Managing Asthma Patients With AMAZE™: A Novel Disease Management Platform, A Clinical Pilot Study
Phase: NA
Conditions: Asthma
Sponsor: AstraZeneca

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Study Protocol 
Study Code D2287R00166 [EVA-28838] 
Version 7.4 
Date August 10, 2021 
Study Protocol Form 
Version 7.4 
Form Doc ID: AZDoc0059948 
Parent Doc ID: SOP LDMS_001_001643282 
 
TABLE OF CONTENTS 
2 
TITLE PAGE ........................................................................................................... 1 
TABLE OF CONTENTS ......................................................................................... 2 
LIST OF ABBREVIATIONS AND DEFINITION OF TERMS ............................ 6 
RESPONSIBLE PARTIES ...................................................................................... 7 
PROTOCOL SYNOPSIS ......................................................................................... 8 
AMENDMENT HISTORY ................................................................................... 13 
MILESTONES ....................................................................................................... 14 
1. 
BACKGROUND AND RATIONALE .................................................................. 15 
1.1 
Background ............................................................................................................ 15 
1.2 
Rationale ................................................................................................................ 15 
2. 
OBJECTIVES AND HYPOTHESES .................................................................... 15 
2.1 
Primary Objective(s) and Hypothesis(es) .............................................................. 15 
2.2 
Secondary Objective(s) and Hypothesis(es) (Optional)......................................... 16 
2.3 
Exploratory Objective(s) and Hypothesis(es) (Optional) ...................................... 16 
3. 
METHODOLOGY ................................................................................................ 16 
3.1 
Study Design – General Aspects ............................................................................ 16 
3.1.1 
Data Source(s) ........................................................................................................ 18 
3.2 
Study Population .................................................................................................... 18 
3.3 
Inclusion Criteria ................................................................................................... 18 
3.4 
Exclusion Criteria .................................................................................................. 19 
4. 
VARIABLES AND EPIDEMIOLOGICAL MEASUREMENTS ........................ 19 
4.1 
Exposures ............................................................................................................... 19 
4.1.1 
Patient-Completed .................................................................................................. 21 
4.1.1.1 
AMAZETM Patient App ......................................................................................... 21 
4.1.1.2 
Patient Demographic Questionnaire ...................................................................... 21 
4.1.1.3 
Patient User Experience Survey ............................................................................. 21 
4.1.1.4 
Patient Visit Experience Survey ............................................................................ 21 
4.1.1.5 
System Usability Scale .......................................................................................... 22 
4.1.1.6 
PSQ-18 ................................................................................................................... 22 
4.1.1.7 
Follow-up Process Interviews with Patients .......................................................... 22 
4.1.2 
MGH Completed .................................................................................................... 23 
4.1.2.1 
Clinical Case Report Form ..................................................................................... 23 

Study Protocol 
Study Code D2287R00166 [EVA-28838] 
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Date August 10, 2021 
Study Protocol Form 
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Parent Doc ID: SOP LDMS_001_001643283 
 
4.1.2.2 
Chart Review Case Report Form ........................................................................... 23 
4.1.2.3 
System Usability Scale .......................................................................................... 23 
4.1.2.4 
Post-study Survey .................................................................................................. 23 
4.2 
Outcomes ............................................................................................................... 23 
4.2.1 
Primary Outcome ................................................................................................... 23 
4.2.2 
Secondary Outcome ............................................................................................... 24 
4.2.3 
Exploratory Outcome One ..................................................................................... 24 
4.2.4 
Exploratory Outcome Two..................................................................................... 24 
4.3 
Other Variables and Covariates ............................................................................. 24 
5. 
STATISTICAL ANALYSIS PLAN ...................................................................... 25 
5.1 
Statistical Methods: General Aspects .................................................................... 25 
5.1.1 
Primary Objective: To generate evidence on the feasibility, usability, 
perceived value, and potential benefits of the AMAZE™ implemented in 
clinical practice ...................................................................................................... 25 
5.1.2 
Secondary Objective(s) .......................................................................................... 25 
5.1.3 
Exploratory Objective One: To assess how the implementation of AMAZETM 
affects clinical outcomes ........................................................................................ 25 
5.1.4 
Exploratory Objective Two: To identify patients who are most likely to benefit 
from using AMAZETM ........................................................................................... 25 
5.2 
Bias ........................................................................................................................ 26 
5.2.1 
Methods to Minimize Bias ..................................................................................... 26 
5.2.2 
Adjustment for Multiple Comparisons .................................................................. 26 
5.2.3 
Strengths and Limitations ...................................................................................... 26 
5.3 
Sample Size and Power Calculations ..................................................................... 26 
6. 
STUDY CONDUCT AND REGULATORY DETAILS....................................... 26 
6.1 
Study Conduct ........................................................................................................ 26 
6.1.1 
Procedures .............................................................................................................. 26 
6.1.1.1 
Recruitment ............................................................................................................ 26 
6.1.1.2 
Baseline Visit ......................................................................................................... 27 
6.1.1.3 
Longitudinal Follow-up Interviews and Assessments ........................................... 27 
6.1.1.4 
Cross-Sectional Follow-up Interviews and Assessments ...................................... 28 
6.1.1.5 
Claims Data Export ................................................................................................ 28 
6.1.2 
Quality Control ...................................................................................................... 29 
6.1.2.1 
Monitoring ............................................................................................................. 29 
6.1.2.2 
Contacts with the sites to: ...................................................................................... 29 
6.1.2.3 
Remote Monitoring activities for: .......................................................................... 29 
6.1.2.4 
Training of Study Site Personnel ........................................................................... 30 
6.1.2.5 
ePRO Programming and Hosting ........................................................................... 30 
6.2 
Protection of Human Subjects................................................................................ 30 
6.2.1 
Informed Consent ................................................................................................... 31 
6.2.2 
Confidentiality of Study/Patient Data .................................................................... 31 

Study Protocol 
Study Code D2287R00166 [EVA-28838] 
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Date August 10, 2021 
Study Protocol Form 
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Parent Doc ID: SOP LDMS_001_001643284 
 
6.3 
Collection and Reporting of Adverse Events/Adverse Drug Reactions ................ 32 
6.3.1 
Collection of Adverse Events ................................................................................ 32 
6.3.2 
Reporting of Adverse Events ................................................................................. 32 
6.3.3 
Aggregate Safety Review from PRO Instruments ................................................. 33 
7. 
REFERENCES ...................................................................................................... 34 
8. 
APPENDIX A. PATIENT SCREENING SCRIPT ............................................... 35 
9. 
APPENDIX B. ELECTRONIC CONSENT EMAIL ............................................ 39 
10. 
APPENDIX C. RECRUITMENT EMAIL AND FLYER ..................................... 40 
11. 
APPENDIX D. INTRODUCTORY EMAIL ......................................................... 43 
12. 
APPENDIX E. AMAZETM PATIENT MOBILE APPLICATION 
SCREENSHOTS .................................................................................................... 44 
12.1 
Flyer for App .......................................................................................................... 44 
12.2 
Account Creation and Login .................................................................................. 45 
12.3 
Terms of Use .......................................................................................................... 49 
12.4 
Air Quality ............................................................................................................. 51 
12.5 
Appointments ......................................................................................................... 53 
12.6 
Asthma Control Test .............................................................................................. 54 
12.7 
Daily Asthma Log .................................................................................................. 59 
12.8 
Education ............................................................................................................... 66 
12.9 
Email Password Reset ............................................................................................ 67 
12.10 
Home ...................................................................................................................... 68 
12.11 
Messages ................................................................................................................ 69 
12.12 
Feedback ................................................................................................................ 72 
12.13 
My Plan .................................................................................................................. 73 
12.14 
Notifications ........................................................................................................... 76 
12.15 
Settings ................................................................................................................... 77 
12.16 
Trends .................................................................................................................... 81 
12.17 
Study Ending .......................................................................................................... 85 
13. 
APPENDIX F. CLINICAL CASE REPORT FORM ............................................ 87 
14. 
APPENDIX G. PATIENT DEMOGRAPHIC QUESTIONNAIRE ...................... 91 
15. 
APPENDIX H. PATIENT VISIT EXPERIENCE SURVEY ................................ 95 
16. 
APPENDIX I. POST-STUDY SURVEY (FOR HCPS) ........................................ 97 
17. 
APPENDIX J. PATIENT SATISFACTION QUESTIONNAIRE-18 (PSQ-18) 101 

Study Protocol 
Study Code D2287R00166 [EVA-28838] 
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Date August 10, 2021 
Study Protocol Form 
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Parent Doc ID: SOP LDMS_001_001643285 
 
18. 
APPENDIX K. SIX-MONTH CHART REVIEW CASE REPORT FORM ...... 104 
20. 
APPENDIX L. MGH WORKFLOW FOR IMPLEMENTATION OF DMP IN 
CLINICAL PRACTICE ....................................................................................... 108 
21. 
APPENDIX M. PATIENT USER EXPERIENCE SURVEY ............................. 110 
22. 
APPENDIX N.1 SYSTEM USABILITY SCALE (SUS) ADMINISTERED 
AT MONTHS 1 AND 6: Patients ........................................................................ 114 
23. 
APPENDIX N.2 SYSTEM USABILITY SCALE (SUS) ADMINISTERED 
AT MONTHS 1 AND 6: MGH Staff .................................................................. 115 
24. 
APPENDIX O. FOLLOW-UP SEMI-STRUCTURED INTERVIEW GUIDES 116 
25. 
APPENDIX P. RECRUITMENT TRACKING LOG ......................................... 124 
26. 
SIGNATURES ..................................................................................................... 126 
 
 
 

Study Protocol 
Study Code D2287R00166 [EVA-28838] 
Version 7.4 
Date August 10, 2021 
Study Protocol Form 
Version 7.4 
Form Doc ID: AZDoc0059948 
Parent Doc ID: SOP LDMS_001_001643286 
 
LIST OF ABBREVIATIONS AND DEFINITION OF TERMS 
Abbreviation or 
special term 
Explanation 
ACT™ 
Asthma Control Test 
AE 
Adverse event 
AZ 
AstraZeneca 
CFR 
Code of Federal Regulations 
COPD 
Chronic obstructive pulmonary disease 
CRF 
Case report form 
CRO 
Clinical research organization 
DES 
Data entry site 
EMR 
Electronic medical record 
ePRO 
Electronic patient-reported outcome 
FDA 
Food and Drug Administration 
GCP 
Good Clinical Practice 
HCP 
Healthcare practitioner 
HIPAA 
Health Insurance Portability and Accountability Act 
ICH 
International Council for Harmonization 
ICS 
Inhaled corticosteroid 
ID 
Identifier 
IEC 
Independent Ethics Committee 
IRB 
Institutional review board 
LABA 
Long-acting beta agonist 
MC 
Marketing company 
MEOR 
Medical Evidence and Observational Research 
MGH 
Massachusetts General Hospital 
OCR 
Optical character recognition 
SD 
Standard deviation 
SOP 
Standard operating procedure 
SUA 
Severe uncontrolled asthma 
 
 

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Study Protocol 
Study Code D2287R00166 [EVA-28838] 
Version 7.4 
Date August 10, 2021 
Study Protocol Form 
Version 7.4 
Form Doc ID: AZDoc0059948 
Parent Doc ID: SOP LDMS_001_001643288 
 
PROTOCOL SYNOPSIS 
AMAZETM Asthma Implementation Clinical Pilot Study: MGH 
 
Background/Rationale: AstraZeneca (AZ) has developed the AMAZETM disease management 
platform to be used across multiple disease indications to provide a unified experience for the 
management of patients throughout their patient care journey. AMAZETM integrates multiple 
systems, including a patient Application where patients can enter daily symptoms and impact to 
communicate this information to their healthcare provider (HCP), as well as access disease 
educational materials. Both the patient Application and a clinician dashboard are integrated with 
the patient’s electronic medical records (EMR) to provide a clear view of the patient’s health 
status both in and out of the clinic. Implementation of AMAZETM within clinical practice has not 
yet been evaluated. The results from this study will be used to inform any changes or 
modifications that need to be made to the technology platform, its implementation process, and 
explore impact on clinical outcomes. 
Objectives and Hypotheses: 
The primary study objective is to generate evidence as to the feasibility, usability, perceived 
value, and potential benefits of implementing the AMAZETM platform into clinical practice. This 
objective will be accomplished through the generation of evidence in two key outcome types: 
1. 
Technology Outcomes: Key questions to be asked regarding the technology outcomes 
are:  
• How much is the platform utilized, and what is the perceived value by both clinical 
staff and patient users?  
• How user friendly is the platform?  
• Are staff comfortable with the display and type of data shown?  
• Which features are/are not useful to patients and clinicians?   
• Which features need removed or improved upon?   
• What, if any, bugs are encountered?   
• How accessible is the app/portal?  
• What is the optimal frequency of completing the patient log that is achievable and 
meaningful for asthma management? 

Study Protocol 
Study Code D2287R00166 [EVA-28838] 
Version 7.4 
Date August 10, 2021 
Study Protocol Form 
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Parent Doc ID: SOP LDMS_001_001643289 
 
2. 
Process outcomes: How does the implementation of AMAZETM affect clinical 
process? For example, is patient communication improved, or is there an increase or 
decrease in time spent with patients? 
The exploratory objectives are: 
1. 
Clinical outcomes: How does the implementation of AMAZETM affect clinical 
outcomes? For example, is there an increase or decrease in utilization of patient 
services, emergency department visits, or clinician contacts? 
2. 
To identify which segments of patients are most likely to benefit from using 
AMAZETM. 
Since this study is exploratory regarding the feasibility, usability, and perceived benefit of using 
an electronic platform for disease management, there is no hypothesis testing.  
Methods: 
Study design: This is a longitudinal study in which the process of integrating the 
AMAZETM disease management platform (DMP) into clinical practice will be assessed by 
implementing this program at MGH for six months.  
For the clinical pilot study, patients with asthma of varying severity will be recruited. A 
target of up to 50 total patients will be recruited and consented for the purposes of the 
clinical pilot study, consisting of approximately 33 young adult (18-35 years old) and up 
to 17 adult patients (36 years of age and older). Approximate recruitment targets for the 
study include a subset of patients who are new to the practice (less than 3-month history 
with the practice) and with uncontrolled asthma (n = approx. 10) as well as patients 
experiencing at least 1 exacerbation in previous 12 months (n=approx. 40).  Exacerbations 
are defined as a change in asthma symptoms requiring a course of oral steroids or steroid 
injection and/or a hospitalization or emergency department visit for asthma. MGH staff 
responsible for recruiting patients will participate in a training prior to recruitment starting, 
including the workflow for steps for the clinical pilot.  
After collecting electronic informed consent via Research Electronic Data Capture 
(REDCap), participants will be instructed to download the AMAZETM application 
software (app) to record their daily asthma symptoms and access educational materials and 
other features of the app. Participants will be allowed to retroactively complete their daily 
asthma symptoms log for up to 7 days prior to the current date. All entries will be date and 
time stamped to track entries. After downloading the app, participants will be emailed a 
sociodemographic form to complete. If the participant enables reminder notifications 
within the app, they will be sent one notification a day at their preferred time if they do not 

Study Protocol 
Study Code D2287R00166 [EVA-28838] 
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Date August 10, 2021 
Study Protocol Form 
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Parent Doc ID: SOP LDMS_001_0016432810 
 
access the app daily. On a monthly basis, the app will prompt them to complete the 
Asthma Control Test (ACT™). Importantly, participant responses to the app will be 
monitored twice daily by a clinical and research team and alerts may be sent to their 
physician based on responses (e.g. participant reports of ED visits, multiple “bad” day 
reports, etc.) via the AMAZETM interface to facilitate communication and to guide 
treatment. 
A random selection of up to 12 participants will be asked to participate in longitudinal 
follow-up interviews at study months one, three, and six with the Evidera study team to 
monitor the implementation of the AMAZETM platform. MGH personnel will be 
consented prior to completing any interviews. At study months 2, 4, and 5, a one-time 
random selection of up to 5 participants may be selected to complete a follow-up interview 
by the AZ DMP product team. During the follow-up longitudinal and cross-sectional 
interviews, participants will be asked questions regarding their use of the app/platform and 
what features may need improvements or are particularly of value. 
Additionally, all participants will be asked to complete a patient user experience survey at 
study months 1, 3, and 6, as well as the System Usability Scale (SUS) at study months 
1and 6. All electronic surveys sent outside the app will be sent through REDCap. Clinical 
staff research participants will be asked to complete the SUS at study months one and six. 
Lastly, any time a participant attends a clinic visit (in-person or telehealth), they will be 
emailed a link to complete a patient visit experience satisfaction survey. At the end of the 
study, HCPs will be asked to complete a post-study survey via emailed link, while patients 
will be asked to complete the Patient Satisfaction Questionnaire (PSQ-18).  
Study Sites:  MGH outpatient adult and pediatric pulmonary clinics will be implementing 
the clinical pilot study.  
Data Source(s): MGH was selected to implement AMAZETM into their clinical practice 
based on the principal investigators’ experience and qualifications, the number of asthma 
patients treated in the clinic, the diversity of the asthma patients treated by the clinic, the 
ability of the site to complete the study tasks in the allotted timeframe, and the anticipated 
unique component of clinical pilot initiatives anticipated by the study site.  
Study Population: Clinic staff will invite eligible patients age >18 years with a diagnosis 
of asthma to enroll in the study. Up to 50 patients will be enrolled, including 
approximately 33 young adults (18-35 years old) and up to 17 adults (36 years of age and 
older).  

