
section for each MLHC program session completed, along with session-specific 
educational and self-management tasks for the patient to complete after the session. 
These will mostly consist of links to session-specific educational content, but there will 
also be medication reminder notifications, and reminders to discuss specific topics with 
their respiratory healthcare providers. This app may also contain individualized tasks 
created between the CRE and MLHC participant during their sessions. A final report of 
all completed tasks will be generated on program completion and available in the 
participant’s Epic electronic health record, which can be reviewed by their respiratory 
healthcare providers.  
5.2 
Treatment Regimen  
MLHC will be delivered virtually through secure videoconferencing software (Zoom) by 
CREs. Participants will be contact by the CREs to organize an acceptable program 
schedule. Ideally, participants will have 1 session every 2 weeks, for a total of 6 
sessions over 12 weeks. They will be free to engage with the MLHC Care Companion 
app at their own leisure throughout this period and after program completion. 
5.3 
Method for Assigning 
Participants  to Treatment Groups  
N/A – single arm study 
5.4 
Administration of 
Study  Intervention  
MLHC will be delivered virtually through secure videoconferencing software (Zoom) by 
CREs as detailed above. All onboarding for the virtual program will be completed by the 
CREs. Upon study consent, patients will also be oriented to the use of the MLHC Care 
Companion app by study staff virtually or in-person. They will be shown how to 
download and login to the Epic Care Companion app, and how to navigate through the 
MLHC materials. Any tech support needed throughout the study will also be provided by 
study staff at WCH.  
5.5 
Participant Compliance Monitoring
 
Participation in the virtual MLHC program will be tracked by the CREs using 
standardized forms (using the Lung Health Foundation’s Salesforce architecture 
developed for MLHC administration). This information will be securely sent to WCH and 

 
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integrated into Epic in collaboration with the Womens’ Virtual Care Research 
Laboratory. Use of the Epic Care Companion MLHC companion app will be tracked 
internally at WCH.  
5.6 
Concomitant Therapy  
COPD medication use/treatments (inhalers, antibiotics, prednisone, and oxygen) will be 
recorded at baseline, at 3 months follow-up, and at 6 months follow-up. 
5.7 
Packaging  
N/A 
5.8 
Blinding of Study Intervention  
N/A  
5.9 
Receiving, Storage, Dispensing and Return
 
5.9.1 
Receipt of Study Intervention  Supplies  
N/A  
5.9.2 
Storage  
N/A  
5.9.3 
Dispensing of Study Intervention  
N/A  
5.9.4 
Return or Destruction of Study 
Intervention  
N/A 
 
6.0 RESEARCH PROCEDURES 
6.1 
Research Visits  
 
• Pre-Screening Visit / Screening Visit (virtual or in-person) 
o Informed consent 
o Review of eligibility criteria 
o Orientation to the Epic Care Companion MLHC companion app  
o This visit will be performed by study staff (research assistant, or study 
investigators) 
 
• Baseline Visit (virtual) 
o Collection of baseline outcome data 
o This visit will be performed by CREs as part of the MLHC program, study staff 
(research assistant, or study investigators) will confirm data collection and if 
needed supplement data collection using Epic or by contacting the participant 

 
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• Delivery of MLHC program – 6 virtual sessions over 12 weeks, delivered by CREs, 
no outcome collection during this phase of the study 
 
• Follow-up Visit at 3 months post baseline (virtual) 
o Collection of follow-up outcome data 
o This visit will be performed by CREs as part of the MLHC program, study staff 
(research assistant, or study investigators) will confirm data collection and if 
needed supplement data collection using Epic or by contacting the participant 
 
• Follow-Up Visit at 6 months post baseline (virtual) 
o Collection of follow-up outcome data 
o This visit will be performed by CREs as part of the MLHC program, study staff 
(research assistant, or study investigators) will confirm data collection and if 
needed supplement data collection using Epic or by contacting the participant 

 
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6.2 
Schedule of Events  
 
 
Procedures  
Screening 
Day -7 to -1 
Baseline 
Visit 1, Day 
1 
Study Visit 
2,  
3 months  
Study Visit 
3, 
6 months  
Informed consent 
X 
 
 
 
Confirming eligibility 
X 
 
 
 
MLHC companion app orientation 
X 
 
 
 
Demographic information 
X 
 
 
 
Health system utilization 
 
X 
X 
X 
COPD severity (CAT and mMRC scores) 
 
X 
X 
X 
Health-related quality of life (CAT score) 
 
X 
X 
X 
Mediation review 
 
X 
X 
X 
Smoking status review 
 
X 
X 
X 
Vaccination status review 
 
X 
X 
X 
Adapted COPD-Q score (knowledge of COPD) 
 
X 
X 
X 
Adapted COPD Self-Efficacy score 
 
X 
X 
X 
Partners in Health Scale score (self-management) 
 