Study Protocol 
Study Code D2287R00166 [EVA-28838] 
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Date August 10, 2021 
Study Protocol Form 
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Exposure(s): 
Participants will complete the following measures at differing timepoints: 
• AMAZETM Patient App, including a daily symptom log, daily medications, 
healthcare resource utilization (HCRU), ACT™ completed every month, and 
educational resources  
• Demographic characteristics questionnaire 
• Patient User Experience Survey 
• Patient Visit Experience Survey  
• SUS 
• Qualitative Semi-structured Interviews  
• PSQ-18   
MGH personnel will complete the following measures: 
• Screening script for patient recruitment (CRC) 
• Clinical Case Report Form (CRF) (CRC) 
• Chart Review CRF (CRC) 
• SUS (Clinical staff) 
• Post-Study Survey (Clinical staff) 
Outcome(s): 
• Onboarding process evaluation 
• Product attributes 
• Patient visit and user experience 
• Clinical staff experience 
• Clinical process assessment  
• SUS scores 
• PSQ-18 scores 
• Post-study survey responses 
• Qualitative interview responses  
 
Sample Size Estimations: As the aim of this study is to assess the process and feasibility of 
implementing AMAZE™, inferential statistics will not be performed, and a formal sample size 
estimation is not applicable. MGH will target up to 50 patients. Implementing AMAZE™ among 
up to 50 patients will provide MGH with enough experience to provide feedback on the outcomes, 
barriers, benefits, challenges, ease of implementation, and areas for improvement for future 
integration as a platform. 

Study Protocol 
Study Code D2287R00166 [EVA-28838] 
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Date August 10, 2021 
Study Protocol Form 
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Statistical Analysis: Descriptive statistics (n, frequency, mean, and standard deviation [SD]) will 
be used to characterize the sample in terms of sociodemographic and clinical characteristics. The 
sociodemographic and clinical characteristics will be summarized for the sample overall as well 
as for each site. Descriptive statistics (n, frequency, mean, and SD) will also be used to 
summarize the results from the patients’ frequency of use of the daily log and educational 
resources, ACT™ scores, responses to the Patient Visit Experience Survey, the SUS, and the 
results of the patient PSQ-18 and HCP Post-study survey.  
Qualitative interviews will be summarized based on interviewers’ notes using a detailed 
interviewer matrix. The interviews will be audio recorded, and transcribed by a third-party vendor 
(TransPerfect), should the audio need to be reviewed to summarize findings. The interview results 
will be summarized in tabular format, with key recommendations, advantages, and disadvantages 
grouped. Specifically, barriers, benefits, challenges, ease of implementation, and areas for 
improvement will be summarized.  
Safety Handling Plan: A Safety Handling Plan has not been developed for this study. 

Study Protocol 
Study Code D2287R00166 [EVA-28838] 
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AMENDMENT HISTORY 
Date 
Section of study protocol 
Amendment or update 
Reason 
 
 
N/A 
 

Study Protocol 
Study Code D2287R00166 [EVA-28838] 
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MILESTONES 
Milestone 
Planned date 
Final Protocol 
Q4 2020 
Internal Review Board Approval 
Q2 2021 
Site Trainings 
Q2 2021  
First Participant In 
Q2 2021 
Last Participant in 
Q2 2021 
Database Lock 
Q4 2021 
High Level Results in Tabular Format 
Q4 2021 
Final Report  
Q1 2022 
 
 

Study Protocol 
Study Code D2287R00166 [EVA-28838] 
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Date August 10, 2021 
Study Protocol Form 
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1. 
BACKGROUND AND RATIONALE 
1.1 
Background 
Uncontrolled and severe uncontrolled asthma (SUA) are common disorders that are often difficult 
to identify and manage. The clinical and economic burden of SUA is disproportionately high, 
accounting for nearly 40% of asthma-related costs1,2 and uncontrolled asthma affects over 50% of 
children and adults with asthma. With advances in asthma therapies, an urgent need exists to 
optimize uncontrolled and SUA recognition and clinical management. 
1.2 
Rationale 
Poor asthma control is often unrecognized as asthma patients learn to adapt to their disease and 
adjust to a suboptimal level of control. This can result in frequent exposure to systemic steroids 
along with frequent urgent care/ER visits and hospitalizations. The AMAZETM platform aims to 
address this clinical need through better communication between patients and their clinical teams 
regarding the patients’ level of asthma control with the ultimate goal of improvement asthma 
management and improved health outcomes. This study aims to test the feasibility of 
implementing AMAZETM in a specialist clinical practice to manage asthma.  
2. 
OBJECTIVES AND HYPOTHESES 
2.1 
Primary Objective(s) and Hypothesis(es) 
The primary study objective is to generate evidence on the feasibility, usability, perceived value, 
and potential benefits of the AMAZETM disease management platform implemented in clinical 
practice. Since this is an exploratory study involving a mobile app and DMP, there is no 
hypothesis testing. The primary objective will be assessed through the following key outcomes:  
1. Technology Outcomes: Key questions to be asked regarding the technology outcomes 
are: 
• How much is the platform utilized, and what is the perceived value by both clinical 
staff and patient users?  
• How user friendly is the platform?  
• Are staff comfortable with the display and type of data shown?  
• Which features are / are not useful to patients and clinicians?   
• Which features need removed or improved upon?   
• What if, any bugs, are encountered?   

Study Protocol 
Study Code D2287R00166 [EVA-28838] 
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Date August 10, 2021 
Study Protocol Form 
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• How accessible is the app/portal?  
• What is the optimal frequency of completing the patient log that is achievable and 
meaningful for asthma management? 
2. Process outcomes: How does the implementation of AMAZETM affect clinical process? 
For example, is patient communication improved, or is there an increase or decrease in 
time spent with patients? 
2.2 
Secondary Objective(s) and Hypothesis(es) (Optional) 
There are no secondary objectives for this study.  
2.3 
Exploratory Objective(s) and Hypothesis(es) (Optional) 
There are two exploratory objectives for this study.  
1. Clinical outcomes: How does the implementation of AMAZETM affect clinical 
outcomes? For example, is there an increase or decrease in utilization of patient 
services, emergency department visits, or clinician contacts?  
2. To identify segments of patients that are most likely to benefit from using AMAZETM. 
3. 
METHODOLOGY 
3.1 
Study Design – General Aspects 
This is an implementation study to assess the feasibility, usability, perceived value, and potential 
benefits of integrating the AMAZETM DMP at MGH. The AMAZETM platform (developed by 
AstraZeneca/BrightInsight) consists of a clinician dashboard to guide treatment and asthma 
management, and a patient application to enter daily symptoms and medications that can trigger 
alerts to the clinician dashboard. For this implementation study, the sites will be trained on the use 
of the AMAZETM platform and will launch the program in the target patient population. 
For clinical pilot study launch, MGH will recruit up to 50 patients with asthma, including 
approximately 33 young adults (18–35 years old) and up to 17 adults. Approximately 10 new 
patients to the practice (less than 3-month history with the practice) but with uncontrolled asthma 
will be recruited, along with approximately 40 patients who have had at least one exacerbation per 
year. Eligible participants will be invited to participate in the study either in person or via 
telephone or Zoom call using a standardized recruitment script (Appendix A). Alternatively, a 
recruitment email will be first sent from a physician with a flyer attached to introduce the app and 
the study to participants (Appendix C). A follow-up Zoom video conversation can also be 
scheduled with the participants. If interested in participating in the study, they will provide their 

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email address to the site staff so that a consent form can be sent to them via email (Appendix B) 
to sign via REDCap. The MGH staff will confirm the email address provided by the participant is 
consistent with the email address within the DMP dashboard system. If the email address differs, 
the staff will modify the dashboard to the correct email. The email address collected during the 
screening visit will be used for emailing the surveys throughout the study. The MGH staff will 
review the consent with the patient either in person or via telephone or Zoom call and answer any 
questions they may have.  
After consenting to participate, patients will be sent an introductory email (Appendix D) with link 
to download the app (Appendix E), and register as a patient with a unique identifier (ID). Once 
the app has been downloaded, the patient will be asked to create their unique ID. Within the app, 
participants will be provided with access to all educational materials and asked to complete the 
daily symptom log. The MGH research staff will complete a clinical case report form (CRF; 
Appendix F) to record baseline clinical information about the patient, while participants will be 
asked to complete a sociodemographic form (Appendix G) via an emailed link. If the participant 
enables reminder notifications within the app, they will be sent one notification a day at their 
preferred time if they do not complete the app daily.  BreezoMeter, a third-party air quality 
vendor, will be assisting in the tracking and alerting of the air quality in the participant’s location 
if the location setting is turned on. 
After study launch, Evidera will conduct qualitative, longitudinal, follow-up interviews regarding 
process implementation with a random selection of patient participants (approximately 1 out of 5) 
at study months one, three, and six to gain a deeper understanding of the feasibility of 
implementing the asthma AMAZETM platform. Prior to launching the interviews, approximately 
12 patient participants will be randomly selected to participate in the qualitative interviews at 
study months one, three, and six to understand the feasibility and usability of the patient app over 
time, the perceived benefit (e.g., if there is an increase in the patient’s ability to interact with their 
physician, if it enhances speed and/or quality of response, etc.), and how it can be improved. In 
addition to the longitudinal interviews, a one-time, cross-sectional interview may be conducted by 
the AZ DMP Product Team at months 2, 4, and 5 with a random selection of up to 5 patient 
participants at each timepoint (excluding the up to 12 participants who will be participating in the 
longitudinal interviews). The cross-sectional interviews are meant to help capture any new 
features or feedback from participants during the off-months in the longitudinal interviews and 
will be conducted on an as-needed basis.   
In addition to the qualitative interviews, patient participants will be emailed a link to complete an 
electronic patient visit experience survey (Appendix H) after attending an in-person or telehealth 
visit with their doctor to evaluate their overall satisfaction with AMAZETM and its impact on the 
visit. Evidera will receive a data report from BrightInsight with participant BrightInsight ID, date 
of visit, and status of visit completion. Evidera will then share the IDs with MGH to generate a 

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visit survey email. All participants will be asked to complete electronic Patient User Experience 
surveys, sent via email, as well as the SUS at study months one and six. These surveys are meant 
to allow participants the opportunity to provide feedback on the app as they continue to interact 
with the app longitudinally throughout the study. At the end of the study (approximately 3 months 
after completion of enrollment) prescribing providers and study coordinators at MGH will 
complete a Post-study Survey (Appendix I) and patient participants will complete the PSQ-18 
(Appendix J). The focus of these questionnaires will be to obtain additional feedback on the 
implementation of AMAZE™ and participant satisfaction with the medical care they receive, 
respectively. All electronic surveys sent outside the app will be sent through REDCap. At study 
month Six, MGH staff will also be asked to complete a chart review CRF (Appendix K) for each 
patient. The patient app and/or clinician dashboard may be revised throughout the clinical pilot 
study based on feedback from patients and clinical staff.  
3.1.1 
Data Source(s) 
Participants will be recruited from MGH. MGH will recruit approximately 33 young adults (18–
35 years old) and up to 17 adults for a total sample of up to 50 patients. In addition, MGH will 
aim to recruit patients who are new to the practice (less than 3-month history with the practice) 
but with uncontrolled asthma (n= approx. 10) and patients experiencing at least 1 exacerbation in 
previous 12 months (n=approx. 40).  
3.2 
Study Population 
Clinic staff will invite patients age >18 years with an asthma diagnosis who are presenting for a 
clinic visit or via telephone to download the AMAZETM App. Up to 50 patients will be recruited.  
3.3 
Inclusion Criteria 
Patients must meet all the following criteria to be considered for enrollment: 
1. >18 years of age at the time of enrollment 
2. Clinically confirmed diagnosis of asthma (with or without COPD) 
3. Access to a smartphone with internet access with the following requirements: iOS 
(Operating System iOS 13 or newer and Devices iPhone 8 or newer) or Android 
(Operating System 8.0 or newer)  
4. Able to understand and speak English sufficiently to be able to use the AMAZE™ patient 
app 
5. Willingness to participate in a telephone interview and be audio-recorded  
6. Consenting to participate in the study 

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3.4 
Exclusion Criteria 
Patients meeting any of the following criteria will not be included in the study: 
1. No current diagnosis of asthma 
2. Has a cognitive impairment, hearing difficulty, acute psychopathology, medical condition, 
or insufficient knowledge of the English language that, in the opinion of the investigator, 
would interfere with his or her ability to agree to participate and/or complete the ACT™. 
4. 
VARIABLES AND EPIDEMIOLOGICAL MEASUREMENTS 
4.1 
Exposures 
Prior to enrollment in the study, MGH staff will approach patients during an in-person or 
telehealth clinic visit or via telephone to assess interest and confirm eligibility. For the clinical 
study launch, a standardized screening script (Appendix A) will be used that provides an overview 
as to the purpose and nature of the implementation study, as well as a description of the potential 
to participate in the longitudinal or one-time follow-up interviews (if randomly selected to 
participate).   
The timing of each key procedure/exposure, and the responsible party for each procedure is 
depicted below in Table 1. Following the baseline visit, Evidera will randomly select up to 12 
patient participants for longitudinal interviews, as well as up to 5 participants per timepoint to 
take part in cross-sectional interviews. A detailed workflow of the implementation of the DMP in 
MGH clinical practice is included in Appendix L.  
Table 1. Schedule of Study Assessments 
Procedures 
Baseline 
Month 
One 
Month 
Two 
Month 
Three 
Month 
Four 
Month 
Five 
Month 
Six 
Screen and Recruit1 
M 
 
 
 
 
 
 
Consent via RedCap for 
Participants 
M/P 
 
 
 
 
 
 
Download App 
P 
 
 
 
 
 
 
Completion of App 
P 
P 
P 
P 
P 
P 
P 
Monitor Clinician 
Dashboard 
M 
M 
M 
M 
M 
M 
M 
Clinical CRF 
M 
 
 
 
 
 
 
Sociodemographic Form 
P 
 
 
 
 
 
 
Patient User Experience 
Survey 
 
P 
 
P 
 
 
P 
System Usability Scale  
 
P/M 
 
 
 
 
P/M 

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Procedures 
Baseline 
Month 
One 
Month 
Two 
Month 
Three 
Month 
Four 
Month 
Five 
Month 
Six 
Patient Visit Experience 
Survey2 
 
P 
P 
P 
P 
P 
P 
Participant Longitudinal 
Follow-up Interviews 
(n=approx. 12) 
 
P/E 
 
P/E 
 
 
P/E 
Participant Cross-sectional 
Follow-up Interviews (n= 
approx. 5) 
 
 
P/AZ 
 
P/AZ 
P/AZ 
 
Consent for MGH staff 
participating in surveys 
 
M 
 
 
 
 
 
Patient Satisfaction 
Questionnaire-18 
 
 
 
 
 
 
P 
MGH Staff Post-Study 
Survey 
 
 
 
 
 
 
M 
Chart Review CRF 
 
 
 
 
 
 
M 
1MGH will recruit approximately 50 patients for the clinical pilot study. Any additional patients invited to use the app 
beyond the maximum sample size will not be included in any analyses.  
2The Patient Visit Experience Survey will be sent after a confirmed visit with their HCP at the site following baseline 
visit.  
Abbreviation: AZ=AstraZeneca DMP Product Team; CRF = case report form; E=Evidera; M=MGH; P=Participant 
Patient participants will be compensated $10 after completion of applicable surveys from baseline 
through month 6. In addition, if a participant is randomly selected for an interview, they will also 
be compensated $75 per interview completed. Patient participants will be randomized into one of 
three groups, and will only complete one of these groups: 
1. Longitudinal (three total) interviews and receive up to $265  
2. Cross-sectional (one-time) interview and receive up to $115 
3. Not randomized to be interviewed and receive up to $40 
 
Below is a table outlining the remuneration payment schedule for patient participants.   
Table 2. Remuneration Payment Schedule for Patient Participants 
Procedures 
Baseline 
Month One 
Month Three 
Month Six 
Completion of Electronic Surveys 
$10 
$10 
$10 
$10 
Completion of Interview  
(if randomly selected) 
 
$75 
$75 
$75 
Total Possible Remuneration  
$10 
$85 
$85 
$85 
 

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4.1.1 
Patient-Completed 
4.1.1.1 
AMAZETM Patient App 
At the initial baseline visit, participants will be asked to download the AMAZETM app (Appendix 
D). The patient app includes a daily log of asthma symptoms, as well as additional questions on 
their asthma experience. As a part of the app, patients will have access to educational resources 
about their asthma and asthma medication. The resources are meant to be informative in nature 
based on how the participant responds to questions in their daily log. The app allows participants 
to communicate with the MGH staff as well as see daily and weekly trends in their asthma. My 
plan, a component within the app, contains medications, air quality and information regarding 
upcoming appointments.  
Every four weeks, the ACT™ will also be administered and completed by the participant.3 The 
ACT™ consists of five items with the total score used to identify participants with poor asthma 
control. The ACTTM classifies well controlled as ≥20, not well controlled as 16–19, and very 
poorly controlled as ≤15. The ACT™ questions with a four-week recall period address medication 
use, asthma symptoms and asthma-related impairment. The English version will be used in this 
study only.  
4.1.1.2 
Patient Demographic Questionnaire  
Participants will complete a brief self-administered Patient Demographic Questionnaire 
(Appendix G) following download of the patient application and providing their informed consent 
to participate; this questionnaire will be sent to all participating patients via an email link. This 
form collects the participant’s age, ethnicity, living situation, employment, and education, and 
will be used to describe the sample and assist with interpreting the results.  
4.1.1.3 
Patient User Experience Survey  
All participants who consent to participate in the full clinical study will be emailed at months 1, 3, 
and 6 the patient user experience survey (Appendix M). The survey is meant to allow participants 
the opportunity to provide feedback on a monthly basis as they continue to interact with the app. 
The survey results will be reviewed to identify if any changes to the app are needed.  
4.1.1.4 
Patient Visit Experience Survey 
The patient visit experience survey (Appendix H) will be sent electronically any time a participant 
attends an in-person or telehealth clinic visit. Bright Insights will generate weekly reports to 
provide Evidera with IDs for those who completed clinic visits. Evidera will subsequently notify 
the electronic survey vendor to send the survey via email. This survey will evaluate patient 
satisfaction with their visit and any benefits the App provided for the visit.    

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4.1.1.5 
System Usability Scale 
The System Usability Scale (SUS) (Appendix N.1) will be sent electronically at months one and 
six for participants to provide feedback on the AMAZE patient app. The SUS has been validated 
in previous usability studies to quantitatively evaluate the usability of a system, including mobile 
apps.4  
4.1.1.6 
PSQ-18 
At the end of the clinical pilot study (approximately 6 months), all participants who consented and 
participated in the clinical pilot study will be emailed a link to the Patient Satisfaction 
Questionnaire-18 (PSQ-18; Appendix J).5 The PSQ-18 is a generic measure used to assess 
patient’s overall satisfaction with their medical care and interactions with their HCPs. A higher 
score indicates greater satisfaction.  
4.1.1.7 
Follow-up Process Interviews with Patients  
Longitudinal Interviews  
A semi-structured interview guide (Appendix O) will be used to obtain information from a 
randomly selected subset of patients at months one, three, and six during longitudinal, follow-up 
interviews to gain a deeper understanding of the feasibility of implementing the AMAZE™ 
platform. The semi-structured interview guides will include an introduction and follow with 
specific questions and probes designed to facilitate discussion and optimize consistency across 
interviews. The interview guide will elicit recommendations for improving the AMAZE platform 
experience for patients. Additional unscripted probes may also be used to gain further information 
or clarification. The interview guides may be modified as necessary during the study.  
Cross-Sectional Interviews  
Semi-structured interview guides for months 2, 4, and 5 (Appendix O) may be used to obtain 
information from a randomly selected subset of patients at months 2, 4, and 5 during one-time, 
follow-up interviews with the AZ DMP Product team to gain a deeper understanding of the 
usability of the AMAZE™ platform. The interviews will be conducted as needed. The interviews 
are meant to be briefly provide feedback on any new roll outs or issues with the app that cannot be 
captured during the longitudinal interviews. The semi-structured interview guides will include an 
introduction and follow with specific questions and probes designed to facilitate discussion and 
optimize consistency across interviews. The interview guide will elicit recommendations for 
improving the AMAZE platform experience for patients. Additional unscripted probes may also 
be used to gain further information or clarification. The interview guides may be modified as 
necessary during the study.  

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4.1.2 
MGH Completed  
4.1.2.1 
Clinical Case Report Form 
For each participant, MGH will complete a paper clinical case report form (CRF; Appendix F) 
during the initial site visit after informed consent is obtained. The clinical CRF serves to 
characterize patients based on their history of asthma, current medications, and the HCP’s rating 
of the patient’s asthma severity and control. 
4.1.2.2 
Chart Review Case Report Form 
For each participant, MGH will complete a chart review clinical CRF (Appendix K) at month six. 
The follow-up clinical CRF will evaluate exacerbation history during the last 6 months, healthcare 
resource utilization, change in therapy, and COVID-19 diagnosis. 
4.1.2.3 
System Usability Scale 
The SUS (Appendix N.2) will be asked verbally to clinical staff during the telephone interviews at 
months one and six to provide feedback on the clinical dashboard.  
4.1.2.4 
Post-study Survey 
All clinical staff who participate will be asked to complete the Post-study Survey (Appendix I) 
after patient enrollment has completed (approximately four months after study launch). The 
purpose of this survey is to obtain feedback on the implementation of the AMAZE™ platform 
within each site’s medical practice. 
4.2 
Outcomes 
4.2.1 
Primary Outcome 
To address the primary objective to generate evidence on the feasibility, usability, perceived 
value, and potential benefits of the AMAZE™ implemented in clinical practice, the following 
outcomes will be assessed: 
• Technology Outcomes: Technology outcomes will be assessed in a variety of ways 
throughout the clinical pilot study. Usage metrics will be collected by BrightInsight to 
assess the frequency of use by patients completing the daily log, and utilizing the 
educational resources provided. The usage of the clinical dashboard will also be tracked to 
evaluate the utility of the dashboard to MGH. Usage metrics will be analyzed by Evidera 
once provided by BrightInsight.  
o The qualitative interviews from the longitudinal months one, three, and six 
interviews as well as the cross-sectional months two, four, and five interviews will 
provide data regarding the usefulness of the technology from a patient perspective.  

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o The patient user experience surveys may be evaluated as well to determine how the 
platform is being utilized and the user friendliness of the App.  
• Process Outcomes: Similar to the technology outcomes described above, process 
outcomes will be evaluated using the patient follow-up interviews, patient visit experience 
survey, PSQ-18 scores, SUS scores, and post-study survey results. Analyses for the 
process outcomes will focus on variables evaluating the impact of AMAZETM on clinical 
practice, including duration of patient visits and services, as well as responses to survey 
items on changes to timing of scheduling visits, communication during the visit, and 
satisfaction with medical care received.  
4.2.2 
Secondary Outcome 
There are no secondary objectives for this study.  
4.2.3 
Exploratory Outcome One 
To address the first exploratory objective to assess how the implementation of AMAZETM affects 
clinical outcomes, the following outcomes will be assessed: 
• Clinical Outcomes: As part of AMAZETM, all patients will be asked to utilize the App by 
completing the daily log and monthly ACT. Additionally, sites will be asked to complete a 
baseline clinical CRF and a six-month chart review CRF for each participant. The baseline 
clinical CRF will capture information on the patient’s asthma and smoking history as well 
as current asthma medications. The chart review CRF will include questions on recent 
exacerbations, healthcare resource utilization, change in asthma therapy, and exposure to 
COVID-19. The variables collected from these CRFs will be used to evaluate how 
AMAZETM impacts key clinical outcomes of interest. Descriptive statistics (n, frequency, 
mean, and SD) will be utilized. 
4.2.4 
Exploratory Outcome Two 
To address the second exploratory objective on identifying which segments of patients are most 
likely to benefit from using AMAZETM, information collected from the patient sociodemographic 
form and clinical CRF will be used and analyses will be stratified by patient subgroups/segments. 
The following patient segments may be considered: age cohorts (TBD); sex; asthma severity 
cohorts (TBD); educational cohorts (TBD); and minority cohorts (TBD). Other patients’ segments 
may be considered after reviewing sample distribution.    
4.3 
Other Variables and Covariates 
Demographic and/or clinical patient data will be used to summarize the sample overall and by 
site. 

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5. 
STATISTICAL ANALYSIS PLAN 
5.1 
Statistical Methods: General Aspects 
Descriptive statistics (n, frequency, mean, and SD) will be used to characterize the sample in 
terms of sociodemographic and clinical characteristics. The sociodemographic and clinical 
characteristics will be summarized for the sample overall as well as for each site. 
5.1.1 
Primary Objective: To generate evidence on the feasibility, usability, perceived 
value, and potential benefits of the AMAZE™ implemented in clinical practice  
The technology outcomes described in section 4.2.1 above will be analyzed both qualitatively and 
quantitatively. The interview (longitudinal and cross-sectional follow-up) results will be 
summarized in tabular format, with key recommendations, advantages, and disadvantages 
grouped. Specifically, barriers, benefits, challenges, ease of implementation, and areas for 
improvement will be summarized. Results from the patient visit experience survey, monthly 
patient user experience surveys, PSQ-18, post-study survey, and usage metrics provided by 
BrightInsight will be analyzed using descriptive statistics (n, frequency, mean and SD).  
The process outcomes described in section 4.2.1 above will be analyzed similar to the technology 
outcomes. The interview results will be summarized in tabular format; survey results will be 
analyzed using descriptive statistics. 
5.1.2 
Secondary Objective(s)  
There are no secondary objectives for this study.  
5.1.3 
Exploratory Objective One: To assess how the implementation of AMAZETM 
affects clinical outcomes  
The variables collected from the baseline Clinical CRF and six-month chart review form will be 
used to evaluate how the AMAZETM patient App impacts key clinical outcomes of interest (e.g. 
clinician visits, healthcare resource utilization, change in therapy). Descriptive statistics (n, 
frequency, mean, and SD) will be utilized. 
5.1.4 
Exploratory Objective Two: To identify patients who are most likely to benefit 
from using AMAZETM  
The variables collected form the patient sociodemographic form and Clinical CRF will be used to 
stratify patients into segments/subgroups. Proposed variables of interest are age, sex, asthma 
severity, educational subgroups, and minority status. Additional variables may also be used in the 

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exploratory analyses. Descriptive statistics (n, frequency, mean, and SD) will be used to 
characterize patients most likely to benefit from the App across these variables.  
5.2 
Bias 
5.2.1 
Methods to Minimize Bias 
Bias may occur with patient selection into the study based on availability of the appropriate phone 
and operating system. For this initial implementation study, the age and sex of patients who are 
interested in participating but do not have access to the appropriate devices will be tracked. 
5.2.2 
Adjustment for Multiple Comparisons 
Not Applicable.  
5.2.3 
Strengths and Limitations 
The strengths of this study are that it aims to include a diverse sample of patients across MGH. 
The limitations of this study include that MGH may not be generalizable to all clinical sites 
treating asthma patients across the US and that the sample of patients may not be generalizable to 
all asthma patients >18 years of age. 
5.3 
Sample Size and Power Calculations 
As the aim of this study is to assess the process and feasibility study of implementing the 
AMAZE™ in clinical practice, inferential statistics will not be conducted, and a formal sample 
size estimation is not applicable. MGH will target 50 patients. Implementing the AMAZE™ with 
up to 50 patients will provide MGH with enough experience to provide feedback on the outcomes, 
barriers, benefits, challenges, ease of implementation, and areas for improvement for future 
integration as a platform. 
6. 
STUDY CONDUCT AND REGULATORY DETAILS 
6.1 
Study Conduct 
6.1.1 
Procedures 
6.1.1.1 
Recruitment  
Participants will be recruited from MGH. MGH will identify potential participants through 
chart/database/electronic medical record (EMR) reviews. Potentially eligible patients will also be 
identified using the Research Patient Data Registry (RDPR) Scheduled Query feature. We will 
search for patients diagnosed with asthma with or without COPD. Upon receipt of each updated 
patient list, study staff will perform a chart review of listed patients to confirm eligibility. Once 
patient eligibility is confirmed, study staff will provide the confirmed list to appropriate clinical 