X 
X 
X 
COPD referrals review (rehab, smoking cessation) 
 
X 
X 
X 
Adverse event review and evaluation 
 
X 
X 
X 
Complete Case Report Forms (CRFs) 
X 
X 
X 
X 

 
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7.0 STATISTICAL CONSIDERATIONS 
7.1 
Statistical Hypotheses
 
This is a pilot study of feasibility, so there are no a priori null hypotheses to test 
7.2 
Sample Size Determination  
 As this is a pilot study, a sample size of 50 participants was chosen in order to 
adequately evaluate system feasibility first and foremost. The clinical outcomes of 
interest will be collected and analyzed, but the study will not be powered to capture a 
specific predicted difference at this stage. The results we do obtain will help inform the 
sample size calculations for a future larger clinical trial with control group. 
7.3 
Populations for Analyses
 
Feasibility outcomes will be assessed for all patients referred to study enrolment  
Clinical outcomes will be assessed for all patients who complete the MLHC program 
and provide follow-up information. Essentially a Per-Protocol Analysis format. 
7.4 
Statistical Analyses  
7.4.1 
General Approach  
7.4.2 
Analysis of the Primary Endpoint(s)  
Feasibility endpoints:  
- 
MLHC program participation 
o Number of patients who started program over total offered 
o Number of patients who completed program over total started 
o Number of providers who referred patients to the program over total 
- 
MLCH Care Companion app use 
o Number of times app opened 
o Number of sessions accessed within the app 
o Number of session tasks marked completed 
o Use of other app features (ex: medication reminder notifications) 
o Time spent using the app each time used 
7.4.3 
Analysis of the Secondary Endpoint(s)
 
Clinical endpoints: 
▪ Assessed prior to study start, at 3 months (end of MLHC program) and at 6 months 
(follow-up after program completion). Outcomes will be collected by MLHC CREs 
using a standardized form in Salesforce, as well as a research assistant based on 
Epic electronic chart review. For continuous variables, difference in the mean (SD) 
will be calculated at 3 months and 6 months compared to baseline. For dichotomous 
variables, difference in proportions at 3 and 6 months compared to baseline will be 
calculated. 
 

 
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- 
Healthcare system utilization (number of COPD-related outpatient visits, hospital 
admissions, ED visits, ICU admissions (at baseline will be over the previous 12 
months) 
- 
COPD severity (CAT and mMRC scores, and number of COPD exacerbations) 
- 
Health related quality of life (CAT score) 
- 
COPD medication use (COPD controller medication use, oxygen therapy, oral 
corticosteroid use, antibiotic use, rescue inhaler use) 
- 
Smoking status (packs per year, quit attempts) 
- 
Vaccination status (routine guidelines recommended vaccines received) 
- 
COPD knowledge (Adapted COPD-Q score) 
- 
Self-efficacy score (Adapted COPD Self-efficacy scale score) 
- 
Self-management score (Partners in Health Scale score) 
- 
Healthcare provider referrals prior to using the program (pulmonary rehab, 
smoking cessation counseling referrals 
7.4.4 
Safety Analyses  
 
CRE will liaise with clinical team during delivery of MLHC session if any safety concerns 
arise  
 
At 3- and 6-month follow-up periods, clinical outcomes detailed above will be assessed 
by study investigators to determine if there are any concerning safety signals (for 
example, increased exacerbation rates or health service use, COPD severity scores). 
7.4.5 
Baseline Descriptive Statistics
 
Gender, age in years, education (highest level completed), race/ethnicity, type of 
smartphone used, smartphone use frequency, baseline clinical outcomes listed above 
7.4.6 
Planned Interim Analyses
 
N/A   
7.4.7 
Sub Group Analyses  
N/A 
7.4.8 
Tabulation of Individual Participant Data
 
N/A 
7.4.9 
Exploratory Analyses
 
N/A 
 

 
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8.0 SAFETY AND ADVERSE EVENTS 
8.1 
Definitions  
Adverse Event  
An adverse event  (AE) is any untoward medical occurrence in a research participant 
administered an investigational product and which does not necessarily have a causal 
relationship with this treatment. An adverse event (AE) can therefore be any 
unfavourable and unintended sign (including an abnormal laboratory finding), symptom, 
or disease temporally associated with the use of a medicinal (investigational) product, 
whether or not related to the investigational product.   
 
Serious Adverse Event  
A serious adverse event  (SAE) is any AE that is:  
• Fatal; 
• Life-threatening; 
• Requires or prolongs hospital stay; 
• Results in persistent or significant disability or incapacity; 
• A congenital anomaly or birth defect; or 
• An important medical event (events that may not be life threatening but are of major 
clinical significance, such as a drug overdose or seizure that did not result in in-
patient hospitalization).  
 