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staff who, at their discretion, will approach their patients regarding participation in the research 
study. 
MGH staff will approach patients during a regularly scheduled clinic visit or call potentially 
eligible participants and introduce the study using an introductory script (Appendix A). The script 
provides an overview as to the purpose and nature of each study. Alternatively, a recruitment 
email will be first sent from a physician with a flyer attached to introduce the app and the study to 
participants (Appendix C). A follow-up Zoom video conversation can also be scheduled with the 
participants. For the clinical pilot study, best efforts will be made to recruit approximately 10 
patients who are new to the practice (less than 3-month history) but with uncontrolled asthma and 
approximately 40 patients experiencing at least 1 exacerbation in the previous 12 months. In 
addition, over half the sample will be young adults (18–35 years old). The research staff will 
document patient interest and the recruitment quota using the Recruitment Tracking Log 
(Appendix P), including documentation of the number of patients who choose not to participate.  
6.1.1.2 
Baseline Visit  
During the baseline visit, interested participants that have verbally consented to participate will be 
sent an email (Appendix B) by the clinic staff via REDCap to provide electronic consent to 
participate in the clinical pilot study. The email address will be confirmed during screening and 
staff will add the email address in the dashboard system if it differs from the email address in the 
dashboard. MGH staff will review the consent either in person or via telephone and answer any 
questions they may have. Once the participant and MGH staff have signed, a fully executed 
version will be available for download. The consent will acknowledge the random selection of 
patients who will be asked to complete either a longitudinal or cross-sectional follow-up 
interview. After consent, patients will be provided with a link to download the App (Appendix E) 
and register as a patient with a unique identifier (ID). After completion of the baseline visit, 
patients will be emailed a brief sociodemographic questionnaire (Appendix G). MGH will also be 
asked to complete a clinical CRF (Appendix F) to capture initial clinical characteristics. Patients 
will be remunerated $10 for completing the sociodemographic questionnaire at the baseline visit. 
Evidera will provide the email addresses collected at the screening visit to the web survey vendor 
in order to email the follow-up survey links.  
6.1.1.3 
Longitudinal Follow-up Interviews and Assessments  
Throughout the study duration, participants will be able to access the daily log of symptoms, 
questions on their asthma experience, and educational resources each day they interact with the 
AMAZETM app. Every month, the app will prompt the completion of the ACTTM. Based on the 
responses on the patient App, a notification or alert may be triggered in the clinician dashboard 
for the sites to contact the patient and assess the severity of their symptoms and propose next steps 
(e.g., complete a clinic visit). In addition to the daily App completion, patients will be emailed a 

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monthly patient user survey to complete, as well as the SUS at months one and six. Patients will 
be remunerated $10 with payment at months 1, 3, and 6 on their ClinCard for completion of 
applicable surveys. In addition, patients who are randomly selected will be compensated $75 for 
each successfully completed interview.  
Up to 12 randomly selected patients from MGH will be asked to participate in qualitative, 
longitudinal, follow-up interviews at months one, three, and six to evaluate the implementation 
and convenience of AMAZETM. Interviews will be conducted over the phone with Evidera staff. 
The interviews will be audio recorded and transcribed by a third-party vendor (TransPerfect). 
Interviews are expected to last approximately 30 to 45 minutes for patients. Patients will be 
remunerated $75 for their time via ClinCard at each interview time point.  
6.1.1.4 
Cross-Sectional Follow-up Interviews and Assessments  
Participants will be asked to complete the patient visit experience survey after attending an in-
person or telehealth visit with their doctor. The survey will be emailed to participants after 
confirmation of completion of the visit.  
A random selection of up to 5 patients at MGH will be asked to participate in a cross-sectional, 
one-time, follow-up interview either at month two, four, or five. The cross-sectional interviews 
will be conducted by AZ DMP Product team. Evidera will contact the participants to schedule the 
cross-sectional interview. To maintain data privacy, a teleconference line will be provided to the 
participants and AZ team. The goal of the one-time interview will be to evaluate any usability and 
feasibility issues with patients and provide an opportunity for participants to provide feedback on 
areas for growth or change in the patient App that cannot be captured during longitudinal 
interviews. Patient participants will be remunerated $75 at the completion of the interview and 
paid at months 2, 4, and 5.  
Approximately 6 months after first patient in, MGH staff will be asked to complete a post-study 
survey and patients will complete the PSQ-18, both provided via email to provide final feedback 
on the implementation of feasibility of the AMAZETM patient App and clinician dashboard, and 
satisfaction with medical care received, respectively. MGH staff will also complete a 6-month 
clinical CRF.  
6.1.1.5 
Claims Data Export 
After the participants consent to participate, Evidera, and AZ will work to export deidentified 
claims data at months 6. The linking of deidentified data with the clinical pilot de-identified data 
will be outlined in detail in a subsequent study amendment prior to month 3. Alternatively, claims 
data may be linked to clinical pilot participants. The processes related to claims linking will be 
revised during an amendment. Any procedures related to this will not be implemented until IRB 
approved.  

Study Protocol 
Study Code D2287R00166 [EVA-28838] 
Version 7.4 
Date August 10, 2021 
Study Protocol Form 
Version 7.4 
Form Doc ID: AZDoc0059948 
Parent Doc ID: SOP LDMS_001_0016432829 
 
6.1.2 
Quality Control 
6.1.2.1 
Monitoring 
Before the first subject is recruited into the study, the Medical Evidence and Observational 
Research (MEOR) Delivery Director, MEOR Operations Lead or CRO Representative (i.e., 
Evidera) will: 
• Establish the adequacy of the facilities and the investigator’s capability to appropriately 
select the sample; and 
• Discuss with the investigator(s) (and other personnel involved with the study) their 
responsibilities with regards to protocol compliance, and the responsibilities of AZ or its 
representatives. This will be documented in an Interventional Study Primary Agreement or 
equivalent between AZ/delegate and the investigator. 
During the study the local marketing company (MC) representative or delegate can implement 
different activities to assure compliance with AZ standards of quality. These activities could 
include but are not limited to: 
6.1.2.2 
Contacts with the sites to: 
• Provide information and support to the investigator(s) 
• Confirm that the research team is complying with the protocol and that data are being 
accurately recorded in the CRFs 
• Ensure that the CRFs are completed properly and with adequate quality 
6.1.2.3 
Remote Monitoring activities for: 
• Checking informed consent forms (ICF) 
• Review enrollment forms and subsequent CRFs  
• Export of claims data  
The extent and nature of monitoring will be decided during the study planning based on design, 
complexity, number of subjects, number of sites, etc. Interventional Research Center (multi 
country)/MC will give some recommendations that could be locally adapted. 
Different signals (e.g., high rejection rate in a site) should be used as potential identification of 
low protocol compliance by investigators. 
If these or any other signal occurs or if the CRO is suspicious of a potential non-optimal level of 
protocol compliance by the site investigator, specific measures should be adopted to evaluate the 
situation, identify the issue and implement specific action plans to correct the situation. 

Study Protocol 
Study Code D2287R00166 [EVA-28838] 
Version 7.4 
Date August 10, 2021 
Study Protocol Form 
Version 7.4 
Form Doc ID: AZDoc0059948 
Parent Doc ID: SOP LDMS_001_0016432830 
 
6.1.2.4 
Training of Study Site Personnel 
Evidera will ensure training of MGH personnel for the implementation of AMAZETM clinical 
pilot study procedures outlined in the study protocol. MGH principal investigators will ensure that 
appropriate training relevant to the study is provided to MGH staff, and that any new information 
relevant to the performance of this study is forwarded to the staff involved. 
6.1.2.5 
ePRO Programming and Hosting 
REDCap will be used for the electronic patient and clinical site staff surveys and clinical case 
report forms (CRFs). The survey hosted will include the sociodemographic form, monthly patient 
user experience survey, patient visit experience survey, SUS, post-study survey, and PSQ-18. A 
separate HIPAA-compliant vendor, BrightInsight, will host the data management system to 
collect and monitor data captured by AMAZETM.  
For both vendors, the quality assurance process will include extensive end-to-end testing. During 
all data collection, the survey responses will be tracked by unique participant identifiers—not 
participant names. All electronic surveys will be emailed to patient participants and clinical staff 
research participant through REDCap.  
MGH will export and transfer the CRF and survey data in SAS format to Evidera via MGB 
Secure File Transfer. The CRF and survey data will then be entered into the database and 
reviewed by project scientific staff. Data discrepancies will be identified and resolved. 
The web survey developed for the patient and MGH staff surveys will be tested prior to study 
launch.  
6.2 
Protection of Human Subjects 
This Interventional Study will be performed in accordance with ethical principles that are 
consistent with the Declaration of Helsinki, ICH GCPs, GPP and the applicable legislation on 
Non-Interventional Studies and/or Interventional Studies.  
The Investigator will perform the clinical pilot Study in accordance with the regulations and 
guidelines governing medical practice and ethics in the country of the clinical pilot Study and in 
accordance with currently acceptable techniques and know-how. 
The final protocol of the clinical pilot Study, including the final version of the Patient Informed 
Consent Form, must be approved or given a favourable opinion in writing by the Ethics 
Committee/Institutional Review Board (IRB)/Independent Ethics Committee (IEC). 
The Ethics Committee/IRB/IEC must also approve any amendment to the protocol and all 
advertising used to recruit subjects for the study, according to local regulations.  

Study Protocol 
Study Code D2287R00166 [EVA-28838] 
Version 7.4 
Date August 10, 2021 
Study Protocol Form 
Version 7.4 
Form Doc ID: AZDoc0059948 
Parent Doc ID: SOP LDMS_001_0016432831 
 
6.2.1 
Informed Consent  
MGH staff will be responsible for ensuring that each participant (patients and MGH staff) fully 
understands the study’s nature, purpose, procedures, risks, and benefits. For those patients and 
MGH staff taking part in the clinical pilot launch, electronic consent will be presented to them via 
REDCap. At the screening, the MGH staff will confirm the email address to send the REDCap 
document to and update the dashboard as needed with any patient email addresses that are not in 
the system. Evidera will provide the email addresses collected at the baseline visit to the web-
based survey vendor via secure portal. MGH staff will review the consent (either in person or via 
telephone) and answer any questions. MGH staff will confirm the email address with the 
participant during the initial screening process.  
Participants (patients and MGH staff) will also be informed of their rights as a participant, 
including that they may refuse to take part or withdraw at any time without penalty or giving up 
any benefits to which they are otherwise entitled. The participants also will be informed that, 
should they choose not to participate in all or any part of the study, their current or future 
treatment at the site will not be affected. 
This study involves participant-completed measures for information purposes only; the study does 
not involve the use of an investigational drug or device. There are no known risks or benefits to 
participants. During or following the research study, patients may become more aware of how 
they feel about their condition—and how their condition may affect certain aspects of their life. 
Patients will be encouraged to talk with their asthma provider about their questions or concerns. 
The elements of federal regulations pertaining to consent procedures, disclosure of potential risks 
and benefits, and patient confidentiality will be strictly observed. 
6.2.2 
Confidentiality of Study/Patient Data 
All data collected will be strictly confidential, in accordance with local, state, and federal law. 
Personnel from the following organizations may examine the research study records: Evidera, AZ, 
and regulatory agencies (such as the FDA and the IRB). Only MGH staff involved in participant 
recruitment, clinical data extraction, and questionnaire administration will know the identities of 
the patients. Staff will be instructed to maintain complete confidentiality of all collected data. 
Participant data files collected by MGH and shared with either Evidera or AZ will be kept in a 
locked file cabinet separate from their identifying information and will be destroyed per Evidera’s 
SOPs after a period of seven years. The summary report generated from the completed 
questionnaires will not contain any participant-identifying information. Medical data collected 
will not be associated with personal health identification data. All study data will be de-identified. 
Evidera retains records for a minimum of two years on site, and an additional five years off site. 
Upon enrollment, participants will be assigned unique identification numbers. These unique 

Study Protocol 
Study Code D2287R00166 [EVA-28838] 
Version 7.4 
Date August 10, 2021 
Study Protocol Form 
Version 7.4 
Form Doc ID: AZDoc0059948 
Parent Doc ID: SOP LDMS_001_0016432832 
 
identifiers will be used to track the participants throughout the study. Only the unique participant 
identification numbers and participant initials will be entered into the database and recorded on 
the participant questionnaires—not participant names. 
This interventional study will be performed in accordance with ethical principles that are 
consistent with the Declaration of Helsinki, International Council for Harmonization (ICH), Good 
Clinical Practice (GCP), and the applicable legislation on Interventional Studies. 
The investigators will perform the clinical pilot study in accordance with the regulations and 
guidelines governing medical practice and ethics in the country of the interventional study, and in 
accordance with currently acceptable techniques and know-how. 
The final clinical pilot study protocol, including the final version of the Patient and MGH 
Informed Consent Form, must be approved or given a favorable opinion in writing by the Ethics 
Committee/IRB/Independent Ethics Committee (IEC). 
The Ethics Committee/IRB/IEC must also approve any protocol amendment and all advertising 
used to recruit subjects for the study, according to local regulations. 
6.3 
Collection and Reporting of Adverse Events/Adverse Drug Reactions 
6.3.1 
Collection of Adverse Events 
This is an interventional study with no requirements to actively collect adverse events during the 
study since enrollment in the study is based on disease diagnosis and does not require the 
administration of an AZ drug. However, if an investigator (or patient) would like to report an AE 
that is not required to be collected, this can be reported as a spontaneous report according to local 
regulations. The open-ended question in the feedback section of the App will be monitored for AE 
reporting by the AZ Production team. 
6.3.2 
Reporting of Adverse Events 
It is not necessary to report potential AEs based on answers to the ACTTM. 
The rationale is, the signs and symptoms collected by these instruments are prevalent among 
asthmatic patients. It is not feasible to evaluate associations between a specific drug and events 
reported by patients based on these instruments due to lack of baseline disease information and 
temporal relationship of drug and event. According to the literature, more than 50% of asthma 
patients who are under medication will have such signs and symptoms.  
Patients will be informed that their healthcare providers (including MGH staff and their clinician) 
will not be reviewing their responses to the study questionnaires in real time. They will be 

Study Protocol 
Study Code D2287R00166 [EVA-28838] 
Version 7.4 
Date August 10, 2021 
Study Protocol Form 
Version 7.4 
Form Doc ID: AZDoc0059948 
Parent Doc ID: SOP LDMS_001_0016432833 
 
instructed to report any health concerns or issues that they may experience directly to their 
healthcare providers.  
6.3.3 
Aggregate Safety Review from PRO Instruments 
An aggregate data report (in the form of a summary) of the PROs’ scores from patients on AZ 
product(s) will be provided to the Global Safety Physician (GSP) and Safety Surveillance and 
Management Team (SSaMT) Lead for their review at the end of the study, so that the data can be 
considered in the context of the overall benefit: risk assessment of the product(s). 
 
 

Study Protocol 
Study Code D2287R00166 [EVA-28838] 
Version 7.4 
Date August 10, 2021 
Study Protocol Form 
Version 7.4 
Form Doc ID: AZDoc0059948 
Parent Doc ID: SOP LDMS_001_0016432834 
 
7. 
REFERENCES 
1. 
Moore WC, Bleecker ER, Curran-Everett D, et al. Characterization of the severe 
asthma phenotype by the National Heart, Lung, and Blood Institute's Severe Asthma 
Research Program. J Allergy Clin Immunol. 2007;119(2):405-413. 
2. 
Nunes C, Pereira AM, Morais-Almeida M. Asthma costs and social impact. Asthma 
Research and Practice. 2017;3(1):1. 
3. 
Nathan RA, Sorkness CA, Kosinski M, et al. Development of the asthma control test: a 
survey for assessing asthma control. J Allergy Clin Immunol. 2004;113(1):59-65. 
4. 
Bangor A, Kortum PT, Miller JT. An Empirical Evaluation of the System Usability 
Scale. International Journal of Human–Computer Interaction. 2008;24(6):574-594. 
5. 
Marshall GN HR. The Patient Satisfaction Questionnaire Short-Form (PSQ-18). In. 
Santa Monica, CA: Rand Corp.; 1994. 
 
 

Study Protocol 
Study Code D2287R00166 [EVA-28838] 
Version 7.4 
Date August 10, 2021 
Study Protocol Form 
Version 7.4 
Form Doc ID: AZDoc0059948 
Parent Doc ID: SOP LDMS_001_0016432835 
 
8. 
APPENDIX A. PATIENT SCREENING SCRIPT 
Prior to initiating screening contact, please confirm the following from the patient’s chart: 
The patient has a clinical diagnosis of asthma 
Confirmed  
The patient is at least 18 years of age 
(Recruitment quota: approximately 33 young adult patients 
(18–35 years of age) 
Confirmed  
Recruitment Quota only:  
New patients to the practice (less than 3-month history) and 
with uncontrolled asthma 
Confirmed  
Recruitment Quota only:  
At least one exacerbation per year  
Confirmed  
 
Introductory Script for Clinical Pilot Study Participants  
Hello [patient name], my name is [interviewer name] and I am working with MGH and 
AstraZeneca on a research study to evaluate a new smart phone app called AMAZE™ to monitor 
asthma symptoms and to provide resources that may be helpful for asthma patients like you. I will 
provide some basic information about this study and ask you some questions to find out if you 
might qualify for the study. This conversation will take about 20 minutes, is this a good time to 
talk? _____Yes  _______ No 
If no, thank you for your time today!  
If yes, thank you for your interest.  
We are participating in a research study with Evidera and AstraZeneca, a health outcomes 
research organization and Pharmaceutical company, to evaluate a new patient App that will help 
you monitor your asthma daily and provide resources that may be helpful for asthma patients like 
you. The goal of this study is to see if the patient App helps improve your care. Information from 
your medical records, such as your age, medications, existing medical conditions, will be 
collected for this study.  
You will be asked to use the App over the next six months by completing the daily questions and 
will have access to educational materials provided in the App. A brief sociodemographic form 
will be sent via email for your completion, as well as periodic surveys to gain additional 

Study Protocol 
Study Code D2287R00166 [EVA-28838] 
Version 7.4 
Date August 10, 2021 
Study Protocol Form 
Version 7.4 
Form Doc ID: AZDoc0059948 
Parent Doc ID: SOP LDMS_001_0016432836 
 
information about your experiences using the App. If you agree to participate, you will be emailed 
a link to download the App with a unique ID. You will be compensated $10 for each visit 
completed and paid at baseline, months 1, 3 and 6 for a potential total of $40. 
As a part of this study, some participants will be randomly selected to complete a series of 
telephone interviews (around 1, 3, and 6 months after enrolling in the study) or just one interview 
(around 2, 4, or 5 months after enrolling in the study) to be conducted by Evidera or AstraZeneca. 
If selected for the interviews, the interview will be audio recorded and transcribed by a third-party 
vendor (TransPerfect), and should last approximately 30 to 45 minutes.  
Subjects will get $10 for each visit completed and $75 for each interview. The maximum each 
subject may receive for completion of visits is $40. Subjects will be randomized into one of three 
groups. Participants will only complete one of these groups: 
4. Longitudinal (three total) interviews and receive up to $265  
5. Cross-sectional (one-time) interviews and receive up to $115 
6. Not randomized to be interviewed and receive up to $40 
As a participant in this research study, there will be no direct benefits for you; however, 
information from this study may help health care providers improve the way they ask patients 
questions about their asthma. 
The risks of the study are expected to be minimal. There is the risk that allowing us to record your 
name with your answers and accessing your health information is a possible loss of 
confidentiality. We will take reasonable steps to protect the confidentiality of your information.  
Taking part in this study is voluntary. You may choose not to take part in this study, or if you 
decide to take part, you can change your mind later and withdraw from the study. Your decision 
will not change any present or future relationships with MGH or its affiliates.  
Are you interested in participating this study? _____Yes  _______ No 
If no, thank you for your time today!  
If yes, thank you for your interest.  
Before moving forward, would you be willing to answer some questions to find out if you might 
qualify for the study? I will record your answers in writing, but only collect detailed contact 
information if you qualify for the study. May I begin? _____Yes  _______ No 

Study Protocol 
Study Code D2287R00166 [EVA-28838] 
Version 7.4 
Date August 10, 2021 
Study Protocol Form 
Version 7.4 
Form Doc ID: AZDoc0059948 
Parent Doc ID: SOP LDMS_001_0016432837 
 
 
Can you confirm if you have a smartphone with internet access? _____Yes  _______ No 
 
If yes, what type of smartphone and operating system do you have?  
_____iPhone (OS and Type)  _______ Android (OS) _____Other  
 
If the participant does not have an iPhone 8 or newer with an Operating System of 13 or newer or 
an Android with an Operating System of 8.0 or newer, the participant is not eligible to participate 
and thank them for their time!  
 
 
As a part of the study you will be sent an emailed link with your unique ID to log-in to the 
application as well as instructions for how to download the app.  
 
 
I need to collect some information from you to share with Evidera in order to make your profile 
for the reloadable gift card, ClinCard, and share your email address for sending you the study 
consent form and for future survey completion.  
 
 
Do you grant permission for the study team to send you the full study consent form via email for 
you to review and sign? _____Yes  _______ No 
 
 
Do you grant permission for the study team to leave a brief voice mail message if you are not 
available when the study team schedules calls? _____Yes  _______ No 
 
 

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Study Protocol 
Study Code D2287R00166 [EVA-28838] 
Version 7.4 
Date August 10, 2021 
Study Protocol Form 
Version 7.4 
Form Doc ID: AZDoc0059948 
Parent Doc ID: SOP LDMS_001_0016432839 
 
9. 
APPENDIX B. ELECTRONIC CONSENT EMAIL  
Signature Line Subject:  
AMAZETM Health Management MGH Asthma Mobile App Study – Electronic Consent Form 
 
Body of Consent E-mail: 
Dear [Participant]: 
Thank you for your interest in our research study about a newly developed mobile app for asthma 
patients.   
 
Prior to participating in the study, you will need to provide consent electronically.  When 
instructed to do so by the MGH staff, please go to the following URL: <insert consent URL> 
  
 
Thank you, 
 
<insert MGH contact person signature line> 
 
 
 

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Study Protocol 
Study Code D2287R00166 [EVA-28838] 
Version 7.4 
Date August 10, 2021 
Study Protocol Form 
Version 7.4 
Form Doc ID: AZDoc0059948 
Parent Doc ID: SOP LDMS_001_0016432843 
 
11. 
APPENDIX D. INTRODUCTORY EMAIL 
The code and invitation code expiration date and time will be modified for each individual 
participant.  
  
 

Study Protocol 
Study Code D2287R00166 [EVA-28838] 
Version 7.4 
Date August 10, 2021 
Study Protocol Form 
Version 7.4 
Form Doc ID: AZDoc0059948 
Parent Doc ID: SOP LDMS_001_0016432844 
 
12. 
APPENDIX E. AMAZETM PATIENT MOBILE APPLICATION 
SCREENSHOTS 
12.1 
Flyer for App  
 

Study Protocol 
Study Code D2287R00166 [EVA-28838] 
Version 7.4 
Date August 10, 2021 
Study Protocol Form 
Version 7.4 
Form Doc ID: AZDoc0059948 
Parent Doc ID: SOP LDMS_001_0016432845 
 
12.2 
Account Creation and Login 
 

Study Protocol 
Study Code D2287R00166 [EVA-28838] 
Version 7.4 
Date August 10, 2021 
Study Protocol Form 
Version 7.4 
Form Doc ID: AZDoc0059948 
Parent Doc ID: SOP LDMS_001_0016432846 
 
     
 

Study Protocol 
Study Code D2287R00166 [EVA-28838] 
Version 7.4 
Date August 10, 2021 
Study Protocol Form 
Version 7.4 
Form Doc ID: AZDoc0059948 
Parent Doc ID: SOP LDMS_001_0016432847 
 
 

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Study Protocol 
Study Code D2287R00166 [EVA-28838] 
Version 7.4 
Date August 10, 2021 
Study Protocol Form 
Version 7.4 
Form Doc ID: AZDoc0059948 
Parent Doc ID: SOP LDMS_001_0016432849 
 
        
 
12.3 
Terms of Use  
AZ - MGH - AMAZE 
DMP - Clinician Port 

Study Protocol 
Study Code D2287R00166 [EVA-28838] 
Version 7.4 
Date August 10, 2021 
Study Protocol Form 
Version 7.4 
Form Doc ID: AZDoc0059948 
Parent Doc ID: SOP LDMS_001_0016432850 
 
AZ - MGH - AMAZE 
DMP - Privacy Policy  
AZ - MGH - AMAZE 
DMP - Patient Terms  

Study Protocol 
Study Code D2287R00166 [EVA-28838] 
Version 7.4 
Date August 10, 2021 
Study Protocol Form 
Version 7.4 
Form Doc ID: AZDoc0059948 
Parent Doc ID: SOP LDMS_001_0016432851 
 
12.4 
Air Quality 
          
  

Study Protocol 
Study Code D2287R00166 [EVA-28838] 
Version 7.4 
Date August 10, 2021 
Study Protocol Form 
Version 7.4 
Form Doc ID: AZDoc0059948 
Parent Doc ID: SOP LDMS_001_0016432852 
 
      
 

Study Protocol 
Study Code D2287R00166 [EVA-28838] 
Version 7.4 
Date August 10, 2021 
Study Protocol Form 
Version 7.4 
Form Doc ID: AZDoc0059948 
Parent Doc ID: SOP LDMS_001_0016432853 
 
         
12.5 
Appointments 
 

Study Protocol 
Study Code D2287R00166 [EVA-28838] 
Version 7.4 
Date August 10, 2021 
Study Protocol Form 
Version 7.4 
Form Doc ID: AZDoc0059948 
Parent Doc ID: SOP LDMS_001_0016432854 
 
12.6 
Asthma Control Test 
 

Study Protocol 
Study Code D2287R00166 [EVA-28838] 
Version 7.4 
Date August 10, 2021 
Study Protocol Form 
Version 7.4 
Form Doc ID: AZDoc0059948 
Parent Doc ID: SOP LDMS_001_0016432855 
 
 

Study Protocol 
Study Code D2287R00166 [EVA-28838] 
Version 7.4 
Date August 10, 2021 
Study Protocol Form 
Version 7.4 
Form Doc ID: AZDoc0059948 
Parent Doc ID: SOP LDMS_001_0016432856 
 
 

Study Protocol 
Study Code D2287R00166 [EVA-28838] 
Version 7.4 
Date August 10, 2021 
Study Protocol Form 
Version 7.4 
Form Doc ID: AZDoc0059948 
Parent Doc ID: SOP LDMS_001_0016432857 
 
        
 

Study Protocol 
Study Code D2287R00166 [EVA-28838] 
Version 7.4 
Date August 10, 2021 
Study Protocol Form 
Version 7.4 
Form Doc ID: AZDoc0059948 
Parent Doc ID: SOP LDMS_001_0016432858 
 
        
 

Study Protocol 
Study Code D2287R00166 [EVA-28838] 
Version 7.4 
Date August 10, 2021 
Study Protocol Form 
Version 7.4 
Form Doc ID: AZDoc0059948 
Parent Doc ID: SOP LDMS_001_0016432859 
 
12.7 
Daily Asthma Log 
 

Study Protocol 
Study Code D2287R00166 [EVA-28838] 
Version 7.4 
Date August 10, 2021 
Study Protocol Form 
Version 7.4 
Form Doc ID: AZDoc0059948 
Parent Doc ID: SOP LDMS_001_0016432860 
 
         
 

Study Protocol 
Study Code D2287R00166 [EVA-28838] 
Version 7.4 
Date August 10, 2021 
Study Protocol Form 
Version 7.4 
Form Doc ID: AZDoc0059948 
Parent Doc ID: SOP LDMS_001_0016432861 
 
      
 

Study Protocol 
Study Code D2287R00166 [EVA-28838] 
Version 7.4 
Date August 10, 2021 
Study Protocol Form 
Version 7.4 
Form Doc ID: AZDoc0059948 
Parent Doc ID: SOP LDMS_001_0016432862 
 
      
 

Study Protocol 
Study Code D2287R00166 [EVA-28838] 
Version 7.4 
Date August 10, 2021 
Study Protocol Form 
Version 7.4 
Form Doc ID: AZDoc0059948 
Parent Doc ID: SOP LDMS_001_0016432863 
 
        
 

Study Protocol 
Study Code D2287R00166 [EVA-28838] 
Version 7.4 
Date August 10, 2021 
Study Protocol Form 
Version 7.4 
Form Doc ID: AZDoc0059948 
Parent Doc ID: SOP LDMS_001_0016432864 
 
      
 

Study Protocol 
Study Code D2287R00166 [EVA-28838] 
Version 7.4 
Date August 10, 2021 
Study Protocol Form 
Version 7.4 
Form Doc ID: AZDoc0059948 
Parent Doc ID: SOP LDMS_001_0016432865 
 
 

Study Protocol 
Study Code D2287R00166 [EVA-28838] 
Version 7.4 
Date August 10, 2021 
Study Protocol Form 
Version 7.4 
Form Doc ID: AZDoc0059948 
Parent Doc ID: SOP LDMS_001_0016432866 
 
12.8 
Education 
 

Study Protocol 
Study Code D2287R00166 [EVA-28838] 
Version 7.4 
Date August 10, 2021 
Study Protocol Form 
Version 7.4 
Form Doc ID: AZDoc0059948 
Parent Doc ID: SOP LDMS_001_0016432867 
 
12.9 
Email Password Reset 
 

Study Protocol 
Study Code D2287R00166 [EVA-28838] 
Version 7.4 
Date August 10, 2021 
Study Protocol Form 
Version 7.4 
Form Doc ID: AZDoc0059948 
Parent Doc ID: SOP LDMS_001_0016432868 
 
12.10 
Home 
 

Study Protocol 
Study Code D2287R00166 [EVA-28838] 
Version 7.4 
Date August 10, 2021 
Study Protocol Form 
Version 7.4 
Form Doc ID: AZDoc0059948 
Parent Doc ID: SOP LDMS_001_0016432869 
 
12.11 
Messages 
 

Study Protocol 
Study Code D2287R00166 [EVA-28838] 
Version 7.4 
Date August 10, 2021 
Study Protocol Form 
Version 7.4 
Form Doc ID: AZDoc0059948 
Parent Doc ID: SOP LDMS_001_0016432870 
 
      
 

Study Protocol 
Study Code D2287R00166 [EVA-28838] 
Version 7.4 
Date August 10, 2021 
Study Protocol Form 
Version 7.4 
Form Doc ID: AZDoc0059948 
Parent Doc ID: SOP LDMS_001_0016432871 
 
 

Study Protocol 
Study Code D2287R00166 [EVA-28838] 
Version 7.4 
Date August 10, 2021 
Study Protocol Form 
Version 7.4 
Form Doc ID: AZDoc0059948 
Parent Doc ID: SOP LDMS_001_0016432872 
 
12.12 
Feedback 
 

Study Protocol 
Study Code D2287R00166 [EVA-28838] 
Version 7.4 
Date August 10, 2021 
Study Protocol Form 
Version 7.4 
Form Doc ID: AZDoc0059948 
Parent Doc ID: SOP LDMS_001_0016432873 
 
12.13 
My Plan 
     

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Study Protocol 
Study Code D2287R00166 [EVA-28838] 
Version 7.4 
Date August 10, 2021 
Study Protocol Form 
Version 7.4 
Form Doc ID: AZDoc0059948 
Parent Doc ID: SOP LDMS_001_0016432876 
 
12.14 
Notifications 
         
 

Study Protocol 
Study Code D2287R00166 [EVA-28838] 
Version 7.4 
Date August 10, 2021 
Study Protocol Form 
Version 7.4 
Form Doc ID: AZDoc0059948 
Parent Doc ID: SOP LDMS_001_0016432877 
 
12.15 
Settings 
 

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Study Protocol 
Study Code D2287R00166 [EVA-28838] 
Version 7.4 
Date August 10, 2021 
Study Protocol Form 
Version 7.4 
Form Doc ID: AZDoc0059948 
Parent Doc ID: SOP LDMS_001_0016432879 
 