Adverse Event Collection Period  
The period during which adverse events must be collected is normally defined as the 
period from the initiation of any research procedures to the end of the study treatment 
follow-up.  For this clinical trial, the study treatment follow-up is defined as 30 days 
following the last administration of the study intervention.  
 
Post -study Adverse Event  
At the last scheduled visit, the PI and/or QI will instruct each participant to report any 
subsequent event(s) that the participant believes might reasonably be related to 
participation in this clinical trial.  The PI and/or QI will notify the study sponsor of any 
death or adverse event occurring at any time after a participant has discontinued or 
terminated participation that may reasonably be related to this clinical trial.  The sponsor 
will also be notified if the PI and/or QI should become aware of the development of 
cancer or of a congenital anomaly in a subsequently conceived offspring of a participant 
that was involved in this clinical trial.  
 
Abnormal Laboratory Values
 
N/A 
8.2 
Recording of Adverse Events
 
All adverse events occurring during the study period will be recorded. At each contact 
with the research participant, the research team will seek information on adverse events 
by specific questioning.  Information on all adverse events will be recorded immediately 

 
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in the participant’s research record and/or legal health record, and transcribed into the 
adverse event log.  
8.3 
Reporting of Serious Adverse Events
 
8.3.1 
Investigator Reporting: Notifying the Sponsor
 
SAEs will be reported to the sponsor within 24 hours of becoming aware of the event. 
8.3.2 
Investigator Reporting: Notifying the REB
 
The process for notification to the REB for applicable serious adverse events (SAEs) 
will be completed as per REB reporting requirements. SAEs and unanticipated events 
will be recorded and reported to the REB in accordance with the REB’s reporting 
requirements and timelines. Copies of each report and documentation of REB 
notification and REB receipt/acknowledgement will be kept in the Investigator Study 
Binder. 
8.3.3 
Sponsor Reporting of SUADRs: Notifying Health Canada
 
N/A  
8.3.4 
Sponsor Reporting of SUADRs: Notifying Sites
 
N/A  
8.4 
Reporting of Device Deficiencies
 
N/A  
8.5 
Safety Management Plan  
Participants will be followed bi-weekly by CREs during their participation in the MLHC 
virtual program. Should any safety concerns arise during this period of the study in 
relation to COPD severity, exacerbations, or increased healthcare visits, CREs will 
contact the study team and cases will be discussed on an individual basis. The study 
team will then liaise with the participant’s regular health care team to arrange any 
necessary follow-up. Following completion of the program, participants will be assessed 
for clinical outcomes at 3 months and 6 months post-study initiation, at which time 
safety concerns will also be evaluated, and communicated with the study PI as needed. 
The study team will then liaise with the participant’s regular health care team to arrange 
any necessary follow-up. As the intervention being delivered represents guideline-based 
self-management and education support, there is unlikely to be any harm associated 
with it (this is supported by recent systematic review and meta-analysis data of self-
management interventions in COPD). However, though the study is not powered to 
detect clinical effectiveness, if there are any safety concerns related to study 
participation at follow-up visits in terms of increased health service use and COPD 
severity (ED visits, hospitalizations, COPD exacerbations), these will be communicated 
to the study team, REB and the next appropriate steps will be considered, including but 
not limited to study termination. 

 
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8.6 
Unblinding Procedures
 
N/A 
8.7 
Data and Safety Monitoring Board
 
N/A 
 
9.0 CLINICAL TRIAL DISCONTINUATION AND 
CLOSURE 
9.1 
Clinical Trial  Discontinuation  
This clinical trial may be temporarily suspended or prematurely terminated if there is 
sufficient reasonable cause (i.e. closure based on PI decision, sponsor/funder decision, 
REB or other oversight bodies’ decision; review of serious, unexpected and related AEs; 
noncompliance; futility). Notification, which includes the reason for study suspension or 
termination, will be provided by the suspending or terminating party to research 
participants, the PI, funding agency, WCH, and regulatory authorities.  If the clinical trial 
is prematurely terminated or suspended, the PI will promptly inform research 
participants, the REB, and the sponsor, and will provide the reason(s) for the 
termination or suspension. All communication with participants for this purpose will go 
through REB review and approval.  Research participants will then be contacted, as 
applicable, and be informed of changes to the study visit schedule. 
 
10.0 DATA HANDLING AND RECORD KEEPING 
10.1 
Source Documents  & Case Report Forms  
Please reference this study’s Data Management Plan (DMP). 
 
Data for this clinical trial will be managed using REDCap electronic case report forms. 
This system is maintained on central WCH servers with data backed up daily, and is 
supported by the WCH REDCap Administrator.  
 
This study will involve the collection of system use and clinical data by study staff (which 
may include PI, co-investigators, or research assistants) from securely transferred data 
collection from CREs, medical records from EPIC, and/or REDCap questionnaires in 
order to evaluate system feasibility and effectiveness. CRE notes from participation in 
the MLHC program will be kept in LHF servers and transferred securely to WCH 
servers.  
 