      

Study Protocol 
Study Code D2287R00166 [EVA-28838] 
Version 7.4 
Date August 10, 2021 
Study Protocol Form 
Version 7.4 
Form Doc ID: AZDoc0059948 
Parent Doc ID: SOP LDMS_001_0016432880 
 
 

Study Protocol 
Study Code D2287R00166 [EVA-28838] 
Version 7.4 
Date August 10, 2021 
Study Protocol Form 
Version 7.4 
Form Doc ID: AZDoc0059948 
Parent Doc ID: SOP LDMS_001_0016432881 
 
12.16 
Trends 
 

Study Protocol 
Study Code D2287R00166 [EVA-28838] 
Version 7.4 
Date August 10, 2021 
Study Protocol Form 
Version 7.4 
Form Doc ID: AZDoc0059948 
Parent Doc ID: SOP LDMS_001_0016432882 
 
    
 

Study Protocol 
Study Code D2287R00166 [EVA-28838] 
Version 7.4 
Date August 10, 2021 
Study Protocol Form 
Version 7.4 
Form Doc ID: AZDoc0059948 
Parent Doc ID: SOP LDMS_001_0016432883 
 
      
 

Study Protocol 
Study Code D2287R00166 [EVA-28838] 
Version 7.4 
Date August 10, 2021 
Study Protocol Form 
Version 7.4 
Form Doc ID: AZDoc0059948 
Parent Doc ID: SOP LDMS_001_0016432884 
 
 

Study Protocol 
Study Code D2287R00166 [EVA-28838] 
Version 7.4 
Date August 10, 2021 
Study Protocol Form 
Version 7.4 
Form Doc ID: AZDoc0059948 
Parent Doc ID: SOP LDMS_001_0016432885 
 
12.17 
Study Ending 
 

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Study Protocol 
Study Code D2287R00166 [EVA-28838] 
Version 7.4 
Date August 10, 2021 
Study Protocol Form 
Version 7.4 
Form Doc ID: AZDoc0059948 
Parent Doc ID: SOP LDMS_001_0016432887 
 
13. 
APPENDIX F. CLINICAL CASE REPORT FORM 
Clinical Case Report Form 
 
Screening ID 
__________________________________ 
Participant ID 
__________________________________ 
BI linked ID 
__________________________________ 
Date of Enrollment 
__________________________________ 
 
Confirmation of Eligibility Into the Study 
Patient is ≥ 18 years of age at the time of enrollment?  
Yes 
No 
 
Patient diagnosed with asthma?  
Yes 
No 
 
Patient has access to smartphone with internet access with the following requirements: iOS 
(Operating System iOS 13 or newer and Devices iPhone 8 or newer) or Android (Operating 
System 8.0 or newer)? 
Yes 
No 
 
Patient is able to understand and speak English sufficiently to be able to use the AMAZE™ 
patient app? 
Yes 
No 
 
Patient provided consent to participate?  
Yes 
No 
 
Does the patient have a cognitive impairment, hearing difficulty, visual impairment, acute 
psychopathology, medical condition, or insufficient knowledge of the English language that, in 
the opinion of the investigator or interviewer, would interfere with his or her ability to provide 
electronic consent and/or participate/complete the questionnaire? 
Yes 

Study Protocol 
Study Code D2287R00166 [EVA-28838] 
Version 7.4 
Date August 10, 2021 
Study Protocol Form 
Version 7.4 
Form Doc ID: AZDoc0059948 
Parent Doc ID: SOP LDMS_001_0016432888 
 
No  
(If yes - patient CANNOT be enrolled into the study) 
 
Investigator/Coordinator Full Name 
Dawei Jiang 
Remona Kanyat 
Dalton Lancaster 
Peter Moschovis 
Jehan Alladina 
Investigator/Coordinator Signature: _____________________________________   
Date: _____________________ 
 
Did the patient download the AMAZE DMP App? _____ yes, _____ no 
IF YES, please record the BrightInsight ID Number: _________________ (Add a comment if BI 
ID has not been provided yet.) 
 
Patient Characteristics 
 
 
  Sex:   Male    Female 
Age (years): ___ 
Height:  _____ ft ___ in; Weight: ____ lb  
ASTHMA DIAGNOSIS 
Age when first diagnosed with asthma: _____(Years (if unknown, please mark the box below))  
 Unknown  
Duration patient seen by a health care provider for asthma: __ years __months 
Duration patient seen by a healthcare provider at MGH for asthma: __years __months 
Smoking status (tobacco products, electronic cigarettes, vaping, marijuana) 
Smoking Status  Never smoked  Previously Smoker  Current Smoker 
Previously smoked  Cigarettes   Vaping   Marijuana 
Number of years smoked __________________ 
Average cigarette packs/vaping or marijuana times per day: __________________ 
Choose an option to Record “Time Since Last Smoke”  Weeks  Months  Years 
Time since last smoked:  
Weeks _________________ (Weeks)  
Months ________________ (Months)  
Years __________________ (Years) 
 
Currently smoking  Cigarettes   Vaping   Marijuana 

Study Protocol 
Study Code D2287R00166 [EVA-28838] 
Version 7.4 
Date August 10, 2021 
Study Protocol Form 
Version 7.4 
Form Doc ID: AZDoc0059948 
Parent Doc ID: SOP LDMS_001_0016432889 
 
Number of years smoked __________________ (Years) 
Average cigarette packs/vaping or marijuana times per day: __________________ 
Date last smoked: _____________ (Date) 
Time last smoked: _____________ (Time)  
Was spirometry lung function testing performed on this patient in the last 12 months?  
 Yes   No 
Date of the most recent Spirometry test __________________ 
 
FEV1: Liters __________________ (Liters) 
FEV1: % Predicted __________________ (% Predicted) 
FVC: Liters __________________ (Liters) 
FVC: % Predicted __________________ (% Predicted) 
FEV1:FVC: __________________ 
FEV1/FVC: % Predicted __________________ (% Predicted) 
 
Was a test for eosinophil blood count performed on this patient in the last 12 months?   
        Yes     No 
Date of highest Absolute Eosinophil Count Test __________________ 
Absolute Eosinophil Count (Highest) __________________ (Absolute Eosinophil Count) 
How would you rate this patient’s asthma severity? 
 Intermittent 
 Mild persistent 
 Moderate persistent 
 Severe persistent 
At the last visit, do you think patient was: 
 Well controlled (NO hospitalizations and NO ER visit and NO steroid prescriptions in the 
past 12 months) 
 Not well controlled (NO hospitalizations, and 1 ER visit or 1 steroid prescription in the past 
12 months) 
 Very poorly controlled (1+ hospitalization, and/or 2+ ER visits, and/or 2+ steroid 
prescriptions in the past 12 months) 
MAINTENANCE PHARMACOLOGIC THERAPY  
Please only include current medication the patient is currently prescribed and taking. Please check all that apply. 
ICS 
 QVAR HFA/Redihaler (beclomethasone 
dipropionate) 
 Beclovent HFA (beclomethasone 
dipropionate) 
 Vanceril HFA) (beclomethasone dipropionate) 
 Pulmicort Flexhaler/Respules (budesonide) 
 Aerospan (flunisolide) 
 Flunisolide 
 Flovent HFA/Disc (fluticasone propionate) 
LAMA 
 Incruse Ellipta (Umeclidinium) 
 Spiriva Respimat/Handihaler (tiotropium bromide) 
 Tudorza/Aclidinium (aclidinium bromide) 
Triple Therapy (fixed dose combination) 
 Trelegy Ellipta (fluticasone/umeclidinium/vilanterol) 
LTRA 
 Singulair (Montelukast) 
 Accolate (Zafirlukast) 
 Zyflo (Zileuton) 

Study Protocol 
Study Code D2287R00166 [EVA-28838] 
Version 7.4 
Date August 10, 2021 
Study Protocol Form 
Version 7.4 
Form Doc ID: AZDoc0059948 
Parent Doc ID: SOP LDMS_001_0016432890 
 
MAINTENANCE PHARMACOLOGIC THERAPY  
Please only include current medication the patient is currently prescribed and taking. Please check all that apply. 
 Azmanex Twisthaler/HFA (mometasone 
furoate) 
 Arnuity Ellipta (fluticasone furoate inhalation 
powder)) 
 Triamcinolbone Acetonide 
 Alvesco  
ICS/LABA 
 Advair Diskus/HFA (fluticasone propionate and 
salmeterol) 
 Wixela Inhub (fluticasone propionate and 
salmeterol) 
 Airduo Respiclick (fluticasone propionate and 
salmeterol) 
 Breo Ellipta (fluticasone furoate and vilanterol) 
 Dulera HFA (mometasone furoate and 
formoterol fumarate dihydrate) 
 Symbicort (budesonide/formoterol fumarate 
dihydrate) 
 Budesonide/formoterol 
LABA (Single inhaled medicine, not in a fixed 
dose combination with an ICS or ICS/LAMA) 
 
 Serevent (Salmeterol xinafoate) 
 Foradil (formoterol fumarate) 
 Arcapta (Indacaterol) 
 Brovana (arformoterol tartrate) 
 Indacaterol 
 Arformoterol 
 Striverdi (Oldaterol) 
Theophylline Preparations 
 Theo-24 (Theophylline) 
 Elixophylline (Theophylline) 
 Theochron (Theophylline) 
Chronic Add-on Therapy (Macrolides) 
 Zithromax (Azithromycin                 ) 
 Biaxin (Clarithromycin) 
 Erythromycin (Erythrocin) 
Biologics 
 Cinqair (reslizumab) 
 Dupixent (dupilumab) 
 Fasenra (benralizumab) 
 Nucala (mepolizumab) 
 Xolair (omalizumab) 
 
SABA/Rescue Inhaler Use 
 Daily Use (SABA) 
 SABA alone 
 SABA+ICS  
 LABA+ICS 
 Nebulizer 
 SAMA 
Nebulizer – Please Specify 
______________________ 
 Other – Please Specify 
______________________ 
 
Which of the following did you do to the patient’s medication after their LAST visit? (Check all that apply) 
 Step-down of controller medicines  
 No change of controller medicines  
 Step-up of controller medicines  
 Prescribe a course of systemic corticosteroids  

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Study Protocol 
Study Code D2287R00166 [EVA-28838] 
Version 7.4 
Date August 10, 2021 
Study Protocol Form 
Version 7.4 
Form Doc ID: AZDoc0059948 
Parent Doc ID: SOP LDMS_001_0016432892 
 
 White 
 Black or African American  
 Asian  
 Native Hawaiian or other Pacific Islander  
 American Indian or Alaska Native  
 Other (specify): ____________________________________ 
 Prefer not to say 
 
 
What is your current living/domestic situation?  
 Living alone 
 Living with a spouse, partner, family, or friends  
 Other (specify): _____________________________ 
 
How would you describe your employment status? 
 Employed, full-time 
 Employed, part-time 
 Homemaker 
 Student 
 Unemployed 
 Retired 
 Disabled 
 Other (specify): _________________________________________________ 
 
  What is the highest level of education you have completed?  
 Less than high school 
 Secondary/high school 
 Associate degree, technical or trade school 
 College/university degree  
 Postgraduate school  
 Other (specify): _________________________________________________ 
 
  What is your household’s total income from all sources over the past 12 months?  
 Less than $15,000 
 $15,000 to $29,999 
 $30,000 to $44,999 
 $45,000 to $59,999 
 $60,000 to $74,999 
 $75,000 to $99,999 
 $100,000 or more 
 Prefer not to answer 
 
 Age when you were first diagnosed with asthma? _____ (year-old) 

Study Protocol 
Study Code D2287R00166 [EVA-28838] 
Version 7.4 
Date August 10, 2021 
Study Protocol Form 
Version 7.4 
Form Doc ID: AZDoc0059948 
Parent Doc ID: SOP LDMS_001_0016432893 
 
 
 How many years (and months) seen by a health care provider for asthma with asthma  
 _____ (years (and months)) 
 
   How many years (and months) seen by a MGH provider for asthma with asthma  
   _____ (years (and months)) 
 
  Do you currently smoke? 
 Yes, smoker  
 Not currently, but previous smoker  
 No, never smoked  
 
 
  Do you currently vape? 
   Yes, vaper 
   Not currently, but previous vaper 
   No, never vaped 
 
  Do you have any of the following health conditions? (Check all that apply) 
 No other health conditions 
 Allergy diagnosed by blood or skin testing 
 Allergic rhinitis (nasal allergies, “hay fever”) 
 Heart disease (history of heart attack, heart failure or heart valve problems) 
 Anxiety 
 Anaphylaxis (severe allergic reaction to a food, bee sting, allergy shot, medication or other) 
 Arthritis 
 Aspirin sensitivity (aspirin causes hives, swelling or breathing problems) 
 Atopic dermatitis/Eczema 
 Chronic bronchitis 
 Chronic Obstructive Pulmonary Disease (COPD) 
 Chronic sinusitis 
 Depression 
 Diabetes 
 Emphysema 
 GERD (heartburn/reflux) 
 Hypertension (high blood pressure) 
 Nasal Polyps 
 Sleep Apnea 

Study Protocol 
Study Code D2287R00166 [EVA-28838] 
Version 7.4 
Date August 10, 2021 
Study Protocol Form 
Version 7.4 
Form Doc ID: AZDoc0059948 
Parent Doc ID: SOP LDMS_001_0016432894 
 
 Stroke 
 Other (specify): ________________________________________________________ 
 Don’t know 
 
Do you currently have health insurance? 
 Yes  
 No  
 Prefer not to answer  
 
[Programmer note: If answered “yes”] What type of health insurance coverage do you have? 
(Check all that apply) 
 Third-party payer (for example, United Healthcare, Blue Cross/Blue Shield, Aetna. )  
 Managed care organization 
 Tricare (military health insurance) 
 Medicare 
 Medicaid (MassHealth) 
 Self-pay 
 Unsure 
 Other (please specify): ___________________________ 
 
 
 

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Study Protocol 
Study Code D2287R00166 [EVA-28838] 
Version 7.4 
Date August 10, 2021 
Study Protocol Form 
Version 7.4 
Form Doc ID: AZDoc0059948 
Parent Doc ID: SOP LDMS_001_0016432896 
 
need for my asthma during 
my most recent visit 
6) I was included in making 
decisions about my asthma 
treatment during my most 
recent visit 
□ Not 
applicable 
 
 
 
 
 
7) The AMAZE™ App 
helped the appointment with 
my doctor go more smoothly.  
□ Not 
applicable 
 
 
 
 
 
8) The time spent with my 
healthcare provider(s) 
discussing my asthma during 
my most recent visit was 
better compared to my last 
visit.  
□ Not 
applicable 
 
 
 
 
 
9) I found it was easier to 
schedule an appointment with 
my doctor using the 
AMAZE™ App 
□ Not 
applicable 
 
 
 
 
 
10) The visit helped avoid an 
ER or Urgent Care center 
visit or hospitalization 
□ Not 
applicable 
 
 
 
 
 
 
 
 

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CCI

Study Protocol 
Study Code D2287R00166 [EVA-28838] 
Version 7.4 
Date August 10, 2021 
Study Protocol Form 
Version 7.4 
Form Doc ID: AZDoc0059948 
Parent Doc ID: SOP LDMS_001_0016432898 
 
 
On average, what percentage of your patients would you classify as: 
___ % Well-controlled 
___ % Not well-controlled 
___ % Very poorly controlled 
= 100% 
 
 
On average, what percentage of your asthma patients do you feel are at (1) low, (2) medium, 
and (3) high risk for adverse outcomes from their asthma? Please fill out below. 
 
___ % Low risk  
___ % Medium risk  
___ % High risk  
= 100% 
 
Did AMAZE™ help you identify patients who were at risk for adverse health outcome (e.g., 
hospitalizations, exacerbations, medication side effects) from their asthma that you would 
have otherwise missed? 
 Yes 
 No 
 
What did you find most useful about the AMAZE™ platform? Check all that apply 
 Ability to track symptoms 
 Ability to asthma triggers 
 Ability to track reliever medication use 
 Ability track ER visits/ hospitalizations 
 Ability to track air flow measurements 
 Patient-HCP messaging feature  
 
 Ability to assign another healthcare provider to a patient 
 
 Integration of AMAZETM platform with electronic health records 
 Ability to track level of impairment through ACT™ scores 
 Ability to receive alerts (flags) based on patient responses in the app 
 Other: ____________________ 
 
What did you find least useful or cumbersome about AMAZE™ platform? Check all that 
apply 
 Ability to track symptoms 

Study Protocol 
Study Code D2287R00166 [EVA-28838] 
Version 7.4 
Date August 10, 2021 
Study Protocol Form 
Version 7.4 
Form Doc ID: AZDoc0059948 
Parent Doc ID: SOP LDMS_001_0016432899 
 
 Ability to asthma triggers 
 Ability to track reliever medication use 
 Ability track ER visits/ hospitalizations 
 Ability to track air flow measurements 
 Patient-HCP messaging feature  
 
 Ability to assign another healthcare provider to a patient 
 Integration of AMAZETM platform with electronic health records 
 Ability to track level of impairment through ACT™ scores 
 Ability to receive alerts (flags) based on patient responses in the app 
 Other  (Please Specify): ____________________ 
 
 
How frequently would you want to track the following for appropriate management of 
patients?  
Symptoms                          
 Daily  Weekly  Monthly  Other__________ 
Asthma triggers                 
 Daily  Weekly  Monthly  Other__________ 
Rescue medication use      
 Daily  Weekly  Monthly  Other__________ 
Maintenance medication use     
 Daily  Weekly  Monthly  Other__________ 
Steroid medication use       
 Daily  Weekly  Monthly  Other__________ 
ER / Urgent Care visits        
 Daily  Weekly  Monthly  Other__________ 
Peak flow / FEV1                  
 Daily  Weekly  Monthly  Other__________  
 
Did AMAZE™ improve any of the following: Check all that apply 
 Increased recognition of patients whose asthma placed their health at risk  
 Increased recognition of conditions/risks, comorbidities driving poor asthma control 
 Improved recognition of patient goals 
 Improved patient engagement with their treatment, risk, or control 
 Improved patient adherence with their treatment 
 Improved efficiency of patient visit 
 Increased educational efforts 
 
While using AMAZE™ disease management platform (DMP), how often did you change 
treatment? 
 No different than before using the AMAZETM 
 More often than before  
Was the treatment change more often a:  
 
 Step down (for example: lower dose/fewer drugs) 
 
 Step up (for example: higher dose/additional drugs) 
 
 Same level (for example: similar class/level of treatment) 
 Less often than before 
 

Study Protocol 
Study Code D2287R00166 [EVA-28838] 
Version 7.4 
Date August 10, 2021 
Study Protocol Form 
Version 7.4 
Form Doc ID: AZDoc0059948 
Parent Doc ID: SOP LDMS_001_00164328100 
 
What features of AMAZE™ do you think could be improved? 
______________________________________________ 
______________________________________________ 
______________________________________________ 
 
 
What barriers did you encounter in implementing AMAZE™ into your clinical practice? 
______________________________________________ 
______________________________________________ 
______________________________________________ 
 
Do you have any other comments or suggestion? 
______________________________________________ 
______________________________________________ 
______________________________________________ 
 
 
 

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Study Protocol 
Study Code D2287R00166 [EVA-28838] 
Version 7.4 
Date August 10, 2021 
Study Protocol Form 
Version 7.4 
Form Doc ID: AZDoc0059948 
Parent Doc ID: SOP LDMS_001_00164328102 
 
 

Study Protocol 
Study Code D2287R00166 [EVA-28838] 
Version 7.4 
Date August 10, 2021 
Study Protocol Form 
Version 7.4 
Form Doc ID: AZDoc0059948 
Parent Doc ID: SOP LDMS_001_00164328103 
 
 
 
 

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Study Protocol 
Study Code D2287R00166 [EVA-28838] 
Version 7.4 
Date August 10, 2021 
Study Protocol Form 
Version 7.4 
Form Doc ID: AZDoc0059948 
Parent Doc ID: SOP LDMS_001_00164328105 
 
                        New Medication/ Continued, Same Dose/ Continued, Increased Dose/ Continued, Decrease Dose/ Discontinued/ Not Applicable 
 
ICS - Aerospan (flunisolide) 
ICS - Alvesco (ciclesonide) 
ICS - Arnuity Ellipta (fluticasone 
furoate inhalation powder) 
ICS - Asmanex Twisthaler/HFA 
(mometasone furoate) 
ICS - Beclovent HFA 
(beclomethasone dipropionate) 
ICS - Flovent HFA/Disc 
(fluticasone propionate) 
ICS - Flunisolide 
ICS - Pulmicort 
Flexhaler/Respules (budesonide) 
ICS - QVAR HFA/Redihaler 
(beclomethasone dipropionate) 
ICS - Triamcinolone Acetonide 
ICS - Vanceril HFA 
(beclomethasone dipropionate) 
ICS/LABA - Advair Diskus/HFA 
(fluticasone propionate and 
salmeterol) 
ICS/LABA - Airduo Respiclick 
(fluticasone propionate and 
salmeterol) 
ICS/LABA - Breo Ellipta 
(fluticasone furoate and 
vilanterol) 
ICS/LABA - 
IBCuSd/eLAsoBnAi d-e D/fuolremrao tHeFrAol 
(mometasone furoate and 
formoterol fumarate dihydrate) 
ICS/LABA - Symbicort 
(budesonide/formoterol 
fumarate dihydrate) 
ICS/LABA - Wixela Inhub 
(fluticasone propionate and 
salmeterol) 
LABA - Arcapta (Indacaterol) 
LABA - Arformoterol 
LABA - Brovana (arformoterol 
tartrate) 
LABA - Foradil (formoterol 
fumarate) 
LABA - Indacaterol 
LABA - Serevent (Salmeterol 
xinafoate) 
LABA - Striverdi (Oldaterol) 

Study Protocol 
Study Code D2287R00166 [EVA-28838] 
Version 7.4 
Date August 10, 2021 
Study Protocol Form 
Version 7.4 
Form Doc ID: AZDoc0059948 
Parent Doc ID: SOP LDMS_001_00164328106 
 
LAMA - Incruse Ellipta 
(Umeclidinium) 
LAMA - Spiriva 
Respimat/Handihaler (tiotropium 
bromide) 
LAMA - Tudorza/Aclidinium 
(aclidinium bromide) 
Triple Therapy (fixed dose 
combination) - Trelegy Ellipta 
(fluticasone furoate, 
umeclidinium, vilanterol) 
LTRA - Accolate (Zafirlukast) 
LTRA - Singulair (montelukast 
sodium) 
LTRA - Zyflo (zileuton) 
Theophylline Preparations - 
Elixophylline (Theophylline) 
Theophylline Preparations - 
Theo-24 (Theophylline) 
Theophylline Preparations - 
Theochron (Theophylline) 
Chronic Add-on Therapy 
(Macrolides) - Zithromax 
(Azithromycin) 
Chronic Add-on Therapy 
(Macrolides) - Biaxin 
(Clarithromycin) 
Chronic Add-on Therapy 
(Macrolides) - Erythromycin 
(Erythrocin) 
Biologics - Cinqair (reslizumab) 
Biologics - Dupixent (dupilumab) 
Biologics - Fasenra 
(benralizumab) 
Biologics - Nucala 
(Bmioelopgoilcizsu -m Xaobla)ir (omalizumab) 
Rescue Inhaler Use - Daily Use 
(SABA) 
Rescue Inhaler Use - SABA alone 
Rescue Inhaler Use - SABA+ICS 
Rescue Inhaler Use - LABA+ICS 
Rescue Inhaler Use - Nebulizer 
Rescue Inhaler Use - SAMA 
Other - Please specify 
Name of Nebulizer 

Study Protocol 
Study Code D2287R00166 [EVA-28838] 
Version 7.4 
Date August 10, 2021 
Study Protocol Form 
Version 7.4 
Form Doc ID: AZDoc0059948 
Parent Doc ID: SOP LDMS_001_00164328107 
 
ASTHMA EXACERBATION HISTORY 
An asthma exacerbation is defined by a change in asthma control requiring a course of oral 
steroids (i.e., at least 3 days with at least 10 days between each burst) and/or steroid injection 
and/or a hospitalization or emergency department visit for an asthma exacerbation. 
Importantly, record only the highest utilization for each exacerbation, do not double 
count exacerbation episodes. If an OCS course was due to a hospitalization, do not record 
as OCS course but as the hospitalization 
 
4. Number of times since enrollment asthma symptoms required an emergency 
department or urgent care visit (but not an overnight stay in the hospital): 
 _____ ER/urgent care visits (with no overnight hospital stay) 
 
5. Number of times since enrollment that there was a worsening in asthma symptoms that 
required a hospital stay for greater than 24 hours: ______ times admitted to hospital  
 
6. Number of unplanned ambulatory clinic visits due to exacerbation in since enrollment: 
_____ unplanned visits  
 
7. How many courses of oral corticosteroids (OCS) was the patient prescribed over the 
since enrollment for asthma exacerbations unrelated to emergency department, urgent 
care or, unplanned ambulatory clinic visits or hospitalizations? _______ 
 
 
Investigator Final Confirmation 
 
Investigator/Coordinator Full Name  
 
Dawei Jiang 
Remona Kanyat 
Dalton Lancaster 
Peter Moschovis 
Jehan Alladina 
 
Investigator/Coordinator Signature: _____________________________________ 
 
Date:  ____________________ 
 
 

Study Protocol 
Study Code D2287R00166 [EVA-28838] 
Version 7.4 
Date August 10, 2021 
Study Protocol Form 
Version 7.4 
Form Doc ID: AZDoc0059948 
Parent Doc ID: SOP LDMS_001_00164328108 
 
20. 
APPENDIX L. MGH WORKFLOW FOR IMPLEMENTATION OF 
DMP IN CLINICAL PRACTICE  
 
 
Screening: 
~33 young adults (18–35 yr) and up to 17 adults (>=36 yr).  
Inclusion Criteria:  
-  >=18 yr with Dx of asthma (with or 
without COPD).  
-  Own smartphone with compatible OS.  
-  Able to sufficiently use the AMAZE™ 
patient App.  
-  Consenting to participate in the study 
procedures.   
Exclusion Criteria:  
- No current diagnosis of asthma. 
-  Cognitive impairment, hearing 
difficulty, insufficient knowledge of 
English, or any medical condition 
interfering with study participation. 
Enrollment: 
-  eConsent via REDCap. 
-  Download AMAZE™ App, set up account, provided with a unique identifier.  
Baseline Visit: 
-  Patient to complete sociodemographic form.  
-  Staff will complete a clinical CRF in REDCap. 
Patient to complete:  
- Daily log 
- ACT™ (every four weeks) 
- Patient User Experience Survey (months 1, 3, and 6 via email)  
- Patient Visit Experience Survey (after each in-person or telehealth clinic visit )  
- System Usability Scale (months 1 and 6) 
- Patient Satisfaction Questionnaire-18   
- 12 patients for longitudinal interviews at months 1, 3, and 6; 
- 5 patients for one cross-sectional interview at months 2, 4, or 5.  

Study Protocol 
Study Code D2287R00166 [EVA-28838] 
Version 7.4 
Date August 10, 2021 
Study Protocol Form 
Version 7.4 
Form Doc ID: AZDoc0059948 
Parent Doc ID: SOP LDMS_001_00164328109 
 
 
 
MGH staff to complete:  
- Clinical Case Report Form (initial visit) 
- Chart Review Case Report Form (month 6)  
- System Usability Scale (months 1 and 6) 
- Follow-up Process Interviews (n=4, months 1, 3, and 6) 
- Post-study Survey    
Study monitoring:  
- Nurse to monitor the patient 
dashboard twice a day 
- Physician to review the 
dashboard during every clinical 
visit 
Outcomes:  
Primary Outcome: Feasibility, usability, perceived value, and potential benefits of the AMAZE™ 
implemented in clinical practice.  
 
Process Outcomes: Evaluating the impact of AMAZE™ on clinical practice, including duration of 
patient visits and services, as well as responses to survey items on changes to timing of 
scheduling visits, communication during the visit, and satisfaction with medical care received. 
Exploratory Clinical Outcomes: evaluate how AMAZE
TM impacts key clinical outcomes including 
exacerbations, HCRU, change in therapy, and exposure to COVID-19 

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Study Protocol 
Study Code D2287R00166 [EVA-28838] 
Version 7.4 
Date August 10, 2021 
Study Protocol Form 
Version 7.4 
Form Doc ID: AZDoc0059948 
Parent Doc ID: SOP LDMS_001_00164328113 
 
  
How likely are you to recommend the AMAZETM App to another patient at MGH who has 
asthma? 
Very Unlikely 
Unlikely 
Undecided  
Likely 
Very Likely 
 
Please share any additional feedback you have about the app (suggested topics below): 
• What you like vs do not like about the app 
• What works well vs what does not  
• Any issues / bugs you have found in the app 
• Anything else you think we should know about the app 
 
 
 
 

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Study Protocol 
Study Code D2287R00166 [EVA-28838] 
Version 7.4 
Date August 10, 2021 
Study Protocol Form 
Version 7.4 
Form Doc ID: AZDoc0059948 
Parent Doc ID: SOP LDMS_001_00164328116 
 
24. 
APPENDIX O. FOLLOW-UP SEMI-STRUCTURED INTERVIEW 
GUIDES 
Longitudinal Follow-up Interview Guide [For months One, Three, and Six] 
Hello, my name is [interviewer name] and I am working with [MGH] and AstraZeneca to see how well the 
new asthma app is working for you. You previously consented to participate in this study regarding the 
asthma app and you have been randomly selected to participate in up to three interviews periodically 
through the duration of the study (roughly 1, 3, and 6 months after you enrolled in the study). During each 
interview, we will ask for your feedback on the [MGH] asthma app that you have been using, including 
ease of use, suggestions for changes.  There are no right or wrong answers; we’d like to hear your personal 
experience with the app.  
I would like to have your permission to audio record this session. The recording will be used to help us 
improve the app and write a report about the things we talked about here today. The audio will be 
transcribed by a third-party vendor, TransPerfect, but any identifying information you say during the 
interview will be removed from the transcript. It will be kept confidential and your name will not be linked 
with your responses. If an adverse event (side effect) for an AstraZeneca product were to come up during 
the course of this interview, I am required to report that. 
Begin Recorder:  This is participant ID [Insert number here] for [month one/three/six] longitudinal follow-
up interview of study EVA-28838.  Do I have your permission to record this session?  I want to confirm 
that you still consent to participate in the interview.  
Thank you for completing the asthma app so far.    
Introduction 
First, we’ll be going over a brief introduction to your experience with medical apps and your smartphone.  
1. How long have you have been using the asthma app?  
2. When you initially started the study, you had an [iPhone or Android]. Just to confirm, do you still have 
that phone?  
3. Do you use any medical health apps beside the asthma app?  
a. [If needed]: If yes, what do you use and what do you use it for?  
Asthma App – App Use and Experience  
Now I’d like to ask you a few questions on your overall thoughts on the app and the notification/reminder 
system.  
1. Overall, what do you think of the app?  
a. In what ways is it easy to use? 
b. In what ways is it hard to use?   