The personal health information (PHI) required for this study is described in the Patient 
Data collection form.  PHI is required for this study because we are evaluating 
measures of clinical effectiveness in order to inform future larger trials.  

 
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10.2 
Protocol Deviations  
No deviations from or changes to the protocol will be implemented without prior 
agreement from the sponsor as required, and approval from the REB, unless to 
eliminate an immediate hazard to a participant.  
10.3 
Record  Retention  
Records will be maintained for a duration of 7 years following study completion on 
internal WCH servers. 
10.4 
Clinical Trial Registration
 
The trial will be registered on ClinicanTrials.gov prior to study initiation. 
11.0 STUDY MONITORING, AUDITING, AND 
INSPECTING 
11.1 
Study  Monitoring Plan  
Site monitoring is conducted to ensure that the rights and well-being of research 
participants are protected, the reported trial data are accurate, complete, and verifiable, 
and the conduct of the clinical trial is in compliance with the currently approved 
protocol/amendment(s), ICH GCP, and applicable regulatory requirement(s).  
• An on site monitoring plan will be developed with the Quality Assurance Office at 
WCH. N2 SOP will be used for all study operating procedures.  
11.2 
Auditing and Inspecting
  
The PI and site will permit study-related audits, and inspections by the REB, WCH, 
sponsor, and applicable granting agencies or regulatory bodies, including access to all 
study-related documents (e.g. source documents, regulatory documents, data collection 
instruments, study data, etc.). The PI will ensure the capability for audits/inspections of 
applicable study-related facilities (e.g. research pharmacy, clinical laboratory, imaging 
facility, etc.).  
12.0 ETHICAL CONSIDERATIONS 
.  
12.1 
Research Ethics Board (REB) Approval  
Research Ethics Board (REB) approval will be obtained prior to beginning any research-
specific procedures. Following initial ethics approval, ongoing ethical approval will be 
maintained and the clinical trial will undergo REB review at least annually, in 
accordance with regulatory and REB requirements. The clinical trial will be conducted in 
accordance with the REB-approved study documents and the determinations (including 
any limitations) of the REB, and in compliance with REB requirements.  
Whenever new information becomes available that may be relevant to participant 
consent, a consent form and/or consent for addendum will be presented to the REB for 

 
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review and approval prior to its use. Any revised written information will receive REB 
approval prior to use. 
12.2 
Informed Consent Process & Documentation
 
Prior to the consent discussion, research personnel will contact participants/SDMs using 
a verbal consent script. Research personnel will obtain consent to send a copy of the 
ICF to the participant prior to the consent discussion, which may occur via REDCap or 
email according to participant/SDM preference. 
 
The consent discussion will occur by telephone or Micorsoft Teams/Zoom, at the 
participant’s preference. The consent discussion will be conducted by research 
personnel who are not the PI and do not have a clinical relationship with participants. 
 
Informed consent will be documented through REDCap e-Consent. 
 
After informed consent has been obtained, a complete (fully signed) copy of the ICF will 
be provided to participants by email or mail, according to their preference. 
 
13.0 PRIVACY AND CONFIDENTIALITY 
All clinical trial-related documents and data will be held in strict confidence and stored at 
WCH or on WCH servers, and will follow WCH policies and procedures to ensure 
participant privacy and confidentiality. Data in the Epic Care Companion app will be 
used to assess feasibility of using this app as a companion to the MLHC program. The 
app is managed by WCH and participant data is stored locally. Data is accessible by the 
research team only. Data is encrypted and data is protected in the tool via standard 
PHIPA EHR protocols while traveling in and out of the app and while stored in it. 
Participants may continue to access the data at the end of the clinical trial. The 
participant will have to agree to a Terms of Use and Privacy Policy to use the app prior 
to data collection. No information concerning the clinical trial or the data will be released 
to any unauthorized third party without prior written approval of the sponsor, and the 
consent of the participant (where applicable).  
 
All research activities will be conducted in as private a setting as possible. The study 
monitor, other authorized representatives of the sponsor, representatives of the REB, 
regulatory agencies may inspect all documents and records required to be maintained 
by the PI, including but not limited to, medical records and pharmacy records for the 
participants in this clinical trial. The participant’s contact information will be securely 
stored at WCH for internal use during the clinical trial. At the end of the clinical trial, all 
records will continue to be kept in a secure location in accordance with applicable 
institutional and regulatory requirements. 
 

 
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14.0 CLINICAL TRIAL FINANCES 
14.1 
Funding Source  
This study is funded through a grant from the Women’s College Hospital Foundation. 
14.2 
Conflict of Interest  
No conflicts of interest present. 
 
15.0 PUBLICATION POLICY/DATA SHARING 
16.0 REFERENCES