Study Protocol 
Study Code D2287R00166 [EVA-28838] 
Version 7.4 
Date August 10, 2021 
Study Protocol Form 
Version 7.4 
Form Doc ID: AZDoc0059948 
Parent Doc ID: SOP LDMS_001_00164328117 
 
2. [For month 1 interview only]: What did you think about the app when you were first contacted by 
[MGH]?  
a. Walk me through the process of finding, downloading, and using the app.  
b. Was there anything confusing or difficult for downloading the app and gaining access to the 
features?  
3. Is there anything confusing about using the asthma app? 
a. [If yes]: What is confusing? 
4. Do you have any trouble accessing any of the features in the app? 
a. [If yes]: Tell me more about that.  What trouble do you have? 
5. What notifications or reminders, if any, do you receive from the asthma app?  
a. Do you find the reminders helpful?  
i. Do you recall what time of day you set the reminders for? Why did you choose that time? 
ii. [Probe as needed]: Do you recall what you received a reminder for (i.e., medications, daily 
log, air quality alerts)?  
b. [If no]: Did you turn your notifications off? Would daily reminders have been helpful?  
6. How often did you use the app? What time of day did you use it?  
a. [If less than once a day]: Why did you use it less than once a day? Is there anything missing that 
would have made you more likely to use the app every day?  
7. How, if at all, did you report issues/problems that you found in the app? (Note to interviewer: there is 
an option for participants to report bugs/issues in the app.)  
Features of the App  
1. What features of the Asthma App (i.e., daily log, trends, messaging) do you use? 
Now I’d like to go through each of the features with you. Feel free to open your app while we go through 
the sections. [Interviewer to wait for participant to open app if needed.]  
a. Interviewer for each of the features go through the following probes:  
i. Do you use this feature in the app? If yes, how often do you use the app? If no, why do you not 
use this feature?  
ii. How helpful is the feature? Would you continue to use this feature to help monitor your 
asthma?  
iii. Is there anything confusing or unclear about this feature? What ideas do you have to make the 
feature better? 
iv. [For daily log only]: Have you ever had to change any of your answers for the daily log? If so, 
did you have any problems making changes?  
v. [For daily log only]: What did you think about the amount of time it took you to complete the 
daily log? Was it too long, too short, or enough time?  

Study Protocol 
Study Code D2287R00166 [EVA-28838] 
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Date August 10, 2021 
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Parent Doc ID: SOP LDMS_001_00164328118 
 
Feature 
Use 
Helpfulness  
Suggestions  
Daily Log 
 
 
 
Air Quality 
 
 
 
Appointments 
 
 
 
ACT  
 
 
 
Education  
 
 
 
My Plan  
 
 
 
Trends 
 
 
 
Messaging 
 
 
 
Notifications 
 
 
 
Text and Image Size  
4. Did you have any problems with the font size on any of the screens? 
a. Would you change anything about the way the text or images appear on any of the screens? 
Using the App to Communicate with Doctor or During Visits  
Now I’d like to discuss how you used the app to communicate with your doctor via the messaging feature 
or during a doctor’s visit.  
[Note to interviewer: the previous section probes on the messaging feature so use these probes if not fully 
addressed to this point.]  
1. How do you typically communicate with your doctor outside of appointments? 
2. Did you use the messaging feature to send communication to your doctor?  
a. If yes, what things did you discuss while messaging your doctor?  
i. Would you continue to use the messaging feature in the future? Why or why not?  
ii. How often did you send messages to your doctor through the app?  
iii. Which subject line did you typically use and why? [Note to interviewer: if needed explain that 
there is a forced choice for the subject line.] 
b. If no, why did you not use the messaging feature?  

Study Protocol 
Study Code D2287R00166 [EVA-28838] 
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Date August 10, 2021 
Study Protocol Form 
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Parent Doc ID: SOP LDMS_001_00164328119 
 
3. We noticed you had a doctor’s visit on [insert date]. Did you and your doctor discuss anything 
regarding the app during the visit?  
a. If yes, what was discussed? Did you open the app during your visit and show any specific log or 
trends?  
i. How did the app change the communication with your doctor during the visit compared to 
previous visits?  
b. If no, do you think discussing the app or any feature of the app would have been helpful during 
your visit?  
Long-Term Use  
1. Would you consider using this app as a part of your long-term asthma care? Why or why not?  
a. If no, what would improve your experience with completing this app every day?   
2. What do you hope to gain from the app? What do you think your doctor will gain from you using the 
app?  
3. Do you feel like using the app has helped you avoid ER or hospital visits? Why or why not?  
4. Are you likely to recommend this app to a person living with asthma? Why or why not?  
5. What other feedback would you like to give us on this app today? 
 
Thank you!  We are all done with the interview. Interviewer should confirm the participant still 
has a ClinCard and let them know the $[insert payment] will be uploaded within 24 hours of the 
interview. 
 
Cross-Sectional Patient Discussion Guide:  AMAZE™ Asthma App 
● Purpose. Hi, my name is [________] and I’m a researcher with AstraZeneca, a 
pharmaceutical company. We wanted to speak with you today to get your feedback on the 
AMAZE™ asthma app that you have been using.  We want to know what you think of the 
app so we can continue making this app better for people like you.  
● Anonymity / Confidentiality.  The research is all confidential and anonymous and none 
of your data will be directly paired to you.  To keep things confidential, please never say 
your full name or any other identifiable information like your phone number or address, 
etc.  We’ll stick to first names only. 
● Honest Feedback. Feel free to provide your honest feedback about the app today.  Don’t 
be afraid to share negative feedback, if you have any.  I didn’t personally create this so it 
won’t hurt my feelings.   
● Adverse Events. I’m not here to sell or market you any drug, but, if you should mention 
you had an adverse reaction come up on an AstraZeneca drug, I am required for 

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compliance reasons to report any details of that event you experienced.   
● Questions.  Do you have any questions for me before we get started?  
 
Patient Intro 
1. Tell me a little about yourself – what keeps you busy? 
2. How long have you been living with asthma? 
a. How would you characterize it: mild, moderate, severe? 
3. What are some of the biggest challenges you face living with asthma? 
 
Phone Type + Health Apps 
1. What type of phone do you have? I.e., Apple, Android?  
2. How do you typically use your phone?  What apps do you use the most?  
3. Besides the asthma app, what kind of health apps/tools do you use or have you used in the 
past?  
a. Examples:  Think AppleHealth, Fit Bit, Clinician portal, Headspace, etc.  
4. Do you use MyChart?  If so, how?  
 
Experience with AMAZE™ 
App Introduction   
1. How did you first learn about the asthma app? 
a. What was your reaction when you heard about it?  
b. Why do you think your clinician(s) wanted you to use the asthma app?  
c. What made you decide to join the asthma study?  
Onboarding  
2. Can you walk me through the process of finding and getting started with the app? 
a. Who, if anyone, helped you get started with the app?  i.e., caregiver, staff, doctor 
b. How easy / difficult was it for you to find the app?  How did you find it?  
c. How easy / difficult was it for you to create an account?  
d. What issues, if any, did you encounter with getting started with the app? 
i. I.e., finding it, downloading it, creating an account, etc. 
3. Is there anything that could have been done differently to make onboarding to the app 
easier for you?  
Overall 
1. How have you been using the app?  How often?  
2. Have you encountered any issues / problems with the app?  

Study Protocol 
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a. How did you resolve the issue, if at all?  
3. Overall, what do you think of the asthma app? 
a. What parts are most / least useful?   
4. Did it remind you of any other apps you’ve used before? 
Specific Features 
[Explore use and satisfaction of the following app features] 
Questions for below:  
 
 -Did you use [feature]? 
 
 -How useful/helpful or not is [feature]?  
 
 -Any issues / problems with [feature]?  
 
 -What could be done to make this [feature] better?  
Feature Set  
Daily Log  
Air Quality  
Appointments  
Asthma Control Test (ACT 
Education  
My Plan  
Trends  
Messaging  
Notifications  
 
[Additional questions to probe on when exploring a given feature]  

Study Protocol 
Study Code D2287R00166 [EVA-28838] 
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Date August 10, 2021 
Study Protocol Form 
Version 7.4 
Form Doc ID: AZDoc0059948 
Parent Doc ID: SOP LDMS_001_00164328122 
 
1. Daily log 
a. How often do you typically fill out your log?  
i. What was your longest log streak?  
b. What time of day do you generally fill out the log?  Why that time?  
c. Are there any questions in the daily log that are confusing?  That do not apply to 
you? 
i. Do you own a peak flow meter?  Ability to record FEV1?  
d. Were the symptoms you were experiencing always reflected in the list of symptom 
options?  
i. What about triggers?  
e. To what extent did the medication question make sense?  Is ‘Quick-relief / as-
needed’ a familiar term?  
f. How helpful was the review screen? 
g. How often did you go back and add a log for days that you missed?  
h. How often did you go back in and edit logs?  
i. How, if at all, do you know that a clinician is looking at your log data? 
j. Do you have any thoughts on how we can make filling out the log easier for you? 
2. Air Quality 
a. How important is air quality to track for you?   
b. Is this something you tracked prior to the app? 
c. How else did you use this feature i.e., did you use it to track allergens like pollen, 
ragweed, etc.?  
i. If yes, how helpful?  If no, why not?  
3. Appointments 
a. How accurate was the information reflected in the appointments card?  Anything 
unusual?   
b. How many appointment reminders did you receive?  
c. Did you use the link to schedule additional appointments?  Why/why not? 
4. Asthma Control Test (ACT)  
a. How was this different from the daily log for you? 
b. How easy / difficult were the questions?  
c. Have you ever taken this questionnaire before?  
d. Why do you think your clinicians wanted you to answer these questions?  
5. Education 
a. Which articles did you explore if any?  
i. Asthma EDU?  Depression EDU?  
b. What education is missing that would be important to have?  
c. What type of media format do you prefer:  video, articles, podcasts, etc.?  
6. My Plan 
a. How helpful was it to have your list of medications available?  How did you use it?  
i. How accurate was the list of medications?  How accurate were the images 
of your medications?  
ii. Was there anything confusing about the list?  
b. Did you use the medication reminder feature?  If so, how helpful was that?  
7. Trends 

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Date August 10, 2021 
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Parent Doc ID: SOP LDMS_001_00164328123 
 
a. How did you use Trends?   
i. To what extent did you use Trends in your appointment(s) with your 
doctor?  
ii. Which view (daily, weekly) did you use the most? 
b. What do you think is the purpose of Trends?  
c. To what extent is this the type of information you are interested in seeing?  
d. How easy/difficult were the graphs to understand and interpret?   
e. Did you use the ‘share with caregiver’ feature?  If so, who did you share with and 
why?  
8. Messaging 
a. What types of messages did you send to your clinician? 
i. Which subject line did you most commonly select?  
b. What was the response time like? 
c. How would you normally get in touch with your clinician before you had this app?  
9. Notifications 
a. What types of notifications did you receive from the app? 
b. How helpful were those notifications?  
c. Did you turn on/off any notifications? What did you think of the frequency? 
 
Bugs / Reporting  
1. Have you encountered any bugs in the app? 
a. [if yes] were you able to report the bug? 
2. Did you have to contact the support team at all?   
a. If so, how helpful were they?   
b. Were they able to resolve the issue you had?  
 
Appointments with Doctor 
1. Have you had any appointments with your doctor since you started using the app? 
a. If yes, how if at all was that appointment different than what you’re used to? 
b. How if at all did they talk about the data that you put in the app?   
c. At any point during the appointment, did you pull up your app to show them 
anything you had recorded?  
 
Value 
1. What have you gained, if anything, from using this app? 
2. If you had a magic wand, what would you change about this app? 
3. On a scale of 1 to 5 (1=not at all; 5=extremely), how likely would you be to recommend 
this app to someone else living with asthma?  
a. Why a [#]? 
b. [if less than 5] What would bring your score closer to a 5? 
What else do you think the team should know about the app that we haven’t already discussed 
here today? 
 
 

Study Protocol 
Study Code D2287R00166 [EVA-28838] 
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Date August 10, 2021 
Study Protocol Form 
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Form Doc ID: AZDoc0059948 
Parent Doc ID: SOP LDMS_001_00164328124 
 
25. 
APPENDIX P. RECRUITMENT TRACKING LOG 
RECRUITMENT TRACKING LOG (EVA-28838): SITE [XXX] 
Please send the Recruitment Tracking Log to Evidera via SharePoint 
Participant 
ID 
BI Linked ID 
Patient 
Age 
Patient 
Sex 
Recruitment Quotas 
Phone Type (Operation 
System) 
Outcome 
Reason for 
Ineligible 
 
 
 
 Male 
❑ Female 
❑ New in practice (< 3 
months) but uncontrolled  
❑ ≥ one exacerbation in 
past 12 months 
❑ Young adult 
❑ Adult 
❑ iOS (iOS 13 and iPhone 8 
or newer) 
❑ Android (OS 8.0 or newer) 
❑ Other 
 
 Eligible 
❑ Ineligible 
❑ Declined 
 
 
 
 
❑ Male 
❑ Female 
❑ New in practice (< 3 
months) but uncontrolled  
❑ ≥ one exacerbation in 
past 12 months 
❑ Young adult 
❑ Adult  
❑ iOS (iOS 13 and iPhone 8 
or newer) 
❑ Android (OS 8.0 or newer) 
❑ Other 
 
❑ Eligible 
❑ Ineligible 
❑ Declined 
 
 
 
 
❑ Male 
❑ Female 
❑ New in practice (< 3 
months) but uncontrolled  
❑ ≥ one exacerbation in 
past 12 months 
❑ Young adult 
❑ Adult  
❑ iOS (iOS 13 and iPhone 8 
or newer) 
❑ Android (OS 8.0 or newer) 
❑ Other 
 
❑ Eligible 
❑ Ineligible 
❑ Declined 
 
 
 
 
❑ Male 
❑ Female 
❑ New in practice (< 3 
months) but uncontrolled  
❑ ≥ one exacerbation in 
past 12 months 
❑ iOS (iOS 13 and iPhone 8 
or newer) 
❑ Android (OS 8.0 or newer) 
❑ Other 
❑ Eligible 
❑ Ineligible 
❑ Declined 
 

Study Protocol 
Study Code D2287R00166 [EVA-28838] 
Version 7.4 
Date August 10, 2021 
Study Protocol Form 
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Form Doc ID: AZDoc0059948 
Parent Doc ID: SOP LDMS_001_00164328125 
 
❑ Young adult 
❑ Adult  
 
 

Study Protocol 
Study Code D2287R00166 [EVA-28838] 
Version 7.4 
Date August 10, 2021 
Study Protocol Form 
Version 7.4 
Form Doc ID: AZDoc0059948 
Parent Doc ID: SOP LDMS_001_00164328126 
 
26. 
SIGNATURES  
ASTRAZENECA SIGNATURE(S) 
AMAZE Asthma Implementation clinical pilot Study - MGH 
This Interventional Study Protocol has been subjected to an internal AstraZeneca review.  
I agree to the terms of this Study protocol. 
AstraZeneca representative 
<<Name, title>> 
<<Email address and telephone number>> 
Date 
(Day Month Year) 
AstraZeneca representative 
<<Name, title>> 
<<Email address and telephone number>> 
Date 
(Day Month Year) 
This document contains confidential information, which should not be copied, referred to, 
released or published without written approval from AstraZeneca. Investigators are 
cautioned that the information in this protocol may be subject to change and revision.